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Pfizer has begun giving Americans its experimental coronavirus vaccines for their clinical trial in collaboration with BioNTech SE, the pharmaceutical giant announced Tuesday.
The US drug maker USA And the German partner said that if the vaccine proves to be safe and effective in trials, it could be ready for wide distribution in the US. USA By the end of the year, which would reduce the typical vaccine development period by several years.
The vaccine, which uses messenger RNA (mRNA) technology, has the potential to be among the first vaccines against the virus that has infected more than 1 million people in the United States and killed about 68,000.
Pfizer joined the race to be late for the coronavirus vaccine, but hopes that with its trial of 360 healthy volunteers, it can accelerate and have more than 20 million doses ready by the end of the year, if the vaccine is safe.
Pfizer announced Tuesday that it began injecting the first of 360 healthy American volunteers with its experimental coronavirus vaccines (file)
Pfizer joined the vaccine race late, but has already developed four different candidate vaccines
There are currently no approved treatments or vaccines for the new coronavirus, although some medications are being used in patients under an emergency use authorization.
The United States study is part of a larger global program already underway in Germany, where BioNTech is located. Dosing there started last month.
Moderna Inc is using similar technology for the development of its vaccine together with the United States government. The phase I trial of that vaccine candidate has also begun, with intermediate-stage trials planned in the current quarter.
Pfizer said last week that it expects to receive emergency authorization from the United States Food and Drug Administration (FDA) in early October, and that it could distribute up to 20 million doses by the end of 2020, with a view to producing hundreds of million doses next year.
“Even going from a few million to 20 million will allow you to protect the epicenters of the virus and then drive the virus out of our society as we grow to hundreds of millions,” Pfizer research chief Mikael Dolsten told Reuters in an interview. . .
The use of synthetic mRNA technology may allow the vaccine to be developed and manufactured faster than traditional vaccines, the companies said.
Pfizer said last week that it expects vaccine safety data to be available in late May.
The trial will initially aim to test different dosing regimens of four potential vaccine candidates on about 360 healthy volunteers divided into a younger cohort and a group of older people.
The trial will be expanded to more subjects after researchers determine which compounds and dosing regimens are most effective, said Kirsten Lyke, director of the Center for Vaccine Development and Global Health at the University of Maryland, which is participating in the trial.
Most experts have estimated that the world will not have a COVID-19 vaccine until next year, but developing and distributing one will be the key to ending the pandemic.
Doses have already been administered to some volunteers at NYU Grossman School of Medicine and the University of Maryland School of Medicine.
Pfizer plans to expand the trial to sites across the United States in early July and can ultimately enroll more than 8,000 participants, a company spokeswoman said.
If successful, the US clinical trial. USA It would be one of the fastest progressions of a vaccine from initial studies to regulatory approval, compressing a development process that often takes a decade to just over nine months.
“This is the equivalent of doing phases one, two, and three of a typical clinical trial, but all compressed into the May-October time frame,” said Lyke.
BioNTech is producing the vaccine for testing at its European manufacturing facilities.
Pfizer is investing in developing its own manufacturing capacity for the vaccine, and is preparing sites in Massachusetts, Michigan, Missouri, and Belgium to start producing it.
Both companies will jointly market the vaccine, if approved. (Report by Carl O’Donnell and Michael Erman in New York; Bill Berkrot edition)
