Health care worker taking the temperature of an asymptomatic COVID-19 postive individual in an assisted living facility in Ohio.

Two new studies published this week highlight the challenges to health policy posed by COVID-19 – with seriously ill COVID-19 patients continuing to suffer with “Long COVID”  months after being released from the hospital – while completely asymptomatic cases drive more than half of overall disease transmission.  

More than three quarters of patients diagnosed with COVID-19 have at least one persistent symptom six months after falling ill, finds a new study published Saturday in The Lancet, the largest yet on the long-term effects of the virus.  Some 76% of over 1,700 patients studied reported experiencing at least one symptom half a year after their initial onset of symptoms and hospitalization.

The study found that fatigue or muscle weakness – the most common persistent symptom – was reported by 63% of patients, while a quarter experienced sleep difficulties, and 23% experienced anxiety or depression. 

Researchers from several universities and hospitals in China, including the Jin Yin-tan Hospital in Wuhan and the China-Japan Friendship Hospital in Beijing, examined 1,733 patients discharged from the Jin Yin-tan Hospital with COVID-19. The follow-up study, conducted between June and September, contains the longest follow-up period of a peer-reviewed study on the long term effects of SARS-CoV2 infection. 

“Our analysis indicates that most patients continue to live with at least some of the effects of the virus after leaving the hospital, and highlights a need for post-discharge care, particularly for those who experience severe infections,” said Bin Cao, vice-director of the National Clinical Research Center for Respiratory Diseases and co-author of the study. 

According to the study’s scale of disease severity, the risk of reporting at least one symptom was higher among those hospitalized and requiring ventilation than those hospitalized but not requiring supplemental oxygen. 

Doctor checking on a COVID-19 patient connected to a ventilator in the ICU in Louisiana.

Those higher on the disease severity scale were found to have more problems with mobility, pain and discomfort, as well as reduced lung function – characterized by decreased flow of oxygen from the lungs to the bloodstream – compared to those with a less critical COVID-19 infection. 

Diminished exercise capacity was noted among patients with more severe disease, with 29% of those high on the severity scale walking less in six minutes than the lower limit of the normal range, compared with 24% at the lower end of the scale. 

Age and gender were also risk factors for symptoms. Older age was associated with higher levels of lung diffusion impairment and fatigue or muscle weakness, while being a woman was a risk factor for persistent psychological symptoms, such as higher levels of stress, anxiety and depression. 

The results of the study are consistent with previous data gathered on long term SARS symptoms. In a study from 2007, 33% of patients reported significant reductions in mental health and 18% had lowered exercise capacity a year after their illness. A four year follow-up study found that 40% of patients still had a chronic fatigue problem, along with other psychiatric morbidities.  

Beyond influencing mental health and lung function, COVID-19 has also been linked to adverse impacts on other organs. Approximately 13% of patients with normal kidney function at the time of their hospitalization with COVID-19 had lower levels of kidney function at the follow-up. 

Additionally, six months after COVID-19 infection, the levels of neutralizing antibodies were 52% lower than at the time of infection. The authors warn of the potential implication for re-infection. 

“Our work also underscores the importance of conducting longer follow-up studies in larger populations in order to understand the full spectrum of effects that COVID-19 can have on people,” Bin Cao said. 

COVID-19 Infections Driven By Asymptomatic Carriers

Paradoxically, however, while some people suffer serious long-term impacts, it is asymptompatic individuals who are responsible for more than one-half of all SARS-CoV-2 transmission, according to another study published in the Journal of the American Medical Association on Thursday.

The study reported on the results of a model, developed by the US Centers for Disease Control (CDC), which found that 59% of transmission of SARS-CoV-2 is caused by asymptomatic carriers.

“The bottom line is controlling the COVID-19 pandemic really is going to require controlling the silent pandemic of transmission from persons without symptoms,” Jay Butler, deputy director for infectious diseases at the CDC and co-author of the study, said in an interview with the Washington Post. 

The analytical model is based on a series of assumptions about peak infectiousness, the proportion of individuals that never develop symptoms, and the infectiousness of presymptomatic or asymptomatic individuals. 

The proportion of transmission due to all individuals without symptoms at the time of transmission. For example, peak infectiousness at the same time as median symptom onset (0 days difference) with 10% of transmission from individuals who never have symptoms would mean that approximately 51% of transmission is from asymptomatic individuals.

According to authors of the study, under a range of scenarios and assumptions, the model consistently indicated that at least 50% of transmission is linked to individuals without symptoms at the time of transmission. 

The baseline scenario assumed that asymptomatic individuals are 75% as contagious as those who develop symptoms and established that 35% of asymptomatic transmission originated from presymptomatic individuals and 24% from those who never develop symptoms. 

These findings highlight the importance of wearing masks, hand hygiene, social distancing, and strategic testing in order to slow the spread of COVID-19. 

“The community mitigation tools that we have need to be utilized broadly to be able to slow the spread of SARS-CoV2 from all infected persons, at least until we have those vaccines widely available,” said Butler.

Although the model simplifies the complex phenomenon of transmission and makes several assumptions, the findings could assist in beginning to understand and control asymptomatic transmission. 

This is particularly important in the context of the global spread of two more contagious variants of SARS-CoV2. 

Image Credits: Flickr – The National Guard, Flickr – US Navy, JAMA.

A doctor preparing the Moderna COVID-19 vaccine at the Naval Hospital in Bremerton, Washington, US.

Some 42 countries around the world are now rolling out brand new COVID-19 vaccines to their populations. But 36 of those are high-income countries, 6 are middle-income countries, and none at all are low-income countries, said WHO’s Director General Dr Tedros Adhanom Ghebreyesus at a WHO press briefing on Friday. 

He and other WHO officials at the briefing called upon pharma manufacturers and countries to stop arranging bilateral deals on vaccine supplies – and channel new vaccine procurement through the WHO co-sponsored COVAX facility – In what seemed at times like an almost quixotic vision, in terms of how the real-world rollout is actually proceeding.

Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday.

Although the COVAX facility has indeed secured funding and deals to provide at least 2 billion vaccine doses to countries around the world in 2021 – the fact that high and middle income countries, including South Africa and India most recently, are now organizing huge vaccine purchases outside the framework of the global procurement initiative, is a signal of the lack of leverage that the global facility wields to see that vaccines are distributed equitably. 

