COVID-19 vaccines may be recommended only for certain high-risk people this fall.
The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) on Tuesday discussed the possibility of changing its recommendation for universal vaccination but will not make a decision until June. The new recommendation typically would need to be approved by the CDC director. A CDC spokesperson said the chief of staff "will take receipt" of the recommendations in the absence of a director.
During an all-day meeting, the advisers also discussed the ongoing measles outbreak, an at-home flu vaccine, adolescent recommendations for HPV and mpox vaccines, and vaccines to protect against cytomegalovirus (CMV) and Lyme disease (Click each to jump to that section).
Amid declining COVID-19 hospitalizations and low vaccination rates, the majority of ACIP’s COVID-19 work group supports a risk-based COVID-19 vaccine recommendation instead of calling for everyone ages 6 months and older to get vaccinated.
Just 13% of children and 23% of adults have received the 2024-’25 COVID-19 vaccine, according to CDC data.
Among work group members supporting risk-based recommendations, most would include people based on specific conditions and exposures as well as certain age groups. However, they also support allowing anyone wanting the vaccine to continue to be able to receive one.
Some medical organizations have raised concerns about implementation of a risk-based recommendation for COVID-19 vaccines as well as communication, equitable access to the vaccines, and confidence in the recommendations.
The full committee will continue discussing the recommendations and vote on them in June.
People who receive the COVID-19 vaccines next season also may have a new option from Moderna. Its mRNA-1283 vaccine has a streamlined design instead of containing the entire spike protein. It could be given at one-fifth the dose of the original vaccine.
A phase 3 trial in people ages 12 years and older found no safety concerns, including myocarditis or pericarditis, according to Moderna. The updated vaccine also elicited higher immune responses than the original vaccine.
As measles cases continue to rise, a CDC official acknowledged Tuesday that state and federal resources for responding to outbreaks are limited, including in Texas where the highest number of cases have been reported.
The Department of Health and Human Services (HHS) recently cut $11 billion in public health funding to states. While some states have sued, Texas is not among them. HHS also has cut 20,000 of its personnel this year.
Capt. David Sugerman, M.D., M.P.H., FACEP, U.S.P.H.S., a senior scientist for the CDC’s 2025 measles response, said Texas is moving public health staff around to respond to the outbreak, and the CDC has deployed personnel to the state. However, the CDC also is receiving requests for assistance around the country. Each measles case costs about $30,000 to $50,000 for the public health response, he said.
“That adds up quite quickly,” he said. “ … I think that we are scraping to find the resources and personnel needed to provide support.”
There have been 712 confirmed measles cases impacting nearly half of states, according to the CDC. However, this likely is a significant undercount. Seventy-nine people have been hospitalized, including 45 children under 5 years. Three people have died, including two children.
About 97% of cases are among people who are unvaccinated or have unknown vaccination status.
“There’s no reason why we have healthy children dying of measles in the U.S. when this vaccine is amazing,” said ACIP Chair Helen Keipp Talbot, M.D. “It’s highly effective (and) has very long-lasting immunity.”
The AAP is urging Congress to stem the growing measles outbreak by unequivocally promoting vaccination as the only prevention and restoring cuts to vaccine-related funding and public health workers.
AstraZeneca addressed questions Tuesday about making its FluMist nasal spray vaccine available for at-home use next season.
FluMist contains a weakened form of the live influenza virus and has been in use since 2003. In September 2024, the Food and Drug Administration approved at-home use for people ages 2-49 years. Children under 18 years would need an adult caregiver to administer it.
AstraZeneca representatives said the at-home option would increase convenience and flexibility and could help improve vaccination rates. About 48% of children have received a flu vaccine as of March 29, lower than this time last year (52.4%), according to CDC data.
An online pharmacy would determine a person’s eligibility for the at-home vaccine and write a prescription for those eligible. If state laws prohibit prescribing the vaccine to children of a certain age, they would be directed to their pediatrician or pediatric health care clinician.
Packaging would provide step-by-step instructions with pictures, and the pharmacy would provide support when needed. Studies have found people following the instructions were able to administer the spray without mistakes.
The at-home vaccine would be available through private health insurance. Children in the Vaccines for Children program would have access only in provider offices.
If a parent isn’t able to give a child a full dose, such as if the child wiggles during administration, the online pharmacy would report it to the Vaccine Adverse Event Reporting System and work with the family’s insurance to get a second dose spaced out by four weeks, according to AstraZeneca.
ACIP will vote on its influenza recommendations in June.
ACIP is continuing to look at reducing the number of recommended doses of HPV vaccine and rewording recommendations on the ages to get vaccinated.
Gardasil 9 from Merck protects against HPV-related cancer and anogenital warts. HPV is estimated to have caused about 37,800 cancer cases in the U.S. annually from 2017-’21, according to the CDC.
