The memo was sent just two days before the Centers for Disease Control and Prevention (CDC) 免疫实践咨询委员会 (ACIP) is set to meet, although as of Monday there was no draft agenda for the meeting available on the agency’s website.
It was widely believed that the FDA would issue a decision on Pfizer-BioNTech’s request early this week, with Dr. Anthony Fauci speculating that the agency would take “several days” to respond to the companies’ request. It was not clear if the announcement of the June 10 meeting would impact the agency’s plans regarding a decision.
“Vaccines continue to be an important public health measure in fighting the COVID-19 pandemic,” 博士说. 彼得·马克斯, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “迄今为止, the FDA has authorized three COVID-19 vaccines for emergency use that have met our rigorous standards for quality, safety and effectiveness — two are authorized for individuals 18 及以上, and one is authorized for individuals 16 及以上.
“We recognize that the next critical step is having vaccines available for use throughout the pediatric population,” Marks continued. “As with the initial COVID-19 vaccine authorizations, we want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and biologics license applications for vaccines intended to prevent COVID-19 in this pediatric age range.”
Fox News has requested additional comments from the FDA and CDC.