FDA Chief Open To Fast-Tracking A Vaccine Before Trials Wrap Up
In interviews with the Financial Times and Bloomberg, FDA Commissioner Stephen Hahn spoke about the conditions under which he would consider granting emergency authorization for a COVID-19 vaccine. The comments come a week after President Donald Trump accused the FDA of dragging its feet on vaccine approval to hurt him politically.
FDA Willing To Fast Track Coronavirus Vaccine Before Phase Three Trials End
The chief of the U.S. Food and Drug Administration is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible, according to an interview in The Financial Times. Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Stephen Hahn told the publication that an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks. (O'Brien, 8/30)
FDA Chief Promises Transparency For Covid-19 Vaccine Review
The head of the U.S. Food and Drug Administration promised that the review of a potential Covid-19 vaccine in the U.S. will be transparent to the public, with any clearance by the agency driven by data alone. In an interview on Sunday, Commissioner Stephen Hahn responded to questions about the different ways the FDA could clear a vaccine for use: either under an emergency authorization, likely based on more limited data and for use in a narrow group, or a broader approval that could lead to wider use. (Armstrong, 8/30)
Gottlieb Questions FDA Chief's Coronavirus Vaccine Fast-Track Comments: Full Approval A '2021 Event'
Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb is questioning FDA Commissioner Stephen Hahn’s comments about fast-tracking a coronavirus vaccine, stating that a full approval of a vaccine for the general population likely won’t happen until 2021. Hahn said in an interview published by The Financial Times on Sunday that he is willing to fast-track a coronavirus vaccine before clinical trials are complete if it is determined to be “appropriate.” (Klar, 8/30)
In related news —
Most Americans See Politics Driving Covid-19 Vaccine Approval Process
Seventy-eight percent of Americans worry the Covid-19 vaccine approval process is being driven more by politics than science, according to a new survey from STAT and the Harris Poll, a reflection of concern that the Trump administration may give the green light to a vaccine prematurely. The response was largely bipartisan, with 72% of Republicans and 82% of Democrats expressing such worries, according to the poll, which was conducted last week and surveyed 2,067 American adults. (Silverman, 8/31)
Covid-19 Vaccines: Experts Call For Independent Commission Separate From FDA To Review Data
Citing criticism of government agencies and increasing public distrust of vaccines, several prominent physicians and experts are calling for the creation of an independent commission to review data from coronavirus vaccine trials before a vaccine is allowed on the market. The US Food and Drug Administration regulates vaccines, and its OK is all that's needed to put one on the market. The physicians fear, however, that after several government blunders during the pandemic, a layer of review independent from the government is needed to give Americans confidence that the shot is safe and effective. (Cohen, 8/31)