FDA authorizes more adults to get 2nd COVID-19 vaccine booster

More Georgians now have the option to get a second coronavirus booster shot.

Extra booster shots used to only be available for people who are immunocompromised, but the Food and Drug Administration announced Tuesday that it’s authorizing an additional booster dose for anyone 50 and older. The announcement, which various media outlets reported was anticipated, applies to both Pfizer and Moderna boosters.

Proponents of the new policy said it helps boost COVID-19 protection as Western Europe and some parts of the U.S. have seen a rise in cases of the new omicron subvariant, BA.2. However, some health experts argue second booster shots may not be necessary at this time and could distract from fledgling efforts to persuade more Americans to get their first vaccine doses.

“How are we going to encourage people who are still vaccine naive to get vaccinated as we’re rolling out more and more boosters?” Dr. Bronwen Garner, an infectious disease expert at Piedmont Atlanta, told The Atlanta Journal-Constitution on Tuesday. “It’s tricky to get individuals who haven’t adopted vaccines in general to adopt it when we’re recommending multiple booster doses.”

Studies have shown protection offered by mRNA vaccines, such as Pfizer and Moderna, wanes after four months, but can still offer protection against hospitalization and death. A study released by the CDC in February showed that when omicron was the predominant variant circulating, the vaccine’s effectiveness against hospitalizations was 91% during the the two months following a third dose and dropped to 78% four months afterward.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a Tuesday news release. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals.”

It’s unclear how various health agencies will react to the announcement. The Georgia Department of Public Health told the AJC it’ll wait for further instruction before figuring out how to administer second booster shots to more people. In a Monday statement, the department said it’ll await recommendations from the Centers for Disease Control and Prevention and its Advisory Committee on Immunization Practices.

Dr. Carlos del Rio, an infectious disease researcher at Emory University, said Monday that additional boosters are a case of diminishing returns.

“If you’re between 50 and 60 and if you’re a healthy individual, there’s really no reason to get it,” he said. “There’s also no downside, so if you get it, that’s fine. But the amount of additional protection you’re going to get is very little.”

The number of Georgians who are now eligible for a second booster shot is a fairly limited group. According to the DPH, about 1.5 million Georgia residents who are 50 or older have gotten a third dose — roughly 41% of that population. This includes either third doses issued to immunocompromised people or booster doses.

In addition, people have to wait at least four months between receiving booster shots. Anyone who got their first booster dose after last November won’t be able to get their second dose immediately. More than half of the 22% of Georgians who received a third vaccine dose did so after Dec. 1, state data shows.

Given that fourth vaccine doses apply to a small portion of the population, it has some health experts questioning whether the focus on additional boosters is time well spent, especially when overall vaccine hesitancy remains high in some areas. Only 56% of Georgians are fully vaccinated.

“I’m more concerned about the people who haven’t been vaccinated and haven’t been boosted than trying to get a fourth shot to people,” del Rio said.

Vaccine efficiency has been a rising question since breakthrough cases increased during the latter half of last year. With the BA.2 subvariant looming, health experts said it’s too soon to know how much extra protection a fourth COVID-19 shot gives against variants.

As of March 19, the BA.2 variant comprises nearly 35% of all new COVID-19 cases in the U.S., according to the CDC. State-by-state data isn’t available yet for March, but the CDC found that BA.2 comprises about 22% of COVID-19 infections for eight southeastern states, including Georgia.

An Israeli study provided some optimistic results for second booster doses. The study, which has not yet been peer-reviewed, found that an additional booster shot provided significant protection from death for adults between 60 and 100 years old. More than half a million adults participated in the 40-day study. Nearly 72% of the participants who died during that timeframe only had one booster.

“The main goal that we always have to focus on is what is the vaccine doing for morbidity and mortality,” Garner said. “That’s why we are still recommending vaccines and adding boosters on top, even though they don’t match the virus (variants) perfectly, because we are still seeing the reduction in morbidity and mortality.”

Del Rio argues that additional boosters can only accomplish so much.

“We need better vaccines. We need vaccines that are more likely to impact the current strains that are in circulation right now,” del Rio said, adding that he’s hoping new vaccines will be released by the fall. “Continuing to boost people is not feasible and is not the way to get out of this pandemic.”

On April 6, the FDA will hold an advisory committee meeting to discuss the next steps for boosters and who should be eligible for additional doses.

Food and Drug Administration booster guidelines

- Anyone 50 or older can get a second booster dose of the Pfizer or Moderna COVID-19 vaccines.

- Anyone 12 or older with certain kinds of immunocompromise may get a second booster dose.

- Second booster dose should be taken at least four months after the first booster dose.

- A second booster dose is widely seen as an extra layer of protection for older and immunocompromised individuals. The new booster guideline does not change earlier recommendations that the best defense against COVID-19 is to become fully vaccinated and boosted.