This process will not be rushed. There will be no shortcuts in developing the relevant phase 3 efficacy results. Any vaccine showing efficacy must also be very safe. While the duration of safety follow-up for a vaccine authorized under an EUA will be shorter than with a traditional BLA (which the agency expects will ultimately be submitted by manufacturers of vaccines that are authorized under an EUA), extensive safety monitoring will be conducted on the millions of individuals who receive a vaccine.
This monitoring is done for other newly-approved vaccines. It will detect new, unusual and rare side effects after vaccination that might not have been observed during clinical trials, as well as monitor for increases in known side effects.
In addition to this careful evaluation by staff at FDA, we intend to take any COVID-19 vaccine EUA or BLA submission to a public advisory committee meeting for open discussion. FDA’s Vaccines and Related Biological Products Advisory Committee consists of leading independent scientific and public health experts, carefully screened for any potential conflicts of interest, who provide input to FDA. The materials discussed during open sessions of these meetings, which will be live-streamed, will be posted on FDA’s website.