US: Pfizer seeks FDA approval of COVID-19 booster shots for all adults ahead of holidays

Pfizer, on Tuesday, submitted a request to the United States Food and Drug Administration (FDA) to amend the Emergency Use Authorization (EUA) for BioNTech’s COVID-19 vaccine booster dose calling for allowing doses for all above 18 years of age. Pfizer presented the request based on results from a randomized Phase 3 trial with over 10,000 participants, the company said in a statement released on Tuesday. The decision came with an eye on the approaching holiday season, during which the health experts have expected to see a spike in COVID-19 infection in the US.

It is to be noted that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine is currently authorised by the FDA for emergency use after completion of a 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 with frequent institutional or occupational exposure to SARS-CoV-2. Apart from this eligible individuals who have completed primary vaccination with a different authorized COVID19 vaccine can also receive a Booster jab against COVID-19, Pfizer said in its statement. "Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series", the statement emphasised.

Pfizer's booster shot restores 95% protection

As per the report published by the leading vaccine manufacturer, Pfizer-BioNTech booster shot restored 95% protection against symptomatic infection of the delta variant. Also, there were no new side-effects apart from those seen with the first two doses of the same shot. The Phase 3 trial evaluated the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older in the U.S., Brazil, and South Africa, Pfizer said.

The vaccine manufacturer further stated,

"All trial participants previously completed the primary two-dose series of the Pfizer-BioNTech vaccine, and then were randomized 1:1 to receive either a 30-µg booster dose (the same dosage strength as those in the primary series) or placebo."

The Biden administration has earlier proposed booster shots for all adults beginning from September. However, FDA authorities rejected the proposal weighing the necessity of providing vaccines to an unvaccinated population over additional shots to young healthy people, the Associated Press reported. Around 194 million Americans are fully jabbed and in case FDA endorsed Pfizer's booster dose for all adults then at least 2 to 3 million vaccinated adults would be eligible for the shot.

Image: AP