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.

The mobile station, which opened Friday in a large city park, allows Israeli citizens and residents over the age of 60 to walk in and be vaccinated on the spot.

BREAKING – Israel’s Ministry of Health on Tuesday approved the administration of Moderna’s COVID-19 vaccine, making it the first country outside of North America to greenlight the US-based startup’s candidate.

The announcement by Moderna said that deliveries of the vaccine to Israel would begin already in January – sharply advancing a schedule that was originally to have begun in March.

“First deliveries are expected to begin shortly,” the press release stated, noting that “Israel is the third country for which Moderna has received authorization for its COVID-19 vaccine” following the US and Canada on 18 and 23 December 2020 respectively. The European Union (EU), Singapore, UK and Switzerland are also reviewing the candidate.

Moderna’s vaccine is based upon a novel mRNA technology similar to that being used by Pfizer/BioNTech, already being deployed in a number of countries worldwide.

The vaccine was approved against the specter of mounting COVID-19 infections in Israel, despite the massive vaccine campaign already underway: more than 1 million people have an initial Pfizer vaccine dose.

Israel’s average rates of new infections, are among the highest in the world currently, with Switzerland holding one of the highest rates in western Europe.

While the campaign has placed Israel at the top of the list of vaccine doses administered per-capita, it is racing against time to beat back infection rates by vaccinating more people.

Israel’s average rates of new infections – which are among the highest in the world currently – are running at about 66 people per 100,000, as compared to 64 per 100,000 in the United States and 82 per 100,000 in the United Kingdom.

Israel has secured around 6 million doses of Moderna’s vaccine. Together with another large order secured from Pfizer, the two vaccines should be sufficient to vaccinate most of the country’s 9 million residents even before a locally-developed vaccine – currently in Phase 2 trials – becomes available, most likely in the summer.

Switzerland Delay of Moderna Vaccine Approval – Doses in Visp Can Ship Immediately To Israel

Ironically, the Moderna vaccine will be imported to Israel from the Swiss-based firm Lonza, where hundreds of thousands of vaccine doses were already in production in December at the company’s manufacturing facility in Visp.

In light of the Swiss and European delays in approving the Moderna vaccine, ready-to-use vaccines can be shifted to Israel for the time being, which is eager to get its order right away.

Swiss approval of the Moderna vaccine by the national regulatory authority, Swissmedic, has lagged behind that of the Pfizer counterpart, which was approved by Swissmedic in December.

That is despite the fact that the expert panel of the US Food and Drug Administration gave the Moderna vaccine an even higher vote of confidence than it did the Pfizer candidate, when it reviewed both vaccines in meetings only a week apart last month.

While the US and China have already rolled out more than 4.5 million doses of COVID-19 vaccines, and Israel and the UK have reached or exceeded the one million mark, the rest of Europe is moving much more slowly.

Switzerland’s slow start to its vaccination campaign has been the subject of sharp criticism.

And among European countries, the number of vaccines administered by Switzerland have so far been negligible. Only half of the country’s Cantons have even begun their campaigns – which major efforts only set to kick off in some regions, such as the heavily populated and heavily infected Canton of Vaud, bordering Geneva, next week.

The slow Swiss start to its own national rollout has become a growing focus of criticism, particularly in light of Switzerland’s high infection rates. At about 40 new cases per 100,000, Switzerland has a new infection rate that is one of the highest in western Europe outside of the United Kingdom.

“In another ten days, all of the Israeli population over the age of 60 will have been vaccinated  – our vaccination programme is a fiasco that is costing lives every day and will continue to destroy still for months our economy,” Swiss lawmaker Philippe Natermod, vice president of the Swiss Freel Democratic Party, (PLR) and a member of the Swiss Federal Council, lamented in a recent Tweet.

Last week, in an exclusive interview with Health Policy Watch, a senior scientist at the University of Lausanne also complained about the unnecessary loss of lives as well as lifelong cases of COVID-related disability that would occur as a result of the delayed vaccine rollout.

“The Department of Health doesn’t seem to understand that in just three weeks of delay, with 4,000 new infections per day, 100 will die everyday. That means in three weeks, more than 2,000 people will die unduly,” said Dr Pierre Goloubinoff, a biologist who has been doing research on COVID-19 treatments, as a result of the pandemic.

“If we could do a vaccine blitz, and vaccinate all of the high-risk population in a month, in terms of the economy it would be completely liberating.”

Switzerland has also been criticised for carrying out far too few tests to adequately chart the spread of coronavirus.

Switzerland has ordered approximately 13 million COVID-19 doses: 4.5 million doses from Moderna, 5.3 million from AstraZeneca, and 3 million of the Pfizer/Biontech vaccine.

But in the absence of a Swissmedic approval of the Moderna vaccine, only the Pfizer vaccine doses are approved for use. And only 107,000 doses of that vaccine have been delivered so far.

Vaud’s Health Minister Rebecca Ruiz told Swiss Radio RTS that regional authorities  have also been left to fend for themselves in terms of setting up an adequate vaccination infrastructure – after requesting help from the army to set up mobile vaccination units. “But our request was refused, so we are left to our own devices”, she pointed out.

In a series of messages conveyed by the Swiss Mission in Geneva to UN international organizations, Swiss health authorities said that the initial phases of the vaccine campaign would be focused on people over the age of 75 living in care homes, as well as health workers, in light of the limited vaccine supplies.

The statements also pointedly stated that the vaccine campaign is of unprecedented logistical complexity.

Image Credits: Our World in Data, Our World in Data.

The administration of the Pfizer COVID-19 vaccine in mid-December.

The United Kingdom’s decision to delay the second dose of the Pfizer/BioNTech COVID-19 vaccine being rolled out en masse in the nation is a risky strategy – not only for those getting the vaccine, but also in terms of the longer-term public health impacts such delays could have in terms of future SARS-CoV2 mutations, some experts are warning. 

