Pfizer and BioNTech executed an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed (OWS) program goal to begin delivering 300 million doses of COVID-19 vaccine in 2021.
Under the agreement, the U.S. government will receive 100 million doses of the COVID-19 vaccine candidate for $1.95 Billion and can acquire up to 500 million additional doses, after Pfizer successfully manufactures and obtains approval or emergency use authorization from U.S. Food and Drug Administration (FDA). All Americans will receive the vaccine for free.
Recently, four investigational vaccine candidates of the companies’ received Fast Track approval from the U.S. Food and Drug Administration (FDA).
Depending on the success of the trials, Pfizer and BioNTech will begin an anticipated Phase 2b/3 safety and efficacy trial later this month, and will seek Emergency Use Authorization as early as October 2020. The companies are expected to manufacture up to 100 million doses globally by the end of 2020 and more than 1.3 billion doses by the end of 2021.
Earlier, biotechnology company Novavax has also been selected to be a part of the U.S. government Operation Warp Speed (OWS) program to deliver a vaccine for COVID-19 in 2021. The Maryland-based biotechnology company, Novavax has been selected to be a part of the U.S. government program, Operation Warp Speed (OWS) that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021.
The company that develops next-generation vaccines for serious infectious diseases, is in its late-stage phase-3 clinical trial and will get a funding of $1.6 Billion from the federal government.
As per the terms of the agreement, Novavax has to show that it can rapidly stand up large-scale manufacturing and transition into ongoing production, including the capability to stock up and distribute large quantities of vaccine NVX-CoV2373 when needed. The funding will also be used for late-stage clinical studies necessary to determine the safety and efficacy of the vaccine, including Phase 3 clinical trials with up to 30,000 subjects beginning in the fall of 2020.
Depending on the success of the candidate in clinical trials, Novavax will have to manufacture 100 million doses for the American people.
Based on the success of the candidate, there can be a follow-on agreement with the U.S. government for additional production and procurement to support OWS’s vaccine production goal.