What does full FDA approval mean for the Pfizer COVID-19 vaccine?

Richard Scott, MD

Chief Clinical Officer, Midlands

The Food and Drug Administration granted full approval for the Pfizer COVID-19 vaccine among ages 16 and older. Rick Scott, MD, explained what this means in the fight against COVID-19.

“Clinicians have been waiting for months for the FDA to grant full approval, which ensures the vaccine is safe, effective and reliable,” Dr. Scott said.

The FDA initially studied the vaccine with 22,000 vaccine recipients and 22,000 placebos to gauge the efficacy among those 16 and older.

“If you look at the Pfizer vaccine in use around the world, and over 209 million doses in this country, there have been few medications that have been as carefully vetted as this one,” he continued.  “Over one-third of the world’s population is now vaccinated, with 5.22 billion doses administered. Virtually all three choices available in the U.S. are well proven to be safe and effective.

“Currently, over 40 million doses are being administered daily across the world, but even at this rate, it will take five months for 75% of the population to be covered. Infectious disease experts are firm in their conclusions that the very small number of complications that have occurred are far outweighed by the benefits of vaccine-induced immunity.”

Will full FDA approval prompt more vaccinations?

In many polls, people said experimental use authorization was a prime reason for them to be hesitant. “Those people can move ahead now with great confidence,” said Dr. Scott. “The data has been consistent from rollout and found to be very safe.”

He said FDA approval might also allow employers to proceed with the expectation that people should be vaccinated for workplace safety.

“One thing is for certain, vaccination has been extremely effective in preventing severe disease, hospitalization, ventilation and death. Although the vaccine was not created before the delta variant existed, it has given a significant amount of protection to people. It won’t stop you from getting the delta variant every time, but over 91% of the time it’s effective in keeping you from developing severe disease. It’s the best weapon we have.”

What about children?

The vaccine will continue to carry emergency use authorization for children ages 12–15, and children under 12 are not yet eligible for the vaccine.

While we wait for the vaccine to become available to this group, Dr. Scott encouraged everyone to continue using prevention tactics such as hand hygiene, masking and social distancing.