Dr Faisal Shuaib, NPHCDA’s Executive Director, inspects the US donation of four million COVID-19 vaccines.

IBADAN – On Sunday 1 August, two planes carrying four million doses of the Moderna vaccine from the US touched down in Abuja, Nigeria’s capital city. 

With the arrival of the new doses, Nigeria will be able to resume its COVID-19 vaccination programme which was suspended on 22 July when the Nigeria Primary Healthcare Development Agency (NPHCDA) announced it had exhausted the four million doses of Covishield (Oxford/AstraZeneca COVID vaccine) the country got via the COVAX facility. 

Even though Nigeria’s delivery was the largest shipment by COVAX at the time, it was a drop in the ocean that did not do much in closing the vaccination gap in Nigeria, which has a population of over 211 million people.

At present, only 1.4 million people are fully vaccinated, which represents 0.68% of the population

“We are excited that this [delivery] presents another opportunity for us to advance the protection of Nigerians against the COVID-19 virus, especially against the Delta variant,” said Dr Faisal Shuaib, NPHCDA’s Executive Director.

The rollout plan is re-started

According to Shuaib, the Moderna vaccines will first be tested by country’s regulatory agency to ascertain they are up to the country’s standard as established by the regulator.

“Random samples of the vaccines have been taken and are being tested. Within 48 hours they will give us feedback on whether we are good to go,” Shuaib told journalists in Abuja.

When the vaccines become certified, NPHCDA said it will then activate its comprehensive logistic deployment plan at sub-national level in partnership with the Coalition Against COVID-19 (CACOVID), a private sector-led organization.

“This is particularly important because we are already experiencing a third wave and there is no need for the vaccine to be at the national level while they are needed by our citizens,” Shuaib said.

Through the CACOVID partnership, vaccines will be distributed and transported to the respective states via the distribution channels that were utilised for the first set of doses received. When these get to their destinations, local health authorities will then redistribute them to centers where the doses will be administered, while still maintaining a cold chain.

Nigerians who want to be vaccinated need to complete an online registration on a dedicated platform operated by the NPHCDA. From the platform, an appointment date for the vaccination exercise is obtained when the individual is expected to visit the health center.

But the reality of the first phase of the vaccination showed appointment dates and locations were not enforced as vaccination officers only required proof of online registration to give vaccine doses to recipients.

After receiving a vaccination, an individual is given a vaccination card that contains the date and details of the administered vaccine. It also contains the expected date for the second dose if the person receives a two-dose vaccine.

Even though there is growing evidence to support mixing vaccine types, the Nigerian government is still reluctant to direct citizens that received Covishield (AstraZeneca) as first dose to get  Moderna as second dose as it argues that additional Covishield vaccine doses will soon be available in the country.

“For those who have taken the first dose of the AstraZeneca vaccine, within the next week or so, an additional consignment of AstraZeneca vaccine will be delivered. We expect that by mid-August, we will get up to 3.9 million doses of AstraZeneca vaccine,” Shuaib said.

In spite of Nigeria’s extensive COVID-19 vaccination rollout plans, there are still concerns about how the country will track the side effects of the vaccines which appear to hinge on patients presenting to government hospitals with symptoms. Experts described this as inadequate but admitted that the unprecedented pressure on the health authorities to quickly roll out vaccines may have limited the available options.

“Don’t forget that nothing as huge as this one has never been done. It’s not too much to ask that when there are scenarios, such are taken to government hospitals where they can be escalated and tracked,” Bimbo Ibukunoluwa, a primary healthcare worker in Ibadan southwest Nigeria, told Health Policy Watch.

A slowly rising third wave?

 

Chikwe Ihekweazu, Director General of the Nigeria Centre for Disease Control

When Dr Chikwe Ihekweazu, Director-General of the Nigeria Centre for Disease Control (NCDC), spoke to Health Policy Watch in late June 2021, the country’s COVID-19 epicurve suggested the pandemic was under control. 

However, the latest epicurve suggested that a third wave is gradually emerging in the country, although this varies from one state to another.

In Lagos, Nigeria’s commercial epicenter, there are indications that a third wave is already underway with recent cases already reaching reported figures for the peak of the first wave. But in Abuja, the number of daily cases remains very low in comparison with the first and second waves.

But the true case load is hard to ascertain as testing remains inadequate. Over a year after the first case was confirmed, Nigeria has only conducted about 2.5 million tests so far.

“At the moment, about 20% to 30% of all the tests we do a week are rapid diagnostic tests. So we do about 40 000 to 50 000 COVID-19 tests every week,” Ihekweazu told Health Policy Watch.

There is also an unequal distribution of testing among Nigeria’s 36 states. According to NCDC’s COVID-19 situation report, while states like Lagos have tested over 626,000 people since the pandemic began, Kogi state which is inhabited by about five million people has only conducted about 6,000 COVID tests as at 25 July.

 But this is not peculiar to Nigeria. Dr John Nkengasong, Director of the Africa CDC, told Health Policy Watch that Africa is still not conducting enough tests. 

“The continent is not testing enough. We would like to see a steady increase over time because the foundation for fighting any infectious disease is good testing. And we have to test at scale all the time and maintain that level of testing,” he said. 

Furthermore, only eight African countries have a system to measure excess mortality and Nigeria is not one of them – so it is hard to see whether the pandemic causing abnormally high deaths.

https://www.worldometers.info/coronavirus/country/nigeria/

Unready for vaccination exercise?

Ihekweazu and Shuaib expressed confidence in Nigeria’s response to COVID and preparedness for the massive rollout of millions of doses of different vaccines requiring different conditions, respectively.

But the country’s health minister Dr Osagie Ehanire said Nigeria’s relatively weak health system is also threatening the country’s COVID response – in addition to vaccine inequity.

“I do not believe that all African countries are prepared, there are countries that require some support,” the minister said.

“We are very worried because of our population, and the similarity with India – with high population density and the fervor for politics and religion, which lead people very often to ignore the public health advisories that we have put in place.” 

He added that Nigeria’s COVID response, including vaccine rollout, will benefit from risk communication and community engagement.

“I don’t think that this can be done in a very short time but there’s absolutely a lot of emphasis and pressure put on governments across Africa, to wake up to the risks,” he said.

Compounding difficulties with the rollout, doctors in Nigerian state hospitals have begun a strike over pay, benefits and poor working conditions. The strike is organised by the National Association of Resident Doctors, which represents about 40% of doctors in the country.

A health worker gets vaccinated with the first donation via COVAX.

Nigeria’s vaccine pipeline 

Nigeria is expecting doses of vaccines from COVAX, the African Union’s COVID-19 Vaccine Acquisition Task Team (AVATT), and donations from various sources including this week’s US donation.

From August, Enahire said Nigeria is expecting over 29 million doses of J&J vaccine through AVATT.

In addition, the country is also expecting over three million doses of Oxford/AstraZeneca vaccine and 3.5 million doses of Pfizer COVID vaccine.

“From the end of July through August, and beyond, we are going to have more doses, and more varieties,” the minister said.

Furthermore, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has also issued authorisation for the AstraZeneca, Johnson & Johnson, Pfizer and Moderna vaccines while Enahire expressed confidence in the country’s ability to meet the storage requirements of the various vaccines, including those that require ultracold chain, and those that require direct refrigeration.

Even though he said there are ongoing collaborations to ensure the doses are quickly distributed and administered, he noted that emphases are being placed on states that are considered as the hotspots of the pandemic in the country.

“We are looking to scale up the vaccination capacity right across the whole country, with a little bit of emphasis on those areas that are already the hotspots,” Enahire said. 

With expanded vaccine access the main goal of Nigeria’s endgame for COVID, Ihekweazu said attention should be on sustaining the gains and securing more doses.

“So the key thing now is to hold on to the fragile successes that we’ve had, [and] continue pushing for more vaccines so that we can get more shots into the arms of our people as quickly as possible,” Ihekweazu told Health Policy Watch.

The Delta variant conundrum

Nigeria is one of the 21 African countries where the Delta variant of the SARS-CoV-2 virus has been reported. Ihekweazu told Health Policy Watch that the variant is becoming worrisome for the country’s public health officials. 

He described quick access to vaccines as a major way through which Nigeria can limit the impact of the pandemic on its people. 

“The good thing is that the variant is still very susceptible to the vaccines. So as we increase our vaccine coverage rates, we will continue to protect ourselves even against the Delta variant,” Ihekweazu said.

With reports of health systems in several African countries becoming overwhelmed and overrun by the Delta variant, Nigerians who were initially reluctant to get vaccinated are now more interested, including a nurse on a psychiatry ward at Nigeria’s first teaching hospital, the University College Hospital in Ibadan.

Initially, Nurse Shade (name changed to protect her identity) refused to be vaccinated because her church pastor, inspired by US-based right wing anti-vaccine messages, preached against the vaccine to his Nigerian congregation.

But with daily reports of deaths due to the Delta variant among the unvaccinated, Shade became afraid and was anxious to quickly receive the jab. However, registration had closed and she would now wait until vaccination resumes.

“Since I heard that one is more likely to die of COVID if one is not vaccinated, I’ve felt very stupid for failing to receive the vaccine when I could easily get it. Now I daily listen to news for updates on when the next round will begin,” she told Health Policy Watch.

Nkengasong also revealed the success of vaccine rollout in many African countries has also shore up confidence for the exercise among the people considering healthcare workers were the first to receive the doses.

“People are seeing that nothing happened to those who received the vaccines against what the misinformation made them to believe. It has been shown that if the vaccines are available, Africans will receive the vaccine,” Nkengasong said.

Image Credits: USAID.

This article is the third in a three-part series on COVID-19 booster vaccines, which is an evolving discussion as more evidence emerges about the performance of vaccines against variants.

Alongside the heated policy debate over the disproportionate consumption of COVID vaccines in rich countries, a handful of senior scientists are pushing back against the scientific rationale of offering booster vaccines to healthy people who are already fully vaccinated.  

They argue that a key metric touted by booster shot proponents – lab-based antibody counts in the blood – is not a watertight proxy for the real-life performance of vaccines. 

Dr Francis Collins, the Director of the US National Institutes of Health (NIH), has recently argued in his blog that immunity against SARS-CoV-2 and variants like Delta could even last “for years”.

