Pfizer, BioNTech get vaccine 'fast track' from FDA
Pfizer Inc and partner BioNTech SE said on Monday two of their experimental coronavirus vaccines received 'fast track' designation from the U.S. Food and Drug Administration, speeding up the regulatory review process.
Jillian Kitchener has more.
Pfizer and its German partner BioNTech on Monday announced two of their experimental coronavirus vaccines received 'fast track' designation from the U.S. Food and Drug Administration.
...meaning the FDA may decide on an approval within six months.
If a vaccine candidate gets the green light, the companies said they expect to make up to 100 million doses by the end of this year.
The companies said the recent testing of an experimental vaccine on 24 healthy volunteers showed that after 28 days they had developed higher levels of COVID-19 antibodies than typically seen in infected people.
Upon regulatory approval, the companies expect to start a large trial with up to 30,000 participants… possibly later this month - paving the way toward a potential release of a vaccine.
The U.S. and other countries have poured billions into developing a safe and effective vaccine for COVID-19.
As of now - none are approved.