The Food and Drug Administration gave full approval to Pfizer/BioNTech COVID-19 vaccine. This is another milestone in the historical immunization campaign. The vaccine was available previously to anyone over 12 years old in the United States, under an emergency authorization. It is now officially licensed in the United States.
Pfizer and BioNTech will be able to directly market the shot once they have received approval. To people over 16, the vaccine will be known as Comirnaty. Under an emergency use authorization, it will be still available to children 12-15 years of age.
Janet Woodcock, acting FDA Commissioner, stated that the FDA's approval of this vaccine was a significant milestone in our fight against the COVID-19 pandemic. This vaccine and others have passed FDA's strict scientific standards for emergency use authorization. However, this is the FDA's first FDA-approved COVID-19 vaccination. The public can feel confident that the vaccine meets all FDA requirements for safety, effectiveness and manufacturing quality.
This approval could push schools and companies to require vaccinations. Although it is legal for them to require vaccinations in an emergency, some people have hesitated to do so. Officials in public health hope that more people will get vaccinated if they are given full approval. Woodcock stated that today's achievement brings us one step closer in halting this epidemic in the U.S.
To submit an application for a Biological License, the companies had to provide six months worth of data about their vaccine safety and efficacy to FDA. Only two months was required by the agency before an emergency use authorization could be applied for. This short timeline enabled the agency to bypass some of the more complicated regulatory steps and quickly get vaccines to people during a crisis.
The approval was based on mountains and mountains of data. This includes a clinical trial which looked at 20,000 patients who were given the vaccine and 20,000 who were given a placebo. The vaccine prevented symptomatic COVID for 91 percent of patients after six months.
Peter Marks, Director of FDAs Center for Biologics Evaluation and Research, said that the vaccine was evaluated by both medical and scientific experts. Marks stated that the agency reviewed hundreds and thousands of pages of data as part of the evaluation. They also conducted new analyses to determine the effectiveness of the vaccines.
Some people may feel more confident getting vaccinated if FDA approval is granted. A May survey revealed that one-third (33%) of adults who have not been vaccinated would prefer to receive a COVID-19 vaccination that is fully approved.
Other pharmaceutical companies won't be able ask the FDA to issue new emergency use authorizations now that the COVID-19 vaccine is approved. Only emergency authorizations can be issued for vaccines or drugs when there are no approved alternatives. AstraZeneca would need to go through the formal approval process if it wanted to make the shot available in the US.
