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Pfizer/BioNTech's Coronavirus Vaccine Gets FDA Fast Track Tag

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Pfizer, Inc. (PFE - Free Report) and its Germany-based partner BioNTech SE (BNTX - Free Report) announced that the FDA has granted fast track designation to two out of four of their experimental vaccines to prevent COVID-19.

Pfizer and BioNTech are currently evaluating four different vaccine candidates in phase I/II studies in the United States and Germany as part of their BNT162 mRNA-based vaccine program, Project Lightspeed, for SARS-CoV-2, the virus that causes COVID-19. The fast track designation was assigned to BNT162b1 and BNT162b2, the most advanced candidates in the program.

We note that the FDA grants fast track status to facilitate the development and quicken the review process for the candidates that are being developed for the treatment of serious conditions that have an unmet medical need.

Shares of Pfizer and BioNTech were up more than 4% and 10%, respectively, on Monday. However, so far this year, Pfizer’s shares have lost 15.5% compared with the industry’s 1.8% decline.

 

 

The designation granted to BNT162b1 and BNT162b2 was based on preliminary data from a U.S. based phase I/II study as well as some pre-clinical data.

Last week, Pfizer and BioNTech announced early positive data from the phase I/II U.S. clinical study on BNT162b1 vaccine candidate, which targets receptor-binding domain (RBD) of the ARS-CoV-2 spike protein. The preliminary data showed that BNT162b1 can produce neutralizing antibody responses in humans at or above the levels observed in convalescent sera, which means the serum of patients who have recovered from COVID-19. Moreover, the candidate could achieve this benefit at relatively low dose levels. Early data from the study of BNT162b1 in Germany are expected later this month.

Once further clinical data on the four vaccine candidates is available, the companies will select the lead candidate and dose level for a larger, global phase IIb/III safety and efficacy study that may begin this month and may enroll around 30,000 subjects.

The companies are also building manufacturing capabilities to support the availability of a vaccine.  Eventually, if the vaccine is approved this year, Pfizer plans to manufacture up to 100 million doses by the end of this year and potentially more than 1.2 billion doses by the end of 2021.

Around a dozen companies are working on developing a vaccine for the deadly coronavirus disease using different technologies such as DNA, RNA, protein and viral vectored vaccines. Of these, other than Pfizer/BioNTech, Moderna (MRNA - Free Report) , Novavax, AstraZeneca (AZN - Free Report) in partnership with Oxford University, and Inovio Pharmaceuticals have initiated human/clinical studies on a coronavirus vaccine. J&J expects to begin a human study this month. In fact, Moderna expects to initiate a pivotal phase III study in July. AstraZeneca/Oxford University partnership also expect to begin late-stage studies with 30,000 participants in a number of countries if data from the phase I/II study, expected to be released shortly, is successful.

However, the FDA made it clear last week that it “will not cut corners” and sacrifice its standards for quality, safety, and efficacy while giving its decision for approving any COVID-19 vaccine. It issued some guidance documents, which mentioned that the primary efficacy endpoint point of a placebo-controlled efficacy trial should be at least 50%, which means the vaccine should be able to lower the risk of the disease caused by the SARS-CoV-2 virus in at-least 50% of the people who are vaccinated.

Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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