Pfizer (NYSE: PFE) and BioNtech (NASDAQ: BNTX) They are jointly developing four candidate mRNA-based vaccines for the SARS-CoV-2 coronavirus. And on Wednesday morning, the companies announced that they had signed an agreement with the US government’s Health and Human Services (HHS) and Defense departments to provide them with at least 100 million doses of any candidate they obtain. regulatory approval or authorization of emergency use, assuming one does.
Washington will pay partners $ 1.95 billion upon delivery of those 100 million doses. The agreement also gives the government the option to buy an additional 500 million doses. Note that on Monday, the two companies announced a similar (albeit smaller) deal with the UK government.
Pfizer and BioNtech are currently running a phase 1/2 clinical trial for coronavirus vaccine candidates in the BNT162 program, and recently published positive study data for BNT162b1, the most advanced of the group. In addition, healthcare companies plan to start a phase 2b / 3 clinical trial by the end of July, pending regulatory approval. That study is expected to enroll up to 30,000 healthy participants, and will test the safety and efficacy of the chosen vaccine candidate. It is also worth noting that the Food and Drug Administration has granted fast track designation to two of the candidates in the program, BNT162b1 and BNT162b2.
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Pfizer and BioNtech are not the only ones trying to develop COVID-19 vaccines based on mRNA: Modern (NASDAQ: MRNA) It is also, and it is also very advanced in the development process. That biotech company plans to start a phase 3 clinical trial on July 27 for its lead candidate, mRNA-1273. The pivotal study will enroll about 30,000 participants, and its primary goal will be “prevention of symptomatic COVID-19 disease.” As global efforts to find a vaccine heat up, the next few months will be critical for Pfizer and BioNtech.
