No financial terms were disclosed, but they are apparently based on delivery time and dose volume.
New York-based Pfizer and Mainz, Germany-based BioNTech, which are developing BNT162, an mRNA-based vaccine against COVID-19, signed a deal with the United Kingdom to manufacture 30 million doses.
No financial terms were disclosed, but they are apparently based on delivery time and dose volume. The BNT162 vaccine is based on BioNTech’s mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities.
“In the face of this global health crisis, Pfizer’s purpose—breakthroughs that change patients’ lives—has taken on an even greater urgency,” said Albert Bourla, chairman and chief executive officer of Pfizer. “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.”
A week ago, on July 13, the two companies reported that two of their four vaccine candidates received Fast Track designation from the U.S. Food and Drug Administration (FDA). The two are BNT162b1 and BNT162b2 and are both currently in Phase I/II clinical trials in the U.S. and Germany. Each of the four experimental vaccines are a unique combination of messenger RNA format and target antigen. The two Fast-Tracked are nucleoside modified RNAs formulated in lipid nanoparticles, which basically means they are engineered pieces of mRNA that are contained in a fat particle that is used as a delivery vector. BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen.
The two companies also announced today initial data from the German Phase I/II trial. It is published on the online preprint server at medRxiv and is currently being peer-reviewed for possible publication. This data is on BNT1621b1. The companies indicate the preliminary data supported and expands on early results from the recently disclosed early data from the US trial of BNT162b1.
The vaccine produced high, dose level-dependent neutralizing antibodies against SARS-CoV-2 and RBD-binding IgG concentrations after the second date. The titers of neutralizing antibodies were comparable to a group of convalescent antibody titers from patients who recovered from COVID-19. They companies stated, “Furthermore, sera of vaccinated subjects displayed broadly neutralizing activity in pseudovirus neutralization assays across a panel of sixteen SARS-CoV-2 RBD variants represented in publicly available SARS-CoV-2 sequences and against the newly dominant D614G strain.”
They also showed induction of high levels of CD4+ and CD8+ T cell responses. They found the strength of the T cell responses varied between patients and there was no clear dose level dependence between the level of doses, suggesting that that stimulation and robust expansion of T cells might be stimulated at low mRNA dose levels.
“It is encouraging that the data on BNT162b1 from the German study cohort are very much in line with what we have seen in the U.S. study cohort,” said Ozlem Tureci, chief medical officer and co-founder of BioNTech. “The preliminary data indicate that our mRNA-based vaccine was able to stimulate antibody as well as T cell responses at remarkably low dose levels. We believe both may play an important role in achieving effective clearance of a pathogen such as SARS-CoV-2.”
Based on data so far, Pfizer and BioNTech expect to submit for Conditional Marketing Authorization or some other type of regulatory approval as early as October 2020. They believe they can manufacture up to 100 million doses by the end of the year and potentially more than 1.3 billion by the end of 2021.
“I would like to thank the UK government for its support and putting trust in us,” said Ugur Sahin, chief executive officer and co-founder of BioNTech. “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 around the world, as quickly as we can.”
