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Pfizer-BioNTech Submits Application for EUA for Second Booster Dose of COVID-19 Vaccine

The application is based on 2 Israeli studies for the additional shot for people 65 years and older.


Updated March 15 6:56pm EDT:

The 2 biopharmaceutical companies submitted their application for an Emergency Use Authorization from the Food and Drug Administration (FDA) late this afternoon for an authorization for their COVID-19 vaccine for a second booster dose for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.

The application is based on 2 real-world Israeli data sets analyzed at a time when the Omicron variant was circulating. According to the companies, both data sets showed evidence that an additional mRNA booster increased immunogenicity and lowered rates of confirmed infections and severe illness.

An analysis of 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. These 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 vaccine administered at least 4 months after a third dose compared to those who received only 1 booster dose.

In addition, the submission included results from an ongoing, open-label, non-randomized clinical trial in healthcare workers 18 years of age and older at a single study center in Israel who had been vaccinated with 3 doses of the Pfizer-BioNTech vaccine. Among the 154 (out of 700) participants who received an additional booster (fourth) dose of the vaccine at least 4 months following the initial booster, neutralizing antibody titers increased approximately 7-fold to 8-fold at two and 3 weeks after the additional booster (fourth) dose compared to 5 months after the initial booster (third) dose.

Additionally, there was an 8-fold and 10-fold increase in neutralizing antibody titers against the Omicron variant (B.1.1.529) at 1 and t2 weeks after the additional booster dose, respectively, compared to 5 months after the initial booster.

Earlier this week, Pfizer CEO Albert Bourla said he expected people to need a fourth dose of the vaccine to prevent another wave of COVID-19 in an interview with the nationally broadcast television show, Face the Nation.

”It is necessary a fourth booster, right now; the protection we are getting from the third is good enough; it is actually quite good for hospitalizations and deaths; it’s not that good against infections,” Bourla said in that interview.

In the United States, cases have been trending downward for several weeks, but cases have been increasing in both the United Kingdom and China.

This week, a Delta and Omicron hybrid variant was identified. The strain, Delta 21J/AY.4-Omicron 21K/BA.1, which some have referred to “Deltacron,” is known as a recombinant virus because it contains genes from both variants.