New COVID Vaccines: Who Is Eligible and When Should You Get Them?

Federal regulators recommended a new COVID-19 booster vaccine for all people aged 6 months and older, paving the way for shots to be doled out this week. The news comes amid a rise in COVID-19 hospitalizations and deaths, especially among older adults and babies.

This approval completes the trifecta of vaccines to protect against common viral infections this fall. Flu vaccines are already available for people aged 6 months and older, as are newly approved vaccines against respiratory syncytial virus (RSV) for people older than 60.

At the Advisory Committee for Immunization Practices (ACIP) meeting Tuesday, advisors to the Centers for Disease Control and Prevention (CDC) estimated that 200,000 hospitalizations and 150,000 deaths could be averted by offering the vaccine to all age groups, rather than approving it only for adults 65 years and older.

Only a fifth of U.S. adults have received a bivalent booster shot, leaving them vulnerable to more severe outcomes of infection, like long COVID, according to data presented to the panel.

While the CDC panelists generally agreed on the importance of prioritizing boosters for high-risk groups, they voted 13-1 to make the shots available to people of all ages.

Here’s what you need to know.

What Makes the New Vaccines Different?

The new boosters from Moderna and Pfizer are the third version of the COVID-19 vaccines. The first was designed to neutralize the original strain of COVID-19, and the second was bivalent, targeting the original COVID-19 and Omicron BA.4/BA.5.

The new versions are monovalent and target only Omicron XBB.1.5, a variant that was dominant in June, when regulators decided on the new formulation. Once providers get access to the new monovalent vaccines, the bivalent vaccines will no longer be available.

ACIP also recommended the new Novavax vaccine, though it hasn’t yet been cleared by the FDA. Because it uses protein-based technology, the Novavax shot provides an option for people who don’t want to get an mRNA vaccine.

While the vaccine makers tweaked their formulations to create the new monovalent vaccines, the products remain the same as the bivalent boosters in terms of basic composition, dosage, and administration.

Who Is Eligible for the New Booster?

The Moderna and Pfizer boosters are now approved for people ages 6 months and older.

All people older than five years are recommended to get one dose of an updated monovalent vaccine, even if they're currently unvaccinated. Children ages 6 months to 5 years who are unvaccinated are recommended to get between one and three doses of mRNA vaccine, depending on their age and the product.

People who are moderately or severely immunocompromised have the option of getting an additional dose this year.

The CDC said its recommendation was made broad enough to also cover Novavax's new vaccine as soon as the FDA signs off. If approved, the Novavax monovalent shot would be available to people ages 12 years and older. The vaccine maker said people who previously got mRNA vaccines could get a Novavax booster.  

When Should You Get It?

The vaccines will be distributed starting this week.

If you're unvaccinated, you should get a shot as soon as possible to protect against getting severely sick, the CDC said. If you've been vaccinated, you can get the new monovalent shot two or more months after your last dose.

Earlier in the pandemic, the CDC recommended waiting three months after recovering from COVID-19 to get another vaccine dose. But now, you can get the shot as soon as you're feeling better if you choose, said Megan Wallace, DrPH, MPH, a CDC epidemiologist.

Where Can You Get Vaccinated and How Much Will It Cost?

The vaccines will be available at “most places you would normally go to get your vaccines,” the CDC said. Major pharmacies including Walgreens and CVS are already taking appointments for COVID-19 vaccinations.

Last year, the Biden administration said it ran out of funding to cover the cost of COVID-19 vaccinations for all people in the U.S.

According to the companies, Moderna will now charge a list price $129 per dose, Pfizer will charge $120 per dose, and Novavax will charge $130 per dose.

Most people will still be able to get a vaccine free of charge. Private insurers, Medicare, and Medicaid are required to cover it. The Vaccines for Children program pays for vaccines for kids who are underinsured or uninsured and reaches about half of U.S. children.

The CDC is also launching a Bridge Access Program to provide free shots to the 25 to 30 million adults ages 18 to 64 who are uninsured. This will make vaccines available for free at thousands of health centers, doctors’ offices, and major pharmacy locations across the country.

