Pfizer Applies to US FDA for Booster Shot Use in All Adults

Booster Shot Phase 3 Interim Results "95.6% Prevention Effect"
CEO "Effectiveness May Last 1 Year... Annual Vaccination Possible"

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kim Suhwan] U.S. pharmaceutical company Pfizer has applied to the U.S. Food and Drug Administration (FDA) to expand the eligibility for COVID-19 vaccine booster shots to all adults aged 18 and older.

On the 9th (local time), according to Bloomberg News and others, Pfizer and German company BioNTech announced this and submitted phase 3 clinical trial data on the COVID-19 vaccine booster shots to the FDA.

Currently, in the United States, Pfizer-BioNTech's COVID-19 vaccine booster shots are only available for seniors aged 65 and older and high-risk groups under 65.

The two companies conducted a phase 3 trial by administering a third dose of 30μg to more than 10,000 people aged 16 and older who had received the Pfizer-BioNTech vaccine at least six months prior in the U.S., Brazil, and South Africa. The phase 3 booster shot trial period coincided with the peak of the Delta variant spread.

Earlier, BioNTech announced last month that the interim analysis of the phase 3 trial showed a 95.6% efficacy rate for those who received the booster shot, with no serious side effects reported.

The FDA is expected to approve Pfizer-BioNTech's booster shot expansion application by November 25, before Thanksgiving, according to The New York Times (NYT).

Pfizer-BioNTech had applied for emergency use authorization for booster shots for all adults in September, but at that time, the FDA's external advisory committee recommended approval only for those aged 65 and older and certain groups.

Regarding this application, the FDA is expected to approve the expansion of emergency use without convening an additional advisory committee.

The company has also actively promoted the necessity of booster shots.

Albert Bourla, CEO of Pfizer, said in an online discussion hosted by the Atlantic Council, a think tank in Washington DC, that the preventive effect of the COVID-19 vaccine booster shot "seems to last for one year" and "it looks likely that annual vaccinations will be needed."

CEO Bourla emphasized that immunity wanes six months after the second dose and claimed that the booster shot can provide a higher level of protection than the initial vaccination.

He also criticized those spreading fake news about the COVID-19 vaccine, calling them "criminals" and stating, "They have sacrificed millions of lives," according to CNBC.

He expressed hope that if unvaccinated people get vaccinated, many lives could "return to normal."

Meanwhile, with the possibility of a COVID-19 resurgence ahead of the cold winter, governments around the world are focusing on expanding booster shots.

Canada's Department of Health approved the use of Pfizer-BioNTech's COVID-19 vaccine booster shots for all adults aged 18 and older on the same day.

This content was produced with the assistance of AI translation services.