Pfizer-BioNTech Covid-19 Vaccine Trials Show Positive Response, Likely To Get Regulatory Approval By October

The US pharma company Pfizer which is collaborating with BioNTech for Covid 19 vaccine has released data showing positive results from phase 1 testing. The company also says that the vaccine may get approval by October.

(Representative Image/ Getty)

New Delhi: The American pharmaceutical company Pfizer which is collaborating with the German Biotech major BioNTech for its Covid 19 vaccine program, has announced that the research development is progressing on the right track and the company might be able to seek regulatory review and approval by October this year. The RNA based vaccine BNT162b2 vaccine candidate being developed Pfizer- BioNTech entered advanced into Phase 2/3 testing last month. The company also recently released the safety and immunogenicity data from Phase 1  testing. According to the data, the vaccine candidate was ‘well tolerated with mild to moderate fever in fewer than 20% of the participants’. It also said that the vaccine demonstrated strong immunogenicity in younger and older adults. The official release has said that 'the research on the T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication.' “The favorable safety profile of BNT162b2 and the breadth of T cell responses we previously announced have supported our decision to select this candidate for the pivotal Phase 2/3 study. As of today, we have already dosed more than 11,000 participants with BNT162b2 in that study,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech in an official statement. The company has also selected BNT162b2 as the lead candidate to continue into phase 2 trials after it along with the other vaccine candidate-BNT162b1. “The totality of the clinical and preclinical data-informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer in a statement.