Pfizer Covid-19 Vaccine Is on Track to Be Submitted for Regulatory Review in October

UTC by Godfrey Benjamin · 3 min read
Pfizer Covid-19 Vaccine Is on Track to Be Submitted for Regulatory Review in October
Photo: Depositphotos

Pfizer COVID-19 vaccine created in cooperation with BioNTech SE is to be submitted for review in October. The duo will not accept any payments until they have successfully manufactured an effective vaccine.

Pfizer Inc (NYSE: PFE) COVID-19 vaccine developed in collaboration with BioNTech SE (NASDAQ: BNTX) is on track to be submitted for regulatory review as early as October. The biopharmaceutical giant made this known in a press release. According to the data shared, the COVID-19 vaccine Candidate BNT162b2 which has advanced into a 2/3 trial stage has shown key safety and immunogenicity trends according to the data from the phase 1 trial from the U.S.

The companies said the vaccine was well tolerated with mild to moderate fever in fewer than 20% of the participants. The companies are continuing to analyze data from the Phase 1 trials in the U.S. and Germany.

Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer said:

“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”.

She continued:

“We are especially pleased to offer these early data showing our vaccine candidate’s promising safety and immunogenicity profile from the U.S. trial and we look forward to sharing T cell immune response data from the German trial in the near future”.

From the Phase 1 trial, the BNT162b2 vaccine candidate, which at 30μg recorded 7 days after the second dose elicited SARS-CoV-2-neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV2 convalescent patients, and in older adults (65-85 years of age), the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults’, the announcement detailed.

As expected, the shares of Pfizer (PFE) and BioNTech (BNTX) are up following the news update. While Pfizer (PFE) is up 1.50% after hours of trading on Friday, BioNTech (BNTX) saw a 1.09% surge to hit $66.99 after hours of trading.

Pfizer Partnerships for COVID-19 Vaccine

Just as is the case for every COVID-19 vaccine candidate, the Pfizer (PFE) and BioNTech (BNTX) COVID-19 vaccine candidate has seen a massive show of support from the government and investors alike.

As Coinspeaker reported earlier, the U.S. Government has signed a $1.95 billion deal with Pfizer and BioNTech for the firms’ COVID-19 vaccine. The deal which is aimed at supplying an initial order of 100 million doses and an additional 500 million, is predicated upon a successful approval from the Food and Drug Administration (FDA), a move that the companies aim will be happening as early as October. Before then, however, Pfizer has declared that the duo will not accept the payment until they have successfully manufactured an effective vaccine.

On the international scene, the United Kingdom’s Government has ordered 90 million doses of Pfizer’s and BioNTech’s COVID-19 vaccine while Japan has inked a deal that will see it get 120 million doses of the mRNA COVID-19 vaccine from the companies.

As the race for a working vaccine mounts, the prospects from Pfizer and BioNTech are notable with promises to “..continue sharing data and related information on our COVID-19 vaccine lead candidate,” – BioNTech MD and CEO, Ugur Sahin noted.

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