Pfizer has begun dosing Americans with its experimental coronavirus vaccines for its clinical trial in collaboration with BioNTech SE, the...
Pfizer has begun dosing Americans with its experimental coronavirus vaccines for its clinical trial in collaboration with BioNTech SE, the pharmaceutical giant announced Tuesday.
The US drugmaker and German partner said if the vaccine proves to be safe and effective in trials, it could potentially be ready for wide US distribution by the end of the year, shaving several years off the typical vaccine development timeline.
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 some 68,000.
Pfizer joined the race to make a coronavirus vaccine late, but hopes that with its trial in 360 healthy volunteers, it can speed ahead and have more than 20 million doses ready by year-end - if the shot proves safe.
Pfizer announced Tuesday that its begun 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 shots
There are currently no approved treatments or vaccines for the new coronavirus, though some drugs are being used on patients under an emergency use authorization.
The US study is part of a broader, global program already underway in Germany, where BioNTech is based. Dosing there began last month.
Pfizer said last week it hopes to receive emergency authorization from the US Food and Drug Administration (FDA) as early as October, and could distribute up to 20 million doses by the end of 2020, with an eye toward producing hundreds of millions of doses next year.Moderna Inc is using similar technology for its vaccine being developed along with the US government. Phase I testing of that vaccine candidate has also begun, with mid-stage trials planned in the current quarter.
'Even going from a few million to 20 million will allow you to protect the epicenters of the virus, and then drive out the virus from our society as we ramp up to hundreds of millions,' Pfizer research chief Mikael Dolsten told Reuters in an interview.
Using synthetic mRNA technology can enable the vaccine to be developed and manufactured more quickly than traditional vaccines, the companies said.
Pfizer said last week it expects to make safety data on the vaccine available by late May.
The trial will initially aim to test different dosing regimens of four potential vaccine candidates on around 360 healthy volunteers divided into a younger cohort and a group of seniors.
The trial will expand to more subjects after researchers determine which compounds and dosing regimens are most effective, said Kirsten Lyke, a director at the University of Maryland's Center for Vaccine Development and Global Health, which is participating in the trial.
Most experts have estimated the world won't 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 may ultimately enroll more than 8,000 participants, a company spokeswoman said.
If successful, the U.S. clinical trial would be one of the fastest ever progressions of a vaccine from early stage studies to regulatory approval, compressing a development process that often takes as much as 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 through October time frame,' Lyke said.
BioNTech is producing the vaccine for the trials in 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 begin producing it.
Both companies will jointly commercialize the vaccine, if approved. (Reporting by Carl O'Donnell and Michael Erman in New York; editing by Bill Berkrot)
No comments