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

By Miranda Greenberg -

November 19, 2020

Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have achieved the safety data milestone required by the US Food and Drug Administration (FDA) for submission of emergency use authorization (EUA) for their mRNA-based COVID-19 vaccine candidate, BNT162b2.

Pfizer and BioNTech plan to submit a request for EUA within days (as reported on November 18, 2020) to the FDA based on the totality of safety and efficacy data collected, as well as manufacturing data relating to the quality and consistency of the vaccine. These data also will be submitted to other regulatory agencies globally.

The companies report that the final efficacy analysis in their ongoing Phase III study of BNT162b2 met all of the study’s primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection in each case measured from seven days after the second dose.

Based on current projections, the companies expect to produce up to 50 million vaccine 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.

Pilot distribution program in the US

Pfizer has also announced a pilot program with four states in the US (Rhode Island, Texas, New Mexico, and Tennessee) to support the states’ planning, deployment, and administration of its and BioNTech’s COVID-19 vaccine. Learnings from this program will be adapted for usage across other states to help them create effective immunization programs for the vaccine.

The four states were selected for pilot program because of their differences in overall size, diversity of populations, and immunization infrastructure, as well as the states’ need to reach individuals in varied urban and rural settings. The four states included in the pilot program will not receive vaccine doses earlier than other states, nor will they receive any differential consideration.

In July (July 2020), Pfizer and BioNTech announced the execution of an agreement with the US Department of Health and Human Services and the Department of Defense to meet the US government’s program goal of Operation Warp Speed, an initiative to speed the development and delivery of COVID-19 vaccines and treatments, to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the US government will first receive 100 million doses of the Pfizer-BioNTech COVID-19 vaccine after Pfizer successfully manufactures and obtains approval or EUA from the FDA. The US government will pay $1.95 billion for those first 100 million doses, with the option to acquire up to an additional 500 million doses.

Clinical Trial in China Gets Regulatory Go-Ahead  

BioNTech and Fosun Pharma, a Shanghai-based pharmaceutical company, have received approval from the China National Medical Products Administration to begin a Phase II clinical trial in Mainland China for BioNTech’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.

BNT162b2 is currently in Phase III clinical trials in the US, Germany, Argentina, Brazil, South Africa, Turkey and other countries. Pfizer and BioNTech initiated a rolling submission to the European Medicines Agency (EMA) last month (October 2020).

Source: Pfizer (Phase III results), Pfizer (distribution), BioNTech (Phase III results), BioNTech (Fosun)