By
Tolu Ajiboye
December 13th, 2023
The start of the review process of the BioNTech-Pfizer vaccine has triggered investors to bet more on BNTX stock.
The European Union’s European Medicines Agency (EMA) has commenced the review of BNT162b2, the BioNTech-Pfizer COVID-19 vaccine candidate being developed by the duo of BioNTech SE (NASDAQ: BNTX) and Pfizer Inc (NYSE: PFE). The review according to the EMA is the second rolling review the EU-owned regulator would be conducting with the first being conducted on AZD-1222, the vaccine candidate from AstraZeneca Plc (LON: AZN) and researchers from Oxford University.
As reported, the review being conducted is a rolling review which is one of the regulatory tools that the EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency, such as the current coronavirus pandemic. The review of BNT162b2 is based on ‘preliminary results from non-clinical and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defenses) that target the virus,’ the European Medicines Agency said in a statement.
The start of the review process of the BioNTech-Pfizer vaccine has triggered investors to bet more on BNTX stock. The stock which ended trading on Monday with a 9% increment soared by more than 10% in the pre-market. BNTX is currently trading at $88.80 at the time of writing. The BNTX performance also had a positive rub-off on the shares of Pfizer (PFE) which climbed 1.22% in the pre-market.
Commenting on the start of the review process with the EMA, Ugur Sahin, M.D., CEO and Co-founder of BioNTech said:
“It is our duty to ensure that while we are working to develop a potential vaccine at unprecedented speed to help address this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles. We will continue to have regular and open dialogue with the EMA throughout the rolling review process.”
In line with this, Peter Honig, M.D., Senior Vice President and Head of Worldwide Safety and Regulatory of Pfizer affirmed that the duo will keep “making every effort to develop a safe and effective vaccine following the guidance of regulatory agencies and are proud to take this historic step with the European Medicines Agency for our COVID-19 vaccine candidate, BNT162b2.”
Development Stage of BioNTech-Pfizer Vaccine Candidate
The BioNTech-Pfizer COVID-19 vaccine candidate is currently undergoing its late-stage trials in the United States, Brazil, South Africa, and Argentina.
In examining how the drug functions, the EMA noted that ‘BNT162b2 is expected to work by preparing the body to defend itself against infection with the coronavirus SARS-CoV-2. The virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause disease’.
With the process for the drug’s approval already started, the regulatory agency affirmed that it “will complete its assessment according to its usual standards for quality, safety, and effectiveness.”