Administering a weakened vaccine formulation, as a result of long delays between the required two vaccine doses could open the door for the more rapid evolution of SARS-CoV virus, including mutations resistant to the vaccines only just now being deployed en masse, several leading virologists have said.  

They spoke in the wake of Britain’s decision on 30 December to postpone the administration of the second dose of the two-dose Pfizer vaccine by as much as 4 to 12 weeks, so that more first doses could be administered right away. 

Delaying the second dose has the potential to generate resistant spike variants that evade the antibody responses induced by vaccines, tweeted Paul Bieniasz, a British-American virologist at Rockefeller University. 

“Generating a pool of hosts with just the right amount of neutralizing antibody to apply selection pressure, but also maintain sufficient levels of partially antibody-resistant virus to allow onward transmission is key here…If we let immunity wane for a little while, say 4 to 12 weeks, we just might hit the sweet spot” to generate vaccine-resistant SARS-CoV2 variants, Bieniasz added. 

While the UK’s novel attempt to provide some form of broad population immunity as fast as possible is laudable, the experts says, potential negative impacts on the mutation of the virus, and thus on vaccine effectiveness, could offset the benefits. 

“The most credible arguments…are: a) the possibility that ‘partial immunity’ will spawn harmful mutations; b) concern that delay means more people won’t return for 2nd dose; c) whether change in vaccine schedule will lead to more vaccine hesitancy,” said Bob Wachter, chair of the Department of Medicine at University of California at San Francisco, in another series of Tweets. 

UK Was First In Pfizer Rollout – But Stretched Resources Leave It Hunting For More Doses

The United Kingdom was the first country in the West to issue an emergency authorization for the Pfizer vaccine, followed by the launch of the mass vaccination campaign on 8 December, beginning with health workers and older people. So far, the vaccine has been administered to about 1 million people nation-wide through the National Health Service, with second shots due three weeks later.

The total number of doses of COVID-19 vaccines administered globally, as of January 4.

The decision to prioritize the administration of the first dose to as many at-risk individuals as possible over providing the two doses according to the recommended schedule was made amid the spread of a variant strain of SARS-CoV2 with a higher rate of transmission and higher viral load. 

These measures were justified as “allow[ing] more people to benefit from the protection provided from the first dose during the roll out phase,” states the updated UK guidelines “Greenbook.”  An accompanying statement by the Joint Committee on Vaccination and Immunisation (JCVI), makes the case, saying that in the case of the Pfizer vaccine, vaccine efficiency would still be at least 70% and possibly as high as 90%, from about two weeks after the first dose, based on models of the clinical trials undertaken so far.    

But with the absence of clear data on the length that protection from the first dose lasts, Britain’s decision could have dangerous ramifications, leaving millions of people with incomplete or waning immunity, other independent experts pointed out. 

“There are good reasons for giving the second dose. It is likely that the second dose is needed to generate long lived and strong immunity,” tweeted Florian Krammer, professor at the Department of Microbiology at the Icahn School of Medicine at Mount Sinai in New York City. “But it will likely also drive affinity maturation of antibodies. This will make the antibodies stronger, and potentially will allow them to better cope with new variants.” 

Moncef Slaoui, head of the US Government’s Operation Warp Speed rollout of COVID vaccines in the US, also criticized Britain’s decision in an interview with CBS “Face the Nation,” saying: “We always said that these vaccines would be developed on the basis of science and all decisions would be made transparently on the basis of data. Changing the decisions made…which was to give two doses of vaccine – the second dose gives you ten times higher immune response than the first – without any data, I think would not be responsible.” 

Meanwhile, Pfizer and BioNTech warned in a joint statement released on Monday that “the safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design.”

Mixing and Matching Of Vaccines also Emerges as an Issue

Last week British regulators also became the first to approve a vaccine developed by AstraZeneca and Oxford University, which is also a two dose regimen – based on a more conventional adenovirus vector technology, and also more temperature resilient than the sensitive Pfizer mRNA vaccine, which requires ultra cold storage.   

British regulators have also suggested that they might allow for the mixing of different vaccine brands, as well, in some situations. According to the UK’s updated vaccination guidelines, in cases “where the same vaccine is not available, or if the first product received is unknown, it is reasonable to offer one dose of the locally available product to complete the schedule.” 

But while the guidelines offer vaccine mixing and matching as an option, this should only take place on very rare occasions and “every effort should be made to give [the patient] the same vaccine,” stressed Mary Ramsay, head of immunizations at Public Health England.  

The US media, meanwhile, has overplayed the impacts of the “mix and match” vaccine option as a part of UK vaccine strategy, Fiona Godlee, editor of The BMJ was reported to have said in a letter to the New York Times. Godlee stressed that the strategy was not a recommendation, but rather a strategy of last resort, the BBC reported. Godlee demanded that the New York Times print a correction to its previous article, which had stated that: “Britain Opens Door to Mix-and-Match vaccinations, Worrying Experts”.

Image Credits: Flickr – Province of British Columbia, Our World in Data.

Dr VG Somani, Drugs Controller General of India (DCGI), has said that two COVID vaccines have been approved for emergency use. He refused to take questions from the press following the announcement, however.

Delhi – India’s chief drug regulator approved two COVID-19 vaccines for “restricted emergency use” in the country on Sunday, opening the doors for a mass vaccination campaign against COVID to begin in one of the world’s largest countries, and a lower middle-income country at that.

However, some watchdog groups said that the review process leading up to the government’s approval had lacked transparency – and in the case case of one locally-developed vaccine, Phase 3 trials had not been completed.

The approved vaccines include the AstraZeneca-Oxford vaccine, to be manufactured at large scale in India by the Serum Institute, and an indigenous vaccine developed by India’s Council for Medical Research, and to be produced by the Hyderabad company Bharat Biotech.