As more and more countries race ahead with their own deals, WHO officials clearly are concerned that COVAX could languish in the backwaters as a kind of  “poor persons” fund supplying some vaccines to the 92 countries that cannot afford to pay on their own – but in limited quantities and at higher prices to boot.    

“The governments and health systems are on standby for global vaccine rollout. We are ready, COVAX is ready, countries are ready. The time to deliver vaccines equitably is now,” Dr Tedros said. 

COVID-19 vaccine doses administered as of 8 January 2021, since 14 December 2020.

But rather than channel vaccine purchases through the global procurement system, bilateral deals are becoming the norm, he protested, saying:  “Both high and middle income countries that are part of COVAX [are] making additional bilateral deals. This potentially bumps up the price for everyone and means high risk people in the poorest and most marginalized countries don’t get the vaccine,” said Tedros. “I want to see manufacturers prioritize supply and rollout through COVAX.

“I urge countries and manufacturers to stop making bilateral deals at the expense of COVAX. No country is exceptional and should cut the queue and vaccinate all their population while some remain with no supply of the vaccine,” said Tedros, adding.  “Science has delivered, let’s not waste an opportunity to protect the lives of those most at risk and ensure all economies have a fair shot at recovery. Vaccine nationalism hurts us all and is self defeating.” 

On the flip side, he added that “vaccinating equitably would not only save lives and stabilize health systems, but also “lead to a truly global economic recovery that stimulates job creation. 

“Importantly it would also help us limit the virus opportunities to mutate,” he added, referring to evidence that the more SARS-CoV2 infections spread, then the more potential dangerous virus mutations occur, which can make the virus more dangerous, more infectious, or more elusive to vaccines.  

The WHO Director General also urged countries to turn over surplus vaccines to the facility, saying: “I urge countries that have contracted more vaccines than they will need, and are controlling the global supply to also donate and release them to COVAX immediately, which is ready today to roll them out quickly.

Appeal To Pharma – Provide WHO With Data on Safety And Efficacy To Facilitate WHO Global Vaccine Approvals
Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.

At the briefing, WHO officials also appealed to Pharma manufacturers to supply them with more up-to-date data on the safety and efficacy of vaccines recently approved by national regulatory authorities – or in the final stages of clinical trials, so that WHO can make informed recommendations on vaccines that countries may choose to use.  

WHO’s own “pre-qualification” and “emergency use” approval processes – can help support and  expedite approvals in countries where regulatory authorities are weak – as well as paving the way for acquisition of more vaccines by COVAX. 

“Some companies and countries have not submitted critical data, which we need to issue emergency use listings [and] which blocks the whole system of procurement and delivery,” said Tedros.

Added Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products, WHO has received at least 13 valid proposals for vaccine approvals since October.  

However so far, WHO has only received complete data from one vaccine manufacturer, Pfizer, which it recently approved for emergency use. 

Transparent access to such trial data is necessary as many countries rely on WHO’s assessment prior to authorizing a medical product, such as a COVID-19 vaccine, for emergency use, she underlined: “It helps international procurers, like UNICEF and others, to procure the vaccines that have been assessed by the region.”

Added Bruce Aylward, senior advisor to the Director General: “We are not in a position to provide a perspective on vaccines that are in use that we’ve not seen the data on. And at this point as I say the vaccine that we have seen is the Pfizer vaccine.” 

WHO Received Data From Chinese Sinopharm Phase 3 Trial – Russia’s Sputnik Data Expected Soon

In the case of Chinese and Russian vaccines, which are already being administered in some countries, both products “are currently being assessed by WHO,” Simão confirmed.

WHO had obtained finalized data from the Chinese Sinopharm candidate’s Phase 3 trial, she said.  More data is expected by the end of this month on the results of trials of Russian Sputnik V vaccine, developed by the Gamalaya Research Institute.

That is significant since WHO review and recommendations on Chinese and Russian vaccines could help build confidence in, and speed to market, the more affordable vaccine products being produced by both countries.  Moreover, neither vaccine has been subjected to a transparent review by an independent regulatory agency. 

Call For Countries & Companies To Transparently Report On Vaccine Procurement Deals Being Concluded
Kate O’Brien, WHO’s head of Immunization, Vaccines and Biologicals, at the Friday press briefing.

In a related issue, the WHO officials said that when vaccine deals are concluded bilaterally, then  countries and companies should report on those deals – in order to facilitate tracking that would also ensure more equitable distribution of other available vaccine doses.  

Said Kate O’Brien, WHO’s head of Vaccines, Immunologics and Biologicals, “Our understanding of…what deals are being made is extremely important in order to help with this whole process of equitable allocation and equitable access to vaccines; 

“We’re calling on countries and manufacturers to be clear and transparent about where vaccine deals are being done, the doses that are being arranged for use in various countries, and their actual rollout.

“Having this information over time is really important for WHO and for the world to respond to this crisis in a way that will have its maximum impact,” she said. 

Said Aylward: “This is where we need the manufacturers working with us and we need…the donor countries and others working with us and working together. If a company does not submit the data that we need, it is slowing equitable access to vaccines around the world. If a company doesn’t sign and work the deals through us and if we don’t have the financing to do it, they’re slowing equitable access.” 

Aylward highlighted Tedros’ call to action for “access to the data on all of these products in real time as it is coming out, so that we can ensure that we can provide a perspective on these products as rapidly as possible and get them out equitably around the world.” 

COVAX Provides Flexibility
Bruce Aylward, Senior Advisor to the Director General of the WHO, at the press briefing on Friday.

Despite the lackluster role played by COVAX so far in the initial stages of vaccine rollout, the officials also tried to sound upbeat about the advantages that COVAX could still offer to countries – giving them more flexible access to a wider range of vaccines.

“The importance of having a portfolio of vaccines that serve different needs of different countries and especially serving the different needs of delivery situations. We know from the different products that we have some that require an ultra cold chain…some require refrigeration, so we have a lot of variability of the products in terms of a range of their characteristics,” said O’Brien. 

“The range of needs of countries and choices of countries is served by having this portfolio of vaccines, where there can be matching of vaccines to the delivery needs and the characteristics that countries have for the access to those vaccines,” she added.  

