Israeli Prime Minister Naftal Bennett (right) is briefed about Sheba Medical Center's COVID-19 fourth shot trial on Tuesday, January 4, by hospital Director-General Prof. Yitshak Kreiss.
Israeli Prime Minister Naftal Bennett (right) is briefed about Sheba Medical Center’s COVID-19 fourth shot trial on Tuesday, January 4, by hospital Director-General Prof. Yitshak Kreiss.

A fourth shot of the Pfizer coronavirus vaccine administered to individuals who received their third shot nearly five months ago produces a five-fold increase in antibodies, according to preliminary results of a first-in-the-world trial being conducted in Israel.

The news comes on the same day that the country announced it would launch a trial to determine the effectiveness of receiving a fourth shot of the Moderna coronavirus vaccine beginning on Wednesday.

Both trials are being run out of Sheba Medical Center at Tel Hashomer and include around 150 medically personnel who received their third doses by August 2021, with a serology result below 700.

Participants in the Pfizer trial were inoculated a week ago. The hospital announced the preliminary results on Tuesday during a visit to the facility by Israeli Prime Minister Naftali Bennett. The data has not yet been published.

Fourth Pfizer shot increases antibodies five-fold

“I am pleased to announce … that the initial research indicates that within one week of receiving the fourth vaccine, there is a nearly fivefold increase in the number of antibodies in the blood,” Bennett said. “[A fourth booster] will probably provide a much higher level of protection than without the shot – a high level of protection for both infection and severe morbidity. In simple terms, the fourth vaccine is safe, it must be. The fourth vaccine is very likely to work.”

He added that in the two days since Israel opened up fourth doses, more than 100,000 Israelis registered to be vaccinated or have already been vaccinated.

Israel is the first country in the world to offer a fourth shot to all citizens over the age of 60 and medical workers who received their last doses at least four months prior.

Chile also announced last month that it would offer citizens a fourth coronavirus vaccine dose, also starting with those who are at highest risk of infection or developing severe disease, but those shots are not expected to begin until February and they are being given only after six months have passed from the previous jab.

Brazil also has approved a fourth shot, but only for the immunocompromised.

Researchers say fourth dose safety profile is as good as expected

Prof. Gili Regev-Yochay, director of the Infection Prevention and Control Unit at Sheba, is overseeing the trial. She stressed that the safety profile of the fourth shot appears similar to the profile in the previous doses.

“These initial findings join the preliminary results on potential side effects, which were obtained following the administration of the fourth dose, which also indicate the safety of the fourth dose,” said Regev-Yochay. “This study will yield more information in the coming days and weeks.”

The Moderna trial is being run in collaboration with Medison Pharma, a company that markets the Moderna vaccine in Israel. Participants will be medical workers who received three shots of Pfizer and will now receive a dose of Moderna. Researchers will be evaluating the degree of immunity and protection against the Omicron variant with this combination.

Both trials are being run on conjunction with Israel’s Health Ministry and with full approval of the Helsinki Committee.

Image Credits: Sheba Medical Center.

Influenza virus
Influenza virus

The world’s first case of “flurona” – a co-infection with both seasonal influenza and COVID-19 was reported in Israel last week, as the Omicron variant sweeps across the world. Since then, small numbers of people co-infected with both viruses have been identified in other European countries as well, a World Health Organization official in the European Regional Office confirmed.

“Small numbers of co-infections of influenza and SARS-CoV-2 have been seen elsewhere and have been reported internationally during the pandemic to date,” Dr. Dorit Nitzan, WHO European Regional Emergency Director, told Health Policy Watch. “Experience and understanding needs to build further whether there are clinical differences in the presentation, management and outcome of these cases.”

WHO so far has not provided any reports on the numbers.

Coronavirus
Coronavirus

Fears of a widespread flu and COVID twindemic did not materialize last year, as masking and social restrictions apparently kept flu cases unusually low.

There are fears that the European region and other parts of the northern hemisphere could now be vulnerable to a “Flurona” wave – as the highly infectious Omicron variant sweeps through the world. And at the same time, many vulnerable people also didn’t get a seasonal flu jab.

Although WHO’s Geneva Headquarters also said Tuesday that the current Omicron symptoms indeed appear much milder than previous waves, largely affecting the upper respiratory tract.

“We are seeing more and more studies pointing out that Omicron is infecting the upper part of the body. Unlike other ones, the lungs would be causing severe pneumonia,” WHO Incident Manager Abdi Mahamud said in a Geneva press briefing.

Seasonal Flu on rise

Already, the number of flu cases detected in the WHO European region was “above what we would normally expect to find in the population,” Nitzan said.

According to WHO European Region,, in any given year 5% to 15% of the population is affected by influenza – around 3 million to 5 million cases resulting in 650,000 deaths.

“With COVID-19 also in high transmission across our region, there is the risk that this so-called twindemic could put excessive pressure on already overstretched health systems,” the WHO website said.

The impact could be especially acute on the most vulnerable populations, such as the elderly or people with underlying medical conditions, explained Prof. Cyrille Cohen, head of the immunology lab at Bar-Ilan University, as both flu and COVID-19 on their own can be lethal for older people.

“One virus might weaken you and the second one could be the straw that breaks the camel’s back,” he said. “You might end up with the Omicron variant that is not so tough but then get the flu and that gives you a high fever and the combination could put your life at risk.”

First case of flurona reported in Israel

The first case reported by Israel was a young woman in her 38th week of pregnancy. The woman was treated with a drug combination that targets both coronavirus and flu, according to Dr. Arnon Wiznitzer, head of the Women’s Hospital at Beilinson Hospital in Petah Tikva, Israel. She and her baby were in stable condition on Monday.

“We did not have any kind of influenza all year last year,” Wiznitzer said, “but this year is different.”

He said that a significant number of pregnant women are presenting in the delivery room with flu-like symptoms and it is difficult to know whether they have influenza or COVID-19. As such, these women are put into special isolation rooms for labor and delivery, where they are tested for both viruses.

Until now, the majority of cases have turned out to be the flu, but he expects the balance will shift as COVID cases rise in the country. Israel is reporting more than 10,000 new cases per day and is expected to reach up to 50,000 – around the same number per capita as some of the hardest hit European countries, such as Denmark.

