FDA OKs Third Shot As Booster For Pfizer Vaccine, Applies To Persons 65+ And 18-64 If At High Risk Of Severe COVID-19 Or With Frequent Job Related Exposure (Incl. Teachers, Grocery Workers, Homeless Shelter Workers)
(Sept. 22, 2021, 9:20 p.m.) -- The FDA today (Sept. 22) issued an emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose administered at least six months after completing the primary series in:
The FDA action will allow a booster dose "in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others," said Acting FDA Commissioner Janet Woodcock, M.D. in the release. "This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day," she said.
Regarding LB teachers and staff, LBUSD management no longer requires weekly nasal swab tests for unvaccinated students (including those under age 12 ineligible receive vaccines.) LBUSD required the nasal swabs for the first three weeks after reopening schools on Aug. 31, didn't explain the reasons for the three week limit and now calls it a "pause" to review its data and consult with local health authoities. LAUSD continues to require the COVID 19 nasal swab tests for all students and staff. On Sept. 17, LB's Health Dept. updated its COVD Health Order, visible here.
The FDA agency release states:
The FDA considered the data that the vaccine manufacturer submitted, information presented at the VRBPAC (Vaccines and Related Biological Products Advisory Committee) meeting, and the committee’s discussion, and has determined that based on the totality of the available scientific evidence, a booster dose of Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 and that the known and potential benefits of a booster dose outweigh the known and potential risks in the populations that the FDA is authorizing for use. The booster dose is authorized for administration to these individuals at least six months following completion of their primary series and may be given at any point after that time...
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The Emergency Use Authorization applies only to the Pfizer-BioNTech COVID-19 vaccine.
FDA'a full release can be viewed here
A CDC advisory commmittee on immunization practices is scheduled to meet Thursday (Sept. 23) and may make its own recommendations on the additional dose.
Moderna has also submitted a request to allow a booster with its vaccine.
On Aug. 13, FDA enabled persons with weakened immune systems to receive a third shot. That action is backed by a recent Israeli study in the New England Journal of Medicine that shows a third Pfizer dose can cut rates of COVID-related illness in people 60 and above.
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