FDA tees up pre-election deep dive into COVID-19 vaccines

Speculation about whether a COVID-19 vaccine developer may be in a position to file for authorization,  potentially on an emergency basis, by the US presidential election on November 3 has intensified in recent weeks. The speculation is shaped by concerns that the US Food and Drug Administration (FDA) could come under pressure from a Trump Administration that may see the authorization of a vaccine as a boost for its prospects of winning re-election, leading to a premature approval. 

A potential flashpoint in the debate about the level of evidence needed to authorize a COVID-19 vaccine is now in the calendar. On October 22, members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet “to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19​.”

Unlike some advisory committee meetings, the VRBPAC session is not due to discuss specific filings for authorization. Instead, the stated aim of the advisory committee is to discuss COVID-19 vaccine development to help the public gain a clear understanding of the process and the data needed to support authorization.

However, the FDA has left the door open to discussions about filings for authorization. In a statement to disclose the meeting, FDA commissioner Stephen Hahn said his agency is “prepared to rapidly schedule additional meetings of this committee upon submission of any applications as appropriate​.”

Pfizer and BioNTech have talked up the prospect of being ready to file for approval of their mRNA vaccine in October. Other groups including AstraZeneca could also have the data to file, particularly if the FDA is willing to grant emergency use authorization (EUA) to vaccine developers that lack the evidence to seek a full approval.

Hahn has indicated that option is available to vaccine developers, most recently in an interview with the Financial Times ​that detailed how the FDA will approach assessments of filings based on limited data.

“It is up to the sponsor to apply for authorization or approval, and we make an adjudication of their application. If they do that before the end of phase 3, we may find that appropriate. We may find that inappropriate, we will make a determination. This is going to be a science, medicine, data decision. This is not going to be a political decision​,” said Hahn.

FDA guidance states authorizing COVID-19 vaccines “prior to the completion of large randomized clinical efficacy trials could reduce the ability to demonstrate effectiveness of the investigational vaccine in a clinical disease endpoint efficacy trial to support licensure​.” However, the guidance also states an EUA may be appropriate in the window between the completion of studies that “demonstrated the safety and effectiveness of the vaccine​” and the submission of a full biologics license application.