ROCHESTER, N.Y. (WROC) – The Pfizer vaccine has surpassed all safety hurdles and regulations by the U.S Food and Drug Administration officially becoming fully approved for those 16 and up.
This extensive process began back in May when Pfizer submitted their application prompting the FDA to send personnel all over the world to inspect where and how Pfizer was making the vaccine, plus analyze all their data for determination of its safety and effectiveness.
Already in the arms of more than 92 million Americans, the FDA believes the data is there qualifying Pfizer to receive its full approval putting it in the same league other longtime vaccines are.
“When you’ve demonstrated 95% efficacy against all infection and then against 100% severe disease in 2.5 months you have data that says let’s move this forward,” Dr. Ed Walsh of Rochester Regional said.
The FDA analyzed effectiveness data from 20,000 vaccine recipients 16 and up and its safety in another 22,000 people who received the vaccine. The trial found the Pfizer doses were 91% effective in preventing the Coronavirus.
“We have the same individuals who are enrolled in the early studies, and we’ve got more information about them and how they’ve done,” Monroe County Health Director Dr. Michael Mendoza said. “We’ve come to the same conclusion that it is safe and effective as any other medication or vaccine that was the same level as FDA approval.”
Studies earlier this summer from the Kaiser Family Foundation showed 31% of unvaccinated adults in the U.S would be more likely to get the shot if the FDA granted full approval. Doctors around Rochester hope this announcement will be the tipping point.
“People are just nervous, and this is the reassurance that they need,” Dr. Ann Falsey with Rochester Regional told us. “And I hope it goes a long way.”
“There is a substantial number of people who have been hesitant that will step forward now that it receives full approval” Infectious Disease Specialist Dr. Walsh added. “But we will have to wait and see if that happens.”
Full FDA approval also gives employers both in the private and public sector more power to require their staff and customers to be fully vaccinated to do business on their property.
Moderna says they are also in the final steps for submitting their applications for full FDA approval which should be done by the end of the month. Johnson and Johnson hope to have theirs in before the end of the year.