Pfizer and Germany’s BioNTech has together reached an agreement with the UK 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.
“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,” said Albert Bourla, Chairman and CEO of Pfizer.
“We would like to thank the U.K. government for its commitment and support in helping to protect the people of the United Kingdom from this deadly virus.”
Alok Sharma, the UK Secretary of State for Business, Energy and Industrial Strategy, said: “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.”
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/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 July 1st, Pfizer and BioNTech announced preliminary data from BNT162b1, the most advanced of the four mRNA formulations.
The early data demonstrates that BNT162b1 is able to produce neutralizing antibodies in humans at or above the levels observed in the plasma from patients who have recovered from COVID-19, and 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.
If the ongoing studies are successful, Pfizer and BioNTech expect to be ready 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.