Pfizer, BioNTech Submit EUA to FDA for COVID-19 Vaccine

Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, reported that they have submitted a request to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2, the virus that causes COVID-19.

The companies say this submission, if approved, will potentially enable use of the vaccine in high-risk populations in the US by the middle to the end of December 2020. The submission is based on a vaccine efficacy rate of 95% in a Phase III clinical study as reported by the companies and reaching required safety requirements.

In addition to the submission to the FDA, the companies have already initiated rolling submissions with several other regulatory agencies, including the European Medicines Agency and the UK’s Medicines & Healthcare products Regulatory Agency, as well as regulatory agencies in Australia, Canada, and Japan, and plan to submit applications to other regulatory agencies worldwide in the coming days (as reported on November 20, 2020). In some cases, governments may have regulatory pathways similar to an EUA.

Based on current projections, the companies say they expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021. Four of Pfizer’s facilities are part of the manufacturing and supply chain: (1) St. Louis, Missouri; (2) Andover, Massachusetts; (3) Kalamazoo, Michigan; and (4) Puurs, Belgium. BioNTech’s German sites will also be used for global supply.

The companies also say they will be ready to distribute the vaccine within hours after authorization. Pfizer has expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months. The company has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70 °C ± 10 °C) up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Once thawed, the vaccine vial can be stored for up to five days at refrigerated (2–8 °C) conditions.

In a separate development, BioNTech and Fosun Pharma, a Shanghai-based pharmaceutical company, have started a Phase II clinical trial in Mainland China for BioNTech’s/PFizer’s COVID-19 vaccine, BNT162b2. BioNTech and Pfizer are partnered to commercialize the vaccine worldwide, excluding China, where BioNTech has a collaboration with Fosun Pharma for both clinical development and commercialization. The Phase II trial is being conducted at sites in in Taizhou and Lianshui, Jiangsu Province, China.

Source: Pfizer and BioNTech (Pfizer) and BioNTech (Fosun)

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