At the heart of this scientific debate is the question of whether the “neutralizing antibody” counts in blood are an accurate proxy of immunity against COVID-19. Like warriors, these antibodies latch onto foreign invaders such as the SARS-COV-2 virus and block their entry into human cells, preventing them from wreaking havoc in the body. But they also are not the only factor in the body’s immune response, experts told Health Policy Watch.

The debate continues to rage even as Pfizer/BioNTech prepare to submit a request to the US Food and Drug Administration for approval of a third booster, based primarily on just that kind of neutralizing antibody data. 

Neutralizing antibodies (green) can latch onto viruses like SARS-CoV-2 and prevent them from entering human cells

Lab antibody responses are not a proxy for immunity

But until more robust evidence emerges, antibody responses from the lab can’t yet be used as a simple benchmark to boil down a complex immune response or to estimate the extent to which a person is protected to SARS-CoV-2, Dr Michael Osterholm, Director of the US Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, told Health Policy Watch in an interview.

“You can do all the lab studies you want, but if you can’t demonstrate in humans that antibody responses are the core of their protection against SARS-CoV-2, then the question is what are you measuring?” said Osterholm. “You can have the most amazing immunological response you want, but if that’s not what’s protecting you, what good is it?”

Surprisingly, early-stage clinical trials for mRNA vaccines have revealed that people are well protected against SARS-CoV-2 within three weeks of their first jab, yet their antibody counts are very low at that point, said Osterholm. This indicates that antibodies on their own can’t fully explain or predict immunity to COVID, at least for now, he added.

“During the early mRNA trials [of Pfizer and Moderna vaccines], the antibody response was not at all correlated with very rapid protection from the vaccines, even at three weeks post first dose, where we already saw a trend towards protection,” explained Osterholm.

“I am not totally convinced that there is perfect parallelism between measures of antibodies and immune response,” added Dr Antoine Flahault, Director of Geneva University’s Institute of Global Health. “There is a lot of evidence in the past history of infectious diseases where such parallelism did not exist.”

It is also a well-known fact among immunologists that antibody counts naturally wane over time following a natural infection or vaccination, but upon re-exposure to a pathogen like SARS-CoV-2, the immune system will mount a quicker and more robust response. This includes massive antibody production that will help neutralize the pathogen, researchers told Health Policy Watch.

Robust immunity may last ‘for years to come’

Last month, NIH director Collins asserted that robust immunity against SARS-CoV-2 could persist “for years”, even against rapidly spreading variants.

Collins was citing an NIH-supported study of 14 fully vaccinated individuals, which revealed that the “germinal centres” in lymph nodes – the training camps where an army of diverse immune cells learns to fight off threats like the SARS-CoV-2 virus – were highly active several months after vaccination, including in people infected with Alpha and Beta (the variants first discovered in the UK and South Africa, respectively). 

“Germinal center reactions that persist for several months or longer usually indicate an extremely vigorous immune response that culminates in the production of large numbers of long-lasting immune cells, called memory B cells,” said Collins.

“Some memory B cells can survive for years or even decades, which gives them the capacity to respond multiple times to the same infectious agent….vaccine protection looks really good right now, including for the delta variant that has all of us concerned.”

Israel set to be world’s guinea pig on booster shots 

Meanwhile in Israel, where cases are rising rapidly even though the country’s vaccination coverage is one of the highest in the world, Dr Eyal Leshem stressed that robust clinical data is still lacking about the real-life benefits of boosters in fully vaccinated people.

“We cannot rely on surrogate markers like seroconversion or neutralizing antibodies to provide a general recommendation for a booster dose,” emphasized Leshem, who is at the helm of the Center for Travel Medicine and Tropical Diseases at the Sheba Medical Center in Israel. “This must be proven clinically, it cannot be based on hunch.”

His comments come as Israel prepares to offer a third booster shot to anyone aged 60 and over this week as a precautionary move in light of a sharp increase from about 200 daily cases in early July to almost 3 000 a day by early August. 

Israel is also concerned about data revealing that the efficacy of two-doses of the Pfizer/BioNTech vaccine has dropped from over 90% to around 40% for the prevention of infection.

That data has sparked concerns that people over the age of 60, who tend to have weaker immune systems and more pre-existing conditions than younger people, need stronger protection, even if 90% of them are already fully vaccinated.

Leshem added that boosters would only be warranted if they were shown to substantially improve primary clinical outcomes like severe disease and hospitalization, rather than secondary outcomes like infection and mild disease – or even results from lab-based studies like antibody counts.

Based on his assessment, the data to support boosters in healthy people appears to be lackluster for now – insofar as two shots of Pfizer confer more than 95% protection against severe COVID-19, even against variants like Alpha, Beta, and most recently Delta.

“The bulk of epidemiologic evidence supports real-life effectiveness of vaccines against severe disease and hospitalization,” emphasized Leshem. “Studies by Public Health England suggest 95% effectiveness against hospitalization against Delta.”

Soon, more large-scale clinical data about the benefits of boosters will become available, as Israel starts administering boosters to people over 60 in the next few months.

While Israeli experts acknowledge that they are taking a gamble with boosters – initial results suggest that they are at least not harmful in people who receive them, based on the lack of adverse effects seen among immuno-compromised people who have already received boosters in France and Israel.


The United Kingdom, which has currently seen some of the highest case counts worldwide even though over half of the population is fully vaccinated, may soon follow with boosters in high-risk groups, as well as Germany, Spain, and Italy.

Meanwhile, in the United States, where regulatory authorities are holding back against a booster for now, there are concerns that people will seek a third shot on their own. This is possible given the fragmented nature of the US health care system, which enables people to receive their third jab at a different clinic or pharmacy than the one that they used for their first two – at least in theory.

Such behavior will be challenging to track in the US, as the country lacks a centralized database of who has been vaccinated, when, and with how many doses – unlike Israel, which has a detailed database that can track the vaccination status of virtually every citizen and resident in the country.

Pfizer pushes US for booster shots in general population 

Pfizer/BioNTech, meanwhile, is already pushing the US drug regulatory agency to consider boosters in the general population and developing an updated booster to target the Delta variant, citing “encouraging” lab-based data to support the move.

“Pfizer and BioNTech have seen encouraging data in the ongoing booster trial of a third dose of the current BNT162b2 vaccine,” said a recent statement by Pfizer/BioNTech. “Initial data from the study demonstrate that a booster dose given 6 months after the second dose has a consistent tolerability profile while eliciting high neutralization titers against the wild type and the Beta variant, which are 5 to 10 times higher than after two primary doses,” said Pfizer.

According to booster shot proponents, antibody counts are sometimes directly linked to the level of protection against SARS-CoV-2. For that reason, they have argued that reductions in antibody counts over time are “likely to be important”.

“The levels of circulating antibodies are likely to be an important part of protection so their waning is likely to be important,” Dr Andrew Hayward, Director of the UCL Institute of Epidemiology and Health Care, told Health Policy Watch

“In many infections, we find a direct relationship between levels of circulating antibody and level of protection which is why some public health bodies measure levels of antibodies in the population to inform vaccination booster programmes.

“There is also some data that suggests higher circulating antibody levels are associated with greater protection across variants, which is an important consideration,” said Hayward, who has tracked how antibody counts change over time.

At the same time, scientists from Pfizer, as well as Hayward, have acknowledged that other components of the immune system – like T cells, B cells, or interferon-gamma – need to be further studied to understand the full breadth of the immune response to vaccines (and to SARS-CoV-2 infection).

“Early protection against COVID-19 without robust serum neutralization indicates that neutralizing titers alone do not appear to explain early BNT162b2-mediated protection from COVID-19,” said a recent study supported by Pfizer. This refers to the fact that people already have some degree of protection against SARS-COV-2 several weeks after their first jab, even though their antibody levels are low at that point.

“Other immune mechanisms (e.g., innate immune responses, CD4+ or CD8+ T-cell responses, B-cell memory responses, antibody-dependent cytotoxicity) may contribute to protection,” the study added.

Known to be a cornerstone of immunity, T cells and interferon gamma are known to be vigorously activated following the Pfizer jab, several studies have revealed.

A marriage between data from the bench and the field 

Going forward, researchers need to marry lab-based data with clinical data from the field to shed light on what is often considered to be the holy grail of immunity: the so-called “correlates of immunity”.

Dr Michael Osterholm, Director of the US Center for Infectious Disease Research and Policy (CIDRAP)

Identification of such correlates would allow scientists to be certain that the metrics they use – like neutralizing antibodies – are an accurate benchmark of the immune response to SARS-CoV-2. 

In addition, such correlates would allow researchers to quickly evaluate how well vaccines are working, for who, and for how long – supercharging COVID-19 R&D and allowing more lives to be saved.

“With regard to what we can say right now about the correlates of protection: they’re clearly inadequate,” said Osterholm. “We don’t know the answers to these questions yet. In the natural history of COVID-19, we are still in the early days.”

“If I had a bag of pixie dust, I would cast it upon the world and marry the immunologic data with data from the field. That will be the ultimate proof of the pudding.”

However, such large-scale studies will take time, he warned. 

“What people have to understand is we’re actually building this plane at 30,000 feet. And that’s hard for people to understand because people want the pandemic to be over.”

Third in a series on COVID-19 booster vaccines. See the second article, COVID Vaccine Boosters in Immuno-compromised People – Could They Also Help Curb Development of New Variants ?

Image Credits: International Monetary Fund/Ernesto Benavides, NIH, CIDRAP.

 

Sixteen countries have pledged more than 610 million COVID-19 vaccine doses for 2021-2022 through COVAX, the global vaccine sharing facility, and low and middle income countries have already received 37.7 million donated doses.

The United States under President Joe Biden is leading the pack with a total pledge of 260 million doses, followed by team Europe (France, Germany, Italy, Spain, Portugal, Norway, Belgium, Sweden, and Denmark)  which is donating more than 200 million vaccine doses over the next few months.

Canada (30.7m), Japan (30m), United Kingdom (80m), Switzerland (4m), New Zealand (1.6m), and United Arab Emirates (1m) have also donated vaccines via COVAX.

This and other COVID-related data is now readily available on a new interactive website which serves as a platform for COVID-19 vaccine information.

It provides information per country income classification and has eight categories including vaccine supply, and deliveries, dose donation to COVAX and financing gaps.

Launched on 30 July, the website is a collaboration between the International Monetary Fund (IMF), World Bank Group, World Health Organization (WHO), and World Trade Organization (WTO).

Announcing the launch of the website, the agencies called on countries with advanced COVID-19 vaccination programs “to release as soon as possible as much of their contracted vaccine doses and options as possible to COVAX, AVAT, and low and low-middle income countries.”

