FDA Panel Recommends Granting Emergency Use Authorization of Moderna COVID-19 Vaccine
A US Food & Drug Administration committee issued a recommendation today for the FDA to grant Emergency Use Authorization for the Moderna mRNA-1273 COVID-19 vaccine.
“Today’s vote will likely lead to the FDA authorizing a second vaccine to help safeguard our community,” said Hawai‘i State Director of Health Dr. Elizabeth Char.
In a statement issued this afternoon, Dr. Char said: “It was vitally important for this committee of scientists and clinicians to complete an in-depth review of this vaccine. That review involved a clinical trial of more than 30,000 people. It gives us confidence about the vaccine’s safety and efficacy. Due to its storage requirements, this vaccine is easier to ship and store than the vaccine already in use.”
The Vaccines and Related Biological Products Committee voted 20 to 0 in favor of recommending authorization of the Moderna vaccine, with one abstention.
The FDA will review the committee’s recommendation and decide whether to grant Emergency Use Authorization. The US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices will then provide guidance on who can be vaccinated. ACIP guidance is expected in the coming days.
If the Moderna vaccine is granted authorization, both the Moderna and Pfizer-BioNTech vaccines will be distributed to all four counties.
Essential health care workers will be vaccinated at Points of Dispensing across the state. Vaccinations will be administered at long-term care facilities through a federal partnership with Walgreens and CVS.
Today’s news follows the arrival of additional doses of the Pfizer-BioNTech vaccine, which were distributed to healthcare facilities across O‘ahu to be shared with their network of facilities including those on the neighbor islands. Together, more than 81,000 doses of both vaccines are expected to arrive in Hawai‘i this month alone.