BioNTech and Pfizer Begin 3rd COVID-19 Vaccine Dose Evaluation
Germany-based BioNTech SE and Pfizer Inc. announced today they had begun evaluating the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) (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.
The study will draw upon participants from the Phase 1 study in the USA 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 the Companies’ clinical development strategy to determine the effectiveness of the third dose against evolving variants.
Separately, to be prepared for any potential future strain changes, Pfizer and BioNTech are in ongoing discussions with regulatory authorities regarding a registration-enabling clinical study to evaluate a variant-specific vaccine having a modified mRNA sequence. This study would use a new construct of the Pfizer-BioNTech vaccine based on the B.1.351 lineage, first identified in South Africa.
This could position the Companies to update the current vaccine quickly if the need arises to protect against COVID-19 from circulating strains.
“We want to be prepared for different scenarios,” stated Ugur Sahin, CEO, and Co-founder of BioNTech, in a press release. “Therefore, we will be evaluating the second booster in the current regimen as well as preparing for a potential rapid adaption of the vaccine to address new variants which might escape the current version of our mRNA-based vaccine."
"The flexibility of our proprietary mRNA vaccine platform allows us to develop booster vaccines within weeks if needed technically."
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. FDA. Still, it has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent COVID-19 for use in individuals 16 years of age and older.
Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.