The U.S. government originally ordered 100 million doses for $1.95 billion with an agreement to buy up to 500 million more doses. This is part of the U.S. Department of Health and Human Services and the Department of Defense’s Operation Warp Speed program. The program’s goal is to begin delivering 300 million doses of a COVID-19 vaccine in early 2021. But first those vaccines have to be proven to be safe and effective.
Two weeks 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 reported a week later 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. The 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.
The U.S. government will pay $1.95 billion once it receives the first 100 million doses after the FDA either gives approval or Emergency Use Authorization. The U.S. public will receive the vaccine free of charge.
“We’ve been committed to making the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help bring an end to this global health crisis,” said Albert Bourla, Pfizer chairman and chief executive officer. “We made the early decision to begin clinical work and large-scale manufacturing at our own risk to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted. We are honored to be a part of this effort to provide Americans access to protection from this deadly virus.”
If the ongoing clinical trials are a success, the two companies believe they will be prepared to file for Emergency Use Authorization or some other form of regulatory approval as early as October 2020. They expect to manufacture up to 100 million doses by the end of 2020 and possibly more than 1.3 billion by the end of 2021.
“This agreement is one of many steps towards providing global access to safe and efficacious vaccines for COVID-19,” said Ugur Sahin, chief executive officer and co-founder of BioNTech. “We are also in advanced discussions with multiple other government bodies and we 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.”