FDA Approval Of Pfizer Vaccine Could Aid Vaccination Efforts In Arkansas

Aug 23, 2021

The Pfizer COVID-19 vaccine has been granted full approval by the Federal Food and Drug Administration
Credit Michael Hibblen / KUAR News

Some Arkansans may have one less reason to be reluctant about getting a COVID-19 vaccine. On Monday, the  Food and Drug Administration announced it had given full approval for the Pfizer-BioNTech's vaccine.

Dr. Rawle Seupaul, chair of the Emergency Medicine Department at the University of Arkansas for Medical Sciences, said some have been hesitant to get vaccinated while the federal regulatory agency had only given it "emergency use authorization."

"I hope that what people take from this is — if they connect the dots between the large number of individuals that have been vaccinated and the very stringent criteria that the FDA uses before full approval of any therapeutic agent, in this case, the COVID-19 vaccine — that they now have a level of comfort, as well as a civic duty and responsibility to get vaccinated to protect themselves and others," Seupaul told KUAR News.

The FDA granted full approval for use of the vaccine in anyone age 16 or older. While additional data is being reviewed, the vaccine will still have emergency use approval for anyone between the ages of 12 and 15.

Dr. Jennifer Dillaha, director of immunizations for the Arkansas Department of Health, said the FDA’s approval represents an independent review of claims made by the vaccine’s maker.

"After the clinical trials are completed for a vaccine, the FDA does their own data analysis. They have analyzed the data and they have found that it shows the Pfizer-BioNTech vaccine is both safe and efficacious," she told reporters.

The approval prompted the U.S. Secretary of Defense to announce that being vaccinated for COVID-19 will be mandatory for all employees of the Department of Defense. Dr. Seupaul said the FDA approval could also make it easier for organizations like UAMS to get all employees vaccinated.

"I hope that we’ll see some benefit overall just from the general population getting vaccinated at higher rates. As a state institution though, we are still beholden to our state legislature, and my hope is that, now that this is no longer in [emergency use authorization], we have a little stronger footing with the legislature to allow for a mandate of the vaccine here at UAMS."

According to Seupaul, the vaccination rate at UAMS is over 80%.

"We have not had a single complication from the vaccine that required hospitalization," he said.

In April, the Arkansas legislature passed a law banning COVID-19 vaccine mandates that would allow public institutions, like UAMS and public schools, to require a vaccine. The Arkansas law includes a provision that allows the legislature to suspend the law in the case of a more virulent mutation of the Sars-CoV-2 virus that "impacts children." A similar state law banning mask mandates is being challenged in court.

According to a statement from the FDA, the Pfizer vaccine will be marketed under the trade name Comirnaty.