Pfizer-BioNTech COVID-19 vaccine shows positive response, may seek approval by October

Pfizer-BioNTech have released data from early trials of ir COVID-19 vaccine candidate on Thursday. According to this data, ir vaccine has shown fewer side effects and a good immune response towards virus. pharmaceutical companies are expecting to submit ir coronavirus vaccine candidate for approval by October 2020. 

Pfizer-BioNTech ahe in COVID-19 vaccine race

US-based Pfizer and Germany based BioNTech SE have been working in collaboration on developing a COVID-19 vaccine. On Thursday, y released early-st data from ir COVID-19 vaccine trials. As per ir official press release, y have decided to move onto phase 2 of ir human trials with second COVID-19 vaccine candidate BNT162b2. This move came after ir second vaccine candidate showed favourable immune response with fewer side effects as compared to ir first candidate. BNT162b1 COVID-19 vaccine led to major side effects in people between of 18 to 85 years but  BNT162b2 vaccine led to fewer side effects in 18-55 years group and side effects in 65-85 years old group. 

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“Our selection of BNT162b2 vaccine candidate and its vancement into a Phase 2/3 study is culmination of an extensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine. Phase 2/3 study protocol follows all U.S. Food and Drug ministration (FDA) guidance on clinical trial design for COVID-19 vaccine studies,” said Kathrin U. Jansen, Senior Vice President and He of Vaccine Research & Development of Pfizer as per press release.

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According to press release, Co-Founder of BioNTech Ugur Sahin said, “Today, we are starting our late-st global study, which will include up to 30,000 participants. We selected BNT162b2 as our le candidate for this Phase 2/3 trial upon diligent evaluation of totality of data generated so far. This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to market as quickly as possible, while we will continue to evaluate our or vaccine candidates as part of a differentiated COVID-19 vaccine portfolio."

According to press release, if COVID-19 vaccine candidate shows favourable response in phase 2/3 trials, Pfizer-BioNTech may seek emergency approval from authorities to use vaccine by October 2020. ir aim is to produce and supply 100 million doses by end of 2020 and about 1.3 billion doses by end of 2021 if y receive approval as planned. Pfizer-BioNTech have also signed an agreement with United States Government to supply m with 600 million doses of COVID-19 vaccine provided y receive a regular or an emergency approval from US FDA. 

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