Pfizer Submits for EUA of Additional COVID-19 Vaccine Booster

Pfizer and BioNTech recently submitted an application to FDA for emergency use authorization (EUA) of an additional COVID-19 vaccine booster dose for adults 65 years and older.  

The companies based their submission on two real-world data sets, which showed that an additional mRNA booster increases immunogenicity and lowers infections and severe illness rates.  

Experts analyzed the Israeli Ministry of Health records of over 1.1 million adults 60 years of age and older with no known history of SARS-CoV-2 infection and who are eligible for an additional (fourth dose) booster. 

Data showed rates of confirmed infections were two times lower and rates of severe illness were four times lower among individuals who received an additional booster dose of the vaccine compared to those who received one booster dose.  

Additionally, submission included results from an ongoing, open-label clinical trial in healthcare workers 18 years and older in Israel vaccinated with three doses of the Pfizer-BioNTech COVID-19 vaccine. 

Among 154 participants who received a fourth dose of the COVID-19 vaccine at least four months following the initial booster, neutralizing antibody titers increased nearly 7-fold to 8-fold at two and three weeks compared to five months after the third dose.  

There was also an 8-fold and 10-fold increase in neutralizing antibody titers against the Omicron variant at one and two weeks after the additional booster dose, respectively, compared to five months after the initial booster. 

In August 2021, FDA granted full approval to Pfizer and BioNTech's COVID-19 vaccine for individuals 16 years of age and older. Comirnaty was the first COVID-19 vaccine to be fully FDA approved.