While the AstraZeneca vaccine was also approved last week in the United Kingdom, Indian government approval of the Bharat Biotech vaccine came before Phase 3 trials had even been completed, prompting criticism over a lack of efficacy data.  The fact that Bharat Biotech has not completed its Phase 3 trials, means that India will now join the ranks of China and Russia as the only countries to have approved vaccines without Phase 3 clinical trial data.

The Drugs Controller General of India (DCGI), Dr VG Somani, said that the drug regulatory body approved the vaccines after “adequate examination”. Approval of the two vaccines was recommended by an expert committee of doctors who examined data from the clinical trials.

The Indian government plans to first immunise 30 million healthcare workers. In this first phase, the government also plans to immunise about 270 million people above the age of 50, and those younger with comorbidities. The vaccine will be given free of cost as promised by India’s Health Minister, Dr Harsh Vardhan.

While the Serum Institute vaccine was granted permission for restricted use in emergency situations “subject to certain regulatory conditions”, the Bharat Biotech vaccine was approved “as abundant precaution, in clinical trial mode.” The Bharat Biotech vaccine was developed the Indian Council for Medical Research, a government research body.

No Phase 3 Trial Data

While the AstraZeneca approval relied upon Phase 3 data gathered abroad, India’s Serum Institute has not yet submitted complete data from the AstraZeneca trials being conducted in India, critics also said. Scientists and other experts questioned the meaning of the approval of the Bharat Biotech vaccine while still in “clinical trial mode”. They warned that a hasty approval process could stoke vaccine hesitancy or even fuel anti-vaccine sentiments.

Phase 3 trials are usually double-blinded, with one arm of the trial participants receiving the vaccine, and the other arm getting a placebo. In case of the COVID-19 vaccine trials, the two arms are compared to see which group had participants that did not suffer from COVID-19. The extent of protection provided in the vaccine group determines its efficacy.

In terms of the AstraZeneca vaccine, the DCGI relied on the safety, efficacy and immunogenicity (the ability to induce immune responses) data generated on 23,745 adult participants from the UK and Brazil which showed vaccine efficacy of 70.42%, the govenrment statement said. The efficacy results were published in The Lancet earlier in December. The Serum Institute in India is still conducting a bridge trial with 1,600 participants in India.

In case of the Bharat Biotech vaccine, the company’s founder Krishna Ella said in a press conference on Monday that the company will be able to submit phase 3 trial data by March 2021.  Under the government authorization, members of the public being administered the vaccine will be tracked and monitored as if they are in a trial. However, critics said that ethically, that could be problematic, insofar as a placebo arm for the trial could not realistically be maintained:

“Once the vaccine has been authorised, it’s unethical to continue Phase 3 and give placebo to participants. You cannot continue clinical trials,” said Dr Amar Jesani, an independent researcher and bioethicist pointed out.

According to the DCGI, Bharat Biotech’s Phase 3 trial has already recruited 22,500 participants so far and was “found to be safe” – although it provided no further details. Other media reports, meanwhile, contradicted that statement, saying that not enough volunteers had even been registered for Phase 3 trials of the vaccine.

The controversy quickly took on political tones as some leaders from opposition parties also questioned the local vaccine’s approval ahead of the completion of Phase 3 trials.

An Indian government official retorted meanwhile, that the opposition’s comments were “disgraceful” and an attempt to politicise the vaccine approvals.

Opaque Approval Process – Indian Watchdog Group Calls for Vaccine Transparency

AstraZeneca’s India trial has already been a subject of controversy.  In October 2020, a trial participant from Chennai, in southern India, sent a legal notice to Serum Institute seeking Rs 5 crores (or approximately US$ 684,000) as compensation, claiming he had suffered serious neurological impairment following one dose of the vaccine.

Serum Institute threatened to counter-sue the trial participant calling the allegations in the notice “malicious and misconceived”, and it was subsequently reported that the adverse event was not vaccine-related.

Dr Jesani flagged that while the trial stopped after a serious adverse event was reported in the UK, the same did not happen in India. That and other issues related to a reproted lack of transparency have stirred debates in the media about about the way in which the local arm of the AstraZeneca trial was conducted and monitored.

And while the US Food and Drug Administration (FDA) live-streamed the 8 hour proceedings that led to the emergency authorization of the Pfizer-BioNTech vaccine, the process in India has been comparatively opaque. The government has provided no criteria by which the vaccines were reviewed. Only a few lines of text described the meeting held to approve the vaccines.

Although DCGI Dr Somani’s statement was published live, he also refused to take any questions from the press.

The All India Drug Action Network (AIDAN), a public health watchdog, demanded that authorities provide more information on the process that had led to the clearances of the two vaccines for restricted emergency use.

“We are baffled to understand what scientific logic has motivated the top experts in the SEC to approve this vaccine posthaste,” it said in a statement.

The statement further demanded the drug controller clarify the legal provisions under which the two vaccines were approved, and asked the regulator to share the “detailed rationale for the decision along with disclosure of the data, evidence and information” reviewed by the expert panel and drug controller.

“There is a stronger case for transparency in the pandemic because of the accelerated process of vaccine regulatory approval. Globally a norm has set in with vaccine companies sharing trial data even through publications and pre-prints in the interest of public disclosure. We have unfortunately not made enough progress in India on the transparency front,” said Malini Aisola, co-convenor of AlDAN.

Image Credits: Flickr – Trinity Care Foundation.

Healthcare workers in Nigeria fight to maintain vaccination services during the COVID-19 pandemic.

Ibadan, Nigeria. Several Nigerian states were unable to carry out preventative yellow fever campaigns late last year because of the COVID-19 pandemic, leaving thousands of people at risk of developing the disease as the country now faces a new winter yellow fever outbreak, Health Policy Watch learned.

