Drugmakers to Pledge Not to File Vaccine Approval Until Certain Standards Met

Multiple drugmakers have reportedly drafted a public pledge not to seek FDA approval of their COVID-19 vaccines until they meet certain safety and efficacy standards even as President Trump said  a vaccine may be ready as soon as October.

The pledge is an unusual move in a hypercompetitive industry not known for corporation cooperation and underscores the intense scrutiny surrounding the widespread perception that the FDA will be politically pressured to approve a vaccine before the Nov. 3 presidential election.

On Monday, in White House briefing, Trump said “it’s going to be done in a very short period of time. Could even have it during the month of October.”

As for the pledge, the drugmakers said they will adhere to certain standards when conducting clinical trials of their vaccines and in the manufacturing processes. The pledge will reportedly be issued as early as this week and includes vaccine makers Pfizer, Moderna, Sanofi, GlaxoSmithKline (GSK) and Johnson & Johnson.

Moderna, Pfizer and AstraZeneca have already forged ahead with phase 3 trials of their COVID-19 vaccines, each aiming to enroll about 30,000 participants. J&J is expected to begin a phase 3 trial of its vaccine this month, aiming to top its competitors with a goal of enrolling 60,000 participants.

And late last month, the Centers for Disease Control and Prevention asked all 50 states to be prepared for COVID-19 vaccine distribution by Nov. 1, just days before the presidential election (DID, Sept. 3).

The FDA has specifically established a threshold for COVID-19 vaccine approval. In a late June guidance, the FDA said a vaccine would have to be at least 50 percent more effective than a placebo for it to be approved (DID, July 1). And in numerous public settings, FDA Commissioner Stephen Hahn has emphatically denied that the FDA is under pressure to OK a vaccine before there is scientifically sound data that would merit an approval.

Yet the FDA has set an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee to discuss COVID-19 vaccine development, authorization and licensure (DID, Aug. 31).

However, there is disagreement as to whether or not data on a vaccine would be ready to discuss by then. Former FDA Commissioner Scott Gottlieb has said having data on the vaccines “sometime in October is the most likely scenario,” with an Emergency Use Authorization for select populations likely before the end of the year. However, National Institutes of Health Director Francis Collins has expressed doubts that phase 3 data would be ready for review by October and thinks it is more likely to be available in November or December (DID, Aug. 31).

Despite recent events, White House Press Secretary Kaleigh McEnany said in a press briefing last week that “no one is pressuring the FDA” to approve a vaccine by election day. She said while the president wants a vaccine as quickly as possible, he still wants to ensure it is “100 percent airtight” before it is distributed to the public.

Moderna did not comment on the pledge but told FDAnews that it “reaffirms our own commitment” to ensuring that data from its clinical trials “drive any regulatory decisions regarding use of our COVID-19 vaccine candidate.” Pfizer, Sanofi, GSK and J&J could not be reached for comment on the pledge. — Jordan Williams