White House Relents on FDA Covid-19 Guidance
The White House 10/6 reversed its opposition to a controversial FDA guidance that outlines stricter requirements for granting an emergency use authorization (EUA) for potential Covid-19 vaccines. On 10/5, news got out that the White House still had objections to the pending guidance, first expressed in president Trump’s comments last month questioning the document’s recommendations on the timing of when a vaccine application can be submitted. Some media predicted the White House might block the guidance. “We may or may not approve it,” Trump had told reporters in the press briefing room 9/23. “That sounds like a political move, because when you have Pfizer, Johnson & Johnson, Moderna, these great companies coming up with these — the vaccines, and they’ve done testing and everything else, I’m saying, ‘Why would they have to be, you know, adding great length to the process?’”
This caused many FDA observers to become increasingly worried over what they saw as political interference from the White House, which had repeatedly suggested that a vaccine could be authorized by Election Day. During the ensuing weeks, FDA repeatedly reassured the public that its independence on reviewing and authorizing vaccine candidates remained intact. Commissioner Stephen Hahn as recently as 10/5 said that the agency’s internal procedures are sufficient to curb any outside interference during vaccine reviews. CBER career employees will have the authority to “make the assessment around safety, effectiveness, [and] quality manufacturing,” Hahn told the medical device trade group AdvaMed, according to FiercePharma. FDA has “processes in place to make sure that the centers are protected from any outside pressure, and that they’re focused solely on looking at the science and the data,” Hahn said, adding “I have absolute faith and confidence in those decisions.”
Under the just-posted guidance, the agency recommends that manufacturers seeking EUAs to follow participants in late-stage clinical trials for at least two months starting after they receive a second vaccine shot. The new EUA standards will likely make it next to impossible for a vaccine to be authorized before the election. And once FDA receives a submission, the agency will take weeks and possibly months to review the data, Hahn told a Senate Health Education Labor & Pensions Committee hearing recently.
Last week, CBER director Peter Marks said that vaccine makers already knew the guidance’s recommendations about what data are necessary to obtain an EUA. Speaking at a Friends of Cancer Research program, Marks dismissed any perceived political interference as “no there there.” The guidance was an exercise on public transparency, Marks said, adding that it is most important to regain the public’s trust in vaccines. He said that the document was intended to help the public understand that EUA Covid-19 vaccine data requirements are the “moral equivalent” of what would be required in a BLA.
The White House reportedly said the initial guidance objection was based on comments it received from industry and those developing vaccines. Many vaccine watchers are keeping a close eye on Pfizer’s investigational vaccine as being a front runner because it only requires one inoculation as opposed to two shots that other investigational vaccine products require. Pfizer CEO Albert Bourla told CBS Face the Nation over the weekend that the company might be able to confirm whether or not its vaccine is effective by the end of the month, and it could then seek authorization for its use. Appearing on the show separately, former FDA commissioner Scott Gottlieb, who is also a Pfizer board member, cautioned that any vaccine would not be widely available until 2021.
After news broke about the White House’s continued dissatisfaction with the guidance, Gottlieb said in a Twitter post: “I speak to a lot of drug makers and I don’t know anyone in the pharmaceutical industry who raised any objections over this guidance. These standards have been broadly communicated for months and they were well understood across the industry.” Bourla also added: “Pfizer has never discussed FDA’s Covid-19 vaccine guidelines with the White House and will never do so as it could undermine the agency’s independence.”