“One of the beauties of the COVAX facility, the way we set it up is we’ve got a very broad portfolio of products. We know we have a broad range of clients that we’re working with,” said Aylward.

“It’s one of the reasons [why] this facility is such an important part of the global solution to equitable access and rollout,” Aylward added. “We’re going to work with [countries] to get that right balance of products.”

Image Credits: Flickr – Official US Navy, WHO, Our World in Data.

The UK is the latest bloc to approve the candidate, but supplies are not expected to be delivered for a short while.

The United Kingdom has approved the mRNA vaccine developed by Moderna, securing an additional 10 million doses to its initial 7 million: but supplies aren’t expected until spring.

Despite procuring 17 million doses of the vaccine, a rollout isn’t anticipated for some time, with Moderna vaguely stating that “deliveries of the COVID-19 Vaccine … from Moderna’s dedicated non-US supply chain are expected to commence early in 2021”.

So far, around 1.5 million people in the UK – including almost a quarter of over-80s in England – have received at least one dose of either the Pfizer/BioNTech or Oxford/AstraZeneca vaccine.

The UK Government has said the current target is to vaccinate 15 million people by mid-February. It is not clear, however, if this means 15 million will have received both doses or a single dose. The country has been criticized by WHO and Pfizer for its decision to delay booster-doses.

Health Policy Watch was told this week that the Moderna vaccine appears to be able to reduce infection and therefore transmission of SARS-CoV-2, based on the limited data available. Both the Moderna and Pfizer candidates appear to share a similar efficacy of around 95%.

The UK is the latest bloc to approve the candidate. On Wednesday, the European Medicines Agency (EMA) recommended a conditional authorization which would mean countries across the European Union (EU) could begin immunizing their populations.

The Moderna vaccine was approved in the United States in December by the Food and Drug Administration (FDA), with its recommendation panel providing no opposition: a stark contrast to the 17-4 vote delivered for the European Pfizer vaccine.

Moderna’s statement can be read here, and the UK Government’s announcement is available here.

Image Credits: Moderna TX.

WHO called on European countries to step up their game to curb the highly contagious COVID-19 variants that are overtaking the region, already straining overstretched health systems.

Meanwhile some researchers were warning that the new virus variants could spell double trouble if the mutation first identified in South Africa, in particular, makes new vaccines just being rolled out less effective.  

WHO European Regional Officials said that so far there was no evidence of that in the case of the UK virus variant that has spread to over 30 countries so far. However, the South African variant, which has a number of additional mutations, is raising far more concern, according to some scientists.

In any case, the surges of infections being seen now constitute an “alarming situation” warned Hans Kluge, head of WHO’s European Regional Office, on Thursday. 

“We need to do more than we have done, to intensify the public health and social measures, … and flatten this steep vertical line.”

He also called on countries to step up “vigilance to identify any variants by first investigating unusually rapid transmission and unexpected disease presentation or severity.” 

Kluge spoke as the region continues to face “extremely” high levels of transmission, with almost a third of the European population under strict lockdowns, and more countries set to announce further restrictions in the coming week. 

Currently, about 25% of European member states are experiencing “very high incidence” and strained health systems, although lower reporting of infections during festivities may have underestimated the true extent of transmission, he added.

Infection trends are at least partially due to the new variant first seen in the UK, also known as “B.1.1.7”, which has potential to become the dominant SARS-CoV-2 lineage in the region. 

So far, B.1.1.7 has been spotted in 22 European countries, said Kluge, and while it doesn’t trigger more severe COVID-19 disease than its predecessors, it appears to be at least 50% more infectious, according to a recent modelling study by the London School of Hygiene and Tropical Medicine.

Kluge also noted that in 2020, the WHO European region saw almost 600,000 deaths as a result of the more than 26 million COVID-19 cases reported. This amounts to a five fold increase in excess deaths from all causes as compared to 2019, he said. 

WHO Says Vaccine Efficacy Should Hold Up To Variant Challenges; Others Not So Sure

Catherine Smallwood, Senior Health Emergency Officer for the European region

Despite the chaos triggered by recent variants of the coronavirus, there is “promising evidence” that the vaccines developed so far will work, said Catherine Smallwood, Senior Health Emergency Officer for the European region, also speaking in Thursday’s press briefing.

“At the moment there is no evidence for any of the variants that have emerged that there would be any decreased effectiveness of the vaccine, but studies are still ongoing,” she said.

But it appeared that the WHO comments were referring largely to the variant first identified in the UK, known as B.1.1.7,. In that case, while the virus has mutations that make it more infectious, none have significantly altered the protein structure of the coronavirus’ characteristic “spike”, which is also the target of most vaccines. 

The UK variant is currently more widespread – it has been reported in over 30 countries; in contrast variants that first were identified in South Africa have been identified in a handful of countries, including Japan, Norway and the United Kingdom, but it could be spreading further under the radar. 

Why South African Variant Could Be More Dangerous

The emerging research is far less reassuring, however, when it comes to the variant first discovered in South Africa, known as 501Y.V2 (or B.1.351).

Some of these variants contain a mutation known as E484K, which changes the protein structure of the “spike” of SARS-Cov-2 – which may make it easier for the virus to elude the body’s antibody defenses.

Earlier this week, researchers at the University of Washington found that this mutation seemed to make it more resilient to attack by the very same “neutralizing antibodies” that are critical to fighting the disease  – and may be naturally produced or stimulated by a vaccine.   

“The South African variant has a number of additional mutations including changes to some of the virus’ spike proteins, which are concerning,” said Simon Clarke, Associate Professor in Cellular Microbiology at the University of Reading in an expert review of the South African variant, published in Science Media Centre.  

“They cause more extensive alteration of the spike protein than the changes in the [British] Kent variant and may make the virus less susceptible to the immune response triggered by the vaccines.“

In a pre-print study mapping antibody responses among eleven patients, the ability of neutralizing antibodies to bind to the virus was reduced by a factor of ten among some of those people infected with the SARS-CoV-2 virus bearing the E484K mutation. 

Those same neutralizing antibodies are critical to the immune response triggered by vaccines. 

