CDC’s vaccines panel recommends COVID vaccine; first doses administered

Regulatory NewsRegulatory News | 14 December 2020 |  By 

The first doses of COVID-19 vaccine were given to healthcare workers around the US less than 72 hours after the US Food and Drug Administration’s (FDA’s) emergency use authorization of the vaccine jointly developed by Pfizer and the German firm BioNTech, and less than 48 hours after the US Centers for Disease Control and Prevention’s (CDC’s) vaccines committee recommended use of the vaccine.
In a 13 December press release that followed the 12 December meeting of CDC’s Advisory Committee on Immunization Practices, CDC Director Robert Redfield, MD, said, “Last night, I was proud to sign the Advisory Committee on Immunization Practices’ recommendation to use Pfizer’s COVID-19 vaccine in people 16 and older. This official CDC recommendation follows Friday’s FDA decision to authorize the emergency use of Pfizer’s vaccine.”
The ACIP meeting, originally scheduled for the afternoon of 13 December, was moved a day earlier after the emergency use authorization (EUA) came from FDA on the evening of the prior day.
At the ACIP meeting, all committee members (except 3 who recused themselves because of conflicts of interest) voted in favor of recommending use of the Pfizer-BioNTech messenger RNA (mRNA) vaccine for individuals aged 16 years and older for the prevention of COVID-19. The vaccine is to be given in two 30 mcg doses spaced about 21 days apart. The committee’s recommendations for the mRNA vaccine were published on 13 December in the CDC’s Morbidity and Mortality Weekly Report.
Previously, ACIP had met to recommend that  initial doses of COVID-19 vaccines be given to healthcare workers and those in long-term care facilities, though actual allocation is left to individual jurisdictions, who are receiving a pro rata number of vaccines based on population of individual states and other jurisdictions.
On 17 December, FDA will again convene its Vaccines and Related Biologic Products Advisory Committee (VRBPAC) to consider EUA for the mRNA vaccine developed by Moderna in collaboration with the National Institutes of Health. ACIP will meet the following day to begin its review of the data for Moderna’s vaccine; the body will adjust its voting meeting according to the issuance of a potential EUA for Moderna, with plans to schedule another emergency meeting should an EUA be issued, in order not to delay deploying a second COVID-19 vaccine.
In his statement, Redfield noted that vaccinations would begin “as early as” 14 December, representing next steps to “help restore some normalcy to our lives and our country.”


© 2022 Regulatory Affairs Professionals Society.

Tags: CDC, coronavirus, FDA, US

Discover more of what matters to you

No taxonomy