Pfizer COVID-19 vaccine declared safe as the FDA issues an emergency use authorization

SACRAMENTO – Governor Gavin Newsom issued the following statement after the U.S. Food and Drug Administration granted an Emergency Use Authorization for the Pfizer COVID-19 vaccine on Dec. 11:

“As California faces reduced ICU capacity, we must remain vigilant over the next few weeks. At the same time, today’s FDA Emergency Use Authorization of a COVID-19 vaccine is a tremendous step toward safe and equitable vaccine distribution in California. Through the Western States Scientific Safety Review Workgroup, our scientists and experts have worked concurrently with the federal process to review the safety and efficacy of a COVID-19 vaccine.

“This important step advances the process of administering a vaccine at first to our critical health care workforce and those in long-term care. More vaccine doses will be arriving in the weeks and months ahead, which will be distributed and administered quickly and equitably across all of California. As always, it remains critical that we continue to take steps to protect ourselves, our families and our communities by staying home, wearing masks and following local health directives.”

The Western States Scientific Safety Review Workgroup today completed their concurrent and thorough review of the federal process and has confirmed the Pfizer COVID-19 vaccine is safe and efficacious. The Workgroup provided their confirmation to the Governors of California, Nevada, Oregon and Washington this morning.

The Governor today visited an ultra-low temperature storage facility at the University of California, Davis Medical Center, which is preparing for the imminent arrival of the Pfizer COVID-19 vaccine.

Video of the visit can be found here.

Governor Newsom tours ultra-low temperature storage facility at the University of California, Davis Medical Center

The UC Davis site is one of several facilities across the state preparing to receive the vaccine. California has initially been allocated 327,600 doses of the Pfizer vaccine, which must be stored in negative 80-degree ultra-low temperature freezers and requires two doses over a three-week period.

The multi-state COVID-19 Scientific Safety Review Workgroup launched by the Governor in October has worked concurrently with the federal process to review and assess data made available and the federal review processes conducted regarding review of the safety and efficacy of a COVID-19 vaccine.

A Vaccine Drafting Guidelines Workgroup – comprised of immunization, public health, ethicists, health care and academic experts – and a Community Advisory Vaccine Committee have prepared California’s Phase 1A prioritization guidelines focused on health workers and long-term care residents. The guidelines will expand to other groups as more vaccine becomes available.