So far, it has shown encouraging preliminary results in a small group of patients and will enter the late-stage testing phase before August.
An agreement between the United States government and Pfizer and BioNTech will have the companies produce an initial 100 million doses of their COVID-19 vaccine candidate, with the potential for 500 million more.
The initial clinical supply of the vaccines are being made in Germany, but Pfizer and BioNTech plan to scale up production in the United States, including at its MI facilities.
The government pledged almost $2 billion to secure 100 million doses of the experimental drug, assuming the vaccine candidate clears the final stage of clinical trials and receives the required regulatory approvals.
BioNTech and Pfizer had said they anticipate they will initiate a massive trial with up to 30,000 participants later this month, given they are granted regulatory approval, sending the stocks higher in trading.
Pfizer's shares rose 4%, while BioNTech's US-listed shares were up about 6% before the bell.
Americans will be able to get a coronavirus vaccine for free under a deal with its makers, the companies say. Of those, at least a dozen are in clinical trials and several are approaching the last stage, which will be the largest.
However, Pfizer and BioNtech took a great measure to help the supply of vaccine all over the world with the help of COVAX facility, a mechanism established by Gavi - the vaccine alliance, the Coalition of Epidemic Preparedness innovation and WHO, to provide the government with access to a large portfolio of COVID-19 vaccine using digital technologies. Almost two dozen are in various stages of human testing around the world, with several entering final test to prove if they really work. And that's exactly what we want them to do in a vaccine, attack body cells that have been infected by the coronavirus.
Over 1.3 billion doses could be produced by the end of 2021.
Like Moderna, the BNT162 vaccine candidate is an mRNA vaccine. They hope to begin the regulatory approval process to get a vaccine licensed by the Food and Drug Administration as early as October. "We're very close to the vaccine. We are very optimistic", he said. A European-led fundraising effort in May brought $8 billion in pledges from the world's governments, philanthropists and leaders for coronavirus vaccine research, even with the United States sitting out the conference.
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