Pfizer and BioNTech on track to submit the regulatory review on Corona virus vaccine in October

Pfizer, the US pharmaceutical company and German biotech firm BioNTech released the safety and immunogenicity data from the phase 1 trial of their second and lead mRNA based vaccine candidate against SARS-CoV-2, the novel virus that causes COVID-19. The companies said that their Covid-19 vaccine candidate, BNT162, is on track to submit for regulatory review as soon as October.

In a press release, Pfizer and BioNTech said that the  data from the phase 1 trial showed that their COVID-19 vaccine candidate elicited SARS-CoV-2-neutralizing geometric mean titers in younger and older adults, representing strong immunogenicity in all the participants. Further, the vaccine was found to be well tolerated across all populations with mild to moderate fever in less than 20 per cent of the participants.

The BNT162b2 vaccine seemed to generate a similar immune response, but fewer side effects than the other vaccine BNT162b1. Systemic events after administration of BNT162b2 were milder than those with BNT162b1, they said in the release. The results have been published on an online preprint server medRxiv and are concurrently undergoing scientific peer review for potential publication.

“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. We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus,” said Ph.D, Senior VP and Head of Vaccine Research & Development, Pfizer, Kathrin U Jansen. “We are especially pleased to offer these early data showing our vaccine candidate’s promising safety and immunogenicity profile from the US trial and we look forward to sharing T cell immune response data from the German trial in the near future.”

MD, CEO and Co-Founder of BioNTech, Ugur Sahin said, “It is important to us to continue sharing data and related information on our COVID-19 vaccine lead candidate,”. “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.”

As per the release, both BNT162b1 and BNT162b2 produced parallel dose-dependent SARS-CoV-2-neutralizing antibody GMTs in both younger and older adults. The neutralizing antibody GMTs were substantially elevated after the second dose, showing a clear benefit of a two dose regimen.

The companies are enduring to analyze data from the Phase 1 trials in the United States and Germany. The findings will support the selection of the BNT162b2 vaccine candidate for global (except for China) Phase 2/3 large-scale safety and efficacy evaluation, which is at present underway. The trial will enroll up to 30,000 participants between 18 to 85 age group. Till date, the phase 2 and 3 trial enrollment has exceeded to 11,000 participants with a second dose underway.

Pfizer and BioNTech stated that they are on track to seek regulatory review for BNT162b2 as early as October 2020. If trials succeed and regulatory authorization or approval is obtained, the companies will plan to supply up to 100 million doses worldwide by the end of 2020 and around 1.3 billion doses by the end of 2021.


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