BioNTech (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) have announced that the European Medicines Agency (EMA) has commenced a rolling review for their leading COVID-19 vaccine development program BNT162b2.
Positive efficacy and safety profile of BNT162b2
The decision to commence the rolling review comes after encouraging preclinical and early clinical results in adults, suggesting that BTN162b2 can trigger neutralizing antibody production. Also, the vaccine can trigger TH-1 dominant CD4+ and CD8+ T-cells targeting SARS-CoV-2. The combination of T Cell and antibody response is vital in prompting protection against the virus and disease. The companies are planning to work with the Committee for Medicinal Product for Human Use of the EMA in completing the rolling reviews and thus enable the final Marketing Authorization Application (MAA).
The CHMP has started evaluating data from the preclinical studies as part of the rolling review. The companies will finalize the formal MAA submission after the rolling review process subject to demonstration of vaccine safety and efficacy as well as EMA’s confirmation that the data submitted is sufficient. Most importantly, the vaccine candidate is likely to remain depending on the EMA’s diligent quality, efficacy, and safety standards.
BioNtech and Pfizer’s mRNA vaccine under EMA review
BioNtech co-founder and CEO Ugur Sahin said they have to make sure they are developing a potential vaccine as quickly as possible to address the COVID-19 pandemic. Sahin said that they are doing so while maintaining the highest ethical standards and adhering to reasonable scientific principles. He added that the company will continue having regular and discussions with the EMA during the rolling review process.
Pfizer’s SVP and Worldwide Safety and Regulatory Head, Peter Honig, said that the global COVID-19 pandemic has completely transformed the development and review process of a vaccine. He added that the company is making efforts to develop an effective and safe vaccine with guidance from regulatory agencies. Peter said that they are proud of this huge milestone with the EMA for the company’s potential COVID-19 vaccine, BNT162b2. The proprietary vaccine is based on the proprietary mRNA technology of BioNTech.