Tension over boosters rises as FDA regulators quit and publicly blast Biden’s plan

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Two major vaccine regulators who previously announced their resignations from the Food and Drug Administration have now come out against the Biden administration’s plan to offer COVID-19 booster shots.

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one in Perspective article published on Monday in The Lancet, Marion Gruber, outgoing director of the FDA’s Office of Vaccine Research and Review (OVRR), and Phil Krause, outgoing deputy director of OVRR, argue against current booster plans.

“Currently available evidence does not show a need for widespread use of booster vaccinations,” the pair, along with colleagues, conclude in the article. Even if there are benefits from the booster, the shots still carry risks, and any benefits “will not outweigh the benefits of providing initial protection to the unwanted,” they write.

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Gruber and Krause co-wrote the Lancet article with 16 international collaborators, including several high-ranking experts from the World Health Organization. Krause is listed as the first author and corresponding author of the article.

The pair’s public opposition to the booster comes just weeks after the FDA announced their resignations. Their departures are scheduled for October 31 and November respectively.

anger and frustration

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His resignation in late August was reportedly sparked by frustration and anger over the Biden administration’s decision in mid-August to begin offering booster doses as early as the week of September 20. According to FDA sources, Gruber, Krauss and others at the agency felt the decision was premature and overstepped the FDA’s role in flagging the booster’s use. At the time, Politico described the FDA’s position as “potential rebellion

The Lancet article appears to confirm internal squabbles in the agency. Instead of backing the Biden administration’s booster plan, Gruber and Krause aligned with the WHO, which also denounced booster shots and called for a moratorium on their use until at least the end of the year.

One of WHO’s co-authors on the Lancet article is Dr. Mike Ryan, executive director of the WHO’s Health Emergencies Programme. He has destroyed plans for the first booster, comparing them to “hand”.[ing] Give extra life jackets to those who already have life jackets, while we are leaving others to drown.”

The Lancet article reiterates most of the WHO’s arguments against giving boosters right now. The biggest argument is that the data shows that the COVID-19 vaccines are time and delta against the coronavirus variant. Vaccines still provide excellent protection against serious illness and death – the primary purpose of vaccines. The US Centers for Disease Control and Prevention published data largely supporting this point last Friday.

ongoing debate

Although some evidence suggests that protection from vaccines may decrease over time, it is not yet clear whether overall protection from serious illness and death will take a dive in the near future. As the author of The Lancet article points out, data has been noisy when vaccine effectiveness is weak. For example, data from Israel shows that vaccine effectiveness against serious disease was lower in people vaccinated in January or April than among those vaccinated in February or March. In addition, those who have been vaccinated the longest now include those with compromised immune systems, making it difficult to interpret whether any reduction in protection would be relevant to the entire population.

Meanwhile, as the data on boosters is a matter of debate, the current vaccine supply is limited, argue the authors of The Lancet article. Any dose known to the vaccinated population is a dose that is not going to non-vaccinated frontline workers and others in high-risk groups in low-income countries.

The authors write, “Even if boosting was eventually shown to reduce the medium-term risk of serious disease, the current vaccine supply could save more lives than if used in a previously unvaccinated population.” If done, the vaccination is used as a booster in the population.” And, he adds, “if vaccines are deployed where they will do best, they could hasten the end of the pandemic by preventing further development of variants.”

Gruber, Krause and other authors caution to mention that boosters may be needed at some point in the future—if protection is significantly reduced and/or if more dangerous forms develop. However, the decision to promote must be made with robust data, which is currently lacking.

The situation is only likely to create more tension this week for the Biden administration’s planned rollout of boosters starting next Monday. FDA is calling A public meeting of advisors this Friday To review data on booster shots for Pfizer/BioNTech vaccines.

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