Covid-19 Vaccine Updates
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Two top scientists who recently announced their retirement from the U.S. Drug Enforcement Administration are criticizing the policy of giving most people Covid-19 vaccinations just 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, are one of the authors of a scathing critique of widespread booster shots, which published in The Lancet Monday.
The article, which argues that the scientific evidence does not yet justify giving most people third-shot mRNA vaccines, provides an insight into the internal tensions in the Biden administration that were ignited by the White House’s sudden decision to to support the plan.
The piece warns: ‘Current evidence does not appear to give a need for a boost in the general population in which the effectiveness against serious diseases is high.’
It adds: ‘The limited supply of these vaccines will save most lives if they are made available to people at significant risk for serious diseases and have not yet received any vaccine. Even if you can finally make a profit by giving a boost, it will not outweigh the benefits of the initial protection of the unvaccinated.
The Biden administration announced last month that it plans to start offering Americans another round of MRNA Covid jobs made by BioNTech / Pfizer and Moderna from September 20 after evidence of declining efficiency several months after the second stitch.
But the announcement was made before one of the companies even submitted an application to the FDA to grant a third dose.
Both companies have now submitted their application for application and an expert panel is meeting Friday to give the FDA an official recommendation on approving the Pfizer application. Moderna’s application is likely to be discussed in the coming weeks.
Handling the announcement causes reactions within the administration. Krause and Gruber left their jobs at the FDA’s vaccine department two weeks ago, with allies saying they were frustrated with the way the regulator was undermined in these and several other important decisions. They are leaving the agency in the coming weeks.
The FDA said in a statement: ‘As noted in the article, the views of the authors do not represent the views of the agency.
‘We are in the process of a deliberation process to review the supplementary approval of Pfizer’s supplementary approval, and the FDA does not comment on virtually any pending issues before the agency. We look forward to a thorough and transparent discussion Friday on the application. “
Neither Pfizer nor Moderna responded immediately to a request for comment.
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