The trial will include up to 30,000 participants between the ages of 18 and 85 at 120 sites around the world, including 39 U.S. states, the companies said. If successful, they plan to submit it for final regulatory review as early as October. They plan to deliver up to 100 million doses by the end of 2020 and around 1.3 billion doses by the end of 2021.
The decision to start the trial reflects “our primary goal of bringing a well-tolerated and highly effective vaccine to market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a COVID vaccine portfolio. -19 differentiated, ”BioNTech CEO Ugur Sahin said in a statement. “Many steps have been taken towards this important milestone and we would like to thank everyone involved for their extraordinary commitment. ”
The companies’ experimental vaccine uses messenger ribonucleic acid, or mRNA molecules, to elicit an immune response to fight the virus. Scientists hope that mRNA, which transmits DNA’s genetic instructions, can be used to train the immune system to recognize and destroy the virus.
Earlier this month, the companies said one of its four coronavirus vaccine candidates produced neutralizing antibodies, which researchers believe are necessary to boost immunity to the virus, in all participants who received two of the doses of 10 or 30 micrograms.
Last week, the U.S. government announced it would pay Pfizer and BioNTech $ 1.95 billion to produce and deliver 100 million doses of their vaccine, if it is found to be safe and effective. The deal was signed as part of Operation Warp Speed, the Trump administration’s effort to accelerate the development and production of vaccines and treatments to fight the coronavirus.
Pfizer has previously announced that it hopes to begin its pivotal late-stage vaccine trial as early as this week.
Pfizer and BioNTech are among several companies in the race to develop a vaccine to fight the virus, which has infected more than 16 million people worldwide and killed at least 650,029 on Monday, according to data compiled by Johns Hopkins University . There are more than 150 vaccines in development around the world, according to the World Health Organization, 25 of which are already in human trials.
The two companies’ announcement came on the same day, biotech firm Moderna, which is also developing a leading vaccine candidate, said it had started its late-stage coronavirus vaccine trial. This trial will also include 30,000 participants. The company said it remains on track to deliver between 500 million and 1 billion doses per year starting next year.
Other competitors include pharmaceutical giants Johnson & Johnson and AstraZeneca.
J&J said earlier this month that it plans to start an advanced human trial for a potential coronavirus vaccine in late September, ahead of schedule. AstraZeneca, working with researchers at the University of Oxford, said they were recruiting for their ongoing late-stage vaccine trial in the UK, Brazil and South Africa.