‘Flurona’ symptoms

When it comes to the symptoms of flu, COVID or flurona, it can be difficult to tell the difference, according to Dr. Richard Peabody, who leads the High-threat Pathogen team and the Surveillance and Laboratory pillar of the COVID-19 Incident Support Management Team at WHO/Europe.

In a WHO Q&A, he explained that “both viruses are highly infectious respiratory diseases and share many of the same symptoms, such as coughing, fever, shortness of breath, and/or loss of taste and smell. Because of the difficulty in distinguishing the diseases from symptoms alone, if you are symptomatic, you should isolate yourself from other people to reduce the risk of the infection spreading, particularly to vulnerable people, and get tested for COVID-19 as soon as possible.

“While both diseases can cause serious illness, COVID-19 is more likely to lead to health complications, admission to hospital and, in some cases, death – so getting tested is essential,” Peabody said.

Flu vaccines important – and so far vaccine rates in European Region appear lower than usual

It is also important to get vaccinated, Peabody stressed.

In Israel, where there are around 2,000 people hospitalized for flu, vaccination rates against influenza are down, in comparison to past years. And this is likely to be reflective of the broader situation in WHO’s European Region, Nitzan said – although WHO’s regional influenza vaccine uptake rates for the 2020/21 season are not yet available.

Until now, the region is mainly seeing three strains of influenza viruses, including: A(H3N2) viruses and some influenza A(H1N1)pdm09 or influenza B viruses, according to WHO’s European Regional Office.

“People at increased risk of severe disease from [flu] infection include older people, pregnant women, young children, immunocompromised people and people with chronic underlying medical conditions,” WHO said. ”These groups represent a sizable proportion of the population in the WHO European Region. Therefore, WHO/Europe recommends that everyone at risk of severe disease from infection with influenza, as well as health-care workers, be vaccinated.”

Although there is limited evidence about people who have received both the COVID-19 and the influenza vaccines at the same time, WHO said that doing so does not show any increase in adverse effects.

Wiznitzer said that in Israel these high-risk groups, especially pregnant women, are encouraged to get both shots, because flu and COVID can have adverse effects on mom and baby.

“Fighting both flu and COVID can be very dangerous,” he said. “I can ensure that both vaccinations are safe during pregnancy and on the baby.”

Image Credits: Flickr.

A child receives a vaccine through the Maccabi Health Fund in Israel in December 2021.
A child receives a vaccine through the Maccabi Health Fund in Israel in December 2021.

Two new large scale reviews of the effects of the two-dose Pfizer’s mRNA vaccine in children aged 5-11 shows fewer severe effects than in older groups.

Tuesday’s report, by the Israeli Health Fund Maccabi covering more than 20,000 children, comes on the heels of a similar US Centers for Disease Control and Prevention (CDC) study of some 42,504 children that found nearly all side effects have been mild as well.

The findings also coincide with a US Food and Drug Administration announcement that it has expanded its approval of booster vaccines to kids aged 12- to 15-years-old. It also said that it would allow some children aged five to 11 who are immunocompromised to get a third shot, such as those who have undergone organ transplants. A CDC expert group is meeting today to decide on implementation of the FDA authorization.

Children ages 5-11 did not experience any severe or unusual side effects after receiving a second dose of the Pfizer coronavirus vaccine, according to a report released Tuesday by Maccabi Health Services – one of Israel’s four national health funds.

No reports of heart inflammation

In the CDC study, there were 12 serious reports of seizure and 11 reports of myocarditis among the children enrolled in the CDC-FDA Vaccine Adverse Event Reporting System (VAERS) – none fatal. Two deaths reported in 5-year-olds with complicated health histories could not be directly linked to the vaccine.

Notably, in the Israeli study, there have been no reports of myocarditis – a rare heart inflammation condition that was found to affect most young men between the ages of 16 and 30 in previous studies of those age groups.

“There were no unusual side effects,” said Dr. Miri Mizrahi Reuveni, director of the Health Division at Maccabi Healthcare Services in a briefing.

According to the report, 70% of children experienced pain at the site of injection – the same percentage who experienced pain after their first jab.

In addition, a third (33%) of children experienced general side effects, such as fatigue, headaches and general achiness. Only 20% of children experienced similar side effects after the first shot.

“One in four (26%) of 11-year-olds vaccinated with a second coronavirus vaccine dose missed a school day or afternoon activity due to side effects,” Reuveni said.

Fewer side effects the younger the age group

She noted that there are fewer side effects the younger the children are. Only 11% of five-year-olds missed a school day or activity. Also, 18% of 11-year-olds experienced a headache, for example, compared to 8% of five-year-olds.

This is also the case when comparing vaccinated children to adults, the Maccabi data shows.

Israel approved vaccines for children 5-11 shortly in late November, shortly after the United States.

So far, around 9% of Israel’s 5-11-year-olds are fully vaccinated, meaning they have had two shots in the last six months, although much higher percentages of children have had their first dose.

Maccabi has vaccinated 44,300 children and another 34,000 have appointments for shots. Around 50% of children have received their second dose.

About one in five children in the US have gotten their first COVID vaccine, according to data by the CDC.

Image Credits: Maccabi Health Services.

First vaccinations of Israeli health workers and people over age 60 roll out on Monday.

JERUSALEM – Israel once again has placed itself in the middle of the global clinical debate on the medical benefits of a fourth Pfizer shot to slow the Omicron wave, when it became the first country to approve such an injection for all citizens over the age of 60 and healthcare workers.

Israeli Prime Minister Naftali Bennett announced the roll-out of the second booster during a press conference Sunday night, where he said that anyone over the age of 60, as well as  medical staff who had received their first booster four months ago or more, could get inoculated. 

“The decision was made after consulting with various experts,” Bennett said. “The significance is great; we will have a new layer of protection.”

He added that the country’s policy of booster shots has kept citizens healthy with per capita death rates among the world’s lowest – as compared to the United Kingdom, where the mortality rate is 50 times greater, Germany 100 times and in the United States, 130 times higher.

Israel was the first in the world to approve a third jab despite international criticism,  including from the World Health Organization, which has repeatedly  warned rich countries  against hoarding shots – saying that leaves variants to flourish in low-income countries, prolonging the pandemic.  

“We must not be complacent,” the prime minister warned. “Everyone who is entitled to a fourth dose, get vaccinated.”

