With FDA clearing Pfizer’s COVID-19 vaccine, vaccination begins for frontline health care workers
FDA issued an emergency use authorization (EUA) on Friday, December 11, for the Pfizer/BioNTech COVID-19 vaccine, which is indicated for those ages 16 years and older. CDC’s Advisory Committee on Immunization Practices (ACIP) gave the vaccine its official recommendation on Saturday, December 12, and finalized its endorsement to prioritize COVID-19 vaccination for health care workers—including pharmacists—and residents of long-term-care facilities with the limited supply that will be available initially.
The Pfizer/BioNTech COVID-19 vaccine could be offered to these priority groups as early as Monday. U.S. Department of Health and Human Services Secretary (HHS) Alex Azar had said previously that Operation Warp Speed would begin shipping COVID-19 vaccines to states within 24 hours after EUA approval.
State jurisdictions will oversee implementation of vaccine allocation and rely on the ACIP recommendations to decide who gets the vaccine first.
CDC recommends staggering vaccination within departments so that health care workers do not experience potential adverse effects at the same time, and that health care workers should schedule vaccination before they have 1 to 2 days off work.
On Thursday, December 10, an FDA advisory panel approved the Pfizer/BioNTech COVID-19 vaccine. The panel based its vote on current data, which found the vaccine 95% effective and safe to use, with few adverse events for people ages 16 years and older. However, at this time the data are insufficient on safety outcomes in pregnant women, prevention of severe COVID-19, and long-term safety.
The December 10 FDA advisory meeting was live-streamed and open to the public to convey the care that has been taken to ensure the vaccine is safe and has not been rushed through the review process for political reasons.
Results of the Pfizer/BioNTech COVID-19 vaccine’s Phase III study results were also published in the New England Journal of Medicine on December 10. Roughly 43,000 people were included in the study.
The federal government has singled out pharmacists as critical partners in vaccinating the public once enough doses of vaccine become widely available. HHS announced a plan in November to distribute vaccines through large chain pharmacies as well as networks like CPESN that represent independent pharmacies and regional chains. Although it’s still unknown when enough vaccine will be available to the general public, pharmacists are encouraged to visit CDC’s resource page to start preparing.
Released in conjunction with the FDA Pfizer/BioNTech COVID-19 vaccine EUA authorization are these fact sheets for health care providers, vaccine recipients, and caregivers:
- Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers) (PDF)
- Fact Sheet for Recipients and Caregivers (PDF)
APhA and other sources are developing additional educational material that will be available on APhA’s coronavirus website.
Upon release of the Pfizer/BioNTech COVID-19 vaccine EUA, a joint statement from 18 pharmacy organizations communicated the profession’s appreciation for the approval process and its readiness to do its part in vaccinating Americans.
This Thursday, an FDA advisory committee plans to meet to discuss issuing an EUA for Moderna's COVID-19 vaccine for adults.