Pfizer Inc. and BioNTech SE announced the initiation of a supplemental Biologics License Application (sBLA) to the FDA for approval of a booster (third) dose of COMIRNATY® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. The companies intend to complete submission of the sBLA by the end of this week.
The sBLA includes data from a Phase 3 clinical trial of 306 participants 18-55 years of age who received a booster (third) dose of COMIRNATY, between 4.8 and 8 months after completing the two-dose primary regimen, with a median follow-up time of 2.6 months post booster. The booster (third) dose of COMIRNATY elicited robust neutralizing antibodies to the wild-type strain in participants who were without evidence of SARS-CoV-2 infection through one month post dose three. SARS-CoV-2 50% neutralizing titers (PRNT50) after the third dose were 3.3 times the titers after the second dose. The post dose three neutralizing titers met the prespecified 1.5-fold non-inferiority criterion for success and were statistically superior. Moreover, 99.5% of participants had a four-fold response after the third dose, compared to 98.0% after the second dose. The titers after dose three met the pre-specified 10% non-inferiority margin for the difference in the four-fold seroresponse rates.
The reactogenicity profile within seven days after the booster (third) dose was typically mild to moderate. The most common events included injection site pain, fatigue, headache, muscle and joint pain, and chills. The frequency of any severe systemic event after the booster dose was low. The frequency of reactogenicity was similar to or better than after dose two of the primary series. The adverse event profile was generally consistent with other clinical data for COMIRNATY.
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