In his own announcement, the country’s Healthy Ministry Director-General Nachman Ash said the move was made “in light of the increase in morbidity,” as new daily cases on Monday topped 6,500 and the prime minister warned of 50,000 new daily cases in the coming weeks. That would be a per capita rate about equal to Denmark, one of the European countries seeing exceptionally high COVID infection rates. 

Still no evidence of fourth dose preventing infection 

But local and international scientists and doctors were quick to highlight that there is still no evidence of the effectiveness of a fourth dose in preventing infection, serious disease or death. 

“The decision must be accompanied by a scientific evaluation by an independent body,” charged the Israeli Association of Public Health Physicians in a statement. “Resources must be directed first and foremost to [encourage the public] to complete their first, second and third vaccines whose benefit is clear and scientifically proven.”

Despite racing ahead of the world on vaccine roll-out, Israel’s overall vaccination rate for people who have received their first two doses now lags behind many other nations, with only 60% of the country vaccinated with two jabs within the last six months or three shots, and some 700,000 entirely unvaccinated.  

Other countries will be closely eyeing moves

As in other virus waves, Israel’s moves will be closely eyed by other countries that are anxious to blunt the full force of the new Omicron variant – which is far more infectious – even if it is also supposedly less deadly.  

That, in the face of mounting evidence from around the world that the degree of protection offered by mRNA vaccines against SARS-CoV2 in general, and against Omicron in particular, declines sharply four to six months after vaccination. Laboratory tests have, however, suggested that even lower levels of neutralizing antibodies, as well as continued T-cell immunity, may still provide protection against the development of serious disease. 

Chile also announced last month that it would offer citizens a fourth coronavirus vaccine dose, also starting with those who are at highest risk of infection or developing severe disease, those shots are not expected to begin until February and they are being given only after six months have passed from the previous jab.

Brazil also has approved a fourth shot, but only for the immunocompromised. 

Giant experiment on safety and efficacy 

Couple awaits their fourth vaccine at a Jerusalem health fund station.

Now Israel’s new campaign, which will be tracked by its  national digitized system of healthcare records, and research teams, is expected to provide real-time information on the efficacy of yet another booster against Omicron – in what amounts to a large-scale national clinical trial. 

There is also still no evidence as to the safety of a fourth shot – although most health experts believe that the mRNA vaccines will not cause any short- or long-term harm. 

Sheba Medical Center at Tel Hashomer last week launched a fourth shot trial in late December of around 150 healthcare workers to see how much an additional COVID shot raises a person’s antibody levels and if there are any negative effects, but no concrete data has been released yet.

On Sunday night, the hospital said that out of 154 people who received the jab, 80% reported mild reactions at the point of injection – similar to after the third dose. Some 45% of recipients experienced fever, weakness, muscle aches or headaches – symptoms that in most cases passed within 24 hours. 

“From these data, it appears at this stage that the fourth vaccine profile is as safe as the previous vaccine doses,” said Dr. Gili Regev-Yochay, director of the Infectious Disease Epidemiology Unit at the hospital who is running the new study. 

Local experts argued that pre-existing vaccine protection could decline to almost nil within another month 

The decision to move to a fourth jab was taken following a December 21 meeting of Israel’s national Pandemic Response Team, when experts warned that within a month’s time, Israel’s population would be as vulnerable to Omicron as they had been to the initial COVID-19 outbreak prior to any vaccination whatsoever.

Another team of researchers told the committee that a third booster shot was not even enough to halt Omicron as its effectiveness against the variant would decline from 75% to 25% after month four. 

The Ministry of Health team ultimately voted in favor of the fourth shot – just 10 days after it had shot down the move. But it took Ash another week and thousands more Omicron cases to give his final approval. 

Other critics still maintain, however, that the Pfizer vaccine was never intended to ward off infection, but to prevent severe disease and death. And it appears that the second dose, and certainly the third shot, does a decent job of that already – even in the face of Omicron. 

Moreover, the Omicron variant causes less serious disease in general than its Delta predecessor, according to all studies and predictions. 

Finally, the Omicron wave appears to be short-lived. Already this week, South African health officials announced that they believed the country had passed the peak of the wave, with new cases dropping by nearly 30%.

But until Sheba’s fourth dose trial is over or enough Israelis over the age of 60 get the jab, the decision to give a fourth dose is just a shot in the dark. 

“In the coming days, we will report preliminary findings regarding the initial increase in antibodies and immunity within a week of vaccination,” Regev-Yochay said. 

Image Credits: Clalit Health Fund , G. Ginsberg.

South African President Cyril Ramaphosa and Deputy President David Mabuza visit an Aspen Pharmacare facility in March 2021, a key partner in the country’s J&J vaccine drive.

A new South African study shows that a second Johnson & Johnson dose, administered 6-9 months after the initial single-dose vaccine provided 84% protection against hospitalization from the Omicron SARS-CoV2 variant – results that even outperformed those of an earlier South African study looking at effectiveness of the two-dose Pfizer regime in the face of Omicron.

The study, published in the medrxiv.org preprint server on Thursday,  measured the vaccine’s effectiveness in a group of some 227,000 health care workers, including 69,000 people who received the vaccine booster, between 8 November and 17 December – just as the Omicron variant was taking hold in the country.

The study found that vaccine efficiency against hospitalizations increased over time since the booster dose was administered from 63% in the first to weeks, to 85% post-boost.

“This data is important given the increased reliance on the Ad26.COV.2 [J&J] vaccine in Africa,” said the team of researchers, led by scientists at the South African Medical Research Council, the Desmond Tutu HIV Centre, and other prominent research centers.

Previous large-scale South African study on two Pfizer jabs yielded weaker results

A University of Michigan researcher administers the Johnson & Johnson COVID-19 vaccine candidate during phase 3 clinical trials in the US and seven other countries. The vaccine was authorized in February 2021 by the US FDA.

The study contrasts with a 14 December report on Pfizer vaccine efficacy in the face of Omicron by one of South Africa’s largest insurance providers.

The study by Discovery Health,  found that a two-dose Pfizer-BioNTech vaccine provided 70% protection against severe COVID cases, requiring hospitalizations, but only 33% protection against COVID infection during the current Omicron wave. The study examined some 211,000 COVID-19 test results obtained between 15 November and 7 December, 41% of which were from adult members who had received two-doses of the Pfizer vaccine.

