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

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

Pfizer-BioNTech ahead 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, they released the early-stage data from their COVID-19 vaccine trials. As per their official press release, they have decided to move onto phase 2 of their human trials with the second COVID-19 vaccine candidate BNT162b2. This move came after their second vaccine candidate showed favourable immune response with fewer side effects as compared to their first candidate. The BNT162b1 COVID-19 vaccine led to major side effects in people between the age of 18 to 85 years but the  BNT162b2 vaccine led to fewer side effects in the 18-55 years age group and no side effects in the 65-85 years old age group. 

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“Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase 2/3 study is the 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. The Phase 2/3 study protocol follows all the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies,” said Kathrin U. Jansen, Senior Vice President and Head of Vaccine Research & Development of Pfizer as per the press release.

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

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

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