In early November, Nigeria’s Center for Disease Control (NCDC) received several reports of a yellow fever-like illness affecting people in 4 states: Delta, Enugu, Bauchi and Benue. The NCDC quickly confirmed the illness was yellow fever.

As of Christmas Eve, 17 deaths and 101 confirmed cases had been reported from 13 Nigerian states, with the 4 states that had first reported the infection, accounting for about 85% of cases.

Rising Epicurve of yellow fever cases in Nigeria
Epicurve of yellow fever cases in Nigeria, by epidemiological week (Epi-Week).

Yellow fever, which is 10 times deadlier than COVID-19, causes headache, muscle pain, nausea and jaundice (from which it takes its name). It is entirely vaccine-preventable, with immunity lasting a lifetime once someone has been vaccinated.

Speaking to Health Policy Watch, NCDC’s Head of Epidemiology Dr Jafiya Abubakar disclosed that Delta and Benue States were part of a cluster of states that were supposed to have undergone a preventive yellow fever vaccination campaign in November – which was then delayed.

“They were supposed to have it earlier but because of the COVID outbreak, it wasn’t held. It was planned for November even before the [current] outbreak,” he said.

Nigeria, Africa’s most populous country, is one of several on the African continent to routinely see outbreaks of yellow fever, an acute viral disease transmitted by mosquitoes, which is entirely preventable with a vaccine, but otherwise kills about half of those who become seriously ill. It is endemic to tropical areas of Africa and Central and Southern America.

Abubakar also revealed that Nigeria had previously mapped yellow fever risk across all 36 states, phasing them into clusters to prioritise vaccination.

Map of Nigeria showing states and local government areas with yellow fever outbreak
Map of Nigeria showing states and local government areas with yellow fever outbreak.

He confirmed that Delta and Benue have since had the preventive vaccination campaign, with Bauchi’s to be held this month. According to WHO, the vaccine provides effective immunity within 10 days for 80-100% of people vaccinated, and within 30 days for more than 99% of people vaccinated.

Abubakar attributed Nigeria’s yellow fever outbreak to the existence of a “critical mass of people that are not immunised”.

Nigeria’s Fraught History with Yellow Fever

In April 2018, WHO Director General Dr Tedros Adhanom Ghebreyesus joined UNICEF representatives in Nigeria’s capital, Abuja, to launch the joint Eliminate Yellow Fever Epidemics (EYE) Strategy.

The strategy aims to rid the continent of these circulating outbreaks by 2026 by introducing the yellow fever vaccine into routine immunization programmes. With support from Gavi, the Vaccine Alliance, EYE aims to vaccinate around 1.4 billion people in Nigeria and 40 other high-risk countries around the world by 2026.

“The eligible age group for the vaccination campaign is from 9 months to 44 years. These are the ages that have been noticed to have missed out in initial vaccination campaigns,” Abubakar said.

The Risk of An Endemic Threat As the Continent Faces Its Second COVID Wave

With the emergence of a yellow fever outbreak roughly coinciding with the onset of a second wave of COVID-19 infections, Abubakar flagged how vital it is to maintain an adaptive response to the pandemic – maintaining and strengthening other critical public health services alongside COVID response.

Throughout the pandemic, Nigeria has aimed to implement and utilise equipment, structures and support systems that can be adapted to multiple public health emergencies.

Nigeria’s Emergency Operations Centers (EOCs), which predated the COVID pandemic, have made a coordinated national response much easier to mount, in comparison to some other African and Western countries, as they work with state governments to allocate resources systematically for emergency purposes.

According to Abubakar, the NCDC will continue to follow in this direction, and it has now activated EOCs in 30 states to facilitate quick yellow fever case finding during the COVID pandemic.

“These centers are hubs: they are coordination centers where the teams have been trained on how to manage emergencies and crisis,” Abubakar told Health Policy Watch. “The multidisciplinary team is also multisectoral and contains all the partners.

“For every outbreak, we use our resources together — human, financial and other resources and things that are required — collaboratively to respond to the outbreak. That is what we are doing. We cannot, just because we are in a pandemic, ignore outbreaks of other diseases and interventions that are needed by our communities.”

PCaregivers must be reminded that yellow fever vaccination is offered at no cost for children under 9 months across the country, Abubakar said.

To avert future yellow fever outbreaks, the NCDC official said more efforts and resources need to be committed to enlightening the general public on the urgent need to be vaccinated, especially as vaccines are available for free for certain age groups across the country.

“We need to encourage caregivers and parents that yellow fever vaccination is given for free [to of children under 9 months] in all our health facilities. They should take advantage of that to ensure that their kids are protected against yellow fever,” Abubakar said.

Image Credits: Twitter: @WHOAFRO, NCDC.

Italy launched its COVID-19 vaccine drive on Sunday, 27 December along with several other European Union countries

As European COVID-19 vaccine campaigns got underway with celebratory first jabs into the arms of citizens in half a dozen countries, some seasoned observers were still wondering if the pace of vaccine roll-outs will move fast enough to outpace the continuing high levels of infection and fatality – now being fuelled by a new mutant SARS-CoV-2 virus strain taking hold on the continent.   

Among the 27 countries of the European Union, Germany, Greece, France, Italy, Spain and Poland were among the first to begin administering shots on Sunday – after receiving the first dispatches of the EU’s order for  some 200 million doses of the Pfizer vaccine, which has been delivered region-wide.  However, some countries were already behind, with the Netherlands not due to start vaccinating until 8 January.

European leaders ranging from Italy’s Prime Minister Giuseppe Conte and Spain’s Pedro Sánchez, to European Commission president Ursula Van der Leyen have heralded the recent moves, expressing hope that the vaccines will be transformational for the continent, which has suffered some of the world’s highest infection and death tolls in the year since the pandemic began. 

