The US Food and Drug Administration is in the "early stages" of looking into whether expanded access — a regulatory pathway typically used for investigational drugs — could be used as a way to make a potential Covid-19 vaccine available to the public, an FDA official said on Friday.
"We're still in early stages of considering whether this would be an appropriate mechanism," Dr. Doran Fink, deputy director of the FDA's division of vaccine and related products applications, said during a virtual meeting of the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices on Friday.
Among the regulatory pathways for making a potential Covid-19 vaccine available, emergency use authorization has been the most discussed so far.
"Emergency use authorization is one of those mechanisms and is dependent upon declaration of a public health emergency, which is the situation we're currently in with Covid-19. Expanded access does not require the declaration of a public health emergency but it does have additional requirements for use," Fink said on Friday. "Expanded access is not an approval process."
Some background: If expanded access were to be considered for a potential Covid-19 vaccine, the vaccine manufacturer would need to have an active "investigational new drug" application on file with the FDA. Then the manufacturer would need to "submit a protocol for use of the vaccine under expanded access regulations and would work potentially with public government agencies" to organize and implement the expanded access protocol, Fink said.
Expanded access has been used before for vaccines, Fink added, just not on the massive scale that would be needed for a potential Covid-19 vaccine.
"We do have recent examples of expanded access treatment protocols that have been used to provide vaccine to thousands of individuals or tens of thousands of individuals," Fink said. "One example was to address meningococcal B disease outbreak on several college campuses prior to FDA licensure of meningococcal vaccines, and then more recently, there's been an expanded access protocol for use of non-US-licensed yellow fever vaccine."