FDA Panel Approves Moderna COVID-19 Booster—Here's What That Means and What Happens Next


Big news for people who have received the Moderna COVID-19 vaccine: Vaccine advisors to the US Food and Drug Administration (FDA) voted Thursday to recommend emergency use authorization of a booster dose.

The FDA panel voted unanimously that a half-dose booster shot is safe and effective at preventing severe COVID-19 in select people six months after their primary vaccination series. Members of the FDA's Vaccines and Related Biological Products Advisory Committee recommended a 50-microgram dose for the booster, which is half the size of the 100-microgram doses administered in the original vaccination series.

There are caveats, though, and as was the case with authorization for the Pfizer-BioNTech booster dose, this recommendation isn't for everyone. Here's what you need to know about the Moderna booster vaccine, plus what happens next.

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Who is the Moderna booster recommended for?

The FDA's advisory panel recommended that the following groups be authorized to receive a booster shot at least six months after their first vaccination series:

  • People aged 65 and up
  • People who are 18 to 64 who are at high risk of severe COVID-19
  • People who are 18 to 64 whose exposure to COVID-19 in their living situation or job puts them at risk for COVID-19 complications or severe illness

When can people get the booster dose?

The FDA's panel recommended that the booster dose be authorized for the groups mentioned above at least six months after their primary vaccination series. That means someone who received a second dose of the two-shot series in early May, for example, would be eligible for a booster beginning in November.

Even if it's been six months or longer since you completed the initial series, don't rush out just yet. Remember, this is just an advisory panel recommendation, not an authorization for Moderna boosters. There are few more steps in the process before shots can go into arms.

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What do experts think?

Overall, they're in favor of it. "This is good news in terms of ending the pandemic," Richard Watkins, MD, an infectious disease physician in Akron, Ohio, and a professor of internal medicine at the Northeast Ohio Medical University, tells Health.

"For Moderna's half-dose vaccine boosters, just as it was the case for Pfizer boosters, the key question to focus on is whether there is evidence of erosion of protection against hospitalization with COVID," infectious disease expert Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, tells Health. "In those age or risk groups where this has occurred, a booster may be warranted."

But Dr. Adalja says it's "unclear" if there would be a booster benefit for people who are at a low risk of being hospitalized from COVID-19 "as there is not enough data to show that boosters protect for a significant amount of time against mild breakthrough infections."

The FDA's panel giving the green light to a Moderna booster "is déjà vu all over again, just like we saw with the Pfizer vaccine," Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York, tells Health.

Dr. Russo also says the half dose of the Moderna vaccine may be more appealing to some people, given that it's less likely to cause side effects.

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So what happens next?

The Moderna booster has yet not yet been granted emergency use by the FDA—but that should come within a few days, Dr. Adalja says. After that, it will go on to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), which will review data on the safety and effectiveness of the booster and make recommendations for its use. That meeting is scheduled for October 21. From there, CDC Director Rochelle Walensky, MD, will issue final recommendations.

And at that point, people will be able to get a Moderna booster—if they qualify.

The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDCWHO, and their local public health department as resources.

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