“Today, we start turning the page on a difficult year,” von der Leyen, the European Commission president wrote in a Twitter post on Saturday. “The  #EUvaccinationdays are a touching moment of unity. Vaccination is the lasting way out of the pandemic. ”

Regulatory Delays Followed by Holidays Hamper Initial Rollout

While Switzerland was in fact the first country in continental Europe to administer a COVID vaccine on 23 December – the start has been largely symbolic. In the intervening period of Christmas and New Year’s holidays, only a few more vaccines have been administered in the Confederation – with more serious efforts only set to get underway in mid-January.  Further dampening enthusiasm was the death of one of the first vaccine recipients, a 91-year old woman in the Canton of Lucerne, just five days after receiving the vaccine – although Swiss authorities said that the timing had been “a coincidence.“

COVID vaccine doses administered in total, by country

But the chain of events have also left some observers worried that delays seen so far could have a lasting impact on the vaccine’s rollout in Switzerland – a country where death rates have been comparatively high throughout the pandemic, and are even more so right now. 

“Israel has vaccinated over 700,000 people and what has Switzerland done so far?” asked Dr. Pierre Goloubinoff, a biologist at the University of Lausanne who has worked in both countries, including collaborations on COVID therapies, in an interview with Health Policy Watch. 

“As of 29 December, there were 6 vaccinations in Canton of Geneva and a few dozen, maximum, in Fribourg and the Valais. At this rate Switzerland will be vaccinated in 250 years.  

“The Department of Health doesn’t seem to understand that in just three weeks of delay, with 4000 new infections per day, 100 will die everyday. That means in three weeks, more than 2000 people will die unduly.”

“If we could do a vaccine blitz, and vaccine all of the high-risk population in a month, in terms of the economy it would be completely liberating,” he said.

Already high Swiss infection and death rates, compounded by the spread of a new mutant strain of the virus originating in the United Kingdom, and which is even more infectious, hold the potential to create more havoc for health systems and economies – just as countries try to regain normalcy, he warned.  

For the moment, COVID vaccines being rolled out still appear to be effective against the mutant virus strains that have surfaced recently in South Africa as well as the UK.  However extensive spread of those strains will also create new opportunities for still further mutations – which could then increase risks that vaccine efficacy could be reduced.

Vaccine Conservatism & Christmas Hamper Swiss Rollout Efforts

In comparison to Israel, a country similar in size to Switzerland, and nearly identical COVID infection rates, Switzerland’s average mortality rate throughout the pandemic has been roughly double – Goloubinoff noted in a provocative Facebook post last week which made the comparisons very directly:

Facebook post last week by University of Lausanne biology researcher Pierre Golubinoff, complaining about Switzerland’s slow pace of vaccines
 Pressing ‘Restart’ – In Slow Motion?

That, he says, reflects broader shortcomings in the non-pharmaceutical approaches tried so far. But even so, the introduction of COVID vaccines should mark a moment when every country can press “restart” on their efforts to combat the virus, he observed: 

“My general prediction was that the vaccines are going to totally change the situation because they are efficient.  They decrease the risks dramatically; it makes the difference between someone like me having a 1 in 50 chance of being hospitalized and a 1 in 100 chance of dying to having a 1 in tens of thousands chance,” said Goloubinoff who is 64.  

However, even when vaccine campaigns do finally get underway in mid-January, he fears that Switzerland is not adequately geared up well for the kind of rapid blitz that is needed now. 

“Switzerland had a year to get organized, to say that we are stuck now because we were not ready, is of the stupidest reasoning,” bemoaned Goloubinoff. “We have a great infrastructure but we are not prepared for pandemic response.” 

Although Switzerland, like Israel, has procured enough vaccines in principle to immunize its entire population, the initial deliveries of the Pfizer vaccine will be in far smaller quantities – with only 357,000 doses due to be available by the end of January 2021.

And that is only enough to vaccinate about 178,500 people in the month of January – when Israel is vaccinating the same number of people in just one or two days [see related story]. 

Eventually, the Moderna vaccine should bolster vaccine availability – particularly since Moderna’s global manufacturing, Lonza, is based in the Valais town of Visp. 

However, Swissmedic has not yet approved the Moderna vaccine.  And that is despite the fact that it was approved on 18 December by the United States Food and Drug Administration with even fewer reservations than those that accompanied that of the FDA’s approval of Pfizer’s mRNA vaccine – which Swissmedic greenlighted earlier in the month.

“I suspect Swissmedic has not made a determination on Moderna because the experts were not asked by the Conseil Féderal to work on an emergency basis during their Christmas holidays,” said Goloubinoff, wryly. 

The damage of vaccine delays, whether due to holidays, supply chain gaps, or an overall lack of preparedness will be cumulative, not only in terms of mortality, but also in terms of long-term disabilities being experienced by younger people suffering from ‘Long COVID’, Goloubinoff says. 

He cited the recent experience of one of his PhD students, aged 35 who became ill with COVID this autumn and nearly died: “He’s still walking with a stick, is very, very weak, and able to carry out maybe half of the intellectual load that he was doing before.”

Official Swiss Vaccine Communications Provide No Timetables

As it stands now, the initial vaccine rollout will be extremely limited. A Swiss Mission missive, sent to UN employees in the Geneva area last week, announced that Geneva’s vaccine drive, beginning on 28 December, would include people aged 75 and older living in care homes, and some hospital staff.

“As more vaccines are delivered by the Confederation, the campaign will be expanded to people aged 65-74 years of age, as well as to people with clinically diagnosed pre-existing conditions under 65 years of age,(e.g. cardiac illness, obesity, etc.),” the notice, dated 22 December, states.  As for anyone under the age of 65, the rollout date remains undetermined.

