COVID Booster Vaccines Gain Traction with New US Campaign – Despite WHO Appeals for Moratorium 
Medicines & Vaccines 19/08/2021 • &
booster
COVID booster vaccines have gained traction in several countries – US, Israel, Germany, UK, and others, but low- and middle-income countries lag significantly behind in shots.

US Health officials confirmed on Wednesday that the country will begin to offer a third COVID ‘booster’ vaccine, beginning the week of September 20, to Americans who were vaccinated earliest in the vaccination rollout.

It’s now “very clear” that immunity starts to fall after the initial two doses, and with the dominance of the Delta variant, “we are starting to see evidence of reduced protection against mild and moderate disease,” according to the US CDC statement announcing the move, and signed by Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci and other U.S. health leaders.

Boosters will be administered 8 months after an individual’s second dose on a rolling basis, the statement said.

The officials said that the plan to offer a third Pfizer or Moderna mRNA vaccine is still “subject” to review and evaluation by the US Food and Drug Administration (FDA) of “safety and effectiveness” along with the CDC’s Advisory Committee on Immunization Practices (ACIP).  But with the FDA having recently  authorised booster shots for severely immunocompromised people – that new layer of FDA approval appears to be almost a foregone conclusion.

Recipients of Johnson & Johnson’s single-shot vaccine will also likely need boosters, the officials said. But they are awaiting more data in the next few weeks before making a formal recommendation.

“Our top priority remains staying ahead of the virus and protecting the American people from COVID-19 with safe, effective, and long-lasting vaccines especially in the context of a constantly changing virus and epidemiologic landscape. We will continue to follow the science on a daily basis, and we are prepared to modify this plan should new data emerge that requires it,” the joint statement read.

Fresh data from Israel shows boosters’ efficacy

The new US push came as fresh data from Israel suggested that a third shot of the coronavirus vaccine is 86 percent effective in preventing COVID-19 infection among people aged 60 and older. The Maccabi Healthcare Services study, the first of its kind in the world, provided the first large-scale data on booster efficacy.

The study surveyed 149,144 people who received a third booster shot against a control group of 675,630 people who received only the two-course series, in January or February, 2021.

Among those receiving the booster,  only 37 people tested positive with the SARS-CoV2 virus, as compared with 1,064 in the group vaccinated with just two doses in a survey a week after the test group receive the third dose.

Israel is currently battling with the fourth highest rate of COVID-19 infections per capita in the world – exceeded only by Georgia, Dominica and Cuba – and well ahead of other former hotspots like the United States, the United Kingdom, India, and Brazil.  Although protection of older people against severe COVID with just two vaccine doses was still 5-6 times higher than among those not vaccinated- that was still not enough to stem the sharply rising stream of intensive care cases, in light of the unprecedentedly high infection rates, the government said.

Now, however, the boosters- which some 1 in 9 Israelis and a total of 1 million people over the age of 50 have now received in just the past two weeks, – seems to be finally bending the curve of serious cases at least, said former Director General Gabi Barbash on an Israeli news channel Tuesday evening.

And that could make the difference between a manaegeable case load and the “tragedy” of hospitals soon becoming overwhelmed with more serious cases than they can handle, he asserted.

US infections ‘vertical’ with widespread vaccine hesitancy

Vaccine coverage across the US – % of population with at least one dose.

While US infections lag well behind Israeli rates for now, they are on a similar trajectory. Experts such as Peter Hotez, of Texas Children’s Hospital, have pointed to an almost “vertical” pattern of increasing infections in the US – particularly in areas where widespread vaccine hesitancy has left coverage levels at 30% or less.

“This [pandemic] is really raging,” he added, noting the new cases are almost as bad as the pandemic had been earlier this year, in January and February.

“We’re pushing up to 150,000 new cases a day. This will probably soon be up to 200,000 cases a day,” he said in an interview Tuesday on CNN. Hotez spoke in favor of booster shots, alongside additional public health measures, as a way to defeat the pandemic.

“As a nation, we have to figure out a way to do both, [getting booster shots and getting unvaccinated people vaccinated].”

Outcry Among WHO officials

WHO Director-General Dr Tedros Adhanom Ghebreyesus

Despite the growing evidence of efficacy, the new booster policies have been fiercely denounced by WHO, led by Director General Tedros Adhanom Ghebreyesus.

Over the weekend and again on Wednesday, Tedros renewed his appeals for a “moratorium” on third jabs until more people in low- and middle-income countries could get their first shots.

“Last week, WHO brought together 2,000 experts from all around the world and debated the available data on COVID-19 boosters. What is clear is that it’s critical to get first shots into arms and protect the most vulnerable before boosters are rolled out,” Tedros stated in a press briefing.

“The divide between the haves and have nots will only grow larger if manufacturers and leaders prioritize booster shots over supply to low- and middle-income countries,” he added.

That followed warnings by Tedros over the weekend that diverting global vaccine supplies to boosters could foster the spread of dangerous variants in vaccine-poor countries elsewhere.

Boosters – Like Handing out ‘Second Life Jackets’

Dr Mike Ryan, WHO Head of the Health Emergencies Programme.

“The fundamental ethical reality is we’re handing out second life jackets while leaving millions and millions of people without anything to protect them,” WHO’s Executive Director of Health Emergencies, Mike Ryan added, noting that around  58% of people in high-income countries have received at least one vaccine dose as compared to just 1.3 % percent in Africa.

