The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the administration of Pfizer and BioNTech’s COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older.
The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future.
If the EC grants the variation regarding a booster dose, the decision will be immediately applicable to all 27 EU member states.
The positive opinion is based on the clinical trial data shared by the companies, real world evidence as well as literature data.
The data submitted by BioNTech and Pfizer include data from their clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of Comirnaty.
A booster dose of the vaccine elicited significantly higher neutralising antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series.
The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for Comirnaty.
Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the EC. The companies do not expect the introduction of booster doses in the US and the EU, if authorized, to impact the existing supply agreements in place with governments and international health organizations around the world.
Comirnaty, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.