FDA Issues Guidance for Emergency Use of COVID-19 Vaccines

FDA recently issued guidance to provide recommendations for vaccine sponsors regarding the data and information that would support an emergency use authorization (EUA) for a COVID-19 vaccine.

Chief among the recommendations in the guidance was the requirement that vaccine sponsors follow patients in Phase 3 clinical trials for a median of at least two months after they complete the full vaccination regimen.

Additionally, the FDA said it needs Phase 3 clinical trials to enroll well over 3,000 vaccine recipients who are followed for serious adverse events for at least a month and sufficient cases of severe COVID-19 among trial enrollees.

Other clinical data the FDA needs to grant an EUA for a COVID-19 vaccine included all safety data from Phase 1 and 2 trials, local and systemic solicited adverse events from a Phase 3 trial, vaccine safety and COVID-19 outcomes, and a plan for active follow-up for safety.

FDA also encouraged vaccine sponsors to continue blinded follow-up in an ongoing clinical trial even if the vaccine candidate is granted an EUA by requiring sponsors to include strategies on how they will continue clinical trials to assess long-term safety and efficacy.

In addition to the clinical information sponsors need for an EUA, the guidance also detailed the chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information sponsors should include to support an EUA request.

“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement on the release of the guidance.

“The FDA’s new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision,” Marks continued.

The guidance should also help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved,” Marks said.

A September study from Pew Research Center found that nearly half of Americans (49 percent) said would definitely or probably would not get a COVID-19 vaccine if available. 

Seventy-seven percent of these individuals think it is very or somewhat likely a vaccine will be approved in the US before its safety and effectiveness are fully understood and 78 percent of individuals think the vaccine process is moving too fast.

Therefore, the slow approval process highlighted in the guidance may actually alleviate concerns these patients have about taking COVID-19 vaccines. 

This timeline a challenge, however, for the current administraiotn, which is striving for a vaccine prior to the election.

In a Twitter statement, President Trump said, “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”

The Pharmaceutical Research and Manufacturers of America (PhRMA) voiced support for the FDA guidance, saying it “supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines.”

“Science is guiding every aspect of our work. We remain focused on ensuring the highest of standards of patient safety, research, clinical testing and manufacturing are upheld throughout the vaccine research and development process,” added Stephen J. Ubl, president and CEO of PhRMA.

The Biotechnology Innovation Organization (BIO) also applauded FDA for releasing the guidance.

“We applaud the FDA for following their tried and true tradition of releasing their guidance in a public and transparent way,” Michelle McMurry-Heath, MD, PhD, president and CEO of BIO, said in a statement. “Science should stand on its own. While we are still reviewing the details, this is an important step forward in providing greater regulatory clarity for vaccine makers and in earning the American people’s trust in any future vaccines.”