The companies announced the conclusion of the vaccine's Phase 3 trial on Wednesday 18 November: reporting 95% efficacy. They also confirmed they had gathered the two months of safety data required by the US' Food and Drug Administration (FDA) for a Emergency Use Authorization (EUA) submission.
Dr. Albert Bourla, Pfizer Chairman and CEO, said: "Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.
“We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”
Other regulatory submissions will follow 'immediately'
Pfizer and BioNTech have already started rolling reviews of the vaccine with regulators in Europe, Australia, Canada, Japan and the UK. Today they also announce their plans to submit applications to other regulatory agencies straight away.
Ugur Sahin, M.D., CEO and co-founder of BioNTech, said: “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.
“Filing for EUA in the US is a critical step in making our vaccine candidate available to the global population as quickly as possible.”
Manufacturing capabilities for scale
While awaiting authorization or approval for regulatory agencies, Pfizer and BioNTech continue to work with governments and health departments around the world on the distribution of the vaccine.
They are geared up to distribute the vaccine within hours of receiving authorization, they state today: with the first doses projected to be distributed to high-risk population in the US by the middle to end of December this year.
The companies expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021.
"Pfizer is bringing its leading in-house manufacturing capabilities to this effort, with the ability and experience to quickly scale, manufacture and distribute large quantities of vaccine at high quality, leveraging multiple sites in the US and Europe, and complementing the mRNA manufacturing expertise of BioNTech, gained over almost a decade."
Distribution mechanisms in place
The vaccine requires ultra-low temperatures for storage and distribution. Pfizer, however, emphasises its 'vast experience and expertise' in cold-chain shipping and says it has an established infrastructure for distributing the vaccine worldwide. This includes distribution hubs that can store vaccine doses for up to six months.
The company has developed special temperature-controlled shippers for the vaccine, which can maintain recommended storage conditions (-70°C ±10°C) for up to 15 days. These contain GPS-enabled thermal sensors to track the location and temperature of each vaccine shipment. Once thawed, the vaccine vial can be stored for up to five days at standard refrigeration (2 - 8oC) conditions.
"Based on our collective experience, we believe in our capability to distribute the vaccine globally upon approval or authorization," say the companies.
Pfizer and BioNTech's COVID-19 vaccine candidate: timeline at a glance
The vaccine, BNT162b2, is a nucleoside-modified messenger RNA candidate.
March 17: Pfizer and BioNTech announce they will co-develop a potential COVID-19 vaccine, using BioNTech’s mRNA-based vaccine candidate BNT162. The project starts with four potential vaccines: building on a 2018 mRNA vaccine partnership for influenza.
July 13: BNT162b2 is granted FDA fast track designation (along with BNT162b1)
July 27: BNT162b2 is selected as the lead mRNA vaccine candidate, which starts Phase 2/3 safety and efficacy trials
Sept 12: Amended protocol submitted to the FDA to expand enrolment of Phase 3 trial to up to 44,000 participants. The Phase 3 trial is carried out at more than 120 clinical sites across the US, Brazil, South Africa and Argentina.
Sept 18: Pfizer makes its Phase 3 study protocol available to all
Oct 6: Pfizer and BioNTech initiate rolling submission to European Medicines Agency
November 18: Phase 3 study concluded with 170 confirmed COVID-19 cases in the 43,000 strong trial. The companies report 95% efficacy for the vaccine candidate.
November 20: Request for EUA submitted to the FDA.
