FDA Proposes Harder-To-Clear Guidelines For Emergency Vaccine Approval
Draft guidelines submitted by the FDA to the White House propose standards for authorizing emergency use of a COVID-19 vaccine that match ones set for regular vaccine approval, The Washington Post reported. The agency's move aims to reassure the public about vaccine safety and lowers the chances that one might be cleared before the Nov. 3 election.
The Washington Post:
FDA Poised To Announce Tougher Standards For A Covid-19 Vaccine That Make It Unlikely One Will Be Cleared By Election Day
The Food and Drug Administration is expected to spell out a tough new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day. The agency is issuing the guidance to boost transparency and public trust as it approaches the momentous decision of whether a prospective vaccine is safe and effective. Public health experts are increasingly worried that President Trump’s repeated predictions of a coronavirus vaccine by Nov. 3, coupled with the administration’s interference in federal science agencies, may prompt Americans to reject any vaccine as rushed and potentially tainted. (McGinley and Johnson, 9/22)
The Wall Street Journal:
Draft Guidelines For Covid-19 Vaccine Authorization Require Strict Review
Among the proposed requirements is that a coronavirus shot reduce the rate of infections by 50% compared with a placebo, which the regulators have already required for a regular approval of any Covid-19 vaccines. ... The draft requirements indicate the Food and Drug Administration wants to hold Covid-19 vaccines to high standards similar to what it would have used for a typical review of the shots, the people said, even though the agency plans to conduct the review more quickly than normal because of the urgent need created by the coronavirus pandemic. (Burton, 9/22)
Reuters:
U.S. FDA Reportedly Plans To Tighten Coronavirus Vaccine Authorization Standards Ahead Of Election
According to the report, the FDA is expected to ask vaccine manufacturers seeking an emergency authorization to follow trial participants for a median of at least two months after they receive a second vaccine shot. It also said the agency is asking that trials identify a specific number of severe cases of Covid-19 in patients who received a placebo in the trials. Few vaccine developers were expected to have definitive trial results before the presidential election. Pfizer had been the exception, although its timetable could slip with the new guidance. (9/22)
The Hill:
FDA To Soon Issue Tougher Emergency Vaccine Standards: Report
The standards come as the FDA is looking to reassure the public that it is following the science and will make sure any vaccine is safe and effective before authorizing it amid fears of political pressure from President Trump. Trump has accused the FDA of harboring a “deep state” that is slowing down the approval of treatments and vaccines. (Sullivan, 9/22)
The government works to prepare for when a vaccine is available —
The Hill:
Federal Panel Delays Vote On Initial COVID-19 Vaccine Distribution
A federal advisory committee on Tuesday discussed but did not formally recommend who should get the initial doses of a limited COVID-19 vaccine when it's available. The Advisory Committee on Immunization Practices (ACIP), which advises the Centers for Disease Control and Prevention (CDC), was expected to vote on prioritization but is now waiting until more data becomes available. (Weixel, 9/22)
USA Today:
First COVID-19 Vaccine Recipients Will Get Daily CDC Check-In Texts
As the United States gears up for a massive immunization effort to begin as soon as a coronavirus vaccine is available, health officials are planning the details of the rollout. While all new vaccines are closely followed once they enter the market, because a COVID-19 vaccine is likely to be released under an Emergency Use Authorization, safety considerations are front and center. (Weise, 9/22)
In other news from the FDA —
Stat:
FDA Proposes A 'Modest' Change To A Rule For Policing Off-Label Marketing
After years of controversy, the Food and Drug Administration has issued a proposed rule to clarify when manufacturers would have to update product labeling to reflect unapproved uses of their medicines. In doing so, the agency has left intact a decades-old rule that stated drug makers must update labeling if there is evidence indicating a company intended its medicine to be used off-label, or for an unapproved use. Doctors are free to prescribe a medicine for any purpose, but court rulings have determined drug makers can make statements about off-label uses only if information provided is truthful and not misleading. (Silverman, 9/22)