A circular from the Canton of Vaud sets the first date for vaccinations two weeks later, on 11 January. There too, the initial phase of immunizations will be limited to people aged 75 living in care facilities, along with health care workers.

The circular also hastens to underline the complexity of the vaccine task being faced, stating: “this vaccination campaign is without precedent in terms of its logistical chalenges, which include conservation of three types of vaccines [Pfizer, Moderna and AstraZeneca] at different temperatures.  In addition, certain products have to be mixed before the injection, and then they all have to be injected in the 5-6 hours after having been placed in ambient temperature conditions. Finally, everyone who wishes to be vaccinated has to go two times, within an interval of four weeks.”

Other Health Policy Watch queries yielded no further clarity regarding vaccination schedules:  “We haven’t yet received word of when we will be receiving the vaccine,” said the head of an outpatient clinic at a hospital in the Canton of Vaud.

In response to another query, a Swiss Department of Health spokesperson also had no further details about timetables, stating only: “The vaccine doses are arriving in a staggered manner, as they do in every country. We expect to have everyone vaccinated by early summer who wants to be,” the spokesperson said.   

That remains in stark contrast to countries like Israel, which are vaccinating everyone 60 and older right now – and soon to move onto teachers and younger people with chronic health conditions. Among the 700,000 people vaccinated so far, there has been one widely reported death in a man aged 70 suffering from multiple health conditions. However, as one prominent Israeli health expert pointed out, among people aged 60 and over, some 700 a week die on average in any case from causes unrelated to COVID.

In the United States Lack of Public Health Infrastructure Inhibits Vaccine Delivery 

On the other side of the Atlantic, frustrations about a slow pace of vaccine rollout also are surfacing in the United States, the Boston-based, Stat News reported this week.

Although the Trump administration has shipped more than 11 million doses of the Pfizer and Moderna vaccines to locales around the country, only 2.1 million people have received their shots since the drive began on 14 December, according to the US Centres for Disease Control (CDC).  

“We are below where we want to be,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, was quoted as saying on CNN. “Not being responsible myself for the rollout, I can’t personally guarantee that we’re going to catch up. I hope we do.”

In the case of the US, the biggest stumbling block appears  to be the lack of budget and coherent public health infrastructure for administering the vaccines – after they are received. 

While outgoing President Donald Trump aggressively invested in, and pushed for Operation Warp Speed’s vaccine R&D – he left the critical field operation underfunded. State and local public health officials have waited for months for  more than $US 8 billion that they said would be needed to develop the infrastructure needed to administer vaccines, while the Trump administration provided only $US 340 million. The coronavirus stimulus package passed by the Congress shortly before Christmas and signed by the US president on Sunday, finally allocated the full amount that had been requested.  

Along with a shortage of funds, the US health system is fragmented between a host of public and private health insurance providers – which make a single coherent campaign of the kind being launched in other countries, such as the UK, Europe, Israel, Bahrain, even more challenging. 

“There appears to be no investment or plan in the last mile,” tweeted Ashish Jha, dean of the Brown University School of Public Health. “No effort from Feds to help states launch a real vaccination infrastructure. Did the Feds not know vaccines were coming? Shouldn’t planning around vaccination sites, etc not have happened in October or November?”

United Kingdom Approves AstraZeneca/Oxford Vaccine – Good News For Low- and Middle-Income Countries

There was was good news in the United Kingdom, however, where the adenovirus-based COVID vaccine jointly developed by AstraZeneca and the University of Oxford, became the third to receive regulatory approval by a globally recognized agency, on Tuesday, 30 December.

Approval of the AstraZeneca vaccine by the Medicines and Healthcare products Regulatory Agency (MHRA) will allow the UK to redouble its aggressive vaccine efforts – while it directly faces the threat of the SARS-CoV2 virus variant on home turf.

On Tuesday, 53,135 new Covid cases were recorded in the UK – the highest single day rise since mass testing began, BBC reported. The UK has ordered 100 million doses of the AstraZeneca vaccine – enough to vaccinate 50 million people – or roughly 75% of its population.  

That is in addition to the Pfizer vaccine, which the UK’s National Health Service was the first to rollout already beginning on 8 December.   With ample supplies now available, the NHS aims to open vaccine campaigns to a much wider swathe of the general public, ramping up the pace of vaccinations to as many as two million people a week.

The UK regulatory approval of the AstraZeneca vaccine also marks an important milestone for low- and middle-income countries – as the vaccine’s modest cold-chain requirements permit storage in a conventional refrigerator making it easier to administer in resource-constrained settings.

Some 3 billion doses of the AstraZeneca vaccine are due to be manufactured in 2021 including  in India and Brazil – with some supplies also being procured and distributed even more widely through the WHO co-sponsored COVAX facility. 

Even so, while vaccine hoarding, vaccine nationalism and inequitable distribution of vaccines remain huge global issues to be surmounted – the problems already being experienced by high income countries seemingly awash in vaccines, may be seen as warning signal to other nations that are only just now starting to plan their vaccine campaigns. 

And the message is this: once you have secured an adequate vaccine supply – that is still only the beginning of the journey.

 

Image Credits: Euoropean Commission , Our World In Data .

Just-vaccinated – Client walks out of Maccabee Health Fund’s night station in Jerusalem’s Arena conference center

Jerusalem – The huge neon sign over the city’s football stadium flashed over the highway and into the night. “Jerusalem is vaccinating” – it proclaimed. 

Across from the stadium, in a giant Arena that in normal times hosts conferences and trade shows, a steady stream of older people – some in wheelchairs, moving with walkers or assisted by family members or caregivers, were entering the big hall at 8 pm to get their first shot of the Pfizer’s Covid vaccine.

