Pfizer seeks emergency authorization of second booster for older adults

Editor's Note

On March 15, Pfizer and BioNTech submitted an emergency use authorization request to the Food and Drug Administration (FDA) for a second booster dose of their COVID-19 vaccine for adults aged 65 and older who have already received a booster of an approved COVID-10 vaccine.

The two companies are basing their authorization request on data out of Israel of over 1.1 million adults aged 60 years or older showing that an additional booster reduced infections and severe illness and increased immunogenicity during a time when Omicron was “widely” circulating. “Data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of [the] Pfizer-BioNTech COVID-19 vaccine compared to individuals who received only an initial booster,” the company statement reads.

According to the statement, there is "emerging evidence" that suggests “effectiveness against both symptomatic COVID-19 and severe disease caused by Omicron wanes 3 to 6 months after receipt of an initial booster (third) dose.”

The data from Israel suggest that “an additional booster dose of the Pfizer-BioNTech COVID-19 vaccine administered at least 4 months after an initial booster dose could restore antibody titers to peak post-third dose titer levels, improve protection against both infection and severe disease in individuals 60 years of age and older in Israel, and have a similar safety profile to that of previous doses,” the statement concludes.