US drug maker Pfizer and German biotechnology BioNTech announced that they started their late human study on Monday for a potential coronavirus vaccine, as pharmaceutical companies are battling for regulatory approval before the end of the year.
Pfizer shares rose more than 3% on Monday after close of trading. BioNTech grew by more than 2%.
The study will include up to 30,000 participants between the ages of 18 and 85 at 120 locations worldwide, including 39 states, the companies said. If successful, they are expected to submit it for final regulatory review in October. They plan to deliver up to 100 million cans by the end of 2020 and around 1.3 billion cans by the end of 2021.
The decision to start the study reflects "our primary goal is to launch a well-tolerated, highly effective vaccine as soon as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio." Ugur Sahin, CEO of BioNTech, said in a press release. "Many steps have been taken towards this important milestone and we would like to thank everyone involved for their extraordinary commitment."
The company's experimental vaccine uses messenger ribonucleic acid or mRNA molecules to elicit an immune response to fight the virus. Scientists hope that mRNA, which passes on genetic instructions from DNA, can be used to train the immune system to recognize and destroy the virus.
Earlier this month, companies said that one of the four coronavirus vaccine candidates produced neutralizing antibodies in all participants who received two of the 10 or 30 microgram doses, which the researchers believe are necessary to build immunity to the virus.
Last week, the U.S. government announced that Pfizer and BioNTech would pay $ 1.95 billion to manufacture and deliver 100 million doses of their vaccine if it proved safe and effective. The contract was signed as part of Operation Warp Speed, the Trump administration's efforts to accelerate the development and production of vaccines and treatments to combat the corona virus.
Pfizer had already announced that it would be able to start the decisive late study of the vaccine this week.
Pfizer and BioNTech are among several companies that want to develop a vaccine against the virus that, according to Johns Hopkins University, infected more than 16 million people worldwide on Monday and killed at least 650,029 people. According to the World Health Organization, more than 150 vaccines are being developed worldwide, 25 of which have already been studied in humans.
The announcement of the two companies came on the same day when the biotech company Moderna, which is also developing a leading vaccine candidate, started to begin its late-stage coronavirus vaccine study. This study will also include 30,000 participants. The company said it is still on track to deliver between 500 million and 1 billion cans a year from next year.
Among other competitors are the pharmaceutical giants Johnson & Johnson and AstraZeneca.
J&J announced earlier this month that a late-stage human trial for a potential coronavirus vaccine is expected to begin early in late September. AstraZeneca, who works with Oxford University researchers, said they are recruiting in the UK, Brazil, and South Africa for their ongoing late-stage study of the vaccine.