The CDC recommends routine vaccination for people ages 11 or 12 years, but it can be given beginning at 9 years of age. ACIP is looking at recommending vaccination at 9-12 years, which is in line with the AAP Red Book.
Proponents of the change say it could provide more clarity and flexibility. Sean T. O’Leary, M.D., M.P.H., FAAP, chair of the AAP Committee on Infectious Diseases and the AAP’s liaison to ACIP, spoke in favor of updating the wording.
“Ultimately, the way I’ve come to think about this policy question, this is really the only circumstance I’m aware of where the wording in the ACIP recommendation represents a barrier to vaccination by not really emphasizing the flexibility of age 9-12,” Dr. O’Leary said.
However, some have concerns that the change could negatively impact the adolescent vaccine platform, which includes two other vaccines, and that some families aren’t ready to discuss the HPV vaccine at ages 9 or 10.
HPV vaccine is given as a two-dose series to people starting before their 15th birthday and a three-dose series for those starting on or after their 15th birthday. ACIP also is considering recommending just one dose for some age groups and changing the ages recommended for two-doses.
Several studies outside the U.S. have looked at efficacy and immunogenicity of a single dose with generally positive results. Questions remain, however, about long-term efficacy and immunogenicity, protection at sites other than the cervix, and efficacy and immunogenicity in males.
A modeling study conducted by researchers at Harvard University and Université Laval in Quebec, Canada, looked at the potential impact of switching to a single dose in some U.S. populations. It found a single dose would have similar reductions in HPV and cervical cancer incidence to a two-dose series. Even in scenarios where effectiveness isn’t as high as anticipated, researchers do not expect significant increases in infections and cancer rates.
HPV vaccination lags other vaccines recommended for teens. About 77% had received at least one dose, and 61% were up to date, according to the 2023 National Immunization Survey-Teen.
All ACIP HPV work group members are in favor of some change to the number of doses but have differing opinions on extending the two-dose schedule and/or recommending one dose in some age groups. The committee will continue to discuss changes to HPV recommendations at its June meeting and also could vote at that time.
Later this year, ACIP may extend its adult recommendations for the mpox vaccine JYNNEOS to adolescents as cases continue to be reported in the U.S.
Under the proposal, a two-dose series of JYNNEOS would be recommended for those ages 12-17 years who are at risk of contracting mpox during an outbreak.
In addition, a two-dose series would be recommended regardless of an outbreak for adolescents with certain risk factors, including those who are gay, bisexual and other men who have sex with men (MSM) or a person who has sex with MSM who have certain additional risk factors. This recommendation also would include sexual partners of people with these risk factors and people who anticipate experiencing any of these risk factors.
A clade II mpox outbreak has been ongoing globally since 2022. In addition, an outbreak of clade I mpox began in 2023. That outbreak primarily has been impacting the Democratic Republic of the Congo and surrounding countries, although travel-associated cases have been seen in multiple countries, including the U.S.
Since May 2022, there have been more than 30,000 mpox cases and 60 deaths in the U.S., primarily affecting people who are gay or bisexual and MSM. There have been 92 cases in adolescents.
While the JYNNEOS vaccine has been administered to adolescents, it hasn’t routinely been recommended. New data from a phase 2 randomized trial presented Tuesday found JYNNEOS vaccine immunogenicity to be noninferior in adolescents compared to adults. Investigators did not detect safety concerns.
While an ACIP work group favored both recommendations, several ACIP members questioned whether routinely vaccinating adolescents outside an outbreak would be a wise use of resources given the relatively small number of people who would qualify. The committee will continue to discuss the proposals in June and could vote at that time.
Moderna is conducting clinical trials of an mRNA vaccine for women of childbearing age to protect their future children from congenital CMV.
The three-dose vaccine is envisioned for women ages 16-40 years. Phase 1 and 2 trials have found no safety concerns and have shown the vaccine produces an immune response. Efficacy data from a phase 3 trial is expected next year for women without previous CMV infection.
Some questions remain including how long immunity would last and its efficacy against passing CMV to a baby. It also is not yet clear whether women would need to be screened for antibodies to CMV before getting the vaccine.
More than 16,000 children are born with congenital CMV infection in the U.S. every year, with most due to a maternal infection, according to the CDC. About one in five babies with congenital CMV will have birth defects or long-term health problems.
An ACIP work group will continue to meet to review new data as it becomes available.
ACIP also is convening a work group to discuss vaccines to protect against Lyme disease, for which about 476,000 people are treated annually, according to the CDC.
Lyme disease has been increasing steadily over the past decade, but no vaccine is available. A multivalent recombinant protein vaccine is in phase 3 trials, and mRNA vaccine candidates are in early clinical trials.
The new ACIP work group will be looking at the latest data on Lyme disease and make a presentation in June.
ACIP will meet again Wednesday to discuss vaccines to protect against meningococcal disease, chikungunya and respiratory syncytial virus.
