- Updated COVID-19 vaccines are approved for adults 65+ and high-risk individuals.
- Eligibility includes conditions like asthma diabetes and heart disease as per CDC guidelines.
- Vaccines will be available at pharmacies and clinics, but access may vary by state.
ATLANTA — This year's updated COVID-19 vaccines have been approved by the U.S. Food and Drug Administration for adults 65 and older and younger people with certain medical conditions that put them at a higher risk of a severe COVID-19 infection.
Although federal officials have emphasized that people who want a COVID-19 vaccine can get one after consulting with a doctor, the narrower approval may limit access to shots for some people who were routinely able to get them in the past.
Here's what to know about getting an updated COVID-19 vaccine.
Who can get a COVID-19 vaccine?
"FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+). These vaccines are available for all patients who choose them after consulting with their doctors," Health and Human Services Secretary Robert F. Kennedy Jr. said in a post on X this week.
According to the Centers for Disease Control and Prevention, the conditions that put someone at a higher risk of severe COVID-19 include:
- Asthma
- Blood cancers
- Cerebrovascular diseases
- Chronic kidney disease
- Some chronic lung diseases
- Some chronic liver diseases
- Cystic fibrosis
- Type 1 and 2 diabetes
- Gestational diabetes
- Disabilities, including Down syndrome
- Heart conditions
- HIV
- Mood disorders, including depression and schizophrenia
- Dementia
- Parkinson's disease
- Obesity
- Physical inactivity
- Current or recent pregnancy
- Primary immunodeficiencies
- Current or former smoking
- Solid organ or blood stem cell transplant recipients
- Tuberculosis
- Use of immunosuppressive drugs
Most of these conditions can affect the immune system in such a significant way that they would inhibit the body's ability to fight off a COVID-19 infection, increasing the risk of that infection causing severe illness or death.
These underlying conditions will make an estimated 100 million to 200 million people in the U.S. eligible for a COVID-19 vaccine under the new framework, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the director of the FDA's Center for Biologics Evaluation and Research, wrote in an editorial in May in the New England Journal of Medicine.
When and where will the vaccines be available?
COVID-19 vaccines are expected to be available at many pharmacies and doctor's offices in the United States this fall.
Both Pfizer/BioNTech and Moderna said their updated COVID-19 vaccines are expected to be available in the "coming days."
Pfizer and BioNTech said that their COVID-19 vaccine this season "will begin shipping immediately and be available in pharmacies, hospitals, and clinics" across the country.
John C. Jacobs, president and CEO of vaccine maker Novavax, said in that company's news release that it will "work with our partner Sanofi to provide access to a protein-based, non-mRNA COVID-19 vaccine for eligible individuals this fall."
Walgreens also said in an email that most of its pharmacies are preparing to offer the COVID-19 vaccine where regulations allow.
"Walgreens is prepared to offer the vaccine in states where we are able to do so. In accordance with FDA approval and state requirements, we will offer the vaccine to all adults ages 65 years and older, as well as to individuals under 65, who are at higher risk for severe outcomes from COVID-19, as determined by the CDC," a spokesperson said in an email Friday.
Most COVID-19 vaccinations in the U.S. have happened at pharmacies. During the 2023-24 respiratory virus season, an estimated 71.5% of shots were given in pharmacies or drug stores, according to CDC data, followed by an estimated 9.2% at clinics or health centers.
Can children and pregnant women get the vaccine?
Access may be different for some pregnant women and children.
In May, Kennedy announced major changes to COVID-19 recommendations for children and pregnant women. In updated recommendations, children are able to get the vaccines after consulting with a health care provider, what's known as shared decision-making.
Then, emergency use authorizations for COVID-19 vaccines were rescinded, which means Pfizer's Covid-19 vaccine, Comirnaty, is no longer authorized for children younger than 5. Moderna's Spikevax vaccine is approved for children as young as 6 months, but only if they have an underlying condition that puts them at higher risk. Children who are 12 and older and have at least one underlying condition that puts them at severe risk of severe disease are eligible for Novavax's COVID-19 vaccine, the only protein-based, non-mRNA vaccine available in the U.S.
The American Academy of Pediatrics broke with the CDC to make a broader recommendation for the COVID-19 vaccine. It says that all children ages 6 months through 23 months should receive a COVID-19 vaccine unless they have known allergies to the vaccine or its ingredients. It also recommends a single dose of the vaccine for children ages 2 through 18 years if they are at high risk of COVID-19, residents of long-term care facilities, have never been vaccinated against COVID-19 or live in a household with people who are high-risk for COVID-19. It also says the vaccine should be available for this age group even if they are not in these risk groups.
AAP President Dr. Susan Kressly said this week's more limited vaccine approvals add "further confusion and stress for parents trying to make the best choices for their children," which could be a barrier to vaccination.
Experiences may vary for women during pregnancy, as well. After the recommendation changes announced by Kennedy, there is no CDC guidance or recommendation for women who are pregnant. Some women reported since the shift that they were unable to get a COVID-19 vaccine.
However, pregnancy or recent pregnancy remain on the list of conditions that put someone at higher risk for severe COVID-19, and the American College of Obstetricians and Gynecologists recently reaffirmed support for COVID-19 vaccination during pregnancy.
Will insurance cover updated COVID-19 vaccines?
People who are covered by public insurance such as Medicare and Medicaid and who meet the new FDA eligibility requirements will probably continue to have COVID-19 vaccines covered, experts say.
There's more uncertainty around how private insurance companies will choose to adjust coverage. Some of the conditions listed as high risk for COVID-19 – such as physical inactivity – are loosely defined and may be left up to individual plans to interpret.
Under the Affordable Care Act, insurance companies are required to cover vaccines for adults if they've been recommended by ACIP, the CDC's vaccine advisers. That group has endorsed COVID-19 vaccines in previous years, but there's a gray area around what will happen if their recommendations differ from the CDC's own recommendations, experts say.
The committee also votes on whether vaccines should be added to the federal Vaccines for Children program, which provides immunizations to children whose families would not otherwise be able to afford them.
Can people who do not meet the new eligibility criteria still get a COVID-19 shot?
FDA Commissioner Dr. Marty Makary said in a post on X that "100% of adults in this country can still get the vaccine if they choose. We are not limiting availability to anyone."
Health care providers can provide COVID-19 vaccines "off-label" for those who do not meet the new eligibility criteria based on their age or overall health, Dr. Tina Tan, president of the Infectious Diseases Society of America, said in a statement Wednesday. A medical product is "off-label" when it's used outside of the terms for which the FDA has explicitly approved it.
"And IDSA strongly urges doctors to continue recommending and administering vaccination to their patients based on the best available science," she said. "However, pharmacists' ability to provide off-label vaccines may be severely constrained, underscoring the vital role of physicians and other clinicians in maintaining access."
