Pfizer, BioNTech Start Late-Stage Study of Lead Covid Shot
A pedestrian wearing a protective face covering and gloves passes in front of Pfizer Inc. headquarters in New York, U.S. (Photographer: Jeenah Moon/Bloomberg)

Pfizer, BioNTech Start Late-Stage Study of Lead Covid Shot

Pfizer Inc. and BioNTech SE said they’ve begun a later-stage trial for their top coronavirus vaccine candidate and set a goal of submitting it for regulatory review as soon as October -- one of the most ambitious timelines to date.

The move pushes the New York-based pharmaceutical giant and its German partner closer to bringing a vaccine to market, and places them alongside frontrunners like Moderna Inc., which announced earlier Monday that it had started its own large, final-stage trial of a shot based on similar technology.

Pfizer and BioNTech said that they had selected a lead vaccine candidate from within a broader development program and will proceed with a later-stage safety and efficacy trial of the experimental shot in a two-dose regimen. The announcement came in anticipation of Pfizer reporting second-quarter earnings on Tuesday.

Governments around the world are now looking to lock up supplies of the still-experimental candidates. Each has hopes of stabilizing local economies and stopping spread of the virus that’s taken more than 650,000 lives globally. Last week, Pfizer and BioNTech clinched a $2 billion deal to supply an initial 100 million doses of a vaccine to the U.S. That set a price ceiling of less than $20 per dose, which will likely impact how much others will charge.

Pfizer shares gained as much as 3% in after-hours trading in New York on Monday, while U.S.-traded shares of BioNTech rose 5.2%.

mRNA Trials Advance

Pfizer and BioNTech will move forward with their BNT162b2 vaccine candidate, they said in the announcement. It’s one of four shots they’d been developing based on a new type of technology known as messenger RNA, a synthetic form of genetic material that prompts the body to make a key protein from the virus, creating an immune response.

The companies had previously announced positive data out of a different candidate, BNT162b1, which had generated an immune response in early-stage trials. The candidate the companies ultimately selected has a more favorable tolerability profile, they said.

On Monday, BNT162b2 moved into a later-stage trial of up to 30,000 patients aged 18 to 85. The companies will use more than 120 clinical sites globally to assess the shot’s efficacy, including 39 states in the U.S., as well as sites in Argentina, Brazil and Germany. The investigator sites were selected because significant transmission of the novel coronavirus is expected there. Many are also located in diverse communities that have been disproportionately affected by the disease. China was excluded.

Meanwhile, Moderna’s mRNA vaccine candidate is being tested in conjunction with the National Institutes of Health in 30,000 people across 89 sites in the U.S. Other developers, including Novavax Inc. and Johnson & Johnson, have ambitions to launch Phase 3 trials of their own candidates in the near future.

Assuming success, Pfizer and BioNTech will seek to submit the shot to regulators for review in October, according to a statement.

Early results from the Moderna trial could be available in November or December, Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, said on Monday. He said though that results could come as early as October if the subjects in places with high case loads are enrolled quickly.

Pfizer, unlike Moderna, has not received funding from the U.S. for its research and development, or production of a vaccine. Both stand to profit from their efforts, should they succeed.

©2020 Bloomberg L.P.

BQ Install

Bloomberg Quint

Add BloombergQuint App to Home screen.