FDA Gives Full Approval To Pfizer Coronavirus Vaccine
The Pfizer-BioNTech coronavirus vaccine today was given full approval by the U.S. Food & Drug Administration (FDA), a move that public health officials are hoping will push those who are undecided about getting vaccinated to take a shot in the arm for the greater good.
It’s also expected that employers, universities and other schools and local governments that already have not done so will mandate vaccines amidst the rampaging surge of the delta variant in states with relatively low vaccination rates.
The FDA’s action is the first licensing of a vaccine for the coronavirus, which has killed more than 600,000 Americans – and over 4.4 million people worldwide – since the beginning of 2020.
For weeks critics had demanded that the FDA move faster to approve the vaccine. They said that the millions of inoculations administered since late last year under an Emergency Use Authorization (EUA) had demonstrated the shots’ safety and effectiveness. “It will provide an additional nudge but not make a huge difference,” said Jesse Goodman, a former FDA chief scientist who is a professor of medicine and infectious diseases at Georgetown University. A recent surge in vaccinations, he said, appears to be driven by rising concerns about the delta variant.
Others predict the full licensure will lead to more vaccine requirements by colleges, workplaces, concert venues and movie theaters.
Regulators are still reviewing Moderna’s application for full approval of its vaccine. That decision could take several weeks. Johnson & Johnson is expected to apply soon for full approval.