LITTLE ROCK, Ark — The U.S. Food and Drug Administration gave full approval to Pfizer's COVID-19 vaccine Monday. Some Americans cited the vaccine as being unapproved the reason they decided not to get the shot.
Pfizer CEO Albert Bourla called the FDA's action “an important milestone that I think will unlock some of the more skeptical minds."
Beyond vaccine hesitancy for Arkansans, approval could mean that more private companies could be issuing vaccine mandates for employees.
Nathan Read is an attorney with Mitchell Williams Law Firm and said private employers have had the ability to impose such a mandate even before the FDA approval.
"They still have to ensure that employees who have a medical condition that rises to the level of a disability or hold religious beliefs, they have the opportunity to exempt out of [the vaccine]," said Read.
Act 977 was passed through legislation prohibiting state entities from imposing a vaccine mandate.
For health professionals who have been administering the vaccine since December nothing's changing for them except making sure they're ready for an influx of Arkansans.
Allison Ingram with Cornerstone Pharmacy at Rodney Parham Road said she has full confidence in the vaccine being up to the standards of the FDA.
"They've been working on it a lot longer than people realize I think and that in itself gives me more confidence," said Ingram.
Ingram said she's getting more staff certified so they can administer the shot.
The formula made by Pfizer and its German partner BioNTech now carries the strongest endorsement from the agency, which has never before had so much evidence to judge a shot’s safety.
More than 200 million Pfizer doses have been administered in the U.S. — and hundreds of millions more worldwide — since December. But up to now, they were dispensed in this country under what is known as emergency use authorization from the FDA.
What does the FDA approval mean?
Full approval means Pfizer's COVID-19 vaccine meets the same “very high standards required of all the approved vaccines we rely on every day,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.
That should help “anyone who still has concerns gain confidence” in the shots.
Approved vaccines undergo the agency’s standard process for reviewing the quality, safety, and effectiveness of medical products, according to the FDA. For all vaccines, the agency evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA).
The FDA conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Which age group has been approved?
The U.S. Food and Drug Administration approved the first COVID-19 vaccine for individuals 16 years of age and older.
The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
The Associated Press has contributed to this article.