FDA grants full approval to Pfizer COVID-19 vaccine

As grocery retailers begin offering COVID-19 booster shots, the Food and Drug Administration today gave full approval to the Pfizer/BioNTech coronavirus vaccine, the first vaccination for the virus to earn that status.

The FDA said Monday that the Pfizer vaccine — now to be marketed under the name Comirnaty — is approved for the prevention of COVID-19 disease in people ages 16 older. Pfizer’s COVID immunization also can be given to adolescents 12 to 15, but  inoculations for that age group remain under emergency use authorization (EUA) and haven’t received full approval.

Pfizer/BioNTech’s vaccination gained EUA from the FDA on Dec. 11, 2020, the first COVID-19 shot to receive that designation. The vaccine’s EUA was expanded to include children 123 to 15 on May 10, 2021.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock said in a statement. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.

Related:Hy-Vee starts providing COVID-19 third shots

With many Americans citing the lack of full FDA approval as the reason for not getting a COVID vaccine, a key barrier has now been removed, Woodcock noted.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” she explained. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

Expedited trials have been one of the top reasons cited by Americans declining to get vaccinated against COVID, behind only potential side effects. In a mid-July Morning Consult survey of nearly 39,000  U.S. adults, 32% of respondents uncertain about getting a COVID shot (and 23% of those who don't plan to get vaccinated) said they're worried the vaccines moved through clinical trials too quickly. Thirty-seven percent of people uncertain about receiving a COVID vaccine (and 25% of those not looking to get a shot) said they were concerned about side effects.

Through Aug. 22, 60.7% of the U.S. population had received at least one COVID-19 vaccine dose, and 51.5% had been fully vaccinated, with 362.7 million vaccines administered of the 428.5 million delivered by manufacturers, according to data from the Centers for Disease Control and Prevention (CDC). About 73% of Americans ages 18 and older had gotten at least one shot (62.4% fully vaccinated), while 71% of those ages 12 and older have received at least one dose (60.2% fully vaccinated).

Related:Meijer offers COVID-19 vaccine coupon to college students

“We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, commented on the Pfizer vaccine approval. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

Supermarkets have continued to help raise those percentages, including the recent launch of booster vaccinations. On Aug. 12, the FDA amended emergency use authorizations for the Pfizer and Moderna COVID-19 vaccines to allow for the use of a third dose in certain immunocompromised people. The CDC followed a day later by recommending a booster for this population, which includes recipients of organ or stem cell transplants, people with advanced or untreated HIV infection, active recipients of treatment for cancer, and people taking medications that weaken the immune system, among other conditions. Both the Pfizer and Moderna immunizations require two shots, and the third dose is recommended to be administered 28 days after the second shot.

H-E-B recently said surging demand for COVID shots led the company to curtail walk-in vaccinations and recommend appointments.

West Des Moines, Iowa-based Hy-Vee began offering third doses of the Pfizer and Moderna COVID vaccine on a walk-in basis on Aug. 13 at its more than 275 pharmacies. This past weekend, Hy-Vee also annnounced plans to hold drive-thru booster shot clinics on Aug. 25 and 28 in the parking lot at Community Choice Credit Union Convention Center in downtown Des Moines. The Midwestern food and drug chain noted that those seeking a third COVID vaccine shot must self-attest that they have moderately to severely compromised immune systems but don’t need to show proof of their condition.

Southeastern grocer Publix Super Markets started administering Pfizer and Moderna COVID booster shots to eligible patients on Aug. 17. Third doses are available via appointments and on a walk-up basis. Moderna vaccines are available at all pharmacies, while the Pfizer shot currently is available only at locations in Florida’s Brevard, Duval, Orange and Polk counties. Lakeland, Fla.-based Publix didn’t begin offering the Pfizer COVID vaccination until Aug. 11.

The nation’s second-largest supermarket operator, Albertsons Cos., announced the availability of third Pfizer and Moderna doses at its pharmacies today, following the CDC’s recommendation for immunocompromised patients. No appointment is necessary.

“Customers who are unsure about whether they qualify for the third shot under the new CDC guidelines or who have other questions about COVID-19 vaccinations can visit with our immunization-trained and certified pharmacists at any Albertsons Cos. pharmacy location,” Boise, Idaho-based Albertsons stated. “We expect additional guidance from the CDC in early September on extending the eligibility of the population to receive an additional COVID-19 vaccine. We are prepared to begin those inoculations immediately upon receiving the updated guidance.”

With the fast-spreading Delta variant of COVID-19 hoisting infection rates around the country, especially in the South and Midwest, more grocery retailers have been encouraging customers to opt for appointments when getting their shots.

Texas grocer H-E-B on Aug. 12 reported a surge in customer traffic for COVID vaccines, noting that demand for shots at its pharmacies has “significantly grown.” The San Antonio-based chain said the number of vaccinations administered at its pharmacies has more than doubled weekly, and that week alone its pharmacy team was expected to provide over 75,000 shots. As a result, the company on Aug. 16 began accepting walk-ins for COVID vaccines only from noon to 5 p.m. weekdays, with weekend vaccinations by appointment only.

“These are temporary moves that will improve wait times and make the process more efficient,” H-E-B stated. Since launching COVID-19 vaccines late last year, the retailer has administered almost 2 million doses via its in-store pharmacies and community outreach events.

*EDITOR'S NOTE: Article updated with survey data.