Although the U.S. Food and Drug Administration was one of the first regulatory agencies to authorize the Johnson & Johnson/Janssen COVID-19 vaccine in February 2021, and following that, a booster shot, the vaccine had fallen from favour more recently in the United States. And that was following warnings from the US Centers for Disease Control and Prevention about rare but life-threatening blood clots that could be linked to the vaccine.

The South African Medical Association in November also had protested the exclusive arrangements between Johnson & Johnson and the government which led to health workers having only one booster option – a second J&J jab – while the company ran research on the results.

Latest South African results – turn earlier assumptions on head

Johnson & Johnson can ship vaccines standard cold chain technologies, because the temperature requirements are not as strict as for Pfizer’s and Moderna’s vaccines.

At the time, the South African Medical Association complained that the Pfizer jabs appeared to generate a more robust response – and should thus also be made available to highly exposed health workers.

Now, those assumptions may be turned on the head.

The J&J vaccine has been an anchor of the South African vaccine response from the beginning of vaccine rollouts – where the jab is also being produced in a collaboration with Aspen Pharmaceuticals for domestic use – as well as for the wider African market.

Along with stimulating a high degree of response with the first shot, the J&J vaccine can remain stable for up to three months at  2°C to 8°C, while the Pfizer and Moderna mRNA vaccines require cold chain storage at -28°C to 70°C.

The J&J vaccine uses a inactivated adenovirus  (cold virus) to deliver a genetic fragment of the SARS-CoV2 spike protein into the body, which in turn stimulates immune response.

In contrast, the Pfizer and Moderna vaccines deliver messenger RNA (mRNA) – a single strand genetic instruction making part of a SARS-CoV2 spike protein – into the body.  And that mRNA triggers and immune response.

Unexpectedly potent T Cell responses to Omicron Variant

In another a pre-print laboratory study published on 26 December, South African researchers also found that T-cells taken from people who received Johnson & Johnson vaccines recognized Omicron-infected cells almost as well as they recognized cells infected with other variants. That study is also significant as it suggests that even if antibody response to Omicron is not as robust in vaccinated individuals, the other critical factor in the body’s immune response remains more resilient.

“We found that 70-80% of the CD4 and CD8 T cell response to spike was maintained across study groups. Moreover, the magnitude of Omicron cross-reactive T cells was similar to that of the Beta and Delta variants, despite Omicron harbouring considerably more mutations,” wrote the authors, led by scientists at the University of Cape Town.

See here a video about how the four main categories of SARS-CoV2 actually work:

https://youtu.be/lFjIVIIcCvc

Image Credits: Johnson & Johnson, NBC News.

A major new British study has provided encouraging data that people infected with the Omicron variant are 20% less like to visit a hospital and 40% less likely to be admitted overnight than those with the Delta variant.

The Imperial College study, published Thursday, looked at everyone with a confirmed infection of either variant in the UK between 1-14 December – for a total of more than 324,000 cases.   

At the beginning of the tracking the 164 Omicron cases detected comprised only .6% of total daily cases recorded  By day 14, however, there were 15,804 Omicron cases –  more than 50% of the nearly 30,000 cases a day being reported – reflecting the steep rise in infections from the new variant.  

“Overall, we find evidence of a reduction in the risk of hospitalisation for Omicron relative to Delta infections, averaging over all cases in the study period,” concludes the study, undertaken by researchers at Imperial College. 

“The extent of reduction is sensitive to the inclusion criteria used for cases and hospitalisation, being in the range 20-25% when using any attendance at hospital as the endpoint, and 40-45% when using hospitalisation lasting 1 day or longer or hospitalisations with the ECDS discharge field recorded as “admitted” as the endpoint.

However, the proportionately smaller rate of hospitalizations must be balanced against the “the larger risk of infection with Omicron, due to the reduction in protection provided by both vaccination and natural infection,” the researchers warned.  

Imperial College, UK, study reveals 40% lower hospital admissions for Omicron cases as compared to Delta, even as Omicron rapidly becomes the dominant SARSCoV-2 variant.

Hospitalization risks for people vaccinated and previously infected

The study also found that previous COVID infection reduced the risk of any hospitalisation by approximately 50% and the risk of a hospital stay of 1+ days by 61%.

Cases vaccinated with Pfizer or Moderna for doses 1 and 2 have a similar or higher risk of hospitalisation with Omicron compared with Delta, while cases vaccinated with AstraZeneca for their primary series tended to have a lower risk of hospitalisation relative to Delta. 

The studies authors noted that the small overall numbers of people hospitalized with Omicron so far limits their ability to interpret the data – in light of vaccination status. 

“As more data accumulate, with longer periods of follow-up, assessment of more severe outcomes will become feasible,” report the study’s authors, who are part of the Imperial College COVID response team, and also a WHO Collaborating Center. 

“Currently, vaccination-status stratified hazard ratio estimates … remain very sensitive to small numbers of hospitalisation, particularly in the unvaccinated Omicron group. 

“It is quite possible that larger reductions in hospitalisation risk for Omicron vs Delta may be estimated [among  those vaccinated] for the endpoints of ICU admission and death, given that remaining immune protection against more severe outcomes of infection are expected to be much higher than those against milder endpoints.”

Image Credits: PAHO.org, Imperial College, UK.

Exclusive end year WHO media briefing in Geneva behind closed doors on Monday

Driven by Omicron, Africa is facing a steep wave of new COVID infections – last week reporting the fourth highest number of cases ever recorded in a single week, said WHO Director General Dr Tedros Adhanom Ghebreyesus on Monday. 

He was speaking at an exclusive media briefing in Geneva behind closed doors to a handful of international media outlets with UN-accredited Geneva bureaus.

The rambling two-hour long briefing, released a day later on YouTube, excluded Geneva-based health media as well as most African, Asian, and Latin American media across the world – which the UN press office in Geneva does not recognise or credential. 

While some reporters linked up online, the in-person gathering with reporters hosted by the UN Office at Geneva occurred at a time when Switzerland is facing one of the highest infection rates in the world – and other mass gatherings in Switzerland, such as the World Economic Forum’s 2022 meeting in Davos, have recently been cancelled. 