“This does not mean that the existing COVID-19 vaccines will not work at all, just that the antibodies induced by the current vaccines may not bind and neutralise the South African variant as well as it would the other circulating viruses – including the UK variant,” said Julian Tang from the University of Leicester. 

https://twitter.com/jbloom_lab/status/1346442049663340544 

Vaccines should still be effective for “quite a while”, even if they turn out to be less effective than previously assumed, emphasized Jesse Bloom, the head of the Seattle-based laboratory that published the study. He said that it could take “years” for current vaccines to become ineffective.

Welcome News From Pfizer, But More Robust Data Needed

Just on Thursday, a study by Pfizer and researchers from the University of Texas Medical Branch revealed that its mRNA vaccine effectively neutralized a virus variant with the N501Y mutation, offering some relief that Pfizer’s vaccine is resilient against an important and increasingly common mutation. The study has not been peer-reviewed yet.

“This is welcome information”, said the World Health Oranization’s director for immunization, vaccines and biologicals Kate O’Brien at a press briefing on Friday. But she said that understanding of the variants remains “dynamic” and the most “powerful information” will be “evidence from efficacy trials that are being conducted in areas where the variants are circulating.”

The N501Y mutation is among several key mutations that have given the British and South African variants a highly infectious edge. Similarly to Bloom’s study, researchers extracted blood samples from two dozen volunteers immunised with the Pfizer-BioNTech vaccine to test how well their antibodies held up against the N501Y mutation. 

While the results were welcomed as “very encouraging news”, the study authors acknowledged they had only tested the effect of one mutation in isolation – rather than the full set of mutations in either of the variants.  Yet, unlike the Bloom lab, Pfizer’s team did not investigate whether the alarming E484K mutation in the South African strain reduced antibody neutralization.

Also, the mutation that was tested was created in a laboratory, and not naturally derived, the authors said in a paper on the preprint server Bioxriv. “A limitation of this finding is that the Y501 virus [variant studied] does not include the full set of spike mutations found on the rapidly spreading strains in the UK or South Africa,” admitted the study authors. 

The preprint study covers just one of the 16 virus mutations that Pfizer has investigated so far, according to a top Pfizer scientist, interviewed by Reuters on Friday.  However that work has still not gone far enough to explore the most dangerous mutations that the variants are displaying, said Lawrence S. Young, a virologist from England’s University of Warwick. 

Other changes which might affect infectivity have not been examined

“For both [British and South African] virus variants there are other changes which might affect infectivity and these have not been examined. This is particularly a concern with the South African variant,” noted Young, referring to the E484K mutation, in an expert reaction published by the Science Media Centre.

 “These changes are very likely to influence the infectiousness of this South African variant and may also impact its ability to be blocked by antibodies,” he said. Additionally, he noted that the blood samples examined in the Pfizer study were those of volunteers who had quickly received the second dose of the vaccine – within three weeks of the first dose, as per Pfizer’s protocol. 

This, he said, “highlights the importance” of quickly receiving the second dose.

His comment came on the heels of the United Kingdom’s controversial move to delay the second dose by as much as 12 weeks – or six weeks longer than the WHO’s recommendations – in a desperate attempt to expand vaccine efforts. Some scientists have warned that delaying the second dose of the vaccine could in fact promote more mutations, lead to poorer immunity, or even exacerbate vaccine hesitancy. 

Still, Pfizer hopes to gather more comprehensive data on the full set of mutations in the British and South African variants “within weeks”.

If any of these mutations turn out to reduce vaccine efficacy, the Pfizer/BioNTech and Moderna vaccines could be “updated” in as little as six weeks, noted experts.  

However, if an updated mRNA vaccine ends up being developed, its soaring price and complex cold-chain requirements suggest that low- and middle-income countries would wait in the queue for a long time before getting their hands on it, in a similar vein to what is happening now. 

 

CAPE TOWN – As South Africa reported its highest COVID-19 cases ever this week – over 20,000 in one day – Health Minister Dr Zweli Mkhize announced that the country had procured 1.5 million doses of the AstraZeneca-Oxford vaccine and would start vaccinating health workers by the end of this month.

The South African government has bought the vaccines directly from the Serum Insitute of India, with one million doses arriving this month and the balance being delivered in February.

The minister said that an estimated 1.25 million health workers are working in both public and private health, and these would get the vaccine first. However, the AstraZeneca vaccine requires two doses so it appears that all health workers will receive one initial dose.

Three doctors died of COVID-19 this week in KwaZulu-Natal, one of the country’s nine provinces worst affected by the pandemic. The SA Medical Association (SAMA), which represents health professionals, says that there is a “dire shortage” of medical staff, oxygen and personal protective equipment (PPE) in the province.

The Western Cape province, which has the highest infection rate per 100,000 (3326), has reported that over 7200 health workers had been infected since March, over 1000 are currently infected and more than 240 have died. 

“As recently as yesterday, our teams from the National Department of Health and the South African Health Products Regulatory Authority (SAHPRA) were fine-tuning and aligning all the regulations processes to ensure that there are no unnecessary delays or regulatory impediments to activate this rollout,” Dr Mkhize told the South African Parliament’s Health Portfolio Committee.

“We are happy that the SII/ AstraZeneca vaccine has already been approved by various regulators and is being rolled out in other countries. Therefore, as part of expediting the regulatory process, SAHPRA is applying reliance on that regulatory work,” said Mkhize.

Just last week, the United Kingdom approved the AstraZeneca vaccine, which was co-developed with Oxford University – followed by Indian approval of the vaccine this week. Unlike the Pfizer and Moderna vaccines, based on cutting edge mRNA technology which requires ultra-cold storage, the AstraZeneca vaccine can be stored in a refrigerator – and while it is also to soon be deployed in Great Britain, it has also been considered one of the best vaccine candidates for large-scale rollout in countries with less cold-chain capacity.  

Announcement Comes as South Africa Battles New Virus Variant 

The announcement came as South Africa battled the highly infectious “501.V2” variant, which, according to preliminary research,  could reduce vaccine efficacy as a result of three mutations in the so-called “receptor-binding domain” of the viral spike protein – including N501Y, K417N and E484K.

Although South Africa’s rate of new infections is still far lower than those being seen in the UK, Europe or the US, rates here are the highest on the continent and they have risen sharply over the past month.  

