Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and more than 1.3 billion doses by the end of 2021.
Pfizer and BioNTech announced an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, currently in development, subject to clinical success and regulatory approval. Financial details of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses.
“In the face of this global health crisis, Pfizer’s purpose – breakthroughs that change patients’ lives – has taken on even greater urgency. Consequently, we’re harnessing our scientific expertise. We’re marshaling our manufacturing resources to ensure that the vaccine would be available as soon as possible if our clinical trials prove successful and regulatory approval is granted,” said Albert Bourla, chairman and chief executive officer, Pfizer. “This agreement is a testament to our shared goal to have millions of doses of a vaccine against Covid-19 available before the end of the year. We want to thank the UK government for its commitment and support in protecting the people of the United Kingdom from this deadly virus.”
“I would like to thank the UK government for its support and putting trust in us. This agreement is part of our commitment to address the pandemic by creating a global supply. We are in advanced discussions with multiple other government bodies and hope to announce additional supply agreements soon. Our goal remains to bring a safe and effective Covid-19 vaccine to many people worldwide, as quickly as we can,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.
“Finding a vaccine is one way that we will end the pandemic and return to normal life. That is why we are making sure people most at risk in the UK are vaccinated against Covid-19 as soon as a safe vaccine becomes available, by partnering with the world’s foremost pharmaceutical and vaccine companies,” said Alok Sharma, the UK’s secretary of State for Business, Energy and Industrial Strategy.
The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world. BioNTech is the market authorization holder worldwide and will hold all trademarks for the potential product. Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.
The Pfizer and BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. On 1 July 2020, Pfizer and BioNTech announced preliminary data from BNT162b1, the most advanced of the four mRNA formulations. The early data demonstrate that BNT162b1 can produce neutralizing antibodies in humans at or above the levels observed in the plasma from patients who have recovered from Covid-19. This was shown at relatively low dose levels. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported.
Two of the companies’ four investigational vaccine candidates (BNT162b1 and BNT162b2) received Fast Track designation from the US Food and Drug Administration (FDA). This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany and animal immunogenicity studies. Further data from the ongoing Phase 1/2 clinical trials of the four vaccine candidates will enable selecting a lead candidate and dose level for an anticipated large, global Phase 2b/3 safety and efficacy study that may begin as early as later this month, pending regulatory approval.
If the ongoing studies are successful, Pfizer and BioNTech expect to seek Conditional Marketing Authorization or some form of regulatory approval as early as October 2020. The companies currently expect to manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021, subject to final dose selection from the clinical trial.
In addition to the engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that aims to provide governments with early access to a large portfolio of Covid-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers across the world.