booster blast —
Top FDA regulators side with WHO on boosters, citing insufficient data.
Two leading vaccine regulators who had 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.
In a viewpoint article published in The Lancet on Monday, Marion Gruber, the outgoing director of the FDA’s Office of Vaccines Research and Review (OVRR), and Phil Krause, the outgoing deputy director of the OVRR, argue against the current booster plans.
“Currently available evidence does not show the need for widespread use of booster vaccination,” the pair, along with colleagues, conclude in the article. Even if there are benefits from boosters, the shots still carry risks, and any benefits “will not outweigh the benefits of providing initial protection to the unvaccinated,” they write.
Gruber and Krause penned the Lancet article with 16 international colleagues, including several high-ranking experts at the World Health Organization. Krause is listed as the first author of the article and a corresponding author.
The pair’s public opposition to boosters comes just weeks after they announced their resignations from the FDA. Their departures set for October 31 and November, respectively.
Anger and frustration
Their resignations at the end of August were reportedly sparked by frustration and anger over the Biden administration’s decision in mid-August to begin offering booster doses as soon as the week of September 20. According to FDA sources, Gruber, Krause and others at the agency felt the decision was premature and overstepped the FDA’s role in greenlighting the use of boosters. At the time, Politico described the situation at the FDA as a “potential mutiny.”
The Lancet article seems to confirm that internal strife at the agency. Rather than backing the Biden administration’s booster plan, Gruber and Krause aligned with the WHO, which has also denounced booster shots and called for a moratorium on their use until at least the end of the year.
One of the WHO coauthors on the Lancet article is Dr. Mike Ryan, executive director of the WHO’s Health Emergencies Programme. He has previously blasted plans for boosters, likening them to “hand[ing] out extra life jackets to people who already have life jackets while we’re leaving other people to drown.”
The Lancet article rehashes much of the WHO’s arguments against offering boosters right now. The biggest argument is the fact that data suggests COVID-19 vaccines are holding up against time and the delta coronavirus variant. The vaccines are still providing excellent protection against severe disease and death—the primary purpose of vaccines. The US Centers for Disease Control and Prevention published data largely supporting this point last Friday.
Though some evidence seems to suggest that protection from vaccines may be waning over time, it’s not yet clear if overall protection from severe disease and death will dive in the near future. As the authors of The Lancet article note, data on weakening vaccine effectiveness has been noisy