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Departing FDA Officials Oppose Biden’s Booster Shots Plan

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As public health advocates warn that Covid-19 boosters could exacerbate deadly consequences of global vaccine inequality, two leading vaccination officials at the U.S. Food and Drug Administration were part of an international group of medical experts who said Monday that most people don’t require such shots at this time.

“If vaccines are deployed where they would do the most good, they could hasten the end of the pandemic by inhibiting further evolution of variants.” — Public health experts

The experts’ joint opposition to boosters, as The Hill reported, comes as the Biden administration “is pushing for boosters to be widely available to all Americans beginning September 20, despite disagreement from outside scientists and some health agency officials who argue it’s premature, and that the data are not strong enough to support such a move.”

In an editorial (pdf) published in the U.K.-based medical journal The Lancet, the experts—who include Food and Drug Administration (FDA) vaccine reviewers Drs. Phil Krause and Marion Gruber—note that Covid-19 vaccines “continue to be effective against severe disease, including that caused by the Delta variant.”

Krause and Gruber, both longtime FDA employees, recently said they will be leaving the agency later this fall, without providing reasons for their departure.

The authors acknowledge that “boosting could be appropriate for some individuals in whom the primary vaccination… might not have induced adequate protection,” including people who are immunocompromised.

However, they point out that “there could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side effects,” and that “significant adverse reactions” could have “implications for vaccine acceptance that go beyond Covid-19 vaccines.”

“Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate,” the editorial states.

Addressing the issue of vaccine inequality, the experts write:

The limited supply of these vaccines will save the most lives if made available to people who are at appreciable risk of serious disease and have not yet received any vaccine. Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated.

If vaccines are deployed where they would do the most good, they could hasten the end of the pandemic by inhibiting further evolution of variants. Indeed, [the World Health Organization] has called for a moratorium on boosting until the benefits of primary vaccination have been made available to more people around the world.

This is a compelling issue, particularly as the currently available evidence does not show the need for widespread use of booster vaccination in populations that have received an effective primary vaccination regimen.

Last week, WHO Director-General Dr. Tedros Adhanom Ghebreyesus said he was “appalled” that wealthy nations, including the United States, are moving ahead with plans to administer booster shots, even as billions of people around the world still have not received even a single dose of the vaccine. According to Our World in Data, less than 2% of people in low-income countries have been fully vaccinated against the coronavirus.

The Lancet editorial was published as wealthy nations face increasing pressure to support temporarily waiving patent protections on vaccines to allow for their widespread production and distribution. More than 100 nations support a World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) waiver, first proposed by India and South Africa. However, to date, the only wealthy nations backing the proposal are the United StatesFrance, and Australia.

Last week, WHO Regional Director for Africa Dr. Matshidiso Moeti partially blamed the rollout of booster shots in rich countries for a projected 25% shortfall in vaccine deliveries to Africa by the end of the year.

The WTO TRIPS Council is scheduled to convene an informal meeting on Tuesday.

This article first appeared on CommonDreams.org

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