Vero Beach residents who are hoping to be near the front of the line for vaccination against COVID-19 got some good news late Thursday.
The U.S. Food and Drug Administration’s Vaccines and Related Biological Products Committee voted 17 to 4 Thursday in favor of recommending the FDA approve an Emergency Use Authorization of the Pfizer-BionTech vaccine for the SARS2-COVID virus that causes the COVID-19 disease.
Pfizer has requested approval for the vaccine to be given to people age 16 and older, and the majority of the committee voted that the benefits outweigh the risks for those individuals.
The all-day meeting, which took place via teleconference, reviewed data from clinical trials involving nearly 38,000 people in five countries. In those trials, participants received two injections of either the Pfizer vaccine, or a placebo, 21 days apart and were monitored for adverse side effects, for antibody response and for COVID-19 disease and symptoms over several months.
In addition to presentations by the Centers for Disease Control and Prevention and Pfizer scientists, outside doctors and members of the public were allowed to comment and ask questions for up to three minutes each about the safety and effectiveness of the vaccine.
The FDA top brass still needs to sign off on the vaccine, but once that occurs, the first shots could be administered within days.
Gov. Ron DeSantis said Florida is scheduled to receive 179,400 doses of the vaccine initially. “We are prioritizing our most vulnerable residents and high-exposure healthcare personnel to receive the vaccine first,” he said. “We are also mobilizing strike teams to supplement the vaccination of long-term care residents.”
It’s not yet known how many doses will be sent to Indian River County or when they will arrive, but Advent Health in Orlando has been designated by the state as a regional hub of distribution. Locally, Cleveland Clinic Indian River is preparing its freezers and facilities to help with administering doses of the vaccine, which must be kept at ultra-cold temperatures and used within six hours of preparation.
On Tuesday at the Operation Warp Speed Vaccine Summit, DeSantis said he hoped to vaccinate all nursing home residents by the end of December.
Despite Thursday’s vote of confidence, the FDA review process is ongoing. An Emergency Use Authorization can be modified or rescinded, and it is not the same as FDA licensure.
The FDA committee emphasized that its work is far from finished, as members want to see more data on children, pregnant and lactating women, African-American people and long-term care residents going forward. The study also presented very little data related to people with autoimmune conditions. Members will meet again to review more information in one week.
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