The US Food and Drug Administration posted guidance Tuesday for companies hoping to get emergency use authorization (EUA) for coronavirus vaccines, and said they will have to include at least two months of follow-up after volunteers get their second dose of vaccine.
That would mean no company could seek an EUA before mid-November, because the vaccines furthest along in clinical trials – those made by Pfizer and Moderna – both require waiting either 21 or 28 days between doses.
“Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile, including: adverse events; cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect,” the FDA said in the guidance.
"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,” said Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research.
“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. In addition to outlining our expectations for vaccine sponsors, we also hope the agency's guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved."
The FDA earlier Tuesday posted discussion documents for vaccine advisers with similar language.