Story at a glance
- The vaccine candidates, BNT162b1 and BNT162b2, are the two most advanced experimental vaccines of at least four being assessed by Pfizer and BioNTech in ongoing trials.
- Testing of two dosages of BNT162b1 on 24 healthy volunteers showed that after 28 days they had developed higher levels of COVID-19 antibodies than typically seen in infected people.
- The companies expect to kick off a trial with up to 30,000 participants as soon as this month upon regulatory approval.
U.S. pharmaceutical giant Pfizer and German biotech firm BioNTech announced Monday they received “fast track” designation from the Food and Drug Administration (FDA) for two COVID-19 vaccine candidates.
The vaccine candidates, BNT162b1 and BNT162b2, jointly developed by the companies are the two most advanced experimental vaccines of at least four being assessed by Pfizer and BioNTech in ongoing trials in the U.S. and Germany. The designation from the FDA is used to speed up the development and review of potential drugs and vaccines.
“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-Cov-2,” Pfizer Senior Vice President Peter Honig said in a statement.
The two companies said earlier this month that the testing of two dosages of BNT162b1 on 24 healthy volunteers found that after 28 days they developed higher levels of COVID-19 antibodies than normally seen in infected people. They expect to kick off a trial with up to 30,000 participants as soon as this month upon regulatory approval.
The CEO of BioNTech told the Wall Street Journal last week he expects the coronavirus vaccine the company is developing to be ready for approval by December, but said several hundred million doses could be produced before approval, and up to 1.2 billion by the end of 2021.
“I assume that we will only be done with this virus when more than 90 percent of the global population will get immunity, either through infection or through a vaccine,” BioNTech CEO Ugur Sahin told the Journal.
Meanwhile, Moderna is set to begin the phase-three testing stage this month of a vaccine, while AstraZeneca PLC will enter phase three trials in August.
Billions of dollars have been poured into the production of a vaccine against the coronavirus as it continues to spread throughout the world. More than 12.9 million cases have been confirmed globally with more than 570,000 deaths.
The U.S. leads the world with more than 3.3 million cases and more than 135,000 deaths.