Citing “acute and alarming shortage”, the four agencies said less than 20% of the necessary vaccines are scheduled for delivery to low- and middle-income countries through COVAX, AVAT, or bilateral deals, with fewer than 5% of pre-purchased vaccine doses having been delivered. 

The agencies urged COVID-19 vaccine manufacturers to  “redouble their efforts to scale up production of vaccines” and called on richer countries to eliminate barriers to the export of vaccines.

Biden Announces New Donations

The newly launched interactive website shows that 1.1 billion of the world’s population have been fully vaccinated, 2 million short of the 3.1 billion target for the end of 2021.

On Tuesday, just days after the launch of the website, President Biden announced  his latest donation and shipment of more than 110 million doses of vaccines to more than 60 countries, which according to a statement by the White House is: “A major milestone that cements the United States as the global leader in COVID-19 vaccine donations.”

“These more than 110 million doses – that are already saving lives around the world – are just the beginning of the Administration’s efforts to provide vaccines to the world. Starting at the end of this month, the Administration will begin shipping half a billion Pfizer doses that the United States has pledged to purchase and donate to 100 low-income countries in need,” the statement reads.

Biden’s announcement comes as a new wave of COVID-19 infections fuelled by the deadly Delta variant is currently striking countries worldwide. Just last week the WHO announced a special global initiative to respond to the Delta variant, as COVID-19 cases are expected to reach 200 million within the next week, calling for countries to intensify their vaccine roll-out programs.

The data on the new website gives a detailed breakdown of, among other, vaccine administration and vaccine shortages per country.

Rich countries including the US and the UK are streaks ahead of low-and middle-income countries in their vaccination programs.

Biden’s donation announcement comes as the Centers for Disease Control and Prevention announced that 70% of US adults have had at least one shot of a COVID vaccine.

Almost 56% of the UK’s population have been fully vaccinated, with 68.4% having received at least one jab.

African countries lagging with vaccine roll-outs

 

African countries, including South Africa, Kenya, Uganda, and Nigeria are lagging with the vaccination programs largely due to access to vaccine doses.

To date, South Africa has only vaccinated 5.4% of its more than 59 million population with the 8,243,908 vaccine doses delivered to the country. Only 4.78% of SA’s population is fully vaccinated, while 9.98% have received at least one dose.

Less than 1% (0.68%) of Nigerians have been fully vaccinated, while 1.23% have at least received one dose. Uganda and Kenya have vaccinated 0.01% and 1.59% of their populations respectively.

Image Credits: World Bank: Mohamed Azakir.

pregnant
The Delta variant is particularly dangerous for pregnant women.

Unvaccinated pregnant women infected with the Delta variant run a greater risk of contracting severe COVID-19, according to a UK study of 3371 pregnant women admitted to the hospital with symptomatic COVID-19. 

The study, conducted by the UK Obstetric Surveillance System (UKOSS), found that 24% of pregnant women admitted in the first wave had moderate or severe disease, compared to 36% of those infected with the Alpha variant and 45% with the Delta variant. 

The number of unvaccinated pregnant women admitted to the hospital has been on the rise, which Marian Knight, Professor of Maternal and Child Population Health, University of Oxford and chief investigator of the study called ‘concerning’. 

“Around 200 pregnant women were admitted to hospital with COVID-19 last week. I cannot emphasise more strongly how important it is for pregnant women to get vaccinated in order to protect both them and their baby,” said Knight.

Worsening illness and post-birth complications for mother and baby  

Babies born to mothers in the Alpha and Delta periods of the pandemic were more likely to require admission for neonatal care compared to the first wave.

Pregnant women are particularly vulnerable to becoming severely ill from COVID-19 compared to non-pregnant women of a similar age, according to the WHO. Around one in ten women admitted to the hospital with symptoms of COVID-19 require intensive care, and one in five pregnant women give birth prematurely. 

Women admitted during the period when the Alpha variant was dominant in the UK were more likely to require respiratory support, have pneumonia, and be admitted to intensive care than women admitted in the first wave. 

Women admitted during the Delta period had an even further increase in risk, compared to those in the Alpha period, with a greater proportion having pneumonia.

Babies born in the Alpha period were more likely to require admission for neonatal care compared to the first wave, with a similar proportion for babies born to mothers in the Delta period.

Vaccinating pregnant women offers effective protection against COVID-19 

Women in Bongouanou, Côte d’Ivoire, during a prenatal medical consultation.

Protecting both mothers and babies with the vaccine does have its benefits, with data from the study showing that COVID-19 vaccinations offered effective protection for pregnant women against severe illness and other risks. 

Vaccination data has been collected since 1 February 2021. Of the 742 women admitted since that date, only four had received a single dose, and none had received both doses. 

This means that more than 99% of pregnant women admitted to the hospital with symptomatic COVID-19 are unvaccinated. In comparison, 60% of the general population admitted to the hospital with COVID-19 are unvaccinated.

During this time, at least 55,000 pregnant women received one or more doses of a COVID vaccine in the UK. 

‘It is extremely good news that so few vaccinated pregnant women have been admitted to hospital with COVID-19,” said Knight, who advised unvaccinated pregnant women to remain cautious and continue social distancing measures.

 “Until they are vaccinated, pregnant women must continue to be extremely attentive to social distancing measures including mask-wearing, 2m distancing and meeting outdoors where possible,” she added.

“This study shows that very few pregnant women are admitted to hospital with COVID-19 after they have received a vaccine,” said Nicola Vousden, first author of the study. “Other studies have shown that women who have received a vaccine pass on antibodies to their babies, so the benefits of vaccination to both pregnant women and their babies are clear.”

The Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives recommend that unvaccinated women who are pregnant or considering pregnancy get their vaccine as soon as possible, and book their second doses once eligible. 

UK trial to explore optimal vaccination schedule

Meanwhile, a UK clinical trial has been launched in order to alleviate concerns about the vaccine and determine an optimal vaccination schedule to protect pregnant women against COVID-19. 

The clinical trial, called Preg-CoV, will help determine the best gap between doses for pregnant women and explore in greater detail the potential side effects and impact on babies, which researchers hope will offer reassurance for expecting mothers and those thinking of becoming pregnant.  

“We really do need to make sure that when we are vaccinating pregnant women we are doing so in the most optimal way to ensure they are best protected,” said Paul Heath, chief investigator of the trial and professor of paediatric infectious diseases at St. George’s University of London.

In the first phase of the Preg-CoV trial, the team hopes to recruit 600 pregnant women between the ages of 18 and 44 across 13 sites in England. 

Two groups of 200 unvaccinated women at different gestation times will be randomized with either a Moderna or Pfizer vaccine and will be given their second dose four to six weeks or at 8-12 weeks after the first dose. 

Participants will not know which COVID jab they are given, added Heath. 

A third group of 100 pregnant women will be given one dose of a COVID shot at 28-34 weeks gestation, with the second dose of the same vaccine after delivery. 

The fourth group of 100 pregnant women will have already had their first dose of any COVID vaccine before or very early in pregnancy, and will get their second dose of the same vaccine during the trial. 

All women recruited will have follow-up visits and blood tests, and will fill in an electronic diary to help researchers monitor any adverse side effects. The team will also track outcomes for the babies up to 12 months of age to explore safety and impact on their development.

Experts note that there is no evidence of harm to babies, as the shots are beneficial in reducing chances of pre-term birth or stillbirth, and the antibodies can cross the placenta, protecting the child against COVID. 

Pregnant women should be included in future vaccine trials  

Heath said the trial would “fill in the gaps” in current knowledge about vaccinating pregnant women.

While the UK COVID vaccination program has been a success, uptake has been slow among pregnant women. 

“Pregnant women are still concerned because pregnant women were not included in initial COVID vaccine trials,” said Asma Khalil, lead obstetrician for the trial.

“I think there will be some lessons learned from this pandemic. And one of them is that we should consider including pregnant women at a relatively early stage for vaccine trials.”

 

Image Credits: Elizabeth Poll/MMV, USAID/Flickr, UN Photo/Hien Macline.

The Wuhan Institute of Virology, guarded by police officers during the visit of a WHO-led team of scientists in early February, 2021.

A “preponderance of evidence” proves that the SARS-CoV2 virus escaped from the Wuhan Institute of Virology (WIV), the Chinese research institute studying bat coronaviruses, concluded a report by US Congressional Republicans, released on Monday. 

“As we continue to investigate the origins of the COVID-19 pandemic, I believe it’s time to completely dismiss the wet market as the source of the outbreak. Instead, as this report lays out, a preponderance of the evidence proves that all roads lead to the WIV,” Representative Michael McCaul, Lead Republican on the House Foreign Affairs Committee, said in a press release

The report, published ahead of a planned report by the Democratic administration of US President Joe Biden, due to be completed by the end of August, is sure to add a partisan political dimension to the questions hanging over the origins quest.  And that, on top of an already charged triangle of tensions between Washington, Beijing and the World Health Organization in Geneva – over how to proceed with the origins investigation after China last month rejected out-of-hand WHO suggestions that that the lab escape theory should be revisited, along with requesting Beijing to supply for more data and information.

Report cites “ample evidence” that WIV researchers were working to modify coronaviruses – to be even more infective

The report cites “ample evidence” that WIV researchers, aided by US experts and funded by the Chinese and US government, were working to modify coronaviruses to improve their ability to cause disease – ostensibly for vaccine research.

“Much of this research was focused on modifying the spike protein of coronaviruses that could not infect humans, so they could bind to human immune systems. The stated purpose of this work was to identify viruses with pandemic potential and to create a broad-spectrum coronavirus vaccine,” the report said.

But this risky research was taking place in unsafe biosafety conditions, according to the report. 

“With dangerous research like this conducted at safety levels similar to a dentist’s office, a natural or genetically modified virus could have easily escaped the lab and infected the community,” said the report. 

“It is our belief the virus leaked sometime in late August or early September 2019,” said McCaul.

Alleges Chinese, World Health Organization & EcoHealth Alliance coverup

Then, in the wake of the virus escape, the Chinese Communist Party (CCP) embarked on a massive cover-up, detaining doctors and journalists to silence them, destroying lab samples, and hiding evidence of human-to-human transmission, the report claimed, adding that the World Health Organization was compliant in the cover-up. 

