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Answers to questions about booster shots for COVID, now that the FDA has acted

In August, the Biden administration announced that it planned to begin offering booster shots of COVID-19 vaccine to fully vaccinated adults this fall. People would be eligible for a third shot of either the Pfizer-BioNTech or Moderna vaccine eight months after their second.

“This shot will boost your immune response,” President Joe Biden said at the time. “It will increase your protection from COVID-19. And it’s the best way to protect ourselves from new variants that could arise.”

But so far, the Food and Drug Administration has allowed only part of Biden’s plan to proceed. On Sept. 22, the FDA authorized a third shot of the Pfizer vaccine for people age 65 and older or those 18 and older who are frequently exposed to the coronavirus or are at risk of developing severe cases of COVID-19.

The agency says people who qualify should wait at least six months after their second shot before receiving a third.

The decision followed much debate among FDA advisers and others that included accusations that the Biden administration had gotten ahead of the science with its booster proposal. As the rollout of COVID-19 vaccine booster shots evolves, here are answers to some questions about the boosters:

Will I need a booster shot?

There is evidence that the protection offered by the two-shot COVID-19 vaccines made by Pfizer-BioNTech and Moderna begins to wane after six months. That has prompted countries such as Israel and Germany to begin offering booster shots. On Sept. 2, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and Biden’s chief medical adviser, said studies in Israel show significant reduction in risk of infection in people who have had a booster.

But data submitted to federal regulators by Pfizer and Moderna reportedly show that two doses of both vaccines continue to achieve their goal of greatly reducing hospitalization and death from COVID-19. That led some to question whether a booster shot is necessary for otherwise health adults or people in low-risk situations.

An FDA advisory committee met Sept. 17 to consider Pfizer’s request to authorize booster shots and voted against recommending boosters for everyone 16 and older.

But the committee took a second vote and endorsed booster shots for people at risk of severe COVID-19, including those age 65 and older. That’s the course the FDA followed on Sept. 22. The decision applies only to those who have received the Pfizer vaccine.

FDA and Centers for Disease Control and Prevention officials have said they don’t have enough data from Moderna to make a decision about booster shots of its vaccine for the general population, according to The New York Times.

Who can get a booster shot now?

The FDA had already authorized use of a third dose of the Pfizer-BioNTech and Moderna vaccines by people with certain health conditions that compromise their immune systems. Studies had shown that two doses have not provided the desired protection for this group, who are more likely to get seriously ill with COVID-19.

These include those who have had kidney, heart, lung or liver transplants; are undergoing chemotherapy; have HIV; or are taking drugs to suppress their immune systems to treat conditions such as lupus, rheumatoid arthritis or multiple sclerosis. If you think you might qualify, you should talk about it with your doctor.

The CDC recommends people in these groups wait at least 28 days after the second shot before getting the booster.

What occupations does the FDA consider at high risk of getting COVID-19?

There is not a comprehensive list, but Dr. Janet Woodcock, the acting FDA Commissioner, said the Pfizer booster should be available to “health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”

While the Pfizer vaccine is authorized for use in anyone age 12 and older, the FDA has only allowed the third booster shot for people age 18 and older who qualify.

Will people who got a Johnson & Johnson vaccine need a booster?

Johnson & Johnson says its single-dose vaccine “generates strong and robust immune responses” for eight months, and that recent studies show that a booster dose “further increases antibody responses among study participants who had previously received our vaccine.”

The CDC says it is likely that people who received the Johnson & Johnson vaccine will eventually need a booster, but federal regulators say they have not received the data to support that decision yet. Use of the Johnson & Johnson vaccine was not authorized in the United States until the end of February, so an eight-month booster dose wouldn’t be available until October at the earliest.

If a third shot is needed, why wait several months after the initial doses to get it? Why not get it sooner?

The Biden administration said it planned to make the shots available after eight months, and the FDA decided that people should wait six. And there may be good reasons why sooner is not better, says Dr. Cameron Wolfe, an infectious disease specialist at Duke University.

Sometimes waiting helps the body’s immune system produce the strongest response against a virus or other pathogen, Wolfe said.

“The question here is, Can we pinpoint more precisely the waning durability of these vaccines over a six-plus-month period and find that sweet spot where boosting that protection in fact counteracts active viral prevalence that exists in the community?” Wolfe said.

If I got the Moderna or J&J vaccine, can I get the Pfizer booster shot? Can I mix them?

The problem with mixing vaccines, whether between the first and second doses or between the second and third, is that scientists haven’t studied the vaccines in combination with each other.

The studies that led federal regulators to authorize use of the vaccines all involved people taking the same kind. In other words, it’s simply not known whether switching vaccines is less safe or effective than taking the same one.

Will the advice on booster shots change?

Without a doubt. As more studies are done and more people get the vaccines, scientists will learn more about how they work and who might benefit from a boost.

As the FDA authorized the Pfizer booster shots on Sept. 22, Woodcock said people should stay tuned.

“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day,” she said. “As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

Where can I go to get a COVID booster shot or appointment?

The Biden administration says booster shots for the general population will be available through the same channels that brought people the first two shots, and they will also be free.

For those who are immunocompromised, third doses are now available from county health departments, health systems including Duke Health, WakeMed and UNC Health, as well as Walgreens and CVS pharmacies.

Go to MySpot.nc.gov or call 888-675-4567 to find a location. You can also text your ZIP code to 438829 to find vaccine locations near you.