The US Food and Drug Administration granted full approval this week for the Pfizer/BioNTech Covid-19 vaccine for people 16 years of age and older. This is the first of the COVID-19 vaccines to receive full approval from the FDA.
Full FDA approval is a standard process that usually requires at least six months of safety data. The Emergency Use Authorization (EUA) was given after two months of safety data in the setting of the global pandemic and public health emergency.
Full approval means the Pfizer vaccine now carries the FDA’s strongest endorsement of safety and effectiveness.
Due to the seriousness of the pandemic, COVID-19 vaccines were initially made available under EUA, which lets the FDA speed the availability of medical products to be used during emergencies.
Hundreds of millions of people around the world have now received the Pfizer vaccine, and there is significant evidence that the vaccine is safe and effective. The final stamp of approval came via the FDA on Monday.
For full approval, the FDA required six months of follow-up data from the initial clinical trial. FDA inspectors also visited the plants where the vaccines are made and reviewed each step of the production process for extra assurance that the shots are made under safe, sterile conditions.
Pfizer’s vaccine is now fully approved for people 16 years of age and older. Moderna’s COVID-19 vaccine is under review. Johnson & Johnson’s request for full approval for their COVID-19 vaccine has not yet been submitted to the FDA. These two other vaccines continue to remain available under the EUA.
The initial Pfizer studies were done in those 16 and above. That is the data that was submitted for full approval. The vaccine is authorized under the EUA for kids ages 12 to 15. There hasn’t been enough time for the vaccine in this age group to be evaluated for full approval. That said, the EUA was issued based on safety and efficacy data in the adolescent 12- to 15-year-old age group. Especially as kids are returning to school and COVID-19 cases are surging across the country, it’s really important to protect as many kids as possible who are eligible to be vaccinated.
Public health experts hope the change will convince more unvaccinated people to get the vaccine.
“Many individuals were awaiting full FDA approval of a COVID-19 vaccine in making their decision to receive it. Individuals who receive the vaccine are at decreased risk of COVID-19 illness, and significantly lower risk of serious illness and hospitalization, and the vaccines can reduce the spread of the virus to others, including those who are unable to be vaccinated at this time,” says Dr. David Banach, Infectious Diseases Physician and Hospital Epidemiologist at UConn Health.
Among the two other coronavirus vaccines authorized for emergency use in the United States, Moderna has begun applying for full approval for its COVID-19 vaccine in people ages 18 and up. Johnson & Johnson has not yet filed for full FDA approval of its vaccine.
