Two top FDA scientists resigned at the end of August, then posted against the policy of large-scale booster vaccination.
Philip Krause and Marion Gruber, two leading experts at the Food and Drug Administration (FDA), announced their resignation two weeks ago. On September 13, they published an article in the medical journal The Lancet, harshly criticizing the widespread booster vaccination, saying that the current scientific evidence does not prove that most people need the vaccine. third mRNA.
“Current evidence does not suggest a need for booster shots in the majority of the population, because efficacy against severe cases in the majority of people who receive two injections remains high,” wrote the authors, which included Krause and Dr. Gruber, said.
“These limited-supply vaccines would save the most lives if given to people who are at risk of serious illness and haven’t had any. Even if the booster shot delivers some benefits, it also does not outweigh the benefits of providing primary protection for unvaccinated people,” the article added.
This scathing criticism reveals some of the internal tension within the administration of President Joe Biden following the White House’s abrupt decision on the booster shot.
Last month, the Biden administration announced its intention to begin administering BioNTech/Pfizer and Moderna mRNA booster shots to Americans on September 20, following evidence that vaccine efficacy declines a few months after the second dose. The announcement came before Pfizer applied to the FDA for a third shot.
Both companies have applied for the booster shot and an expert panel will meet on September 17 to make a final recommendation to the FDA on whether to authorize the booster shot to Pfizer. . Moderna’s license application is likely to be discussed in the coming weeks.
The White House announcement caused controversy within the administration. Krause and Gruber quit their jobs at the FDA’s vaccines division two weeks ago, saying they were disappointed with the way the FDA handled this and several other important decisions. They will be leaving the agency in the coming weeks.
“As noted in the article, the views of the authors do not represent those of the agency,” the FDA said in a statement. “We are in the process of reviewing Pfizer’s application for approval of the booster shot, and the FDA does not comment on pending matters. We look forward to a practical and transparent discussion on the 17th. /9 on that license application”.
Pfizer said it remains committed to sharing all available data with the FDA and the Centers for Disease Control and Prevention (CDC) through rigorous, transparent review processes, while Moderna has not yet commented.
Earlier, Professor Sarah Gilbert, the scientist who created the AstraZeneca vaccine, on September 10 also said that booster injections are only necessary for the elderly and immunocompromised people.
“We need to vaccinate countries where vaccination rates are low,” said Gilbert. “We have to work harder. The first shot has the biggest impact.”
Huyen Le (Follow Financial Times)