“Africa is now facing a steep wave of infections, driven largely by the Omicron variant,” said the Director General in the briefing, shared only a day later with Geneva health media, as well as other national and regional media worldwide.  

“Just a month ago, Africa was reporting its lowest number of cases in 18 months. Last week, it reported the fourth-highest number of cases in a single week so far,” he said. In fact, while Africa’s rates remain low overall, due to what experts attribute to a complex range of factors include a younger population and widespread underreporting, new infection rates in southern countries like Botswana, Eswatini and South Africa have now soared to worrisome highs. Per capita reported new infections in those states, where Omicron was first discovered, are comparable to those in the most infection-wracked countries of Europe, including Switzerland and Germany. 

“There is now consistent evidence that Omicron is spreading significantly faster than the Delta variant,” said the DG, in a wide-ranging briefing with senior staff, which looked at the pace of Omicron spread, booster campaigns, and new vaccines under review or approval – as well as reviewing WHO’s record for the year 2021.

Given the fast pace of Omicron’s spread, the WHO Director General urged people preparing for the upcoming Christmas and New Years’ holidays to cancel or delay mass events and social gatherings, in order to slow the variant’s advance. 

“All of us are sick of this pandemic. All of us want to spend time with friends and family. All of us want to get back to normal,” the Director-General declared.  

Dr Tedros Adhanom Ghebreyesus, WHO Director General

But given Omicron’s unique ability to avoid previously acquired immunity, “it is more likely that people who have been vaccinated or have recovered from COVID-19 could be infected or reinfected,” he added. 

And faced with that reality, “there can be no doubt that increased social mixing over the holiday period in many countries will lead to increased cases, overwhelmed health systems and more deaths.  

“The fastest way to do that is for all of us – leaders and individuals – to make the difficult decisions that must be made to protect ourselves and others. 

“In some cases, that will mean canceling or delaying events – just as we have had to cancel the reception we planned to have with you today,” he said, referring to a social event that had been planned for the journalists who had gathered physically at WHO headquarters, following Monday’s briefing.  

“But an event canceled is better than a life canceled. It’s better to cancel now and celebrate later, than to celebrate now and grieve later,” he added.  

Walking back on opposition to boosters 

Senior WHO Advisor, Dr Bruce Aylward

The Director General, as well as senior members of his team, also walked back some of their previous messaging opposing booster vaccines- admitting that there is growing evidence about their potential medical value – particularly for older people.  

“Clearly there is increasing evidence that those most vulnerable will benefit from an additional dose.  Yes, there is a role, but we want to ensure the right programme and vaccinate in the right order,” said Dr Bruce Aylward, WHO senior advisor. 

Aylward and other senior staff stressed that WHO remained opposed to mass booster campaigns on equity grounds – due to fears this will divert potential doses needed by  the more than 90 low-income countries which will miss the 40% vaccination coverage target set by WHO for the end of this year.  

“Remember what we are seeing in some places is not just a booster for those at highest risk but a booster for everyone in the population,” said Aylward. 

“And again, that would make a real demand on vaccines in an environment where they simply are not available to everyone who needs them at this time.”

However, Aylward later contradicted himself somewhat saying that in the first quarter of 2022:  “there will be enough vaccines to vaccinate 40% of the population of every country in the world, plus give a third dose to everybody over 50 years old. So we are very quickly getting into a situation where the production capacity is sufficient.

“The challenge is making sure the right products get  to the right places,.. optimising the allocations to get to where its needed .. to these countries that have been starved of vaccines for so long. everyone in high-income countries over the age of 50 as well as to distribute sufficient doses in low-income countries to meet the WHO 40% goals.”

Added Tedros, “There is new evidence emerging now of the benefits for elderly, over 65, so if it [booster] is going to be used, it’s better focusing on those groups. 

“But some countries are doing boosters very aggressively while their hospitals are filled with people who are not vaccinated. 

So the best would be for countries to convince those who are not vaccinated, convince them to be vaccinated and make sure that they are safe.  Their energy should be spent on finding the unprotected and protecting them.” 

He added: “Instead of boostering a child in high income countries, it’s better to vaccinate the elderly in counties who have not been vaccinated even with the primary vaccines. So the equity issue will also come into play.”  

Data on boosters’ impacts on global supplies lacks transparency

So far, WHO has not come up with detailed data around the likely impact of booster campaigns on global supplies for low- and middle-income countries – despite repeated requests by Health Policy Watch for more clarification of the data and its statements.  

An interview with one senior WHO official, published last week in the Financial Times, claimed that mass boosters in higher income countries could leave global supply chains 3 billion doses short of what is needed for developing regions in the first quarter of 2022.   

But those estimates are based on a presumption that 90% of people in high income countries would accept boosters – when in fact not even 70% have received their first and second jabs. 

Financial Times mapping of WHO claims of 3 billion vaccine dose shortfall in “aggressive scenario” – assumes 90% vaccine coverage in high- and upper-middle income countries.

Conversely, in a pharma-sponsored briefing last week, the data forecasting firm Airfinity claimed that boostering 70% of the population in G-7 countries would not significantly dent supplies needed by LMICs – since the world is now producing over 1.5 billion vaccines a month.  

That assessment, however, was based only on projected estimates of booster needs for seven of the world’s richest economies – and not the three dozen or so high- and upper-middle income countries that have already initiated booster campaigns. 

In response to yet another query by Health Policy Watch, Airfinity said it was trying to update its projections to include all G-20 countries – but had not yet completed the analysis as of the time of this publication.  

What is really needed, said Aylward in Monday’s briefing is more “transparency” that ensures manufacturers prioritize their deliveries of doses to the COVAX global vaccine facility – ahead of more deliveries to rich countries.

Aylward also warned about relying too much on vaccine dose donations, saying that while some 1 billion vaccine doses have been donated so far, only about 15% of those have actually been delivered.

“There is a danger that we create a perverse incentive if we keep encouraging donations,” he added, noting that donations come with many strings attached – including deliveries too close to their expiration date and a lack of choices for low-income countries about which vaccine to receive and when.  

How frequent boosters?

WHO Chief Scientist, Dr Soumya Swaminathan

In terms of how frequently boosters might be needed in the future, and for what vaccines, “the fact is that we don’t know,” added  Dr Soumya Swaminathan, WHO Chief Scientist. 

