Scientists who withdrew from FDA criticize extensive Covid-19 booster program


Covid-19 vaccine update

Two top scientists who recently announced their retirement from the US drug regulatory agency criticized the policy of boosting the Covid-19 vaccine for most people a few days before the Biden administration plans to start doing so.

Philip Krause and Marion Gruber, who resigned from the Food and Drug Administration two weeks ago, were among the authors of severe criticisms of the widespread use of booster injections. Published in The Lancet on Monday.

This article believes that scientific evidence does not yet prove that it is reasonable to give most people a third mRNA vaccination. This article provides insight into the tensions within the Biden administration, which was triggered by the sudden decision of the White House to support the boost program. of.

The article warned: “The current evidence does not seem to indicate the need for intensive treatment in the general population, where the efficacy of serious diseases is still high.”

It added: “If the limited supply of these vaccines is provided to people who are at risk of serious diseases and have not yet received any vaccines, most lives will be saved. Even if some benefits from booster vaccination can eventually be obtained, it will not exceed the future. The vaccinated people provide the benefit of initial protection.”

The Biden administration announced last month that it intends to start offering to Americans Another round of mRNA Covid jabs Manufactured by BioNTech/Pfizer and Moderna on September 20, after evidence of diminished effectiveness a few months after the second jab.

But the announcement was made before the two companies even applied to the FDA for approval of the third dose.

Both companies have now submitted applications for enhanced injections, and the expert panel will meet on Friday to make formal recommendations to the FDA on whether to approve Pfizer’s application. Moderna’s application may be discussed in the coming weeks.

The processing of the announcement resulted in Disputes within the governmentTwo weeks ago, Klaus and Gruber quit their jobs in the FDA’s vaccine department, and their allies said they were frustrated with the way regulators were undermined in this and several other key decisions. They will leave the agency in the coming weeks.

The FDA stated in a statement: “As stated in the article, the author’s views do not represent the views of the agency.

“We are in the process of reviewing Pfizer’s enhanced injection supplementary approval submission. As a rule, the FDA will not comment on outstanding issues before the agency. We look forward to a strong and transparent discussion of the application on Friday.”

Neither Pfizer nor Moderna immediately responded to requests for comment.

come back to the office

We want to hear about readers’ plans to return to work. Are you under pressure to go back or look forward to meeting with colleagues?Tell us about your plan by This survey.


Source link