Mkhize said that Phase 2 of the country’s vaccination rollout “will be the essential workers such as teachers, police, the military and other people who are working in settings where they are serving communities and risk exposure to the virus because of their services to the community”. 

On Sunday, the Health Department also said that South Africans over the age of 60 as well as those living with other chronic medical conditions would be targeted in Phase 2 of the rollout – and that 16 million doses would be needed for those groups. 

South Africa is also a member of the WHO co-sponsored COVAX vaccine procurement facility  – which also aims to distribute at least 2 billion doses this year to countries that have joined. COVAX vaccine doses are expected to arrive by April, but as per the distribution plan, those would only cover 10% of South Africa’s population. 

 As a middle-income country, South Africa also has to buy the COVAX vaccine – while some 92 low-income countries will be able to get donor support for their allocations.  

South Africa is also in bilateral discussions with a range of pharmaceutical companies with the aim of getting vaccines for the rest of the population – around 40 million people – but declined to name these or provide any details.

WHO Warns Against Bilateral Agreements Outside COVAX

Dr Tedros Adhanom Ghebreyesus

However, WHO Director-General Dr Tedros Adhanom Ghebreyesus appealed to member countries not to seek deals outside of COVAX when he addressed them at a briefing on the pandemic today.

“Forty two countries have started vaccinating their high-risk populations with various COVID-19 vaccines. Of the 42, 36 are high-income and six are upper middle-income countries,” said Dr Tedros.

“This is clearly a problem and this problem is getting worse because some countries are pursuing new deals outside of COVAX offering higher prices. This compromises our collective commitment to equitable access.”

He added that 190 countries and economies had committed to COVAX and the WHO expected all stakeholders to ensure vaccines are distributed “as swiftly and equitably as possible to all countries”.

“History will not judge us kindly if we fail the low- and middle-income countries in their hour of need and sharing is in the best interest of each and every country.  We can only recover faster as a global community by sharing.”

Tedros said that wealthier member states could improve vaccine access for low and middle-income countries by subscribing to the new COVAX dose-sharing principles with the goal of having the first donations by the end of January or early-February.

“I challenge each and every one of us to do everything possible to reduce cases as quickly as possible while simultaneously increasing production and rollout of vaccines,” urged Tedros.

 

 

Image Credits: WHO.

London in the midst of Brexit, lockdown, and vaccine delays.

After brief holiday respites, countries in Europe, Asia, the Middle East and Africa have reverted to major lockdowns as a strategy to stave off new, and even more infectious, SARS-CoV2 virus variants that have been identified in the United Kingdom and in South Africa – which threaten to overwhelm health systems even as countries also rollout brand new COVID vaccines.

Together, the variants have now spread to nearly 40 countries, with the UK variant named ‘VUI – 202012/01, surfacing in at least 32, including with China, and the South African N501Y mutation appearing in at least five other countries on the continent. 

Most countries in continental Europe – including Austria, Italy, Greece, Ireland, Germany and The Netherlands – are either already in lockdown or tightening the screws now, with the UK joining them in the early hours of Wednesday morning.  In Africa, Zimbabwe imposed a strict 30-day lockdown after a spate of New Years revelry with little social distancing.  After bitter political battles, Israel was also set to close down schools nationwide.  Its aggressive vaccination campaign, in which more than 10% of the population has already received the first dose of a COVID-19 vaccine, also has not yet managed to halt the sharply rising levels of new COVID-19 cases – now exceeding rates in the United States.  

And in the Western Pacific, as Australia was shutting down its northern beaches this week, while the Japanese government considered declaring a state of emergency in Tokyo after experiencing record high levels of new cases in the metropolitan area, as well as nationwide. 

Public health leaders said that the moves were unavoidable. “Redoubling efforts to contain this virus through public health measures is essential while vaccines and treatment efforts continue to progress,” said Dr Jeremy Farrar, Director of the Wellcome Trust.  Commenting on the advance of the virus variants he added that “we should expect further strains to emerge globally.”

Farrar also called on the UK and other international leaders to ensure global access to the first saves of vaccine supplies being produced, saying: “Leave one country behind and we are all exposed to risk, and to life taking longer and longer to returning to anything like normal.”

United Kingdom: U-Turns, School Closures, and Vaccine Delays
Rates of new SARS-CoV2 infections in the United Kingdom are now among the highest in the world as the country moves to a strict lockdown; Israel is close behind.

Following the UK government’s recent U-turn on 18 December – which undid the five-day period of eased restrictions seen over Christmas – Prime Minister Boris Johnson confirmed on Monday night that England would be entering its third national lockdown, with similar measures going into place in Scotland, Wales and Northern Ireland. 

The UK decision came after its Chief Medical Officers warned that if swift action was not taken, the National Health Service would be dangerously overwhelmed within just 21 days. 

Despite support for a full lockdown by leaders of the opposition, the national press, and other influential figures, the announcement was still met with considerable criticism, confusion and frustration by a pandemic-weary public.

The key point of contention this time around is the decision to close all schools and universities, along with the cancellation of all GCSE and A-Level exams – the latter determining a student’s acceptance into college or university.

Many children across the country had only just returned to school on Monday morning after the end of the Christmas and New Years holiday break, as the government assured that schools were safe and the schedule would not be changed. Johnson had repeatedly stressed that schools were not unsafe for children, despite critics pointing out that gatherings in schools would mean children act as vectors.

The fact that their first day of the trimester will also be their last has been the source of much anger, and has sown greater doubts about the government’s ‘too-little-too-late’ handling of the pandemic.

“Parents whose children were in school today may reasonably ask why we did not take this decision sooner,” Johnson said on Monday. “The answer is simply that we have been doing everything in our power to keep schools open, because we know how important each day in education is to children’s life chances.”

Third Lockdown Comes At Difficult Time for National Health Service 

The third lockdown comes at a delicate moment for the National Health Service – which is juggling a masive vaccine rollout with record number of new COVID-19 cases. 

The government recently defended its decision to delay the second dose of the Pfizer/BioNTech COVID-19 vaccine by up to 12 weeks. The official recommendation of the manufacturer is that a second dose should be administered within 21 days, prompting criticism from Pfizer itself, WHO and White House COVID Task Team advisor Dr Anthony Fauci.

