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The FDA Now Recommends Getting Moderna's COVID-19 Vaccine Booster Five Months After Second Dose

Prevention logo Prevention 1/11/2022 Korin Miller, Jake Smith
  • The FDA now recommends that all Americans 18 and older receive a booster dose five months after their final dose of Moderna or Pfizer.
  • The Omicron variant, which appears to be more transmissible than previous strains of SARS-CoV-2, now accounts for over 95% of all COVID-19 cases in the United States.
  • Preliminary laboratory studies from Pfizer and Moderna show that mRNA boosters offer a much stronger antibody response than two doses alone.

Big changes are coming to booster doses this week. On January 7, the Food and Drug Administration (FDA) shortened its COVID-19 booster shot recommendations, suggesting a booster shot five months after the second shot of Moderna's two-dose vaccine for people ages 18 and up.

The FDA's announcement comes in light of the surge of the highly transmissible Omicron variant of SARS-CoV-2 (the virus that causes COVID-19), after 1 million Americans were diagnosed over the weekend. It now accounts for 95% of all COVID-19 cases in the United States, per the Centers for Disease Control and Prevention (CDC), after being first discovered in the U.S. just a month ago. Thankfully, mounting evidence shows that boosters appear to provide more robust protection against Omicron than two doses alone.

Just last week, the CDC shortened its COVID-19 booster shot recommendations for Pfizer-BioNTech’s two-dose vaccine to five months for those ages 12 and up. The Food and Drug Administration (FDA) also expanded its approval of Pfizer boosters to 12- to 15-year-olds, meaning everyone 12 and up can now receive a third dose of the Pfizer COVID-19 vaccine five months after their primary vaccination series ends. (Booster doses of mRNA option Moderna and adenovector option Johnson & Johnson are only approved for those 18 and older.)

Based on the new guidelines, if you initially received the Pfizer vaccine, you are eligible for a booster five months after your second shot. If you initially received the Moderna vaccine, you are eligible for a booster five months after your second shot. And, if you received the Johnson & Johnson vaccine, you are eligible for a booster two months after your shot. In most cases, experts say mRNA boosters are preferred.

As of now, only a single booster dose is recommended by the FDA; so-called “mix-and-match” boosters are allowed, meaning you can elect to get a COVID-19 vaccine booster shot different from the one you already received. But why are boosters necessary in the first place? How effective are boosters against Omicron? And how can you sign up for your dose? Here’s everything you need to know about COVID-19 vaccine boosters, according to doctors.

How do booster shots for vaccines work?

“For some vaccines, after a while, immunity begins to wear off,” the CDC explains. “At that point, a ‘booster’ dose is needed to bring immunity levels back up.” Booster shots are extra doses of a vaccine administered sometime after an initial dosage has been received, re-upping your body’s immune response.

Some boosters are recommended very infrequently, like one for tetanus, which should be received every decade. Others (like the annual flu shot) are more frequent due to factors like changing pathogens and waning immunity. Different types of flu virus circulate each year, making an annual shot necessary to protect against the most dominant strains each flu season.

Is a COVID-19 vaccine booster shot necessary for full protection?

Although COVID-19 vaccine boosters appear to hold up well against Delta, experts say it’s still unclear how effective they are against Omicron; more research is necessary to draw conclusions. But early results are promising: Preliminary studies by Pfizer found that three doses of its vaccine effectively “neutralize” the Omicron variant, offering 25 times more antibody protection than two doses alone.

Similar studies from Moderna produced promising results, too. Although two doses of Moderna offered lackluster protection from Omicron, a booster spurred 37 times the antibodies 29 days after it was administered. (A full third dose of the vaccine also triggered about 83 times more antibodies than two doses alone.) At a healthcare conference hosted by Goldman Sachs on Thursday, Moderna's CEO Stéphane Bancel said the efficacy of Moderna's first booster shot is expected to last through the winter, NPR reported.

The CDC recommends that all eligible Americans receive a booster dose. People 18 and older can choose between any of the three available vaccines, while 12- through 17-year-olds can receive a third dose of the Pfizer vaccine. “Vaccines remain the best public health measure to protect people from COVID-19, slow transmission, and reduce the likelihood of new variants emerging,” the CDC explains.

Although the available vaccines are highly safe and effective, their initial immunity is waning, leading experts to support boosters. Dr. Schaffner explains that the Biden administration has been “very impressed” with the booster shot data from Israel, and it’s easy to see why: A third dose appears to be highly effective in reducing severe COVID-19, hospitalization, and death, according to study after study.

“When you look at the data from Israel, it’s very clear that [a booster] reverses some of the waning effects that you see in people who have been vaccinated for six months or more,” Anthony Fauci, M.D., the nation’s leading infectious disease expert, said in November on the podcast The Daily. In fact, COVID-19 vaccine boosters “are going to be an absolutely essential component of our response. Not a bonus, not a luxury, but an absolutely essential part of the program.”

Booster shots can also address variants like Omicron, explains infectious disease expert Amesh A. Adalja, M.D., senior scholar at the Johns Hopkins Center for Health Security; the vaccines and boosters have remained unchanged since they were first approved, but future booster doses could be tailored to fight variants like Omicron specifically. “The COVID-19 vaccine may eventually become like the annual flu vaccine,” he says.

Why are boosters for Pfizer and Moderna necessary after five months?

Due to “the current state of the pandemic, the latest vaccine effectiveness data over time, and review of safety data from people who have already received a COVID-19 primary vaccine series and booster,” Dr. Walensky explained earlier in November, those extra doses are worth getting. They’re “an important public health tool to strengthen our defenses against the virus as we enter the winter holidays.”

“The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease,” officials from the United States Department of Health and Human Services (including Dr. Walensky and Dr. Fauci) wrote in August.

“Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout,” the announcement continues. “For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.”

For example, a small study of public health data from Israel released in late July estimated that the Pfizer shot was 39% effective at preventing people from COVID-19 infection in June and early July, compared with 95% from January to early April. (However, the vaccine was still more than 90% effective in preventing severe disease in people in June and July.)

“It is true that if you look at antibody levels produced by the vaccine, by eight months, they’re starting to wane,” Dr. Schaffner says. That’s why officials are recommending booster doses—and why you should receive a COVID-19 vaccine in the first place.

Where can you register for a booster dose?

Boosters are now available just about everywhere, and there should be no shortage of available doses, since the White House has committed to producing 1 billion doses of the COVID-19 vaccines per year moving forward.

To sign up for a booster dose, first make sure the correct amount of time has passed since your last dose. Then, use the CDC’s site, contact your primary care provider, or visit your county’s public health website to find a vaccination site near you. Pharmacies like CVS, Walgreens, and Rite Aid also allow people to check availability and book appointments online.

Bottom line: Booster doses are now a reality.

“The vaccines are so important,” explains Abhijit Duggal, M.D., a critical care specialist at Cleveland Clinic. “We need to reach a point of as many people being vaccinated as possible, as quickly as possible. That’s the biggest thing we can do to get back to some degree of normalcy.”

This article is accurate as of press time. However, as the COVID-19 pandemic rapidly evolves and the scientific community’s understanding of the novel coronavirus develops, some of the information may have changed since it was last updated. While we aim to keep all of our stories up to date, please visit online resources provided by the CDC, WHO, and your local public health department to stay informed on the latest news. Always talk to your doctor for professional medical advice.

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