Ryan and other WHO officials, such as Chief Scientist Soumya Swaminathan, also maintain that the science so far remains undecided about whether boosters are actually needed.

“It is the right thing to do”  to wait for the evidence to determine who might need boosters, Swaminathan said.

Dorit Nitsan, WHO European Region’s head of Health Emergencies, and herself an Israeli, called on Israel and other rich governments administering boosters to at least share more of their vaccine stocks with poorer countries.

“I’ve raised this issue repeatedly in the past, and others have also raised it recently, but the issue never took center stage,” said Nitsan in an interview on Sunday with Israel’s liberal news daily, Ha’aretz.  Nitsan proposed that for every dose administered in Israel, the country should donate “one dose, half a dose or some other number to the world.”

‘I disagree’ Biden Pushes Back at WHO

President Joe Biden at White House briefing on COVID vaccinations Wednesday evening.

Speaking at a press conference in Washington DC a few hours later, US President Joe Biden pushed back at the WHO statements, saying: “There are some world leaders who say  America shouldn’t get a third shot until other countries got their first shot. I disagree.

“We can take care of America and help the world the same time, in June and July America administered 50 million shots during the United States. And we donated 100 million shots to other countries. That means that America has donated more vaccine to other countries, and every other country in the world combined.

“During the coming months, fall and early winter. We expect to give out another about 100,000 boosters, and the United States will donate more than 200 million additional doses to other countries. This will keep us on our way to meeting our pledge, more than 600 million vaccine donations over half a billion. I said as I said before, we’re going to be the arsenal of vaccines to beat this pandemic as were the arsenal of democracy to win World War II.”

Israel’s Mission in Geneva, meanwhile responded saying that Israel’s precedent-setting vaccine moves are informing policies elsewhere: “Israel will continue to share data, findings and knowledge with the scientific community world-wide. Throughout the pandemic we have seen that knowledge transfer and accumulation are critical to fighting the pandemic,” a spokesperson said.

“Scarcity Trap’ or Not?

In contrast to governments, the WHO appeals for a moratorium have gained greater traction among global health experts concerned with vaccine equity:

“No, Boosters are NOT good pub health policy now. Not when most of world hasn’t gotten 1st shot & policymakers insist on monopolized production leading to global shortage of doses. If you want to end the pandemic @DrTedros is right, booster moratorium,” said Matthew Kavanagh, a professor of global health at Georgetown University, on his Twitter feed.

Others, however, have observed that the real problem is vaccine scarcity – and the lack of broader access to the most effective vaccine technologies.

“I sympathize with the booster moratorium, yet I wonder whether it falls into the scarcity trap. With the right rules & ambition, there are enough vaccines at the right price & the right dose for everyone. Abundance over scarcity. That has been our demand from the beginning. Non?” said Jon Cohen, Director of New York-based Open Society Health.

Added Lawrence Gostein of the O’Neill Institute at Georgetown Law,”Offering a 3rd dose to the entire US pop will create even more global scarcity, robbing low income countries of lifesaving doses for health workers & the vulnerable. It’s a slap in the face to WHO which called for a booster moratorium.”

Instead, said Gostin: “Biden should limit 3rd doses only to the most vulnerable, including health workers, nursing home residents & the elderly.”

He also should pledge a major global vaccination campaign including billions of donated doses & ramping up global vaccine supplies.”

He further added, in a follow-up tweet regarding CDC’s data on waning protection: “We can’t just view this from a US perspective. Each dose we use in the US is not available to save a life in a low resource country. It’s also tone deaf to the mounting deaths globally & defies WHO’s pleas against boosters.”

US FDA Authorization likely to set off a trend

Israel was the first country in the world to begin offering booster shots 29 July to people over the age of 60 that had received the highly efficacious Pfizer or Moderna mRNA vaccines, even before the US Food and Drug Administration initially authorized an additional vaccine dose for certain immunocompromised individuals.

The US CDC’s most recent authorization for boosters for those vaccinated earliest, which now includes many health care workers, nursing home residents, and other seniors, is now likely to set off an even wider trend of booster shots in other rich countries fearful of a Delta virus onslaught this fall – or already experiencing one this summer.

The United Kingdom’s National Health Service has been given the green light to start planning a COVID vaccine booster program, beginning 6 September, including some 32 million booster doses.

Germany also plans to begin offering booster shots to vulnerable persons beginning in September, including people over age 50 as well as younger people employed in geriatric and health institutions, and those suffering from underlying conditions.

German Health Minister Jens Spahn at WHO briefing in Geneva

During a high-level visit to Geneva in July, German Health Minister Jens Spahn asserted that there should be “no contradiction” between offering booster shots – and getting more vaccines to low- and middle income countries.

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

Fractional doses – for the vaccine impoverished

However, the reality remains that vaccine doses are only beginning to trickle into Africa again now – and at far lower levels than appeals launched by WHO over the summer.

So as some wealthy countries plan booster shots, researchers in poor countries are even calling for “fractional dose” administration to stretch scarce resources.

Meanwhile, European and US officials – while supporting vaccine equity in principle- still have not come up with a formula for ensuring vaccine sharing at the levels that WHO says are needed.

That leaves little chance now that the ambitious WHO goals for achieving a 10% vaccination goal in all countries by end-September will actually be met.

Image Credits: Marco Verch/Flickr, CDC, WHO.

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