Furthermore, the UK virus variant, which was first identified and reported to WHO in mid-December, confirmed to be between 50-70% more transmissible, is fast becoming the dominant SARS-CoV2 virus strain, and that has sharply increased pressure on hospitals and health workers. The number of COVID patients in England’s hospitals now stands at 27,000, with more than 80,000 people testing positive across Britain: a new record. 

Germany: Lockdown Extended So Infection Chain Can Be Contained 
Japan prepares for another lockdown as Asian countries, like those in Europe, battle rising COVID-19 infection rates.

Tighter restrictions on social gatherings and travel are also to be enforced in Germany, as the government announced that it was extending a lockdown already in place by three weeks, to 31 January.

“We must reach a point where we can once again follow the chains of infection,” Chancellor Angela Merkel said on Tuesday, after a lengthy video conference with Germany’s 16 state governors. “Otherwise, we will just go keep going back into a lockdown after a short relaxation.”

Merkel and the state premiers of the federal states of Germany originally launched a partial lockdown in November that saw bars, restaurants, leisure and sports facilities close.

This failed to halt rising infection rates, so a stricter phase of lockdown was put in place on 16 December, with the closure of nonessential shops and schools.  This was initially intended to run until 10 January. 

While new infections have now begun to decline sharply, it’s not enough for Germany to reopen, the government decided.

The aim is to have the number of confirmed cases sit below a seven-day average of 50 per 100,000 residents; that is the maximum level at which contact-tracing can still function effectively, health officials say.

However, numbers on Tuesday saw new infections at a rate of 134.7 per 100,000 nationwide.  In addition, there were 944 deaths reported: one of the highest daily death tolls in a country that once had a relatively low COVID-19 mortality rate.

New restrictions will prohibit people living in communities with seven-day averages of more than 200 new infections per 100,000 residents from traveling only 15 kilometers (just over 9 miles) from their hometown, unless they have good reason to travel further. 

Merkel and state leaders will meet again on 25 January to determine if the lockdown should be extended once more.

Zimbabwe: Cracking Down On ‘Fake’ Vaccine Certificates
Sanitation workers clean up at a Zimbabwe market. The country is implementing a strict 30-day lockdown, following the rise of fake COVID-19 free certificates and large New Years celebrations.

Following a New Year’s Eve that saw celebrations and parties with little social distancing or mask wearing, Zimbabwe’s government has implemented a strict 30-day lockdown, with special efforts being made to hunt down fake COVID-19 certificates.

Speaking at a press conference, Acting President Kembo Mohadi said that security forces and health officials will be on high alert to ensure full compliance with COVID-19 regulations.

More than 2,300 people were arrested on New Year’s Day for breaking lockdown rules.

“Our security agencies, health officials and educational institutional heads will continue to enforce stricter standard operation procedures to ensure the safety of all citizens. They will enforce adherence to the regulations within the stipulated times,” he said.

“We exhort governance structures to provide and enforce measures that will curtail crowds and congestion at places such as water points, bus terminuses, grinding mills, supermarkets and shopping complexes.”

Zimbabwe will switch from a level two lockdown back to level four, with enforced social distancing. Commercial and informal sectors will be closed, with essential services remaining open. Church services and gatherings for public hearings and low-risk sports are to be suspended for the next thirty days. Non-essential travel is also banned.

In addition to the lockdown, efforts are being made to identify fake negative COVID-19 certificates, which allow people to travel more freely.

“The presentation of unauthentic Covid-19 free certificates by some of our citizens has exposed many unassuming people to the disease. Such dishonesty is criminal and detrimental to the very fabric of society and far removed from Unhu/Ubuntu. This has led to the surge of infections,” Mohadi said.

The ban of passenger traffic across land borders is another consequence of the forgeries. 

Zimbabwe has recorded 1,342 COVID-19 cases and 29 deaths within the past week as infections a trend of increases; on 2 January there were 407 new cases and 8 deaths, all from local infections.  Although these rates are still exceedingly low in comparison to what has been seen in South Africa, not to mention elsewhere in the world, Zimbabwe’s leader, like many of his colleagues on the continent, is keen to keep it that way.  This, in view of the dearth of hospital capacity to care for sick COVID-19 patients and the fact that vaccine rollouts remain only a hope on the continent’s horizon.  In addition, it is likely that many COVID-19 cases in Zimbabwe, like those in neighboring states, go unreported.  

“We are our own saviours and it is our behavioural change that will take us out of danger,” Mohadi said. “It is important that there be a major paradigm shift on behaviour. Let those that are infected now be the last as we all together strive that no one else shall be infected.”

Image Credits: Tanveer Shaikh/Flickr, tokyoaaron02/Flickr, International Labor Organisation ILO/Flickr.

US experts are considering whether vaccine doses can be halved, maintaining effectivity while extending supply.

The European Medicines Agency (EMA), the EU drug regulator, recommended issuing a conditional marketing authorization for Moderna’s COVID-19 vaccine, which follows the authorization of the Pfizer-BioNTech vaccine in late December. 

“This vaccine provides us with another tool to overcome the current emergency,” Emer Cooke, Executive Director of EMA, said in the press release. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.” 

The European Commission is expected to grant the vaccine authorization in the coming days. The Moderna vaccine has already been authorized and rolled out in the US, Canada, and Israel. 

The EMA has received criticism for its delay in reviewing the AstraZeneca-University of Oxford vaccine, which has been approved in Britain and India. The drug company has reportedly already submitted its data to the EMA for a conditional marketing authorization as part of the ongoing rolling review process.

US Experts Consider Administering Half Doses of Moderna Vaccine

Meanwhile, in the US, officials at the National Institutes of Health, in collaboration with Moderna, were examining whether vaccine doses can be halved while maintaining their effectiveness, in an effort to extend vaccine supplies.

The prospect of changing the dosing regimen was raised by Moncef Slaoui, head of the US Operation Warp Speed, in an interview with CBS “Face the Nation” on Sunday. 

“We know [a 50-microgram half dose] induces identical immune responses to the 100-microgram doses, therefore we are in discussions with Moderna and with the FDA – ultimately it will be an FDA decision – to accelerate by injecting half the volume,” said Slaoui. 

