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Pfizer, BioNTech Initiate Study To Evaluate COVID-19 Booster And New Vaccine Variants

Pfizer Inc. (PFE) and BioNTech SE (BNTX) said that they have initiated a study to evaluate the safety and immunogenicity of a third dose of their COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants.

According to the companies, the study will draw upon participants from the Phase 1 study in the United States who will be offered the opportunity to receive a 30 µg booster of the current vaccine 6 to 12 months after receiving their initial two-dose regimen.

The study is part of broad development plan to evaluate COVID-19 booster and new vaccine variants.

The companies said they are in ongoing discussions with regulatory authorities, including the U.S. Food and Drug Administration and the European Medicines Agency, regarding a registration-enabling clinical study to evaluate a variant-specific vaccine having a modified mRNA sequence. This would provide a flexible solution for rapidly adapting the vaccine for use against the B.1.351 lineage or other new strains that may emerge as possible immune escape virus variants. The B.1.351 lineage is first identified in South Africa.

Pfizer and BioNTech noted that, based on in-vitro studies conducted to date and observations from real world evidence, they have not observed changes to neutralizing antibody levels that would predict a significant reduction in protection provided by two doses of BNT162b2.

The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

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