Vaccines.gov, the central hub for information about immunizations, will be updated on September 15 with locations offering free shots through the bridge program, said Evelyn Twentyman, MD, MPH, of the CDC's National Center for Immunization and Respiratory Diseases.

Will the Vaccines Protect Against New Variants?

XBB.1.5—the variant that the vaccines are designed to target—has been eclipsed by newer variants, including E.G.5.1 (dubbed "Eris") and FL.1.5.1. But more than 90% of the circulating variants are closely related to XBB.1.5, so the vaccines should produce ample antibodies against them.

Scientists have also been keeping their eye on the highly mutated Omicron BA.2.86. So far, that variant is responsible for fewer than 0.05% of U.S. COVID cases and may not be as dangerous as once suspected. Early data also suggests that immune defenses bolstered by the monovalent vaccine can protect against BA.2.86.

How Safe and Effective Are the Vaccines?

Data on the XBB-containing vaccine is relatively nascent. Moderna conducted a clinical trial in 101 patients to test how the monovalent vaccine compared to the bivalent vaccine. Pfizer and Novavax each submitted preclinical data looking at vaccine-induced antibody levels in animals.

Oliver Brooks, MD, FAAP, ACIP member and Chief Medical Officer at Watts Healthcare Corporation, compared the COVID-19 vaccine approval process to the way scientists assess the annual influenza vaccine, saying they rarely need to collect full clinical trial data to evaluate the new formulation of a well-studied vaccine.

According to real-world and clinical data, the most common side effects from the bivalent vaccines were redness and tenderness where the shot was given, headache, fevers, chills, fatigue, and muscle aches. The CDC said severe allergic reactions, called anaphylaxis, remained very rare during the bivalent booster rollout, occurring in about five in one million cases.

The risk of severe heart inflammation—myocarditis—in young people has been a primary safety concern since the COVID-19 vaccines were first rolled out. A national safety system identified two cases of myocarditis out of 650,000 doses of bivalent boosters given to people ages 12 to 39 years.

The CDC also emphasized that the risk of myocarditis was 1.8 to 5.6 times higher after COVID-19 infection than after vaccination and that those cases tended to be more severe.

Pablo Sánchez, MD, an ACIP member and pediatrics professor at The Ohio State University, was the sole panelist to vote against a universal vaccine recommendation, citing a relative lack of data on the vaccine in children.

“I think we really need to level with our patients and say what is known and unknown rather than make a complete recommendation, especially for some groups that there are limited data,” Sánchez said.

Matt Daley, MD, chair of the CDC's COVID-19 vaccines work group and senior clinician investigator at the Kaiser Permanente Institute for Health Research, countered that there's “quite a bit of data” about the safety and efficacy of the vaccines, even though researchers haven’t had enough time to conduct full clinical trials on the XBB-specific formulations.

Does Everyone Really Need a Booster Shot?

Some experts are not convinced that most healthy people need repeat booster shots. About 97% of people in the U.S. have some immunity from vaccination, natural infection, or both, according to the CDC. There’s evidence that other immune cells can neutralize the virus long after antibody levels drop. And while those people may get reinfected with COVID-19, their lasting immune response may keep them out of the hospital.

However, some panelists emphasized the importance of minimizing long COVID risk across age groups. There is evidence that being vaccinated against COVID-19 before infection, especially with two or more doses, is associated with a decreased likelihood of developing long COVID.

Daley also stressed the importance of increasing vaccination rates among young people, citing evidence that half of the children who have been hospitalized from COVID-19 had no co-morbidities.

“There is serious illness death across all age groups, including among those without underlying medical conditions," Daley said.

Beth Bell MD, MPH, an ACIP member and professor of public health at the University of Washington, said that while the vaccine offers “robust benefits” for all people, a universal recommendation may water down the focus on vaccinating the most vulnerable, including young children, older adults, immunocompromised individuals, and other high-risk groups.

“It’s clear the risk is not equal, and the messaging needs to clarify that a lot of older people and people with underlying conditions are dying, and they really need to get a booster,” Bell said.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.