The arena has been turned into an impromptu vaccine station for one of Israel’s four public health funds – Maccabee.  It features a large, airy waiting room with numbers flashing across a big screen – and 8 vaccination stands down a hallway where people were immunised within minutes behind a flimsy curtain and then ushered back to wait 15 minutes to insure no allergic reaction 

It’s a scene that is being repeated all over Israel – including at some drive in vaccine facilities-  as the country goes into vaccine overdrive. 

“It was just like an A&W drive-thru,” marveled 65-year-old retired teacher Deborah Sullum, who was vaccinated at a drive-in facility in the coastal city of Haifa just last week together with her husband, a medical doctor. “You roll down your window, place your order with your magnetic Maccabee (health fund) card.  At the second station, you get your injection and at the third station you wait in the parking lot for 15 minutes to make sure there are no allergic reactions. Super efficient.”  

As of Tuesday evening, 29 December, some 643,000 people received their first vaccine, making Israel, with nearly 9 million people,  the country with the highest rate of COVID vaccine coverage per capita in the world, and third highest in absolute terms, just beyind the United Kingdom, China and the United States.  As of Wednesday morning, 30 December, that reached and then exceeded 700,000 vaccines, as numbers mounted by the hour.  

With most health care workers and over 20% of people over the age of 60 already having received their first shot, the aim is now to become the first country in the world to vaccinate its entire vulnerable population. Immunizations of teachers and younger people with chronic health conditions are slated to begin next week.  While over 100,000 vaccines a day are being administered already, the goal is to reach 150,000 vaccinations daily. If that pace is sustained, then some 2.25 million people may already be immunized with the full two-dose course of the Pfizer vaccine by the end of January, or about one-quarter of the entire population.

“Jerusalem is vaccinating – maintain hygiene” proclaims a sign over west Jerusalem’s Teddy football stadium
Hype, Efficiency & Creative Chaos  

Of course the process, which kicked off on December 19th with the televised vaccination of Prime Minister Benjamin Netanyahu and Health Minister Yuli Edelstein, hasn’t been entirely smooth going. 

The initial days also saw chaotic moments of long and crowded vaccine queueing in some hastily erected health fund stations – along with well publicized moments of queue jumping, which is almost a national sport in tiny, crowded Israel. 

There has been vigorous media coverage examining which one of Israel’s four public health funds are providing the best and the worst vaccine services – including where people have been getting appointments immediately or after delays of a few weeks. In some cases, wannabe vaccine candidates were able to register online.  In others, they had to call a hotline dozens of times just to make an appointment, some people complained.

Despite the hiccups, the strenous advance preparations, media hype and hopes that vaccines will help return a semblance of normalcy to life have helped propel the campaign – and vaccine acceptance to unexpected heights. 

Vaccine response rates have compared well in progressive, higher income areas of Israel’s central region – and more low-income rural areas on its periphery. It  has lagged in some smaller, and more conservative, Bedouin and Palestinian communities where vaccine hesitancy is higher, but the general assumption is that those pockets of doubt will be overcome by the otherwise huge turnouts seen.  

Vaccines are being administered at stretches of 12 hours a day – even in some cases on the Jewish Sabbath. The demand is so great that lines of younger people and those with chronic conditions, who don’t yet qualify to get vaccinated officially, form outside of some of the larger vaccine stations toward the end of the evening, just before closure, with people aiming to get doses that would otherwise be thrown out – because they won’t survive overnight without the ultra-cold storage that they require. 

Intense media coverage of how many vaccines are arriving, and what health funds and cities are outperforming in terms of vaccine coverage, has added to the hype.

 

The camapign has also been a morale booster, placing the efficiency and muscle of Israel’s four public health funds that provide universal health coverage front and centre on full display.  Although beyond the strength of the health system, there are other obvious ingredients to success. Those include the country’s small size, high-level political commitment despite incessant political infighting – and the ability to pay for a big vaccine supply right away.

Reportedly Israel, which opted to buy the Pfizer/BioNTech COVID vaccine relatively late in the game, paid a premium price of  US$ 28 per dose as compared to the US$ 19.50 paid by the United States and US$18.34 paid by the European Union. But along with the higher price, the deal,  reportedly sealed in a series of late night phone calls between Netanyahu and Pfizer’s CEO Albert Bourla, also included a schedule of rapid, high-volume deliveries.  As a result, Israel will have already received 3.8 million doses of the Pfizer vaccine by the end of this month – out of a total order of 9 million doses. 

Add to that six million doses of Moderna’s vaccine, which is based on a simlar mRNA technology, Israel already has enough vaccines to cover most of its population, as well as ensure a steady supply so that immunizations can proceed uninterrupted over the first four months of 2021.  And that is without considering a domestic vaccine that it is currently in Phase 2 trials.   

Covid vaccination doses administered per 100 people as of 30 December, 2020

Interestingly enough, Israel has not been the only country in the region to have advanced so quickly – while Europe has seen delays due to a more cautious process of regulatory approvals followed by Christmas and New Year’s holidays.

Bahrain, a tiny Gulf country with just 1.7 million people, currently ranks second in the world behind Israel, in terms of COVID vaccine coverage, per capita. 

That rollout also has included Bahrain’s sizeable population of foreign workers who comprise half of the resident population – setting a precedent for other countries in the region where hundreds of thousands of Pakistanis, Bangladeshis, Filipinos and other foreign workers keep oil-based economies operating smoothly.  

Bahrain’s rapid rollout has been built upon pillars similar to Israel’s  – early approval of the Pfizer vaccine by the country’s independent regulator’s; and thanks partly to that, Pfizer commitments of rapid delivery of large quantities of vaccine doses; and an excellent public and private health system which is also patronized by people from around the Gulf.  