“The CCP and the World Health Organization (WHO) went to great lengths to cover up the initial epidemic,” said the report, adding that WHO Director General Dr Tedros Adhanom Ghebreyesus “parroted CCP talking points” and “act[ed] as a puppet of General Secretary Xi.”  

WHO Director-General Dr Tedros Adhanom Ghebreyesus at the biweekly WHO press conference on Friday.

“This was the greatest cover-up of all time and has caused the deaths of more than four million people around the world, and people must be held responsible,” said McCaul.

The report further charges that in the wake of the outrage over the pandemic, researchers at the WIV, along with Dr Peter Daszak, President of EcoHealth Alliance and a member of the joint WHO-China origins investigation team, covered up the real nature of the research being conducted. 

WIV and Daszak singled out for “misleading the world”

Authors of the report claim that scientists at WIV and Daszak misled the world, lied about the research being conducted, and bullied other scientists who questioned whether the virus could have leaked from a lab.

Dr Peter Daszak, President of EcoHealth Alliance and member of WHO’s investigative team.

Top scientists from the WIV, along with Daszak, were “misleading the world about how a virus can be modified without leaving a trace and…directly lying about the nature of the research they were conducting, as well as the low-level safety protocols they were using for that research,” said the report.

“These actions not only delayed an initial investigation into the possibility of a lab leak, costing valuable time, but provide further proof the virus likely leaked from the WIV. These actions also call into question the way in which U.S. government grants are used in overseas labs and call for more oversight of those grants,” the report said. 

“Now is the time to use all of the tools the U.S. government has to continue to root out the full truth of how this virus came to be. That includes subpoenaing Peter Daszak to appear before the House Foreign Affairs Committee to answer the many questions his inconsistent – and in some instances outright and knowingly inaccurate – statements have raised,” said McCaul, in his statement.

The report, authored by the House Foreign Affairs Committee Minority Staff, also calls upon the US Congress to: 

  • Institute a ban on conducting and funding work that includes gain-of-function research, which genetically alters an organism to enhance its biological functions, until international standards are set;
  • Sanction the Chinese Academy of Sciences, which runs the WIV;
  • Financially sanction the leadership of the WIV to block their assets and prohibit US citizens from dealing with them; and
  • Authorize new sanctions for academic, governmental, and military bioresearch facilities that fail to implement the appropriate levels of safety and information sharing.

Daszak, who is a member of the “Lancet COVID-19 Commission Task Force on the Origins, Early Spread of COVID-19, and One Health Solutions to Pandemics,” recused himself from the Commission’s work on the origins of the pandemic in late June.  This decision was made to remove any question over whether there were conflicts of interest with his research ties with the WIV. He continues to work on analysis of the early spread of SARS-CoV2 and One Health solutions.

Republican report comes in wake of recent study linking deleted SARS-CoV2 gene sequences more closely to bat viruses 

The new US report comes on the heels of a recent study posted on the pre-print server Biorxiv.org that unearthed a deleted data set of SARS-CoV2 virus gene sequences circulating in Wuhan in late 2019, in variants “that made it more similar to SARS-CoV-2’s bat coronavirus relatives” – than those circulating in the Huanan Seafood Market. 

The Seafood Market was the first site to be publicly identified as the epicenter of the new virus, when clusters of infection linked to market workers or patrons were first publicly identified in December 2019 and January 2020.  

However, it has since become evident that other virus variants were already circulating in clusters outside of the market in December, and likely well before.  

“At first, we assumed the seafood market might have the virus, but now the market is more like a victim,” Dr George Fu Gao, Director General of the Chinese Centers for Disease Control and Prevention, admitted in May 2020. “The novel coronavirus had existed long before.”

In the new Biorxiv.org study, the lead author Dr Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Research Center, recovered virus sequences that were deleted from US data repositories from a Google cloud. 

 

His study reports on 34 of some 241 SARS-CoV2 genetic sequences that were collected at Renmin Hospital of Wuhan University early in the Wuhan outbreak, and later posted, then deleted from, the US National Institutes of Health’s Sequence Read Archive (SRA) data repository. 

Using raw sequence data from the recovered samples, Bloom was able to reconstruct partial sequences for 13 of the samples.

Most ‘perplexing finding’

Bloom’s most “perplexing” finding was that among the early SARS-CoV2 sequence samples, those collected from people or areas outside of the Wuhan market have a closer relationship to bat coronaviruses – which are presumed to be the animal origins of the virus. 

This suggests that the market sequences, which were initially the focus of the joint WHO-China origins investigation’s epidemiological work, are not really representative of the viruses that were circulating in late 2019. 

“We’d expect the first SARS-CoV2 sequences would be more similar to bat coronaviruses, and as SARS-CoV2 continued to evolve it would become more divergent from these ancestors. But that is *not* the case!” Bloom tweeted on 22 June. 

Samples collected later in other areas of China and other countries were more similar to bat coronaviruses than samples from early Huanan Seafood Market cases. All sequences associated with the market differed from RaTG13, the bat coronavirus with the highest full-genome sequence identity to SARS-CoV2, by at least three more mutations compared to subsequent sequences collected. 

This is “a fact that is difficult to reconcile with the idea that the market was the original location of spread of a bat coronavirus into humans,” said the study. 

Deleted files reported to be back online now

Last week, the New York Times reported that the missing viral genome sequences were back online – after quietly being uploaded in early July to a China National Center for Bioinformation database, overseen by the government following publication of Bloom’s report. 

Speculation by Bloom that the sequences had been deliberately deleted was countered by Chinese government statements that the sequences had gone missing as the result of an editorial error, noted by a German scientific journal. 

Bloom has been involved in the policy decisions around virus origins debate 

Bloom has been involved in the debate over the virus origins, joining 17 other prominent scientists to author a letter in Science critiquing the joint WHO-China origins report

According to the authors, “theories of accidental release from a lab and zoonotic spillover both remain viable” and were not “given balanced consideration” by the report.

In the letter, they demand that the two hypotheses “be taken seriously…until we have sufficient data.”

According to Bloom, “these data provide no direct evidence to favor either a lab accident or a natural zoonosis. However, they do indicate the importance of continuing to seek new data about the origins and early spread of SARS-CoV2.”

Bloom’s study “indicate[s] that we probably have not exhausted all relevant data,” he told the Washington Post

“Scientists need to stay focused on data-driven study SARS-CoV2 origins/early spread,” Bloom tweeted on 22 June. “After spending 4 months studying this closely, I am cautiously optimistic that additional relevant data are still likely to come to light.”

“We should therefore avoid dogmatic arguments about SARS-CoV2 origin/early spread, and instead focus on following two questions: (1) How can we get more data? (2) How can we better analyze the data we have?” he continued

Findings add to previous evidence of earlier virus circulation – with no link to Huanan Seafood Market

Several other studies have also found that many early COVID cases also had no connection to the Huanan Seafood Market. Those include: 

  • A study published in the Lancet in late January 2020, conducted by a large group of Chinese researchers, discovered that the earliest reported case had no link to the market and “no epidemiological link was found between the first patient and later cases.” Only 66% of the patients in the study had direct exposure to Huanan Seafood Market. 
  • In a separate study conducted by researchers at the Jinyintan Hospital in Wuhan, 49% of the 99 patients with COVID-19 had a history of exposure to the market.
  • Researchers from the University of California San Diego used molecular dating tools and epidemiological simulations to identify the first case of SARS-CoV2. In the study, published in the journal Science in April 2021, the researchers estimated that the virus was likely circulating undetected for at most two months before the first human cases of COVID-19 were identified in Wuhan.

Genetic tracking may help determine virus origins  

Regardless of the narrative around the sequences’ disappearance, more knowledge about the genetic sequences of early virus mutations is critical in tracking the virus origins, other scientists agree. 

“This line of inquiry may help us determine the origin of the virus and reconstruct how it spread in the earliest days of the pandemic,” Dr. W. Ian Lipkin, Professor of Epidemiology at Columbia University’s Mailman School of Public Health, told USA Today

During the WHO-mandated origins investigation in Wuhan in January and February of 2021, the team gathered evidence that there were diverse strains of the SARS-CoV2 virus already circulating in the city in December 2019. 

“The SARS CoV-2 virus was circulating in the Wuhan market market in December 2019, but it was also circulating elsewhere in the city, in cases unrelated to each other,” Marion Koopmans, a Dutch virologist and epidemiologist and a member of the joint WHO-China origins investigation, acknowledged at a press briefing in early March.

“The analysis of recovered sequences does not fundamentally change our current understanding of early SARS-CoV2 evolution, but it does make the hypothesis of a single-source wet market outbreak implausible,” Dr Sergei Pond, Professor of Biology at Temple University in Pennsylvania, tweeted.

 

“The progenitor of all known SARS-CoV-2 sequences could still be downstream of the sequence that infected patient zero – and it is possible that the future discovery of additional early SARS-CoV-2 sequences could lead to further revisions of inferences about the earliest viruses in the outbreak,” said the study.

“We should be prepared, however, to revise these ideas and hypotheses further if and when more early sequence data emerge,” Pond tweeted.

Image Credits: CNN, Sputnik.

This article is the second in a three-part series on COVID-19 booster vaccines, which is an evolving discussion as more evidence emerges about the performance of vaccines against variants.

Immunocompromised people are twice as likely to die from COVID-19 compared to healthy people and could benefit from receiving a third booster shot.

Despite heated debates about doling out booster jabs in healthy people who are already fully vaccinated against SARS-CoV-2, there seems to be consensus that at least one group could benefit from a third booster shot – immunocompromised people.

Immunocompromised groups, like those with solid organ transplants, are roughly twice as likely to die from COVID-19 compared to healthy people. And even after receiving two vaccine shots, their antibody responses are woefully inadequate.

But a third booster shot has potential to offer those patients stronger protection against  disease and death from SARS-CoV-2, Eyal Leshem, the Director of Israel’s Center for Travel Medicine and Tropical Diseases, told Health Policy Watch – referring to people with organ transplants, cancer patients, and others who are severely immunocompromised.

“There is some evidence that seroconversion rates [antibody responses] are lower in immunocompromised people like people with organ transplants, compared with people with healthy immune systems,” said Leshem, who is also a researcher for the United States Centers for Diseases Control and Prevention (CDC). 

“But there’s also encouraging evidence that a third booster shot in organ transplant patients increases the rate of seroconversion [antibody responses] in those patients.”

