In a leap forward, the FDA fully approved Pfizer Covid-19, the first vaccine for the coronavirus to meet the FDA’s gold standard for safety, effectiveness and manufacturing quality
In its announcement today, the FDA said the Pfizer/BioNTech vaccine would be marketed as Comirnaty and was authorized for emergency use for individuals from the age of 12 years and up.
Approximately 92 million individuals out of 170 million vaccinated people in the United States have received the Pfizer/BioNTech vaccine. Just days after the Biden administration announced that it would offer booster doses to vaccinated adults starting in September, the FDA has fully approved the Pfizer vaccine.
FDA Acting Commissioner Dr. Janet Woodcock said the approval of the vaccine was a "a pivotal moment" for the United States' fight against the coronavirus. Healthcare providers can continue to existing vaccine supplies they have as the FDA approved vaccine and the EUA authorized vaccine have the same formulation.
U.S. health officials including the U.S. Surgeon General Dr. Vivek Murthy are hopeful that the FDA clearance will pave the way for unvaccinated people to get vaccinated.
“For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans.”
Pfizer’s Work Behind the Scenes
Initially vaccine makers applied for emergency use authorizations (EUA) to get vaccines out to the public due to the gravity of the situation, the emergency of the pandemic and the speed at which the coronavirus was impacting people all over the country and the world. This helped in getting the vaccine out to citizens right away, while Pfizer worked on getting its vaccine fully approved by the FDA.
The FDA fast tracked pharmaceutical company Pfizer’s vaccine in July of this year, working around the clock to ensure that the vaccine was effective. Using real-world data pulled from hundreds of millions of people globally, the FDA also inspected manufacturing facilities. The FDA’s approval process was significantly faster than normal, completed in 97 days.
Moderna has also applied for full approval of its Covid-19 vaccine. Johnson & Johnson has not yet filed an application for FDA approval.
FDA Approval Can Help Overcome Hesitancy in the Unvaccinated
With FDA approval, the vaccines are more likely to gain acceptance in the unvaccinated. A recent Kaiser Family Foundation survey of US adults in July of this year showed that as high as 33% of Americans surveyed were not vaccinated and were reluctant because the vaccine was too new, not sufficiently tested and unknown. Some individuals surveyed said they would not take the vaccine unless it was required.
Some employers including United Airlines, Walmart, Facebook, Google, Disney and Microsoft have announced their plans for requiring vaccines for employees. The Pentagon also plans to make the vaccine mandatory for all active duty members by mid September.
This will impact requirements in educational settings, which has been previously resisted.
What about kids?
Currently, the Pfizer vaccine is available only for individuals aged 12 and older.
Five routine childhood vaccines are required throughout the country to date pre-coronavirus. Theses vaccines are for diphtheria, pertussis, and tetanus or DTaP, chickenpox, poliio and MMR. All of these vaccines are FDA approved.
Pfizer will have trial data for children aged 5 to 11 by the end of September and can then apply for a vaccine for children under the age of 12, and then will be working on the next set for children of aged 2 to 5. Both Moderna and Johnson & Johnson are also working on studies in children for their vaccines.
The FDA reiterated that the vaccine did not apply to children under the age of 12 asa they did not have sufficient data and had not approved the existing vaccine for use in children under the age of 12.