She said that key driving factors include: “The biology of the individual, the age, how strong the immune system is. 

“There is some data now to show that there is a slippage due to the protection in different vaccines at six months or so. But with Omicron, the initial data is showing that it is very successfully able to evade immune responses and therefore needs higher levels of antibodies.  

“For now, we believe boosters may be needed for people who have weaker immune systems, the older individuals who are more vulnerable. 

“And whether there will be a need for additional vaccines every year, like influenza, it’s too early to say and we really need to follow the science on that.”  

Good news on new vaccines being rolled out  

Meanwhile,  the list of WHO-approved vaccines expanded once more on Tuesday with the Agency’s Emergency Use Listing of the European-made version of Novavax’s new Nuvaxovid™ vaccine. The WHO moved followed just after approval by the European Medicines Agency (EMA) earlier Tuesday. 

The new vaccine was developed by Novavax along with the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI), and is the originator product for the Covovax™ vaccine, produced by the Serum Institute of India, that had received WHO emergency use listing last week.

Both two-dose vaccines are made using the same technologies –  using an engineered baculovirus that delivers the gene of a modified SARS-CoV-2 spike protein into the body to provoke an immune response.  The technology, while novel, is more comparable to the traditional vaccines that deliver dead or inactivated viruses rather than to the mRNA models that deliver “instructions” to the body to produce an antibody response – without delivering any part of the virus itself.   

Significantly, the Novavax vaccines remain stable at 2 to 8 °C refrigerated temperatures – making them particularly relevant for vaccine campaigns in countries with poor cold chains.

The global COVAX vaccine facility has pre-purchased hundreds of millions of doses of the new two-dose vaccine, which is based upon has scored high marks in clinical trials. 

“This new vaccine is part of the COVAX portfolio, and we hope that it will play an important role in achieving our global vaccination targets,” said Tedros. 

Sputnik V – another review in early 2022

WHO officials at the briefing also said that the Agency’s long-delayed review of Russia’s Sputnik V vaccine would hopefully move ahead early next year, providing that the Russian-based Gamaleya Institute submits updated clinical trial data, by the end of this month.   

“Providing all information is available by the end of December, we will be able to perform GMP (Good Manufacturing Practice) inspections locally on Sputnik in February,” said Dr Rogerio Pinto de Sa Gaspar, who heads WHO’s “prequalification” activity.

Reported problems in some of the Sputnik vaccine facilities earlier this year stalled the approval processes for the vaccine, which has lagged well behind Chinese, Indian, European or American counterparts. 

In November, Sputnik’s developers have reported comparative results of its vaccine efficacy in Europe – but the studies have yet to be transformed into peer-reviewed papers. 

 

Image Credits: The Financial Times .

The World Health Organization on Friday issued an emergency use listing for a novel COVID vaccine produced – in a move that should help ramp up new rounds of COVID vaccine distributions to low- and middle-income countries in coming months. 

Approval of the novel vaccine, developed by the US-based firm Novavax, and to be produced by the Serum Institute of India under licence, is long awaited because of it’s particularly high marks in clinical trials and modest cold chain requirements – the vaccine remains stable at only 2 to 8 °C. 

Some 350 million doses of the vaccine, dubbed Covovax™, have been promised to Gavi, The Vaccine Alliance, for the COVAX vaccine facility portfolio, which supplies COVID vaccines to some 93 low and middle-income countries.  

Prior to the WHO authorization, the SII-produced vaccine had so far only received authorisation for use in Indonesia, and is in the process of being approved in Japan. 

Another version of the same vaccine is also under review by the U.S. Food and Drug Administration and European Medicines Agency. 

The WHO move opens the way for the jump-starting of Covovax vaccine distribution under the COVAX framework – even ahead of the FDA or EMA approvals. WHO approval also allows low-and middle-income countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. 

SII expects to manufacture 1 billion doses of Covovax in 2022 

According to reports, the Pune-based Serum Institute of India is expected to manufacture one-billion doses of Covovax for supply to low- and middle-income countries by the end of 2022.

COVAX is co-led by the Coalition for Epidemic Preparedness Innovations, Gavi and the WHO to accelerate the development and manufacture of COVID-19 vaccines, along with fair and equitable access for every country in the world. CEPI also invested financially in the R&D of the new Covovax vaccine. 

According to reports on the phase-3 trial of the vaccine in North America, Covovax was 90.4% effective against infection and was 100% effective against moderate to severe illnesses. The shot has proven effective against COVID-19 infection in the United Kingdom and South Africa, according to the New England Journal of Medicine. 

“This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products in a press release. 

First Of A Kind Vaccine

The vaccine is the first of a different class of COVID-19 vaccine – a protein-based vaccine and one would need two doses of it for protection against the virus.

The vaccine is produced using an engineered baculovirus that contains a gene for a modified SARS-CoV-2 spike protein. 

“With robust data on safety and efficacy against several variants, strong potential in mix and match and booster regimens, a nine-month shelf life, and standard storage temperatures, this vaccine can be used in a variety of contexts and will provide countries with another critical option in the quest to protect their populations,” said Dr Seth Berkley, CEO, Gavi, the Vaccine Alliance. 

According to the press release, the originator product produced by Novavax, named NuvaxovidTM, is currently under assessment by the European Medicines Agency (EMA). WHO will complete its own assessment of this vaccine once the EMA has issued its recommendation.

The Technical Advisory Group for Emergency Use Listing that is convened by the WHO determined that the vaccine meets WHO standards for protection against COVID-19 and that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally, according to the press release. 

The vaccine was assessed under the WHO’s EUL procedure based on the review of data on efficacy, quality, safety, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India.

Thanks to a high vaccination coverage, rich countries have curbed down COVID’s death tolls and hospitalizations, and now some of them can afford to keep most services up running with limited restrictions even amid a COVID wave. 

As more vaccine supplies finally become available to the world’s low-and middle-income countries (LMICs), the latent challenges that should have been addressed long before have emerged. Those include vaccine hesitancy and the ability of weak health systems to mount mass vaccination campaigns amidst other pressing health needs. Global policymakers need to shift their attention from focusing only on the sheer numbers of vaccine deliveries – to developing vaccines fit for purpose in LMICs, and building health systems capable of absorbing these life-saving health products.     