Based on this evidence, as well as new data suggesting that vaccines are becoming less effective overall in preventing disease, Israel and France approved a third jab in severely immunocompromised patients earlier this month. 

The United Kingdom and the United States, appear ready to follow suit very soon. Israel has since gone on to announce last week a controversial third jab for all people over age 60 – whose immune systems are generally weaker than their younger counterparts – with other countries likely to follow that move for older, healthy adults.  

“We see a drop in the vaccine effectiveness for those vaccinated early on, and we see it for those elderly people over the age of 60,” said Sharon Alroy-Preis, a top Israeli Ministry of Health expert in a weekend interview with the US television programme “Face the Nation.” 

While protection from disease remains high, protection against infection has dropped precipitously, she added:  “Previously we thought that fully vaccinated individuals are protected [from infection], but we now see that vaccine effectiveness is roughly 40 percent.”

Antibody counts in immunocompromised people rise dramatically following a third vaccine jab, suggesting they could benefit from a booster shot

Third jab among immunocompromised may also help curb some variant mutations 

Although rich countries that offer a third jab already before poorer nations have even been able to get one into the arms of older people leave themselves open to further charges of vaccine nationalism, in the case of immunocompromised groups, the argument may be somewhat different. 

Some researchers have suggested that offering immunocompromised groups an extra jab could also help prevent the virus from replicating in their bodies for long periods of time, and thus mutating into new variants.

To date, a handful of large-scale studies around boosters in immunocompromised people are ongoing or set to begin, including an NIH-led study in 400 people; a double-blind randomized controlled trial by Moderna in 120 people; and a non-randomized Phase 2 trial in 360 people that includes 180 children.

Booster is not magic bullet either 

A third shot may not guarantee potent antibody responses in all immunocompromised patients.

However, a third booster shot won’t always guarantee potent antibody responses in all immunocompromised patients, one report of a retrospective study of 101 patients, published in the New England Journal of Medicine (NEJM) has revealed. In the NEJM correspondence, researchers reported on a retrospective analysis of solid organ transplant patients who had received three jabs of the Pfizer/BioNTech vaccine. 

Strikingly, the NEJM study found that about half of patients who didn’t respond to a second jab also failed to respond to a third one (33 out of 56 patients). Those patients tended to be older and to have weaker immune systems, the study authors said.

Still, the study concluded that a third dose of the Pfizer/BioNTech vaccine “significantly improved the immunogenicity [immune response] of the vaccine, with no cases of Covid-19 reported in any of the patients”.

The lead author of the NEJM letter, Nassim Kamar, has proposed that the families of immunocompromised groups should also be vaccinated – insofar as a third jab is useful, but not always sufficient to protect immunocompromised groups.

“A weak humoral [antibody] response is observed in immunocompromised patients after SARS-Cov-2 vaccination,” Kamar told Health Policy Watch. “This means that most of them are not protected against COVID despite vaccination.”

“Hence, in order to limit the risk of infection, it is required that their relatives be vaccinated,” said Kamar, who is the Head of Nephrology and Organ Transplantation at the Toulouse University Hospital in France.

Second in a three-part series on COVID boosters. See the third article in this series, Boosters: Laboratory Evidence Needs to be Balanced with Field-based Data.

Image Credits: Rhoda Baer/National Cancer Institute, PAHO/Sebastian Oliel, NEJM, International Monetary Fund/Ernesto Benavides.

A health worker wearing personal protective equipment (PPE) carries a patient suffering from the coronavirus disease (COVID-19) outside the casualty ward at Guru Teg Bahadur hospital, in New Delhi, India.

#COVIDReporting: For the past 18 months, Health Policy Watch reporters have covered the COVID-19 pandemic. But they have not been immune from its impacts on their personal lives as the virus has wreaked havoc with their lives. Over the next few weeks, we will bring you their stories.

DELHI – Despite the utmost care, bordering on mild paranoia, COVID found me on 18 April 2021, like it did many in Delhi, during the peak of India’s second wave

I got my first jab of the indigenous Covaxin vaccine on 1 April, the very first day I became eligible, along with a friend (who had been even more careful over the past year) and her two staffers. 

Coincidentally, all of us came down with COVID within days of each other. 

Even before this strange and ruthless virus breached my defences, I’d been watching in silent horror as the numbers of COVID-afflicted in several Indian states, including Delhi, rose sharply during India’s election state election campaigns – in what was clearly the beginning of a second wave.  

I watched with helpless fury at the way every single political party held massive political rallies, entirely overlooking safety norms as they fought elections in three key states. 

None could beat the ferocious enthusiasm of Prime Minister Narendra Modi’s ruling Hindutva-nationalist Bharatiya Janata Party, whose single-minded determination to defeat its biggest rival in West Bengal, state Chief Minister Mamata Banerjee’s All India Trinamool Congress party, drove it to recklessly ignore all Covid safety protocols, even as cases began spiking dangerously.

Religious and political mass gatherings paved the way for the virus

Tens of millions gathered to celebrate the Kumbh Mela festival in India amid surging COVID-19 cases.

What angered me further was the utter irresponsibility and impunity with which the BJP-ruled federal government allowed the kumbh mela – the largest religious gathering of pilgrims in the world, so large that it can be spotted from space – to carry on in early April as if there were no deadly pandemic sweeping the world. 

This was even worse than the chest-thumping victory bugle the Indian Prime Minister had blown internationally, barely a couple of months earlier signaling vanquishing of a virus which, it turned out, was just lying low to strike more venomously in a brutal second wave. With these super-spreader events in full swing, it would have been a miracle if India had not seen a second wave.

It was mid-April when my first-floor neighbours in our two-family bungalow A Dutch-American couple with whom I shared a common driveway and entrance lobby, got it first, along with their staff from where perhaps it reached me via our staff. 

The fact that I had helped the families of all the staff on the premises access their first shot of the AstraZeneca Covishield three weeks ago didn’t seem to make a dent in preventing the spread of the infection. 

Or perhaps I was infected by the double-vaccinated physiotherapist I had taken a session for neck and back pain from. She contracted COVID around the same time. 

Wherever it came from, by the time I showed my first symptoms, Delhi was reeling under a medical crisis, an overwhelmed healthcare system – and a severe shortage of hospital beds, oxygen and lifesaving medicines. Just getting an RT-PCR test was proving challenging.

Isolation, fever and lung damage  

I immediately isolated myself – my biggest concern was to keep the rest of my family safe. 

But as my fever rose to 104 degrees Fahrenheit and my oxygen-saturation levels fell from the safe norm of over 95 to under 92, occasionally touching 90, as paracetamol proved ineffective and Meftal (mefenamic acid), an anti-pyretic pain suppressant used widely in India, remained unavailable, as doctors remained elusive and news of friends and acquaintances struggling for breath, for hospital beds, for oxygen grew, so did my worry. 

Within two days of testing positive, (five days after my first fever) a high resolution lung CT scan showed an almost 50% lung damage from the virus – my score was 14/25, which the diagnostician had shaken his head, stepping back further as he told me I was on the border between moderate and severe COVID. 

‘In some ways, I was more afraid of suffocating than of dying. What if I couldn’t breathe?’

I knew my lungs were already compromised from the polluted air I’d breathed for three decades. Recently, I had seen my non-smoker mother struggle with lung cancer, which her doctors said was triggered by the dirty air she had inhaled all her life, living as she did mostly in highly polluted north Indian cities and towns. 

Helplessly watching her die, gasping for breath in the terminal stages, had propelled me to write my grief memoir on the human cost of air pollution, “Breathing Here is Injurious to Your Health,” citing several scientific studie in an unusual intersection of two disparate genres. 

In some ways, I was more afraid of suffocating than of dying. What if I couldn’t breathe? An entire chapter in my book talked about the air pollution-COVID connection, citing research that proved that those living in high polluted areas were more likely to contract COVID and in fact, get a more severe form of COVID and included the now oft-quoted Harvard School of Public Health study that even measured increased mortality due to higher levels of pollution.

A close friend, who is also a gynaecologist, ended up being my saviour. Anita had been checking on my saturation levels at regular intervals via text from the day I tested positive, ringing me every morning to find out how I was doing. 

One day, soon after my CT scan, I found an oxygen concentrator at my door. She had managed to retrieve her concentrator from a colleague at her practice for whom she had bought it in the first wave. Concerned at my unstable saturation levels, she sent it to me telling me not to hesitate to use it if my oxy-sat fell to 90. 

‘Be prepared for anything’

My children, who had been scouring social media sites for oxygen cylinders and hospital beds, stopped panicking. Soon afterwards, I also managed to get a phone consultation with a pulmonologist known to me from my air pollution work who lost no time in prescribing favipiravir, (an antiviral) and steroids. 

At first, I was unable to source the medicines in local pharmacies. Too many sick people needed the same medicines, a common problem of scarcity in a country of over a billion people. Once again, a network of neighbours, friends and family came to my rescue as whatsapp groups buzzed with numbers of faraway pharmacies that had even one strip of Medrol® . I needed 20. 

This was not just my story. Even as the government failed its citizens, good Samaritans, communities of friends, relatives and families stood in lines for oxygen, medicines, beds – and in more unfortunate cases, cremations – sometimes forced to fight with each other over that last strip of remisdivir, or pouches of plasma. 

A friend who had rushed her COVID-positive father to the ICU in a nursing home in a small town in the neighboring state of Uttar Pradesh (because no beds were available in Delhi or its suburbs) told me how the doctors came around to tell her to “be prepared for anything” since they had only 2 hours of oxygen left.  

‘One morning, when I looked into the bathroom mirror, a grey face looked back at me.’

Throughout my 21-day isolation period, I was in touch with my family only through phone calls or closed doors. A close band of Covid-positive friends and I kept in text- touch with each other, all of us checking in amongst us every day, worried if we didn’t hear back from each other. My pulmonologist prescribed diagnostic tests that were shockingly expensive, but in such high demand that labs quickly ran out of test reagents and other raw materials. I was also monitoring my Covid-positive housekeeper, who sounded breathless every time I spoke to her on the phone. My anxiety for her was tinged with worry at the test expenses I knew she could ill-afford and I would have to help her with, when the time came.

With no one able to cook, my family ordered-in most meals, but despite the heavy, oily outside food – and zero exercise – I lost 6kgs in 10 days, nearly 8% of my body weight. I also lost my sense of smell and taste. 

Jyoti Pande Lavakare

One morning, when I looked into the bathroom mirror, a dull, grey face I could barely recognise looked back at me. I wish I’d taken a photograph. I’ve never seen that kind of metallic pallor on a human face in my entire life.

