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)

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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)

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(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:

individuals 65 years of age and older.
individuals 18 through 64 years of age at high risk of severe COVID-19; and
individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

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...
To support the authorization for emergency use of a single booster dose, the FDA analyzed safety and immune response data from a subset of participants from the original clinical trial of the Pfizer-BioNTech COVID-19 Vaccine. In addition, consideration was given to real-world data on the vaccine’s efficacy over a sustained period of time provided by both U.S. and international sources, including the CDC, the UK and Israel. The immune responses of approximately 200 participants 18 through 55 years of age who received a single booster dose approximately six months after their second dose were assessed. The antibody response against SARS-CoV-2 virus one month after a booster dose of the vaccine compared to the response one month after the two-dose primary series in the same individuals demonstrated a booster response.
Additional analysis conducted by the manufacturer, as requested by the FDA, compared the rates of COVID-19 accrued during the current Delta variant surge among original clinical trial participants who completed the primary two-dose vaccination series early in the clinical trial to those who completed a two-dose series later in the study. The analysis submitted by the company showed that during the study period of July and August 2021, the incidence of COVID-19 was higher among the participants who completed their primary vaccine series earlier, compared to participants who completed it later. The FDA determined that the rate of breakthrough COVID-19 reported during this time period translates to a modest decrease in the efficacy of the vaccine among those vaccinated earlier.
Safety was evaluated in 306 participants 18 through 55 years of age and 12 participants 65 years of age and older who were followed for an average of over two months. The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.

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