BioNTech and Pfizer initiated a rolling submission to the European Medicines Agency (EMA) for BNT162b2, a vaccine development program against COVID-19, according to press release. EMA expected to begin a rolling review after promising results from pre-clinical and early clinical trials.
- BioNTech and Pfizer to work with EMA’s Committee for Medicinal Products for Human Use (CHMP) to finalize the rolling review process.
- Formal MAA submission to be finalized after rolling review process, subject to demonstration of vaccine efficacy and safety, and confirmation by EMA that submitted data is adequate.
- Vaccine to be subject to EMA’s quality, safety, and efficacy standards.
- BNT162b2 triggers production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2.
BioNTech and Pfizer stocks gaining on news announcement of vaccine review. PFE: NYSE is up 1.02%, BNTX: NASDAQ is up 9.50%