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Pfizer, BioNTech on track to make hundreds of millions of COVID-19 vaccine doses this year

Plus Vaxart’s vaccine selected for Warp Speed preclinical testing, and trio of vaccine manufacturing deals

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Pfizer and its partner BioNTech could obtain emergency use authorization for a COVID-19 vaccine as early as October, and expect to be able to produce hundreds of millions of doses in 2020 and a billion doses in 2021, Albert Bourla, chairman and CEO of Pfizer, said Friday.

Pfizer’s news came the same day that Vaxart Inc. (NASDAQ:VXRT) said its vaccine had been selected for a preclinical study sponsored by the Trump administration’s Operation Warp Speed.

Speaking on a webinar sponsored by the Milken Institute, Bourla said the estimates are contingent on “all the stars aligning,” including rapid and successful completion of a 30,000-person Phase III trial, as well as continued trouble-free manufacturing.

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have partnered to develop BNT162, an mRNA-based vaccine.

Data from the Phase III trial of the candidate, which will be run primarily in the U.S., “could convince us that we have a vaccine that is safe and efficacious in the September time frame,” he said. “If that is the case and we are lucky, we could then discuss with the FDA and have approval in the October time frame.”

Bourla emphasized that these are best-case scenarios and said he was surprised that so far no problems have emerged that would slow the vaccine’s development.

His optimism is based in part on preclinical and clinical data that Pfizer will soon publish in a peer-reviewed journal, Bourla said.

The two companies are establishing separate manufacturing capacity in the U.S. and Europe dedicated to serving each market, Bourla said. He also noted the humanitarian need to supply other parts of the world.

Bourla said that Pfizer decided not to seek U.S. government funding because reporting obligations associated with government financing would slow the company’s development of a COVID-19 vaccine.

BioNTech, however, has negotiated a €100 million debt financing from the European Investment Bank to develop and scale up European manufacturing of BNT162.

In contrast to AstraZeneca plc (LSE:AZN; NYSE:AZN), Johnson & Johnson (NYSE:JNJ), and other companies that have committed to providing COVID-19 vaccines at no profit during the pandemic crisis, Bourla said that if it is approved, Pfizer will make a profit from its vaccine.

It will be priced similarly to other vaccines, Bourla said, but “during the pandemic we will try to provide discounts.”

Warp Speed vetting Vaxart

Warp Speed is narrowing a list of 14 vaccine candidates to the seven most promising, which will go through further testing in early-stage clinical trials. The initiative plans to produce 300 million COVID-19 vaccine doses by January (see “Trump Administration Lays Out Path”).

The efficacy of Vaxart’s oral vaccine will be evaluated in a non-human primate study. The candidate was developed with the company’s adenovirus serotype 5-based VAAST platform.

Vaxart also signed a memorandum of understanding with Attwill Medical Solutions Sterilflow L.P. to manufacture at least 1 billion doses per year of the vaccine, which is slated to begin Phase I testing next half. The biotech already has manufacturing agreements with Kindred Biosciences Inc. (NASDAQ:KIN) and Emergent BioSolutions Inc. (NYSE:EBS).

Vaxart shares rose $1.78 (28%) to $8.04 Friday.

Also agreeing to vaccine manufacturing deals this week were Moderna Inc. (NASDAQ:MRNA), which partnered with Catalent Inc. (NYSE:CTLT) for large-scale production; and AstraZeneca, which signed with SymBiosis Pharmaceutical Services to provide doses of AZD1222 for clinical trials.

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