According to Moderna’s Phase II clinical trial data submitted to the US Food and Drug Administration (FDA), the immune responses between the full dose and half dose among participants aged 18 to 55 were comparable when maintained on the schedule with a 28 day interval. 

The research could continue for at least two months, according to John Mascola, director of the Vaccine Research Center at the NIH. “It’s important to do these analyses that we’re doing, and have all that data in our pocket in the event that there’s a need to use it,” he said in an interview with the New York Times on Tuesday. 

The US FDA pushes back against the UK policy decision of extending the interval between the first and second dose of the Pfizer vaccine.
US Food and Drug Administration Pushes Back Against UK Plans To Extend Interval Between Pfizer doses

The FDA, the agency responsible for any changes to vaccine dosing or schedules, issued a strongly worded statement on Monday night, pushing back against a recent UK policy decision permitting an extension of the interval between the first and second dose of the Pfizer vaccine upon – and in some cases, even a mix and match vaccines. 

“These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence,” said Stephen Hahn, FDA Commissioner, in the statement. 

“Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.”

Germany Also Decides Against Delaying Second COVID-19 Dose

Germany also decided to stick to the standard vaccination regimen proposed by Pfizer and BioNTech, after considering following the lead of Britain to delay the administration of the second dose. 

The German independent expert panel advised against making changes to the regimen without sufficient evidence. 

“My impression is that it makes a lot of sense, especially with these sensitive issues, where trust and reliability are important, that we stick to the approval,” said German health minister Jens Spahn at a press conference on Wednesday.

Image Credits: Tanveer Shaikh/Flickr, Bret Bostock/Flickr.

Numbers suggest that the Moderna vaccine reduced asymptomatic transmission by about two-thirds. The data set was very small, however.

Moderna’s mRNA COVID-19 vaccine appears to be able to reduce infection and therefore transmission of the virus, a Harvard expert has told Health Policy Watch, albeit despite the currently limited data sets.

Although both vaccines appear to have incredibly high efficacy (94.1% for Moderna and 95% for Pfizer) in terms of preventing those vaccinated from becoming ill with COVID-19, policymakers have cautioned that people thus immunized might still be able to transmit the virus to others – and public health policies need to take this into account.

Peer reviewed Phase 3 clinical trial results for the Moderna vaccine, published last week in the New England Journal of Medicine, now suggest, however, that vaccination also reduced asymptomatic transmission by about two-thirds, in the case of Moderna’s mRNA-1273 vaccine – although the numbers examined were small.

Pfizer/BioNTech, however, said that their Phase 3 data did “not address whether vaccination prevents asymptomatic infection” and that “a serologic end point that can detect a history of infection regardless of whether symptoms were present … will be reported later.”

“It would be safe to conclude from the very limited findings that the mRNA vaccine has some effect on infection and therefore probably transmission, but it’s a pretty small data set to hang your hat on“, Marc Lipsitch, Professor of Epidemiology and Director of the Center for Communicable Disease Dynamics at the Harvard T.H. Chan School of Public Health, told Health Policy Watch during a media advisory on Tuesday.

Pfizer, which did not address whether vaccination prevents asymptomatic infection in this trial, will report the data when it is available.

In the Moderna study, there were just 15 asymptomatic cases of infection in the mRNA-1273 group of about 14,000 who received the vaccine, or about 0.1% of participants at the time that the second vaccine dose was administered. In comparison there there were 39 symptomatic cases in the  placebo group of a comparable size, or about 0.3% of participants – suggesting that even one dose of the two-dose vaccine had already reduced asymptomatic cases by roughly one-third.

That is extremely encouraging to policymakers looking at how vaccination of large numbers of people can also halt the broader spread of infection.

But this data remains “hard to interpret, for a number of reasons”, Lipsitch said, noting that: “People getting their second dose could have been infected before the first dose kicked in. Moreover, the second dose probably adds more protection compared to the first dose.

He added that in addition, “we don’t know the duration of that effect, or the degree to which the vaccine changes the amount of virus in [people].”

Regardless of Vaccination – Continue Testing

Regardless, Lipsitch still advised governments to continue testing requirements for traveling, as opposed to banking entirely on vaccination for future out-of-country movement. “It’s not completely protective so testing would be more meaningful than the vaccine,” he said.

Though more research is needed to confirm how long immunity from SARS-CoV-2 lasts, Lipsitch estimated that the immunity lasts at least three months, depending both on the product and on individual contribution and responsibility to be protected for longer.

With new variants of SARS-CoV-2 emerging in the United Kingdom and South Africa, there must be redoubled efforts to both control the spread of COVID-19 and to vaccinate as many people as possible. “Anything you can do to delay the spread of this new variant virus will make control easier and will help us in a race to get more people vaccinated before [this variant] becomes more common.”

This may be a challenge in coming weeks, with the new variant 50-70% more transmissible, but ongoing vaccinations and further research gives hope that herd immunity can be reached.

Said Eric J. Rubin and Dan L. Longo of the NEJM, regarding the new vaccines: “What appears to be a dramatic success for vaccination holds the promise of saving uncounted lives and giving us a pathway out of what has been a global disaster.”

Image Credits: Moderna, Pfizer.


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An NHS worker in North London receives a COVID-19 vaccine as British Prime Minister Boris Johnson looks on. WHO has joined other bodies and public health figures in saying that there is no scientific evidence for a delay in a vaccine’s second dose – as per the recent United Kingdom policy decision.

People who have recently had a confirmed COVID-19 infection can choose to delay vaccination, so as to allow others who are not immune take advantage of initial procurements, WHO has recommended.

Following WHO’s approval of the Pfizer/BioNTech vaccine last week, its strategic advisory group of experts (SAGE) said that if a person has had a PCR documented SARS-CoV-2 infection within the last 6 months, they may choose to hold off on being vaccinated until nearer to the end of that period.

“SAGE recommends that COVID vaccination be offered regardless of a person’s history of asymptomatic or symptomatic of SARS-CoV-2 infection,” SAGE’s chair Dr Alejandro Cravioto said at a media briefing on Tuesday, where he announced the body’s recommendations for emergency use of the vaccine. He added: “Available data currently indicates that symptomatic reinfection within 6 months of initial infection is rare.”

As a result, people who waive their initial opportunity to be inoculated would encourage the use of the first available vaccines for those who have not yet been exposed to the virus.

