Under an agreement with Pfizer Inc. and BioNTech SE, the United Kingdom will receive 30 million doses of their BNT162 mRNA-based vaccine candidate for SARS-CoV-2, expected to be delivered over the next year.
While the drug — four vaccine candidates operating under the broader BNT162 category — is currently under development, and still subject to regulatory approval, preliminary data from phase 1/2 studies in the United States and Germany, along with animal immunogenicity studies, have shown promising results. The companies intend to choose a lead candidate and dose level from the drug’s incarnations based on the results of those studies and utilize it in a global phase 2b/3 safety and efficacy study.
That trial should begin later this month.
“In the face of this global health crisis, Pfizer’s purpose – breakthroughs that change patients’ lives – has taken on an even greater urgency,” Albert Bourla, Chairman and CEO of Pfizer, said. “Consequently, we’re harnessing our scientific expertise, and 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. 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.”
The companies intend to seek regulatory review as early as October 2020 and to begin global manufacturing of up to 100 million doses by year’s year. That could scale up to more than 1.3 billion doses by the end of 2021.
“Finding a vaccine is one way that we will end the pandemic and return to normal life,” Alok Sharma, the U.K.’s Secretary of State for Business, Energy and Industrial Strategy, said. “That is why we are making sure people most at risk in the U.K. 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 spawned from BioNTech’s proprietary mRNA technology, and BioNTech remains the market authorization holder worldwide. Pfizer is assisting with its global vaccine development and manufacturing capabilities.