The Food and Drug Administration (FDA) has issued guidance on emergency use authorization (EUA) for coronavirus vaccines to further prevent the spread of COVID-19, the disease caused by the novel coronavirus.
The agency said these recommendations apply, as of Oct. 9, to COVID-19 vaccines, which are complex biological products that are intended to be administered to millions of individuals, including healthy people in an effort to thwart the pandemic.
“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 Peter Marks, M.D., Ph.D., director of 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.”
Under the requirements for the long-awaited EUA, drugmakers are to provide data that shows they followed clinical trial participants at least two months after their final vaccine injection.
The FDA also wants companies to submit vaccines for authorization only after at least five severe cases of COVID-19 have been seen in volunteers who got the placebo, according to the guidance.
“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 agency says an EUA is a different standard than an approval, as noted in the June guidance, however, in the case of an investigational vaccine developed for the prevention of COVID-19, both pathways require the submission of data demonstrating any vaccine’s safety and effectiveness.
The FDA added that the guidance reiterates that any assessment regarding an EUA will be made on a case-by-case basis considering the target population, the characteristics of the product, the preclinical and human clinical study data on the product and the totality of the available scientific evidence relevant to the product.
The guidance for EUA comes almost seven months after the outbreak of the novel coronavirus that has resulted in more than 37 million global cases and one million-plus deaths, according to John Hopkins’ COVID-19 tracker. In the U.S., there have been more than seven million cases and 200,000 deaths.
The pandemic presents an extraordinary challenge to global health, according to the FDA.
The agency added there are currently no FDA-licensed vaccines to prevent COVID-19, and the EUA policy is intended to remain in effect only for the duration of the public health emergency related to the disease.