Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have received approval for emergency use of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2, the virus that causes COVID-19, by the UK’s Medicines & Healthcare products Regulatory Agency (MHRA), making it the first emergency use authorization for a COVID-19 vaccine.

The MHRA’s decision is based on a rolling submission, including data from a Phase III clinical study, which demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose.

Pfizer and BioNTech say they are anticipating further regulatory decisions globally in the coming days and weeks (as reported on December 2, 2020) and are ready to deliver vaccine doses following potential regulatory authorizations or approvals. The distribution of the vaccine in the UK will be prioritized according to the populations identified in guidance from the UK’s Joint Committee on Vaccination and Immunization.

Late last month (November 2020), the companies filed a request for emergency use authorization with the US Food and Drug Administration (FDA) and have submitted the final conditional marketing authorization application following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies globally.

An FDA advisory committee, the Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee, will meet in open session next week (December 10, 2020) to discuss emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 in individuals 16 years of age and older.

The EMA says it will assess the data submitted as part of the formal application for conditional marketing authorization. If the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine, EMA’s scientific committee for human medicines will conclude its assessment during an extraordinary meeting scheduled for December 29, 2020 at the latest. These timelines are based on the type of data assessed so far in the context of the rolling review and may be subject to change as evaluation proceeds.

Manufacturing and supply

Based on current projections, Pfizer’s and BioNTech’s combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021 (subject to manufacturing capacity and regulatory approval or authorization). Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech is able to produce mRNA for commercial supply after having already produced the vaccine candidate doses for clinical trials. BioNTech will also increase its manufacturing capacity in 2021, once a third site in Germany will start manufacturing to provide further capacities for global supply of the potential vaccine. Critical to distribution in the UK will be Pfizer’s manufacturing site in Puurs, Belgium, one of Pfizer’s largest sterile injectable sites. The Puurs site is being used primarily for European supply but will also serve as back-up supply to Pfizer’s site in Kalamazoo, Michigan for the US market.

In July 2020, Pfizer and BioNTech announced an agreement with the UK to supply 30 million doses of BNT162b2, once authorized for emergency use. That agreement was increased to 40 million doses in early October (October 2020). The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts. Now that the vaccine is authorized in the UK, the companies say that they will take immediate action to begin the delivery of vaccine doses. The first doses are expected to arrive in the UK in the coming days (as reported on December 2, 2020), with complete delivery fulfilment expected in 2021.

To date, Pfizer and BioNTech have successfully supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the US, as well as Europe, Latin America, and South Africa, reaching approximately 44,000 participants. Based on their collective experience, the companies say that they believe in their capability to distribute the vaccine globally upon approval or authorization. BioNTech will hold the regulatory authorization in the UK and, if granted, in the US, the European Union, Canada and other countries. Pfizer will have the commercialization right worldwide with the exception of China, Germany, and Turkey.

With regard to shipping, the companies have developed specially designed, temperature-controlled shippers for BNT162b2, which can maintain recommended storage conditions (-70 degrees Celsius ± 10 degrees Celsius) for extended periods of time without any additional equipment but dry ice. The shipper can maintain temperature for 10 days unopened, which allows for transportation to markets globally. Once open, a vaccination center may use the specially designed shippers as a temporary storage solution to maintain the recommended storage conditions up to 30 days with re-icing every five days in accordance with the handling instructions. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment 24 hours a day, seven days a week. Once thawed, the vaccine vial can be stored for up to five days at refrigerated (2 to 8 degrees Celsius) conditions.

Source: Pfizer, BioNTech (UK emergency use approval), US Food and Drug Administration, the European Medicines Agency, and BioNTech (EMA submission)