Meanwhile, every day, news of the deaths of acquaintances, friends, even a first cousin who was younger than me, reached me via texts, until I became afraid to check my phone. Talking tired me. I tried to drown out the cruel pings of bad news with music, or a film, but discovered that I had lost the ability to concentrate.

I had tried to continue tweeting for my clean air non-profit, Care for Air, but Twitter was full of desperate pleas for help, news of undercounting of deaths, pictures of bodies which were being abandoned on the banks of rivers in shallow, sandy graves because people didn’t have the resources to cremate them – information that made me so sad that Anita forbade me to follow the news. 

The isolation of those days – and more than the days, the empty nights, when the thump-thump of the concentrator was the only sound that cut through the stillness – will stay with me for as long as I live. 

‘Feeling for my oxygen mask became my new normal. In fact, the concentrator and the oximeter became my closest friends.’

Sleep was elusive. That, the steroids ensured. Looking out into a vast, purple-polluted sky, barely a star visible, night after night, falling asleep in a prone position as dawn broke and waking up unrested, breathless just hours later, restlessly feeling for my oxygen mask became my new normal. 

In fact, the concentrator and the oximeter became my closest friends. So much so that even after my fever broke and my saturation levels stabilised, I couldn’t bear to send the concentrator back. Only the thought that someone may be needing it more urgently than I spurred me to finally return it to Anita, so that she could pass it onto some other desperate COVID patient, if required. 

The only great part of these days was that the steroids made my body feel like butter. Every ache and pain I had ever experienced, vanished. When I walked, I felt like I was floating, light and agile as a butterfly.

Even after 21 days, I re-tested positive for COVID – and with no one fully-vaccinated at home, my anxious family only allowed me to step out of my room once a day, when I took short, floating walks in the small garden attached to our verandah, a venture that  left me exhausted, but grateful. Often, I would lie on the grass, looking up at an endless sky, practising breathing deep, feeling small, insignificant – but alive. 

For me, it wasn’t those 21 days, but the following 80 days post-recovery, in which I felt the full effects of this strange, ugly disease. 

After I had tapered off the steroids, I felt like a ghostly version of myself. I had zero energy and would get tired just lying in bed. 

I tried to get back to reading and writing but just couldn’t concentrate. Almost constant brain fog made me start feeling that I wasn’t even truly alive. For someone with no serious co-morbidities, I was surprised to find my blood pressure fluctuating wildly. One day, I would see a sudden fall in my systolic blood pressure, followed by high diastolic blood pressure, another day, the exact reverse. The second month, it was  tachychardia, followed by bradychardia, my pulse leap-froggng  between 70-110, even as my oxygen saturation levels remained stable. 

My cholesterol, triglycerides and sugar levels also shot up beyond normal ranges and I often felt a heavy feeling in the chest. And the absolute worst part was the return of every single pain I had ever had – and some joint pains that I had never felt before. 

As days bled into each other, and concerned friends advised me not to push myself to exercise, I started pranayamas, breath-work from my yoga days. I also turned to Ayurveda and homeopathy, all of which helped to different degrees.

It is now more than three months from the day I first tested positive. I still have troubled sleep, get hot flashes every morning, feel breathless occasionally, have mysterious aches and pains and get fatigued more easily. 

I have lost a lot of my confidence and hesitate to commit to work deadlines. 

I’ve lost almost half my hair and my joint pains make me hobble along like an old woman, especially in the mornings. The only thing I have added is weight – those steroids have ensured that.

But many other parameters – pulse, blood pressure included –  are stable and I know I’m luckier than many truly long-haulers who are suffering so much more months after testing negative. 

I got my second shot of Covaxin last week, on 20 July. Fellow sufferers tell me some of my lingering symptoms should resolve after the second jab. I devoutly hope they do.

COVID has been ruthless and relentless 

Recovering in Lodhi Gardens, Delhi

But I know that no vaccine shot will resolve that unnamed, uncomfortable guilt that often creeps up on me as I drift into a determined sleep, nor the sudden feeling of panic when I see photos of crowds of unmasked people. 

I still can’t help thinking that it was our privilege that allowed my friends and me to protect our families. For those living in cramped quarters, it was well nigh impossible to truly isolate.

I shy away from thinking about those who pleaded for hospitals and oxygen, trying not to wonder where they must be now. And I miss my friends, the ones I will never see again. 

For most people, COVID has been ruthless, relentless – sickening and killing loved ones, weakening not just our bodies but our souls as we grieve, endlessly grieve, for those who we took a little bit for granted because we thought we had time with them. 

For others, it has been an indirect cause for a different kind of suffering and frustration, as they lose livelihoods and slip back into a poverty they thought they had left behind. 

What is worse is that it still isn’t over, washing over us in waves, altering us forever, not just physically and mentally, but also socially, emotionally, psychologically and perhaps in other unkown ways that we still haven’t understood.

As my father says, Covid is the perfect disease of Kalyuga.

Jyoti Pande Lavakare pre-Covid

Jyoti Pande Lavakare is a  journalist, author and co-founder of the Indian clean air non-profit Care for Air. She has corresponded regularly for Health Policy Watch on air pollution, climate and health issues. Her memoir, Breathing Here is Injurious to Your Health, on the human cost of air pollution, was recently published by Hachette. 

Image Credits: Flickr – Trinity Care Foundation, Adnan Abidi/Flickr, Sky News.

Samples of SARS-CoV2 variants obtained and monitored by WHO, in collaboration with partners, expert networks, national authorities, institutions and researchers.

The war against COVID-19 has changed with the emergence of the highly transmissible and deadly Delta variant, said an internal US Centers for Disease Control and Prevention (CDC) slide presentation.

The document, which has not yet been released, was obtained by the Washington Post and calls for a new and more aggressive masking and vaccination strategy in the US to combat the spread of the Delta variant.

Most alarmingly, it warns that people with breakthrough infections, which are cases that occur despite full vaccination, may be as contagious as unvaccinated people. 

“We are dealing with a different virus now,” Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases and the Chief Medical Advisor to President Joe Biden, told NPR on Tuesday.

“This is not the original virus that we were dealing with. This has different capabilities [and is] much more efficient in transmitting from person to person,” he said.

Delta variant more transmissible than Ebola, common cold and smallpox

The Delta variant (B.1.617.2), first identified in India in October 2020, has been described by WHO officials as the “fastest and fittest” variant. The variant has been sweeping across the world, now reported in 132 countries

The newest variant of concern is “considerably more transmissible” than previous variants and has a viral load approximately a thousand times higher than the original virus, said Fauci in a closed-door meeting on 29 July with Members of Congress. 

Estimates suggest that an individual infected with the Delta variant will pass the disease on to between five and nine other people, while the original virus would be passed on to two to three people. 

This indicates that the Delta variant is more transmissible than MERS, SARS, Ebola, the common cold, the seasonal flu, and smallpox. The variant spreads as easily as chickenpox, according to the federal health document. 

Delta variant is more transmissible than MERS and SARS, Ebola, the common cold, the seasonal flu and 1918 flu, and smallpox, according to the CDC.

“I think people need to understand that we’re not crying wolf here. This is serious,” Dr Rochelle Walensky, Director of the CDC, told CNN. “It’s one of the most transmissible viruses we know about. Measles, chickenpox, this – they’re all up there.”

The data presented in the internal document was “sobering,” said Walensky. 

The Delta variant may also cause more severe disease than previous strains of SARS-CoV2. Studies conducted in Canada and Scotland found that people infected with the variant are more likely to be hospitalized, while a study from Singapore indicated that patients are more likely to require oxygen, admission into an intensive care unit, or develop pneumonia.  

More drastic action is needed to deal with Delta threat

The CDC’s new masking guidelines for vaccinated people, which were introduced on Tuesday, were based on the data presented in the document. 

“To reduce the risk of being infected with the Delta variant and possibly spreading it to others, wear a mask indoors in public if you are in an area of substantial or high transmission,” said the updated guidelines.

The new guidelines, however, didn’t go far enough in the context of the threat posed by the Delta variant.

“Given higher transmissibility and current vaccine coverage, universal masking is essential,” said the document. 

“The measures we need to get this under control, they’re extreme,” said Walensky. 

“Nonpharmaceutical interventions are essential to prevent continued spread with current vaccine coverage,” the document said. 

Along with universal masking and community mitigation strategies, the document recommends a vaccine mandate for healthcare personnel to protect vulnerable populations.

The CDC also faces the daunting communication challenge of emphasizing the efficacy of the COVID vaccines in preventing severe illness and death, while improving the public’s understanding of breakthrough infections and acknowledging that vaccinated people are transmitting the virus.

Immunized people as vectors for SARS-CoV2 virus

Although unvaccinated people account for the bulk of virus transmission, vaccinated people can also be vectors for the SARS-CoV2 virus, found a new CDC report released on Friday.

The report was based on an outbreak of 469 cases of COVID in Barnstable County, Massachusetts, following a series of large public gatherings in early to mid-July. Approximately 74% of cases occurred in fully vaccinated people and 89% of the cases were caused by the Delta variant.

Among those with a breakthrough infection, 79% reported symptoms, the most common being cough, headache, sore throat, muscle aches, and fever.

The report concluded that, as population-level vaccination coverage increases, vaccinated people are likely to represent a larger proportion of COVID cases. Breakthrough infections are also expected to occur with greater frequency among groups at risk of primary vaccine failure, such as those with compromised immune systems or those over the age of 60. 

The authors suggested that even areas without high COVID transmission should expand prevention strategies by requiring masks indoors and limiting capacity at gatherings.

Vaccinated people may be as contagious as unvaccinated people

Inoculated people infected with the Delta variant carry tremendous amounts of the virus in the nose and throat, said CDC officials. The vaccine-induced antibodies largely remain in the blood, so vaccinated individuals won’t have local immunity in the nose or throat. 

This means that they will be able to transmit the virus to others while they are infected and contagious. 

People with breakthrough infections may be as contagious as unvaccinated people, found the internal CDC document.

There are currently 35,000 symptomatic infections reported per week among 162 million vaccinated Americans. 

“Vaccines prevent more than 90% of severe disease, but may be less effective at preventing infection or transmission,” said the internal CDC slide presentation. “Therefore, [there will likely be] more breakthrough and more community spread despite vaccination.”