Vaccine Nationalism & Vaccine Geopolitics   

The Israeli campaign has not been without criticism – it also reflects the pockmarks of the area’s broader regional disputes. Most of the nearly 3 million Palestinians in the Israeli-occupied West Bank and another 2 million people in Hamas-controlled Gaza, are not part of the vaccine drive – despite soaring rates of infection and serious illness. It’s a vivid illustration of the global differences between the world’s vaccine “haves” – and “have nots”.  In the Israeli context, it’s also an example of how the geopolitics of vaccine nationalism are intertwined here with other deepseated national and territorial conflicts.

Israel has said that the Palestinian Authority, is responsible for procuring its own vaccines for West Bank Palestinians – as it typically does for routine childhood vaccinations – often obtained in bulk through discounted UN procurement deals.  But health activists say that leaving the matter to the budget-strapped PA is self-defeating – insofar as tens of thousands of Palestinians work in Israel – and continued high infection rates in the West Bank will inevitably spill over. 

And precisely because Israel doesn’t recognize the Palestinian Authority as a national entity – large areas of the West Bank aren’t even under the PA’s control  – then Israel still holds ultimate responsibility for ensuring Palestinian access to COVID vaccines, legal and human rights advocates also point out.  

“You don’t have to be a licensed lawyer to understand the absurdity of a position by which [Israel claims that the West Bank] territory belongs to the Jewish people when it comes to settlement, exploitation and annexation, but that when its non-Jewish residents are ill, the territory is Palestinian,” opined human rights lawyer Sari Bashi, in a 2 December op-ed in the liberal national daily, Ha’aretz; she argued that Israel should purchase vaccines for Palestinians as well.  

Universal Health Coverage – Almost 

Then again, the nature of the vaccine distribution, is not precisely etched around national identity either. Rather it is anchored in the Israeli system of national health funds. Those funds do not cover Israelis living abroad. They do include hundreds of thousands of Palestinians in disputed East Jerusalem, who can thus obtain the COVID vaccines right away. 

At the same time, the remaining 2.2 million or so Palestinians living in the West Bank on the other side of the army checkpoints and stark concrete barriers that mark Israeli-defined Jerusalem city limits, must rely upon the health services of the Palestinian Authority – which doesn’t yet have access to any COVID vaccines.

Foreign residents and workers living in Israel, on the other hand, generally belong to Israeli health funds and are eligible to get the vaccine under the same criteria as Israeli citizens  – with foreign caregivers of elderly Israelis getting first priority this week.

The situation is less clear, however, for Israel’s approximately 30,000 African asylum seekers, most of whom fled war-torn Sudan and Eritrea a decade or more ago, slipping into the country via Israel’s border with Egypt, after a tortuous trip through the Sinai desert, but have never been granted formal refugee status by Israel’s Interior Ministry. 

While in principle, asylum seekers are supposed to be covered with health insurance by their employers – in fact they have limited access to medical care.  Some employers duck the rules, while those who are unemployed or unable to work because they are chronically ill, fall into an insurance void. Human rights advocates are hopeful that they may soon be able to make an arrangement, however, whereby vulnerable asylum seekers may also be immunized.  

Palestinian Authority Ordering Russia’s Sputnik Vaccine  

In terms of the current lack of Palestinian access to the vaccines, Israel’s deputy health minister Yoav Kish told Israel’s Kan Radio station last week that “should we see that Israel’s demands have been met and we have additional capability, we will certainly consider helping the Palestinian Authority.”    

However, the Palestinian Authority, which typically procures its own vaccines anyway for routine immunizations, is not waiting for Israel. 

Earlier this month, one PA health official Osama al-Najjar announced  that four million doses of the Russian Sputnik vaccine would be delivered in early 2021.

“We will begin to inoculate those most at risk [for the coronavirus],” al-Najjar said in an interview with Voice of Palestine Radio. Outside of Russia, only Argentina and Belarus have have so far approved the Sputnik vaccine, whose Phase 3 clinical trial results have not yet been fully completed – or independently reviewed. . 

The PA also hopes to vaccinate one-fifth of Palestine’s people under the WHO co-sponsored COVAX facility, starting with healthcare workers, another senior Palestinian health official, Ali Abed Rabbo told the Associated Press last week.

“The remainder will depend on Palestine purchasing from the global supply, and we are working with several companies,” Rabbo said, naming Pfizer, Moderna, AstraZeneca, as other potential candidates, along with the Russian Sputnik vaccine. 

Israel also eyeing Sputnik

The Palestinians are not the only ones eyeing Sputnik; some prominent Israelis have also given the Russian vaccine a nod. Zeev Rothstein,  Director General of Jerusalem’s prestigious Hadassah-Hebrew University Medical Center, said last month that the hospital had secured an agreement to purchase 1.5 million doses of the vaccine from Russia  – with the aim of becoming a regional vaccine distributor. However so far, the hospital, which also has a branch in Russia, has not secured official Israeli Ministry of Health approval for the move.  

Along with the imported vaccine options, an Israeli-developed one-dose COVID vaccine just began Phase 2 trials this week; if all goes well, Phase 3 trials will begin in the spring. With some 10 million doses of that vaccine slated for potential production, it’s possible that in the end, Israel might become a net exporter of COVID vaccines. The question, however, is how much time it may take?

Said an Israeli Ministry of Foreign Affairs spokesperson in Geneva: “Israel, at this point, has made vaccine agreements with both Pfizer and Moderna, and plans to obtain vaccines for all its citizens. 

“At the same time, Israel is part of the COVAX facility, WHO’s instrument to insure that all citizens of the world will be safely vaccinated equitably. 

“Understanding that pandemics know no borders, Israel has strengthened its cooperation with the Palestinian Authority in order to prevent, mitigate and address the spread of the virus in the region. 

“The ongoing cooperation includes consultations, training and information sharing, cooperation with Palestinian medical teams, and delivery of COVID-19-related PPE.  We encourage the international community and donor countries to help the PA with all aspects of dealing with the COVID-19, including access to vaccines.”

Image Credits: Our World In Data .