FDA authorizes Pfizer COVID-19 vaccine booster shots

UPDATE: On Oct. 20, the U.S. Food and Drug Administration (FDA) officially authorized COVID-19 vaccine booster doses for Johnson & Johnson vaccine recipients and some people who received Moderna’s vaccines. 

The agency also authorized the use of each of the available COVID-19 vaccines as a heterologous (“mix and match”) booster dose for eligible individuals who have completed the primary vaccination series with a different COVID-19 vaccine.

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PREVIOUS REPORT: In August, as the highly transmissible delta variant spread rapidly across the country, U.S. health officials recommended that fully vaccinated individuals should get a COVID-19 booster shot at least eight months after they received their second dose of the vaccine.

With over 55% of Americans fully vaccinated against COVID-19, according to CDC data, many people are wondering when they will be eligible to get a booster shot. 

The VERIFY team is answering a few of your COVID-19 booster shot questions. 

Have any booster shots been authorized by the FDA?

Yes, the FDA has authorized Pfizer COVID-19 vaccine booster shots for high-risk Americans.

On Sept. 22, the FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for use of a single booster dose for certain high-risk Americans. This authorization includes:  

• individuals 65 years of age and older
• individuals 18 through 64 years of age at high risk of severe COVID-19 
• individuals 18 through 64 years of age whose frequent institutional or occupational exposure to COVID-19 puts them at high risk of serious or severe complications

The FDA says the booster shot is to be administered at least six months after a person received their second dose of the Pfizer COVID-19 vaccine. 

CDC Director Dr. Rochelle P. Walensky and the CDC Advisory Committee on Immunization Practices (ACIP) also announced their recommendation of a booster shot of the Pfizer COVID-19 vaccine for high-risk Americans on Sept. 24. 

“Many of the people who are now eligible to receive a booster shot received their initial vaccine early in the vaccination program and will benefit from additional protection,” the CDC said. “With the delta variant’s dominance as the circulating strain and cases of COVID-19 increasing significantly across the United States, a booster shot will help strengthen protection against severe disease in those populations who are at high-risk for exposure to COVID-19 or the complications from severe disease.”

The CDC says additional populations may be recommended to receive a booster shot as more data become available, but is not making such recommendations for people outside of the groups listed above just yet.

“The COVID-19 vaccines approved and authorized in the United States continue to be effective at reducing risk of severe disease, hospitalization, and death. Experts are looking at all available data to understand how well the vaccines are working for different populations. This includes looking at how new variants, like delta, affect vaccine effectiveness,” said the CDC. 

If a person received Johnson & Johnson’s single-dose COVID-19 vaccine, should they get a booster shot of Pfizer or Moderna’s mRNA vaccines?

No, it is currently not recommended for a person who received Johnson & Johnson’s single-dose COVID-19 vaccine to get a booster shot of Pfizer or Moderna’s mRNA vaccines. 

The CDC says on its website there isn’t enough data currently to support getting an mRNA vaccine booster shot — either of Pfizer or Moderna — if someone has previously gotten a single dose of the Johnson & Johnson COVID-19 vaccine. 

While the FDA and CDC have authorized a Pfizer COVID-19 booster shot for certain high-risk Americans, individuals who received Moderna or Johnson & Johnson vaccines are not currently recommended to get a booster shot. 

On Sept. 21, Johnson & Johnson announced new data reinforcing the long-lasting protection of its COVID-19 vaccine. The company said in a press release that the new data also showed that protection against COVID-19 increases when a booster shot of its vaccine is administered. 

“When a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster,” said Johnson & Johnson.

Dr. Amesh Adalja told VERIFY people should avoid “mixing and matching” vaccines, saying that a decision on further booster shots is likely on the way. 

“There’s going to be a decision about Moderna in the next couple of weeks,” he said. “We know that Moderna has already submitted information on their third dose to the FDA. There will be a similar process for Moderna. So I don’t think it’s necessary for people to do this right now.”

Can you get a COVID-19 vaccine booster shot and the flu shot at the same time?

Yes, you can get a COVID-19 vaccine booster shot and the flu shot at the same time.

According to the CDC, a person can get a COVID-19 vaccine and other vaccines, like the seasonal flu shot, during the same visit to the doctor or pharmacy. The public health agency also says on its website that people no longer need to wait 14 days between vaccinations as it previously recommended. 

Dr. Anna Durbin, a professor of International Health at Johns Hopkins Bloomberg School of Public Health, told VERIFY that participants in last year’s COVID-19 vaccine trials were allowed to get their flu shots and they had no impact on the results.

“I’m very convinced that it’s very safe to give these vaccines either at the same time or within days of one another,” said Durbin. “It’s unlikely that it’s going to affect the immunogenicity or the protective effectiveness of either of these vaccines.”

Dr. Payal Kohli, a board-certified cardiologist at Cherry Creek Heart, says if a person is still hesitant about taking the COVID-19 vaccine and flu shot at the same time, or if they are immunocompromised, it’s okay to space them out — but for people with normal immune systems, she says it is fine to take them at the same time. 

“For most of us, it’s probably okay to take them together. I think the tolerability or the side effects are probably going to be the same whether you take two or one,” said Kohli. “We’re much more likely to get both of them if we take them together rather than taking them separately.”