BioNTech SE (NASDAQ: BNTX) and Pfizer, Inc. (NYSE: PFE) has announced today that they have started the rolling submission to the European Medicines Agency (EMA) to get approval for the COVID-19 vaccine candidate BNT162b2. European Medicines Agency (EMA) took the decision of review after seeing the promising preliminary results from pre-clinical and early clinical studies in adults.
The preclinical study disclosed that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2, the virus which caused the COVID-19 disease. The study proved that the combination of antibody and T cell are important tools against the novel coronavirus.
Pfizer and BioNTech have disclosed that they are planning to work closely with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to finalize the rolling review process to enable the final Marketing Authorization Application (MAA). In rolling review, CHMP has started evaluating data generated in pre-clinical trials.
The term “rolling review” means that the regulatory authority has begun evaluating the first batch of data on the vaccine. In the rolling review of BNT162b2, the European Medicines Agency (EMA) will evaluate the real-time data which the company gathered after giving doses to patients in different trials. Instead of submitting all that data at once, it is better to start the rolling review so that the company will be able to know where its vaccine candidate stands.
Shares of BioNTech (NASDAQ: BNTX) traded up 6.49% as it gained +5.24 at $85.94 during the trading session of Tuesday. In the past 52-weeks of trading, this company’s stock has fluctuated between the low range of $12.52 and a high range of $105.00. It has moved up 586.15% from its 52-weeks low and moved down -18.15% from its 52-weeks high. This company market capitalization has remained high, hitting $18.96 billion at the time of writing.
On the other hand, Pfizer Inc. (NYSE: PFE) shares were trading down 0.20% as it lost -0.08 during at the time of writing on Tuesday. Pfizer Inc. share price went from a low point around $27.88 to briefly over $ in p40.97ast 52 weeks, though shares have since pulled back to $36.67. PFE market cap has remained high, hitting $204.16 Billion at the time of writing.
The BNT162b2 vaccine candidate is based on the proprietary mRNA technology of BioNTech. It is supported by Pfizer’s global vaccine development and manufacturing capabilities. BioNTech aimed to develop a potential vaccine at this period of uncertainty where COVID-19 is spreading all around the world.
