FDA Grants Full Approval for Pfizer’s COVID-19 Vaccine

CLEVELAND – The FDA has officially granted full approval for Pfizer’s COVID-19 vaccine. The two-dose shot previously only had Emergency Use Authorization. So, what does this mean moving forward?

“This is something that they are comfortable saying that should be available not just in an emergency situation but as something that should be available for all individuals to protect them from COVID infection,” explained Abhijit Duggal, MD, who specializes in pulmonary medicine for Cleveland Clinic. “So, this is the main reason that this announcement is pretty significant.”

According to the FDA, full approval is specifically for individuals 16 years and older. The emergency use authorization still applies for anyone between the ages of 12 and 15, and those needing a third dose if they are immunocompromised.

However, full approval for those groups is expected at some point in the future.

Dr. Duggal hopes this news will encourage more people to get vaccinated. He said the vaccine, no matter which one you receive, is going to be your best line of defense. Especially as the highly contagious Delta variant spreads across the United States.

“I will tell you this, as the Delta variant has come about, we are seeing a very different dynamic in the patients that we are seeing. It is a vast majority of patients who are not vaccinated and these are people that are coming in and are much sicker than what we have seen before,” he said. “We have to be careful that we break the cycle by making sure that we are vaccinated and we don’t allow for propagation of this virus.”

The FDA said they will continue to monitor Pfizer’s COVID-19 vaccine to ensure its safety and efficacy. Meanwhile, Moderna and Johnson and Johnson are still awaiting full approval.