This, however, doesn’t undermine the efficacy of vaccines. The risk of severe disease or death is reduced ten-fold or greater in vaccinated individuals and the risk of infection is reduced three-fold.

Infections, hospitalizations, and deaths on the rise in the US

Infections in the US have increased 145% in the past two weeks, accompanied by rising rates of hospitalizations and deaths, particularly in areas with low vaccination rates. 

According to CDC estimates, over 80% of recent COVID cases in the US have been caused by the Delta variant.

Cases in all but one state have risen in the past seven days.

The current number of new COVID cases is higher than the peak reported last summer and hospitalizations have reached the same level as this time last year, before vaccines were available. Hospitalizations are much more common now among patients aged 30 to 39 years old, compared to those over the age of 70. 

“This sudden turn of events threatens to undermine the significant progress we have made this year to overcome the pandemic,” said Representative James E. Clyburn, Congressperson and Chair of the Select Subcommittee on the Coronavirus Crisis, at a briefing with CDC officials on Thursday. 

“Getting vaccinated remains the most effective way to save lives and stop the spread of the Delta variant,” said Clyburn.

In a recent attempt to revive vaccine efforts, US President Joe Biden will require all federal workers and members of the military to either get vaccinated or face regular testing, social distancing, and mask wearing. 

He urged companies and local governments to follow his lead. “This is a pandemic of the unvaccinated,” said Biden at a press conference on Thursday. “People are dying and will die who don’t have to die. If you’re out there unvaccinated, you don’t have to die. Read the news.”

Some 90 million Americans are eligible for a vaccine but have not yet gotten one. 

“With incentives and mandates, we can make a huge difference and save a lot of lives,” said Biden, who also urged states to offer US$100 to anyone willing to get a jab. 

This move, however, has been criticized by some as rewarding the unvaccinated.

https://twitter.com/LawrenceGostin/status/1420911833305784327?s=20

Image Credits: WHO, CDC.

A special global initiative to respond to the Delta variant has been set up, as COVID-19 cases are expected to reach 200 million within the next two weeks.

Meanwhile, 70% of African countries will miss the World Health Organization’s (WHO) target to vaccinate 10% of their populations against COVID-19 by the end of September, and deaths on the continent have increased by 80% in the past month.

WHO Director-General Dr Tedros Adhanom Ghebreyesus made these announcements as part of the global body’s media briefing on Friday.

The Rapid ACT-Accelerator Delta Response (RADAR) has been launched with an urgent call for $7.7 billion for more tests, treatments and vaccines to address the variant’s rapid spread, said Tedros.

“We need more research and development to ensure that tests, treatments, vaccines and other tools remain effective against the Delta variant and other emerging variants. And of course, we need more vaccines,” said a tired-looking Tedros, who recently returned from trips to the Tokyo Olympics and opening WHO offices in Bahrain and Kuwait.

Dr Maria van Kerkhove, WHO Lead on COVID-19, said while the WHO was working with groups across the world to “get a better handle on the Delta variant”, some laboratory studies suggested that the variant was able to replicate faster in human airways and that those infected had higher viral loads than with previous earlier versions of the virus.

“What we do know is that public health and social measures do work against the Delta variant,” stressed Van Kerkhove.

“We know that our vaccines are safe and effective against severe disease and death. And so those who have access to the vaccine, when it’s your turn, please get vaccinated and make sure that you get the full course.”

Dr Maria van Kerkhove, WHO Lead on COVID-19

Africa might not vaccinate 10% of citizens by end of year

Once again, Tedros sounded the alarm about Africa’s slow vaccine rollout: “Around 3.5 million to 4 million doses are administered weekly on the [African] continent, but to meet the September target this must rise to 21 million doses at the very least each week.

“Many African countries are prepared well to roll out vaccines, but the vaccines have not arrived. Less than 2% of all doses administered globally have been in Africa, less than 2%. Just 1.5% of the continent’s population are fully vaccinated.”

Dr Bruce Aylward, WHO’s representative on COVAX, said that Africa might not even vaccinate 10% of its citizens by the end of the year.

“There’s enough absorptive capacity that they could easily hit 30-40% coverage,” said Aylward. “So our key goal, and what I spent my days doing, and an awful lot of other people like the Director-General, is trying to look at how do we shift more product into that pipeline, so that we can make sure that realistically, we’re well over 20% to 30% by the end of this year.”

But, said Aylward, the decision to supply African countries rests with “CEOs and the boards of companies that manufacture vaccines”.

“We should never be talking about ‘what do we think is going to happen in Africa versus America versus Europe’. We should have the same standard, we should have the same ambition, we should have the same aspiration and be driving for the same coverage levels, right. So if Europe gets to 70-60%, by the end of this year, why should Africa not get there as well?”

Massive fireworks display for crowd of 11,000 athletes and just 950 spectators at Olympic opening ceremony 23 July

Tedros defends Olympics visit 

When asked whether his attendance at the Tokyo Olympics was an endorsement of the Games, which has seen a spike in COVID cases in Japan, Tedros said he had attended the opening ceremony and addressed the Olympic Organising Committee to spread the message of global solidarity to do better against the pandemic.

He appealed to all Olympic athletes to become “ambassadors of solidarity” to defeat the pandemic when they went back to their countries.

“There is no zero risk, but Japan has tried its best,” added Tedros.

“When I was attending the official opening, I saw the torch bearer with a mask and the torch, and that picture still means a lot to me. It shows that we are doing this in very difficult conditions. We’re doing this when we’re taken hostage by a dangerous virus, but at the same time it shows me the determination to fight back.”

While admitting that Tokyo had seen an increase of around 3000 COVID cases in the past 24 hours, WHO Director of Health Emergencies Dr Mike Ryan said that the Olympics’ risk management was “extremely comprehensive”

“The Director General’s trip was to highlight the need for the world to come together, the need for the world to act together, the need for the world to reduce the inequities that are truly driving this pandemic and focus on what are the true drivers of this pandemic,” said Ryan.

“ And the true drivers of this pandemic are not within the Olympic Games. They’re really related to the deep inequities we have in the distribution and availability of vaccine, the deep inequities in health that we have around the world. And his call was a call to the world at a moment of unity of sport: we need a moment of unity amongst health systems, amongst governments, amongst everybody to play fair.”

WHO expects China’s co-operation on virus origin, despite its recent refusal

Zeng Yixin, Vice Minister of the National Health Commission.

In relation to China’s recent refusal to agree to phase two of the planned WHO virus origins research in its country, Ryan said he expected that the country would cooperate.

“There’s a lot of rhetoric out there. The one consistent thing we’ve heard from all countries has been, ‘let’s not politicise the science’ and the next thing that happens is the science is politicised. 

“We believe we have the basis to move forward. We have a set of studies that can be taken forward. We want to bring together the scientific advisory group on origins to help take that forward. We want to bring members of the international team into that process to maintain continuity with the previous process. And we want to reassure our colleagues in China that this process is still, and always has been, driven by science,” said Ryan.

“The objectives that we all want is to control COVID-19, to establish the origins of the virus and put in place what measures we can to prevent a further re-emergence of a similar virus in the future.”

Details of African mRNA hub released

WHO Director-General Dr Tedros Adhanom Ghebreyesus

To boost Africa’s vaccine manufacturing capacity, Tedros released details of the WHO’s partnership with a number of South African companies and the Africa Centres for Disease Control (CDC).

The partnership’s responsibilities, set out in a letter of intent, follows the WHO’s announcement last month of the first COVID-19 mRNA vaccine technology transfer hub in South Africa to enable “vaccine security for Africa in the future”.  

Two South African companies, Afrigen Biologics and the Biologicals and Vaccines Institute of Southern Africa (Biovac), will provide the site, staff and expertise for the hub, while the South African Medical Research Council (SAMRC) will assist with clinical trials and getting products to market.

“Inequitable manufacturing and distribution of vaccines is behind the wave of death, which is now sweeping across many low- and middle-income countries that have been starved of vaccine supply,” said Dr Soumya Swaminathan, WHO Chief Scientist in a media release on Friday.

“Building vaccine manufacturing capacity in South Africa is the first step in a broader effort to boost local production to address health emergencies and strengthen regional health security.” 

“At the Medicines Patent Pool (MPP), we look forward to offering our intellectual property expertise and experience, and to working closely with WHO and partners”, said Charles Gore, Executive Director of MPP. 

“Within the consortium, MPP will provide appropriate intellectual property analysis, define and negotiate terms and conditions of the agreements, provide alliance management and make use of our established robust selection process to allow further technology recipients to benefit.”

Afrigen is a biotechnology company incorporated in South Africa, which established the first adjuvant formulation laboratory in Africa and has a pipeline of vaccines in development. Afrigen has built strong research and development partnerships with leading Universities in South Africa and across Africa.

“We have recently completed a facility suitable for the establishment of a fully integrated mRNA pilot scale production, formulation and fill finish platform,” said Prof Petro Terblanche, Managing Director of Afrigen. “Our platform and facilities are well positioned to deliver on the hub’s objectives, and  Afrigen will focus on ensuring the technical, scientific, quality control and quality assurance and regulatory teams so as to implement the mRNA Hub for Africa.”

Biovac is a South African specialist vaccines company that was established to revive local human vaccine production in Southern Africa. 

“Biovac sources and supplies a comprehensive range of vaccines required by the South African government and its neighbouring countries including childhood disease vaccines among others, and more recently COVID-19 vaccines,” said Biovac CEO Morena Makhoana. 

“It is a long-held desire of Biovac to ensure that the full value chain of vaccines is developed in our continent and our aim is to assemble state of the art manufacturing capacity and help ensure the transfer of mRNA technology and know-how as quickly as possible.”

 

Image Credits: @Olympics , China Daily.

Healthcare professional administering a COVID-19 vaccine at Yankee Stadium in the Bronx, New York in February.

This article is the first in a series on COVID-19 booster vaccines, which is an evolving discussion as more evidence emerges about the performance of vaccines against variants.

A vigorous debate is underway in the global health community over the potential benefits of COVID booster vaccines for healthy people who have already received a full course of a WHO-approved vaccine, with Pfizer pushing hard for boosters to address variants.

Israel announced on Wednesday that it would administer boosters for people over the age of 60 starting next week, joining Hungary, Turkey, Thailand, Bahrain and the United Arab Emirates – although the US is holding back for now.

