White House nixes new FDA guidelines on vaccine approval
The White House has blocked new Food and Drug Administration guidelines on bringing potential vaccines for COVID-19 to market that would probably have prevented their introduction prior to the Nov. 3 election.
A senior administration confirmed the move Monday evening, saying the White House believed there is “no clinical or medical reason” for the excess requirement.
At issue was the FDA's planned instruction that vaccine developers follow patients signed up for their trials for at least 8 weeks to eliminate safety issues before seeking emergency approval from the agency.
The White House action was initially reported by The New York Times.
The intervention by Trump officials may be the latest example of the administration undercutting its medical experts attempting to combat the pandemic that has killed a lot more than 210,000 Americans.
FDA Commissioner Stephen Hahn has been wanting to shore up public confidence in the FDA's vaccine review for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective for mass vaccination.
But President Donald Trump has repeatedly insisted that a vaccine could possibly be authorized before Election Day, despite the fact that top government scientists working on the administration's vaccine effort have mentioned that that timeline is very unlikely.
Last week seven former FDA commissioners blasted the administration for “undermining the credibility” of the FDA in a Washington Post op-ed and needed the release of the pending vaccine guidelines. The former FDA chiefs warned that public perceptions a vaccine was rushed out for political reasons could derail efforts to vaccinate an incredible number of Americans.
Beyond the damaging optics of overruling its own FDA, the practical impact of the White House proceed to block the guidelines could possibly be relatively small.
Only 1 drugmaker, Pfizer, has suggested it might have data on the safety and effectiveness of its vaccine before Election Day. And several variables would still need to align for the business to submit, and the FDA to examine and approve, a vaccine application before Nov. 3. Pfizer's rivals Moderna, AstraZeneca and Johnson & Johnson are working on longer researcher timelines.
Additionally, FDA scientists have already been discussing the contents of the rules publicly for weeks and have clarified that the recommendations have been shared with each one of the vaccine developers.
The FDA released its initial expectations for COVID-19 vaccines in June. Among other metrics, the agency said any vaccine would need to be at least 50% protective against the virus. However the guidelines didn't explain the conditions under which the FDA would use its emergency authorization powers to speed up the availability of a vaccine. Under emergency review, medical products face less standard that merely requires that their expected benefits outweigh their risks for use throughout a public health crisis.
Having less specifics around using the emergency authorization for a vaccine became a flashpoint for outside experts, physicians and even politicians. FDA officials then started out drafting another guidance document with additional details.
Among other things, the rules would have clarified that any vaccine approved through the emergency pathway would still have to meet FDA’s preset safety and effectiveness standards. Instead, the expedited process will be used to bypass certain logistical and regulatory hurdles, including the thousands of pages of manufacturing documentation normally required for a normal vaccine application.
FDA emergency authorization for a vaccine may likely limit initial use to medical and other frontline workers, assisted living facilities and people most vulnerable to catching or becoming seriously ill from the virus. The vaccine would have to undergo review for full FDA approval, a monthslong process, before being qualified for the general population
The FDA has faced criticism for allowing emergency utilization of some COVID-19 treatments backed by little evidence, but FDA officials have clarified that vaccines would face additional standards. Vaccines, unlike therapies, receive to healthy people and thus usually require more proof.
But Trump clarified last month that he was skeptical of any regulatory changes that may delay a vaccine’s authorization, whether or not those changes are aimed at increasing public trust.
The senior administration official, who spoke on the health of anonymity to go over the action, said the White House was intent on getting a safe vaccine to advertise and wanted to make certain “additional loopholes” weren't added that could slow down the process.
FDA spokespersons didn't respond to requests for comment Monday night.
