The US Food and Drug Administration made clear Tuesday it will want to see two months of follow-up data after volunteers get their second dose of a vaccine as part of clinical trials testing potential coronavirus vaccines.
That would make it difficult, if not impossible, for any vaccine maker to apply for emergency use authorization by Election Day, as President Trump has tried to promise, or by the end of October, as the CEO of Pfizer has hinted.
The agency posted documents for an Oct. 22 meeting that has long been scheduled for vaccine advisers to meet and discuss requirements for either emergency use authorization or a full biologics license application for any potential coronavirus vaccine.
The document also outlines other advice for companies seeking FDA consideration for emergency use. It is the first detailed document describing what should be included in applications in order to issue an emergency use authorization for a vaccine.
The agency said it wants to make sure any vaccine is safe before giving authorization to deliver it to millions of people.
That would include “data from Phase 3 studies that includes 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,” it reads.
"In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required," the documents read.
FDA officials have been clear in saying they want to have conversations with vaccine makers, rather than laying down strict rules that must be followed, for providing emergency use authorization for any vaccine.