Also at the briefing, WHO stated that there was no scientific evidence to support a delay of more than 6 weeks when administering a second dose of the Pfizer vaccine, joining the manufacturer itself and the White House COVID Task Team advisor Dr Anthony Fauci in criticising the UK’s decision to delay second doses by up to 12 weeks.

“It is important to note that there is very little empirical data from the trials that underpin this type of recommendation,” Dr Joachim Hombach, executive secretary of SAGE, said, acknowledging that individual countries may need “to be even more flexible in terms of the administration of the second dose”.

The UK decision was taken in light of surging rates of new infections, which are now among the highest in the world.

BREAKING – Two members of a 10 person WHO-sponsored mission to China to investigate the origins of the SARS-CoV2 virus were turned away at China’s doorsteps after official approvals that WHO understood to be finalized were held up at the last minute.

One member has turned around and is now returning home, while the second remains stuck in transit in a third country. Eight other members of the team were told to delay their departures altogether, WHO confirmed on Tuesday.

“Over the past 24 hours, members of the international scientific team on COVID-19 virus origins began travelling from their home countries to China,” Dr Tedros Adhanom Ghebreyesus stated at the WHO press briefing. “This was as per arrangements jointly developed between WHO, the Chinese government, and the countries for which the team was meant to travel through,” he clarified. “Today, we learnt that Chinese officials have not yet finalised the necessary permissions for the teams arrival in China.”

Indicating that WHO had instructed the other eight team members who were not yet airborne to cancel their journeys for the time being: “We did not want to put people in the air, unnecessarily if there wasn’t a guarantee of their arrival in China.”

WHO’s executive director of health emergencies, Dr Mike Ryan said that it had become “clear that the necessary approvals had not been gotten, specifically in regards to visa clearances”.

“We were all operating on the understanding that the team will begin deployment today,” and explained that based upon that understanding, two members of the team had already begun travelling yesterday.

Ryan added: “The two colleagues who have been travelling: one has been turned around and has a reasonably short journey home. The other will stay in transit in a third country, awaiting further details.”

Night view of Wuhan, Hubei, China.

Neither he nor Dr Tedros clarified which two team members had actually been in transit when their entry to China was denied.

The WHO officials expressed hopes that the holdups were the result of a “logistic and bureaucratic issue” that could be resolved quickly.

Dispatch of the team has been long-awaited by many WHO member states, after months of delays in the launch of the mission which was mandated by a World Health Assembly resolution in May.

WHO finally named the investigative team in late November. The Organization also published outlines of a Phase 1 and Phase 2 study for the virus origins investigation. In December, WHO officials said that, the team would travel to Wuhan in January. 

Speaking at Tuesday’s briefing, however, Dr Tedros said: “I’m very disappointed with this news, given that two members have already begun their journeys and others were not able to travel at the last minute.

“I have been in contact with senior Chinese officials, and I have again made it clear that the mission is a priority for WHO, and the international team have been assured that China is speeding up the internal procedure for the earliest possible deployment.”

Mission Aims To Resolve Mystery of Virus Origins

The first clusters of human infection with the SARS-CoV2 virus surfaced in Wuhan China in December 2019, around a seafood market that also sold wild animals for slaughter, and it was presumed that these first infections had passed from animals to people working or shopping at the market.

But in the following months, the origins of the first human infections became far less clear. It emerged that some of the people first diagnosed with the virus in Wuhan had not had any contact with the market. The virus has been traced to a family of coronaviruses that circulates naturally in bats in a province of southwestern China, hundreds of miles from Wuhan.

But how and where the virus may have lept to humans remains more of a mystery. Some critics have suggested that it could have escaped in a biosafety failure from a Wuhan virology laboratory where extensive coronavirus research was in fact taking place, however WHO does not list this as one of its leading concerns.

Meanwhile, China’s state-controlled news channel began to construct an alternative narrative, claiming that the virus may not have originated in China at all. Even if the virus did originate outside of the country, WHO has repeatedly insisted that any epidemiological investigation must begin with the first cluster: those found in Wuhan.

Those assigned to the delicate task of discerning the origin of SARS-CoV-2 include prominent public health figures and animal health experts from across WHO’s Member States. Marion Koopmans – the virology professor leading research into the Dutch outbreak on mink farms – and former UK deputy chief medical officer John Watson are both set to travel to Wuhan. Prominent British zoologist Peter Daszak, who has a history researching bat coronaviruses in southeastern China and who is also president of the US Ecohealth Alliance, will also be dispatched.

Daszak will also head The Lancet’s independent COVID-19 Commission Task Force, which some independent experts say might have an even better chance of fully investigating the origins of the coronavirus than the WHO team. If this task force never sets foot in China, it will still have the advantage of not being beholden to Beijing: a powerful actor in WHO’s member state governing body.

Other experts are traveling from Australia, Germany, Japan, The Netherlands, Russia, Japan, Qatar, Viet Nam and the USA.

US-China Tensions Lend Mission Strong Geopolitical Dimensions

Along with China’s resistance and WHO’s response, the US administration of outgoing President Donald Trump also created a platform for itself in the dispute, accusing WHO of bias and blaming China for the spread of SARS-CoV-2.

At a November session of the World Health Assembly (WHA), the deputy director of the US Department of Health and Human Services charged that the just-published terms of reference for the investigative team were “not negotiated in a transparent way with all WHO member states”.

Garrett Grigsby then went on to say that the terms failed to fulfill the original WHA mandate, adding that “understanding the origins of COVID-19 through a transparent and inclusive investigation is what must be done” in order to meet that mandate.

WHO officials have said that they are regularly consulting with the missions of other governments in Geneva, and that the study process and findings will be transmitted transparently.

And while the incoming administration of US president-elect Joe Biden may lower the accusatory tone against Beijing, there is building pressure from other European and Western Pacific countries applied to WHO to push harder on the Chinese government.

Whether out of deference to Beijing or a realistic assessment that such action would not achieve anything, Dr Tedros and his team have so far resisted naming and shaming Beijing publicly.

There will be no denying the embarrassment to Beijing of the mid-air turnaround of investigative team members, however.

Image Credits: pxfuel.com, Arend Kuester/Flickr.