Pfizer-BioNTech seek FDA approval for second COVID-19 booster for 65 and older

• Pfizer presented data collected in Israel, where a second booster is authorized for people over age 18

• Preliminary data from Israel had a mixed result

Pfizer Inc (NYSE: PFE) and BioNTech SE on Tuesday filed an application with the U.S. Food and Drug Administration (FDA) to seek authorization for a second booster dose for its COVID-19 vaccine for people 65 and older.

The application submitted data collected in Israel, where a second booster is authorized for people over age 18.

Israeli Ministry of Health records was conducted for over 1.1 million adults 60 years of age and older who had no known history of COVID-19 infection and were eligible for an additional (fourth dose) booster.

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The drugmakers in a press release said an analysis of the data showed rates of confirmed infections were two times lower among individuals who received the second booster dose at least four months after an initial booster (third) dose compared to those who received only the first booster dose.

Need for fourth dose and efficacy

Dr. Anthony Fauci, the chief medical adviser of the U.S., has earlier raised the prospects of a fourth shot, suggesting that it might be needed for older people to prepare for the possibility of another outbreak.

Pfizer CEO Albert Bourla said Friday its scientists found that the protection from the first booster began to wane after three or four months, and a fourth dose of the vaccine will be needed to offset waning protection gained with the third shot.

However, the preliminary data from Israel had a mixed result.

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Israel in late January said that the fourth shot of Pfizer’s COVID-19 vaccine boosted antibodies further than the third dose but is insufficient to prevent Omicron infections.

The tests were conducted at the Sheba Medical Center, Israel’s largest hospital, among 154 volunteers.

Preparing for another outbreak

The FDA authorized Pfizer booster shots in January for children ages 12 to 15 years and the third vaccine for children ages 5 through 11 who have compromised immune systems.

U.S. Centers for Disease Control and Prevention (CDC) recommends that everyone above the age of 12 receive a booster five months after the second shot of either the Pfizer or the Moderna vaccine or two months after receiving the single-dose Johnson & Johnson vaccine.

Moreover, there are worries around another COVID-19 outbreak in China, which the data suggests is the worst outbreak since the early days of the pandemic.

Picture Credit: Reuters