Thanks to a high vaccination coverage, rich countries have curbed down COVID’s death tolls and hospitalizations, and now some of them can afford to keep most services up running with limited restrictions even amid a COVID wave. 

COVID19 vaccination was so impactful that some experts suggest that the virus will soon become endemic – rather than the epidemic-cum pandemic that it has been for the past 20 months. 

Nevertheless, the low vaccine coverage in resource-constrained countries may lead to the creation of still more variants, slowing  the endemization process.  In that sense, the discovery of the Omicron variant was a timely reminder to the world that “no one is safe until everyone is safe” and that, in a better world, vaccines should be available for everyone at the same time.

The reality has been somewhat different 

Highly populated Asian countries have only fully vaccinated around 1 in 3 people. Coverage is 27% in Bangladesh, 27% in Pakistan, 35% in India, 39% in Philippines, and 38% in Indonesia,  leaving hundreds of millions with no jabs. 

Proportionally,  the situation is much worse in Africa (from only about 0.2% vaccination coverage in the Democratic Republic of Congo to about 2% in Tanzania, Burkina Faso, Niger and Madagascar. 

This  is far from all being safe at the same time.  And even as more doses finally become widely available in many African countries, the issues are  far from being resolved. Access to vaccines is quite complex and it encompasses technological, social, financial, and systemic dynamics. So in some countries, only a portion of available supplies actually end up being administered. 

Some countries hold off on more deliveries that they can’t absorb

Countries like South Africa, Namibia, and Mozambique have reportedly asked vaccine manufacturers and donors to hold off on sending more shots because they “can’t use the supplies they have”, according to a recent New York Times report. 

In manycountries less well-resourced, any vaccine campaign is likely to be  a real ordeal – even if health authorities have plenty of doses. 

Even the least demanding  COVID vaccines [e.g. AstraZeneca] require a refrigeration cold chain, while  the most effective mRNA jabs  require much lower temperatures  for long-term storage. 

Cold chain challenges will remain a barrier  – new types of vaccines are needed  

Just impossible for many countries with poor electricity coverage and basic logistics. Not to mention the number of health workers necessary to deploy mass immunization campaigns in countries with historical shortages of medical staff. 

That means that essentially, the existing available  COVID19 vaccines are effective and safe – but they are best fit for high-income countries’ contexts.

Massive investments should urgently go into transversal health system strengthening.  But in view of the time that will take, there is also a need to focus research on the development of a new generation of vaccines suitable for low-income countries. 

Much as resource constraints drove the development of rapid tests for HIV/AIDs and malaria, the same constraints should drive research into vaccines that are fit for purpose in health clinics with little access to electricity and few trained staff. . 

An ideal vaccine should be an oral or nasal spray one with a 12-month shelf life which requires no refrigeration nor the assistance of health workers. 

Out of the 137 vaccines in clinical development reported by WHO, less than 1 in 10 belong to a new generation. As their efficacy and safety still have to be proved, it is not clear how much public investment they receive compared to proven products already in the market. 

Out of the 137 vaccines in clinical development reported by WHO, less than 1 in 10 belong to a new generation.

It will take years to strengthen poor countries’ health systems and years to develop new vaccines. COVID-19 pandemic made clear that these investments should not be punted down the field to another time. .

Vaccine hesitancy another barrier 

Additionally, vaccine campaigns suffer from hesitancy among people, and poor countries are not spared. The fact that vaccine hesitancy may be a potential threat to the achievements of traditional vaccination programmes in Africa has been well reported, even before the pandemic hit. 

Although one new survey suggests that in many African countries the willingness to get COVID vaccines is certainly far greater than availability, the picture is not uniform. South Africa has only reached a 26% vaccination coverage – despite comparatively wide vaccine access.  In places like the DR Congo, vivid memories also persist of vaccine coercion episodes or doubtful drug testing. Public awareness campaigns can counteract the distrust but, again, almost no investment has gone into low-income countries for vaccine promotion: education on vaccines is left to the social media. Certainly, this trust cannot be built by shipping close-to-expiration doses or second-class vaccines, as it has been repetitively reported in the media.

Government buy-in – at the price of other health priorities ? 

Finally, COVID19 vaccine campaigns are only partially endorsed by countries facing other pressuring health priorities. For example in Niger, half of the population is below the age of 15 and only 2% of the population is aged above 65, the life expectancy is around 62 years and almost 1 child in 10 dies before the age of 5 from preventable diseases. Burkina Faso, Mali, and many countries in Africa share a similar profile. What is the incentive for those countries to divert their scarce resources to a virus that is predominantly perceived to hit the elder?

Candidates of the vaccine in clinincal phase.

International agenda has been too focused on supply numbers and not quality of delivery

Despite the complexity in deploying COVID vaccine campaigns, starting from the G20 in Rome and their reaffirmed commitment to the Access to COVID-19 Tools (ACT) Accelerator, the focus of the international agenda has been mainly about shipping as many doses as possible. In early November, a Task Force meeting on Scaling COVID-19 Tools was held among International Organizations including World Health Organization and COVID-19 vaccine manufacturers. 

The discussions were disappointingly limited on how to supply more vaccines, how to tackle trade-related bottlenecks, how to diversify manufacturing, etc. 

Agenda for strengthening health systems is too narrowly limited 

Although the latest Strategic Plan of the Act Accelerator  – the umbrella initiative for COVID  vaccination, treatment and testing, does include investment for health systems in the fight against the pandemic, it is narrowly limited to the “the technical, operational and financial resources to translate new COVID-19 tools into effective health interventions” (e.g.to set up ultra- cold chain infrastructure).

Even members of the civil society have recurrently called for more doses or a patent lift, as if it were a magic formula, while it is just a piece of a complex puzzle. 

In a recent opinion piece, Medicins Sans Frontieres’ director of operations Isabelle Defourny, rightly suggested avoiding simplistic views and pointed out the need for more holistic and localized responses to the pandemic. Similarly, the European Federation of Academies of Sciences and Humanities (ALLEA) in a December statement raised similar concerns that the current focus on a patent waiver may distract attention from other measures that are of fundamental importance in striving towards global vaccination. 

If the multiple barriers to vaccination are not surmounted in the first place, we will not reach vaccination for all at once, and no one will be safe. A genuine roadmap to end COVID19 should be inclusive of all countries and not driven by a few. It should consider all stakeholders involved and give voice to them. Failing to do so, the pandemic will likely last for longer.

