The FDA fully approved the Pfizer-BioNTech COVID-19 vaccine for people 16 years old and older on Aug. 23.
Prior to the full approval, the Pfizer vaccine was granted Emergency Use Authorization, followed by the Moderna and Johnson & Johnson vaccines. The EUA will remain in place for individuals 12 through 15 years old, which was permitted to the Pfizer vaccine back in May. While interested in extending the authorization to those under 12, the FDA is unable to give a timeline for the approval of vaccines for children under 12.
The EUA will also stay in place for booster shots given to certain immunocompromised people.
The FDA required six months of follow-up data to fully approve Pfizer’s vaccine, unlike the two months needed for the EUA. Gaining full approval also included visits to manufacturing plants by FDA inspectors and a review of the production process to guarantee safe conditions. Vaccines usually undergo more critical inspection than other medical products.
Now with the FDA’s strongest backing, those hesitant to take the vaccine may feel motivated to do so.
A poll conducted in June by the Kaiser Family Foundation found that 31 percent of unvaccinated Americans would be more likely to get vaccinated if one vaccine received full approval from the FDA. Albert Bourla, CEO of Pfizer, said he hopes the full approval would increase trust in the vaccine.
Other vaccines like Moderna and J&J are seeking FDA approval by the end of the year. Moderna applied for full approval back in June while also applying for EUA for those ages 12 to 17. J&J said they could apply for full approval later in the year.
Full approval of COVID-19 vaccines could make vaccine mandates easier to implement. After the FDA’s announcement, the Pentagon said it would move forward with plans to mandate COVID vaccines for active-duty troops. New York City now requires vaccinations for all educators for the start of the school year. Private companies like Chevron, CVS Health, and Disney World announced their plans as well to mandate vaccines for some employees.
In Massachusetts, Governor Charlie Baker issued a vaccine mandate for 42,000 executive department employees and 2,000 contractors for executive department agencies. The mandate will be enforced regardless of if an employee is working in-person or remotely. Employees will be required to submit proof of vaccination by mid-October. Failure to comply without a medical or religious exemption could result in termination. The vaccine mandate will include booster shots when they become available.
Schools within the University of Massachusetts system are leaning towards enacting a vaccine mandate for employees. Other schools in Boston, such as Boston University, Northeastern University, and Boston College, have implemented vaccine mandates for both staff and students.
President Biden said in his remarks after the approval that he hopes businesses boost their vaccine requirements. He also urged people to get vaccinated if they have not already.
“Let me say this loudly and clearly: If you’re one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened,” said Biden. “The moment you’ve been waiting for is here. It’s time for you to go get your vaccination. Get it today.”