Pfizer is now requesting full FDA approval for their COVID-19 vaccine in people 16 years and older.
Riley Hospital’s Medical Director of Infection Prevention, Dr. John Christenson, said the U.S. has already had roughly one year’s worth of experience with the Pfizer vaccine since Phase 1 trials began in May of last year.
“We have a lot of live experience with these vaccines so we know that they’re very safe,” said Dr. Christenson. “So I think what they call biologic licensing will come quickly from FDA.”
Pfizer and BioNTech say they’ve administered more than 170 million doses in the U.S. since December. It’s currently available to Americans over the age of 16, assuming they have not tested positive for COVID-19 in the last 14 days and don’t have a history of extreme reactions to vaccines.
Dr. Ram Yeleti, Chief Physician Executive at Community Health Network, said a full seal of approval from the FDA would remove EUA restrictons.
“Under Emergency Use Authorization, the FDA puts – very appropriately – limited restrictions on who could get it and how it can be distributed,” Dr. Yeleti explained. “Once it’s fully approved you don’t need that. So any physician could essentially prescribe this as they would something else. So it does open the gate pretty significantly.”
Katharine Head, Associate Professor for the Department of Communication Studies at IUPUI, said the full FDA approval of the Pfizer vaccine, and eventually, the full approval of other COVID-19 vaccines, will even make a big difference in vaccine hesitancy.
“I think that this FDA approval should help people feel more confident about this vaccine,” said Head. “I think we will eventually be able to see, just like all of our other vaccines, we’ll be able to go to our local doctors to get that. We’re not there yet, but I’m hopeful we’ll get there soon.”
Now, the question remains: can a full FDA approval allow schools, universities, and employers to require a COVID-19 vaccine? Dr. Christenson said legally, yes.
“The influenza vaccine in many hospitals throughout the United States is a mandated vaccine meaning that if you want to work in the healthcare system you have to get the flu shot every year,” Dr. Christenson said. “I think COVID will be very similar to that.”
Dr. Christenson points out that many schools already require set vaccinations for registration, like hepatitis, tetanus, and measles. He said mandates vaccines are an effective way of controlling disease within the community.
Overall, experts hope this official seal of approval will boost vaccine confidence.