About the Author:  

Riccardo Lampariello, head of Health Programme, at Terre des Homes, the leading Swiss relief agency for children’s aid, holds an MSc in Applied Statistics and an MBA. He has over 20 years of experience in Health: from Pharma – where he worked for 10 years in various positions in Clinical Development and Business Development – to International Organizations and International NGOs. He worked for GAVI Alliance, the Union of International Cancer Control and in May 2017 Riccardo joined Terre des hommes (the Swiss leading child protection agency improving millions of children’s lives worldwide) where he is Head of the Health division. With a focus on innovation, he drives the development and deployment of innovative projects (both disruptive and incremental), including one of the largest digital health solutions in Sub Saharan Africa. Twitter: @RLampa75 LinkedIn : www.linkedin.com/in/lampariellor

The opinions expressed in this article are the author’s own and do not reflect necessarily the view of Terre des Hommes.

 

Image Credits: WHO.

Global support is needed to ensure equitable distribution of vaccines in Africa. Rollout in Madagascar in early March, just before vaccine supplies to Africa dried up.

An overwhelming majority of people in Africa – 78% of people surveyed across 19 countries in the African Union – are willing to get vaccinated, according to new research from the Partnership for Evidence-Based Response to COVID-19 (PERC).

PERC – a public-private partnership consisting of organizations and institutions such as the African Union, Africa Centres for Disease Control and Prevention (CDC), Vital Strategies, the World Health Organization, and others – polled approximately 23,000 people across 19 African Union Member States. 

The 19 countries surveyed included South Africa, Kenya, the Democratic Republic of Congo, and Morocco – representing countries with wider access to vaccines and almost none at all.  

That is despite the fact that as of November 2021  less than 7% of the African continent has been vaccinated. 

The report, released on Thursday, highlights that vaccine hesitancy is not the top challenge in Africa. 

Despite efforts of the African Vaccine Acquisition Trust (AVAT) and the COVAX facility to expand vaccine access, only three African countries – Egypt, Morocco, and Zimbabwe – have reached the end-of-year WHO vaccination coverage target of 40%, according to the report. 

Vaccination coverage does not match vaccination demand in Africa

This demonstrates a substantial unmet need between acceptance and coverage, and underscores even further the importance of consistent vaccine supply and support for vaccination programmes in Africa. 

“We must work urgently towards equitable access to safe and effective vaccines on the African continent,” said Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention. 

“The PERC data show that demand for vaccines is substantially higher than supply.”

The PERC report considers the inequity surrounding global vaccination efforts and the logistical challenges to vaccinating the African continent. It also further outlines several preventative measures critical to mitigating COVID-19 transmission in the wake of new, more transmissible variants, such as Omicron. 

While respondents’ intention to vaccinate remains high, coverage remains low

High vaccine acceptance contradicts media reports about hesitancy 

Top reasons for vaccine hesitancy in Africa include: low risk perception, lacking information about vaccines, and lack of trust in government

The high vaccine acceptance rates of the African continent, higher now at 78% when compared to a previous PERC survey conducted earlier in the year (67%), contradicts media reports that low vaccination rates across Africa are due to hesitancy.

Five surveyed countries – Guinea, Morocco, Mozambique, Tunisia, and Zimbabwe, even had acceptance at 90% or higher. Acceptance rates were influenced by trust in governments and their handling of the pandemic; perceived risk of COVID-19; availability of information; as well as trust in the vaccines.

Among the 20% of respondents who did express vaccine hesitancy, top reasons included low risk perception, not having enough information about vaccines, and lack of trust in government. 

Misinformation has also been shown to influence decision-making regarding vaccines.

The global reaction to adverse events associated with AstraZeneca’s vaccine at the beginning of Africa’s rollout campaign likely had a lasting impact on vaccine acceptance and product choice in many member states. 

Vaccine production fails to reach global targets 

An insufficient number of vaccine doses have been promised to low- and middle-income countries, with the supply delivered even lower than expected.

Global production targets totaled 20.8 billion doses, but manufacturers’ project that only about 12 billion will be produced by the end of the year. 

In addition, less than 15% of donated doses were actually delivered to LMICs. 

Unpredictable and inconsistent supply act as logistical bottlenecks that threaten countries’ ability to meet demand. 

In its report, PERC called on numerous stakeholders – manufacturers, donor countries, AVAT and COVAX to work collaboratively with recipient governments to ensure advance vaccination campaign planning and rollout.

“As vaccine supply increases in many countries, efforts to identify and address barriers to getting shots into arms are critical,” the report read.

“WIthout immediate, coordinated support to address these bottlenecks, the pace of vaccination will remain slow, in spite of the great demand for COVID-19 vaccination.” 

Recommendations point towards global support and public health measures 

COVAX
COVAX vaccine deliveries in Africa.

The report makes several calls to action, noting that in addition to scaling-up public health infrastructure and implementing preventative measures, the global community would need to support and supply AU Member States with vaccines for more effective and equitable distribution.

Notably, while individual public health measures – handwashing, mask-wearing, and social distancing – all garnered support from at least 90% of survey respondents, preventative measures that restricted gathering received less support. Unemployment and food security made it difficult to adhere to restrictive community measures.

Specifically, the report recommends: 

  • Governments should prioritize strengthening surveillance structures and health data systems.
  • Though reliable supply of safe and effective COVID-19 vaccines is necessary, it is not sufficient. The global community should support vaccine delivery with resources and expertise to ensure coverage.
  • Public health and social measures are critical tools for mitigating COVID-19 transmission, especially as more transmissible variants emerge in under-vaccinated populations. 
  • To the fullest extent possible, the global community and national governments should invest in public health infrastructure and social protection programs. 

“The PERC data enable policymakers to both save lives and minimize impacts on livelihoods,” said Tom Frieden, President and CEO of Resolve to Save Lives, an initiative of Vital Strategies. 

“The global community has an opportunity to invest in health care workers and public health infrastructure to support vaccine delivery and COVID-19 care and prevention in the near term, and also repair and restore health service delivery disrupted by COVID-19 for the long term.”

Image Credits: World Bank/Flickr, PERC , PERC, UNICEF.