On August 23, the US Food and Drug Administration granted full approval for Pfizer/BioNTech’s Covid-19 vaccine for people ages 16 and up.
Previously, all three Covid-19 vaccines used in the US — from Pfizer/BioNTech, Moderna and Johnson & Johnson — were given emergency use authorization (EUA). The FDA had reviewed at least three months of safety and efficacy data and said the benefits of administering the vaccines outweighed the risks — especially given the public health emergency caused by Covid-19.
But an EUA status does not mean a vaccine is less safe or effective than a vaccine that has been fully approved.
“Frankly, the only real difference was in length of follow-up,” said Dr. Paul Offit, a member of the FDA’s Vaccines and Related Biological Products Advisory Committee.
There are two key differences between emergency authorization and full approval, Offit said. The first involves time, and the second involves a very detailed protocol for future production.
“Full approval, for all practical purposes, just means three more months of efficacy data,” Offit said.
When the FDA gave emergency use authorization for the Pfizer/BioNTech and Moderna vaccines, “we could say they’re 95% effective for three months, because that’s how much data we had,” Offit said.
“The FDA, for it to move to full approval — licensure — wants three more months,” or at least six months of data, he said.
In the history of vaccines, the most severe side effects have all been caught within two months of a person getting vaccinated, Offit and other health experts said.
After that, “your body has made the antibodies. It has done what it’s supposed to do,” said Dr. Julia Garcia-Diaz, director of clinical infectious diseases research at Ochsner Health in New Orleans. Any problems outside that window are most likely “not related to the vaccine.”
Another reason why it takes a while to get full approval — or licensure — is because of a detailed validation process to help ensure future production stays precise and consistent.
When the FDA fully approves a vaccine, “they don’t just license the product … they also license the process,” Offit said.
“Because they want to make sure that every lot is consistently produced, they validate every aspect of the production. And they validate the building. So everything – the computers, the cleaning out of the vats, everything that’s done has to be validated.”
As part of the review for full approval, FDA experts have been poring through a massive amount of documents, running their own analyses, getting any clarification needed from vaccine companies and thoroughly inspecting the manufacturing process.
With full approval of the Pfizer/BioNTech vaccine for ages 16 and up, more workplaces will likely issue vaccine mandates to help prevent the spread of the Delta variant, US Surgeon General Dr. Vivek Murthy said.
More people might want to get vaccinated on their own, too. A recent study showed some vaccine-hesitant Americans would be more likely to get a Covid-19 vaccine if it were fully approved.
And with full approval, Pfizer/BioNTech are now allowed to market and advertise their vaccine, which has the brand name Comirnaty.
Source : https://www.cnn.com/interactive/2020/health/coronavirus-questions-answers/632