Vaccines are still a scarce resource and giving third doses to people in wealthy countries means diverting doses from vulnerable people in poor countries, the WHO has warned. Some critics have added that the move is unethical and that it opens the door to the development and global circulation of new variants.

But the pharmaceutical industry, and other booster shot proponents have argued that boosters could be needed in the future, citing lab-based data showing that antibody responses wane six months after the second jab, but rise again following a third jab. 

Booster shot proponents, including a number of leading scientists in Israel, which is now seeing a surge in COVID cases, have also cited new data suggesting that vaccine protection may be waning among older people whose immune systems are weaker  – along with being less effective in protecting people against the Delta variant. 

To address the Delta variant, both Pfizer and Moderna aim to develop new formulations of their vaccines to target more of the SARS-CoV2 spike protein, with plans to roll those new vaccines out by the end of the year.  But a debate is also raging over whether boosters of the existing vaccine are needed even before that among certain groups of people.

Too early to tell?

IFPMA Director-General Thomas Cueni

“Manufacturers and developers are studying the need for boosters based on whether there is waning immunity over time and cross-protection against variant strains,” Thomas Cueni, the head of the International Federation of Pharmaceutical Manufacturers (IFPMA), told Health Policy Watch. “Based on these learnings, companies are also advancing studies of both boosters and new formulations to address SARS-CoV2 variants emerging across the globe.

“If data from studies demonstrate, when available, that there is a need for a booster dose of a vaccine, or a new variant-specific vaccine, we will share the necessary information and work with governments on new agreements or updates to existing agreements to supply booster doses or variant-specific vaccines, subject to regulatory authorization,” he added.

However, booster skeptics have charged that lab-based metrics like antibody responses to vaccines are not a watertight proxy for the real-life performance of vaccines or for immunity against SARS-CoV-2. They have argued that it is too early to tell whether booster shots are needed in the general population.

Still, there appears to be consensus that booster jabs could save lives and precious hospital capacity if they were prioritized in immuno-compromised patients, who are roughly twice as likely to die from COVID-19 as healthy people and often display woefully inadequate antibody responses, even after receiving two vaccine jabs [see related story]. 

Going forward, policymakers will have to re-evaluate whether vaccine policies should aim to prevent infection and symptomatic disease, or whether it is more realistic to prevent severe disease and death – in light of gaping vaccine shortages and the rapid spread of new variants like Delta, public health experts told Health Policy Watch.

Dr Michael Osterholm, Director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, said that there are still too many unknowns.

“What we’re really looking for are these larger studies but that takes time. What’s important is what happens in the next six months or the next year,” he told Health Policy Watch in an interview. “Do [fully vaccinated people] get infected or not? Do they have waning immunity? The pandemic has only been around for 1000 days. We just don’t know yet.”

US health protection agency says boosters not needed for now 

After a private meeting between Pfizer and US regulators about a third booster jab earlier this month, the US Centres for Disease Control (CDC) and the US Food and Drug Administration (FDA) responded that “Americans who have been fully vaccinated do not need a booster shot at this time”.

“We are prepared for booster doses if and when the science demonstrates that they are needed….People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta,” said a joint statement from CDC and FDA in early July. 

“People who are not vaccinated remain at risk. Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated.”

But this week, a leaked CDC report revealed that a person infected with the Delta variant may infect five to nine others on average – making it at least twice as contagious as the original SARS-Co-v2 lineage and as infectious as chicken pox. In addition, the report found that vaccinated people may be as likely to spread the virus as unvaccinated people. Those findings, first reported by the Washington Post, are thought to have pushed the CDC to reverse its mask mandate to recommend that everyone – including those fully vaccinated – wear masks in certain settings in public indoor events.

Thailand, UAE and Bahrain are already giving boosters 

Meanwhile, Thailand, United Arab Emirates (UAE) and Bahrain have pushed ahead with a booster jab in healthy people who have received both shots of Sinopharm, Sinovac, and AstraZeneca vaccines – all viewed as less efficacious than the mRNA vaccines produced by Pfizer and Moderna. 

Soon, other large G-7 nations like the United Kingdom, the United States, and Germany, may also follow suit following fresh concerns that two vaccine shots, even of the most effective vaccines, may not be sufficient to prevent SARS-CoV-2 infection and mild disease against highly contagious variants like Delta.

Yet large-scale data from the UK, Qatar, and Israel, demonstrates that vaccines confer robust protection against hospitalization and death from SARS-CoV-2 – and that those trends persist against variants like Delta.

In addition, a multi-country study supported by Pfizer involving almost 45,000 people revealed that, with the Beta variant, vaccine efficacy against infection drops from 96% to 84% after six months. 

The study, which is not yet peer-reviewed, also stressed that efficacy against hospitalisation stands at 97% after six months. Those findings, researchers said, demonstrate that the Pfizer vaccine “prevents COVID-19 effectively” six months after the second jab:

“The data in this report demonstrate that BNT162b2 [Pfizer] prevents COVID-19 effectively for up to six months post-dose two across diverse populations, despite the emergence of SARS-CoV-2 variants, including the B.1.351 [Beta] lineage, and the vaccine continues to show a favourable safety profile,” concluded the study.

It adds that “ongoing follow-up is needed to understand the persistence of the vaccine effect over time, the need for booster dosing, and timing of such a dose….booster trials to evaluate safety and immunogenicity of BNT162b2 are underway to prepare for this possibility.”

These findings come on the heels of an earlier study in some 40,000 people in the UK, published in the New England Journal of Medicine (NEJM), which, similarly to the Pfizer study, found that two shots of Pfizer still confer strong protection against symptomatic disease, with a protection of 88% against the Delta variant, in comparison to 94% against Alpha, the variant first discovered in the UK. 

The NEJM study indicates that fully vaccinated people are likely to be well protected against variants like Delta, if they receive both shots, concluded the authors of the study.

“Overall, we found high levels of vaccine effectiveness against symptomatic disease with the delta variant after the receipt of two doses,” the authors said. “These estimates were only modestly lower than the estimate of vaccine effectiveness against the alpha variant,” they added, noting that similar trends were seen with the AstraZeneca vaccine.

However, they warned that a single dose of the Pfizer/BioNTech vaccine conferred substantially less protection against Delta compared to Alpha – with a drop in effectiveness from 50% to 31% for symptomatic disease, respectively. 

In US, 97% of people hospitalized for COVID-19 are unvaccinated 

In the US, too, it appears that fully vaccinated people develop mild but not severe disease or death. Rochelle Walensky, the Director of the US Centers for Disease Control (CDC), has said that 97% of hospitalised COVID-19 patients in the US are unvaccinated – suggesting that achieving high vaccination coverage can effectively curb transmission, hospitalisation and deaths from COVID for now.

“We are seeing outbreaks of cases in parts of the country that have low vaccination coverage because unvaccinated people are at risk,” said Walensky. And communities that are fully vaccinated are generally faring well.

“The good news is that if you are fully vaccinated, you are protected against severe COVID, hospitalisation, and death, and are even protected against the known variants — including the Delta variant — circulating in the country,” Walensky.

“If you are not vaccinated, you remain at risk. And our biggest concern is that we are going to continue to see preventable cases, hospitalisations, and, sadly, deaths among the unvaccinated.” 

High-risk groups in poorer countries should be vaccinated first

The WHO, meanwhile, has taken a strong stance against boosters in healthy people who are fully vaccinated, asserting that scarce vaccine doses need to be directed first of all to countries and populations where health workers and older people haven’t yet been vaccinated at all. 

“Some countries and regions are actually ordering millions of booster doses before other countries have had supplies to vaccinate their health workers, and the most vulnerable. I ask you, who would put firefighters on the front line without protection – and who are most vulnerable to the flames of this pandemic? Health workers are on the front lines,” the WHO head Dr Tedros Adhanom Ghebreyesus said earlier this month.

“Currently, data shows us that vaccination offers long lasting immunity against severe and deadly COVID-19. The priority now must be to vaccinate those who have received no doses and protection,” the WHO DG added. 

In light of the gaping shortage of vaccines in low- and middle-income countries, as well as the scarcity of data about the benefits of boosters in healthy people, prioritizing vulnerable populations appears to be a viable policy option, at least for now, experts told Health Policy Watch.

“There isn’t much evidence regarding the third shot in healthy people who are fully vaccinated,” Antoine Flahault, the Director of Geneva University’s Institute of Global Health, told Health Policy Watch. “I am not sure that the priority is to give a third shot to entirely vaccinated populations when large parts of the world remain still very poorly covered.

“I would suggest to ask regulatory authorities (e.g. EMA) to take a position rather than proposals coming from manufacturers which can always be prone to forms of conflicts of interest,” he added. “[Boosters] must be decided by bodies totally independent from producers.”

At the same time, German’s Health Minister Jens Spahn, while visiting Geneva earlier this month, asserted that vaccine shortages elsewhere are not a good reason to hold off on boosters in high-income countries that already have large groups fully vaccinated.

“I think we should be able to do both [administer boosters and vaccinate high-risk groups in other countries]. I want both to be possible for us to be able to provide a third vaccination, while also providing our first vaccination to everyone around the world…One shouldn’t come on the account of the other,” he said at an event at the Geneva Graduate Institute, adding that he expected vaccine surpluses, rather than shortages, by 2022.  

Re-evaluating the aims of vaccine policies

It appears that policymakers have reached a crossroads where they could either attempt to prevent COVID infection, transmission, and mild disease altogether – or instead try to prevent severe hospitalisations and death in vulnerable groups, Eyal Leshem, Director of the Center for Travel Medicine and Tropical Diseases at Israel’s Sheba Medical Center, told Health Policy Watch

But as the coronavirus continues to mutate and vaccine doses remain scarce in poorer countries, preventing infection and transmission of SARS-CoV-2 in the whole population is bound to be a “challenging goal” for now, he added.

“We are learning now that achieving population immunity is going to be a challenging goal in a world where the virus mutates and the vaccine is less effective in preventing infection and mild disease with new variants,” said Leshem. “We know this from other pathogens, where the purpose of the vaccine is to prevent severe hospitalisations and death [protective immunity] rather than to completely prevent infection [sterilizing immunity]. Those are two different approaches to public health protection now.

“If you want to protect persons against severe disease and hospitalisations, then your target population are those that are at highest risk,” he said. 

First in a series on COVID-19 booster vaccines. See the second article, COVID Vaccine Boosters in Immuno-compromised People – Could They Also Help Curb Development of New Variants ?

Image Credits: Flickr – New York National Guard.