but it was approved.
What’s the difference between emergency authorization and full approval?
Way back in January 2020, not knowing the full extent of the threat posed by Covid-19, the Health and Human Services Secretary declared a U.S. public health emergency. This action gave special power to the FDA to authorize medicines, vaccines and tests for use by the American public to fight the virus in an expedited fashion without going through the lengthy full approval process. The amount of data required for what’s known as an emergency use authorization, or an EUA, is at the discretion of the FDA.
The main thing the FDA considers with emergency authorization is, based on the scientific evidence available, that “it’s reasonable to believe that the product may be effective and that the known and potential benefit outweigh the known and potential risks,” explains Nicholson Price, a professor of health law at the University of Michigan Law School in Ann Arbor. The medicine or vaccine also needs to be unique, there can’t be an existing alternative that’s already been approved. For vaccines, manufacturers were required to provide safety data that was “much closer to what a company would need for full approval for the vaccine,” he says. For emergency authorization, the FDA required two months of safety data versus six months for full approval, he explains.
Pfizer/BioNTech received emergency use authorization for its vaccine in December 2020, followed by Moderna a week later and Johnson & Jonson in February 2021. “It's close to incontestable that the EUA process made a huge positive difference in combating COVID-19 at least with respect to vaccines,” says Price. It meant that people could start getting shots in December rather than waiting much longer for full approval. “Those months made a huge difference.”
2 major points to consider,
1) The Coronavirus was way overhyped as a danger to young and skinny people and we now know the FDA and CDC were very wrong in their evaluation.
2) The effectiveness of the vaccine was also way overhyped even going so far as a claim that it prevented the spread of the virus. After millions of vaccinated Americans contracted Covid and every mutated strain, it became very clear the extent of that overhyping.
