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CDC approves updated COVID-19 vaccines for children, adults

September 12, 2023

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The Centers for Disease Control and Prevention (CDC) recommends everyone 6 months and older get an updated COVID-19 vaccine.

The new vaccines from Moderna and Pfizer-BioNTech aim to better match circulating virus strains and are expected to be available later this week.

“We have more tools than ever to prevent the worst outcomes from COVID-19,” CDC Director Mandy K. Cohen, M.D., M.P.H., said in a press release. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”   

The authorizations come as the CDC reports just over 17,000 COVID hospitalizations in the past week, an increase of 15.7%. Deaths rose 10.5% in the most recent week. While these rates are significantly lower than earlier in the pandemic, hospitalization rates have been rising steadily since mid-July and are expected to increase this fall and winter.

The Food and Drug Administration (FDA) authorized the updated vaccines Monday, and the CDC’s Advisory Committee on Immunization Practices (ACIP) held an all-day meeting Tuesday in which members voted 13-1 in favor of recommending the vaccines for everyone 6 months and older.

The updated vaccines are intended to address waning protection and evolving strains. All circulating strains are omicron and most are from the XBB lineage, according to the CDC. The updated vaccines contain the XBB.1.5 strain.

Moderna presented data Tuesday on 101 adults showing the updated vaccine improved the neutralizing antibody response against XBB. Pfizer-BioNTech data in mice also showed a neutralizing antibody response against circulating strains. Safety profiles are expected to be similar to previous versions of the vaccines.

The CDC aimed to simplify the recommendations, which have been especially complex for children. It recommends everyone ages 5 years and older receive one dose of an updated mRNA vaccine. The updated dose should be given at least two months after any previous COVID vaccine dose.

Children ages 6 months through 4 years should complete a multidose initial series (two doses of Moderna or three doses of Pfizer-BioNTech) with at least one dose of the updated vaccine. All doses should be from the same manufacturer. More details are available in the CDC interim clinical considerations.

People who are moderately or severely immunocompromised should complete a three-dose initial series with at least one dose of the updated vaccine and may receive additional updated vaccine doses.

The updated COVID-19 vaccines can be administered at the same time as other age-appropriate vaccines as well as monoclonal antibody nirsevimab to protect young children from respiratory syncytial virus. Bivalent mRNA COVID vaccines are no longer authorized for use. State immunization programs will provide guidance on discarding bivalent vaccines. The AAP expects to have an updated dosing guide ready this week.

CDC advisers considered recommending the updated vaccines only for certain high-risk groups like the elderly, immunocompromised and those with high-risk medical conditions. However, experts ultimately chose a universal recommendation noting the large number of people with underlying conditions and the desire to allow access to everyone who wants a vaccine. Modeling estimated a universal recommendation for the updated vaccines would prevent about 200,000 more hospitalizations and 15,000 more deaths over two years compared to recommending vaccination only for people 65 years and older.

“The disease burden does vary greatly by age, but there is serious illness (and) death across all age groups, including among those without underlying medical conditions,” said ACIP COVID-19 vaccine work group Chair Matthew F. Daley, M.D., FAAP, senior investigator at the Institute for Health Research at Kaiser Permanente Colorado.

The CDC also noted vaccination could help children avoid long COVID and school absences.

ACIP member Pablo J. Sanchez, M.D., FAAP, a neonatologist and pediatric infectious diseases specialist at Nationwide Children’s Hospital in Columbus, Ohio, cast the lone “no” vote saying he would prefer to recommend vaccination for people at high risk of severe disease.

“We have extremely limited data on children and infants and other individuals,” Dr. Sanchez said.

However, other members said they felt comfortable with the data.

“I think today we’ve heard a wealth of evidence about the risks, the benefits, an extremely comprehensive dealing with the issue,” said ACIP member Beth P. Bell, M.D., M.P.H., clinical professor in the Department of Global Health at the University of Washington. “ … I think that it indicates there’s all kinds of robust information that show robust benefits of vaccination on severe illness, on death, probably on long COVID.”

ACIP member Camille N. Kotton, M.D., FIDSA, FAST, clinical director, transplant and immunocompromised host infectious diseases at Massachusetts General Hospital, said she is “strongly in favor of a universal recommendation providing clarity and hopefully confidence in the CDC.”

The vaccines recommended Tuesday are the first COVID vaccines that will be distributed commercially instead of through the U.S. government. Most commercial and government insurance plans and the Vaccines for Children program will cover the vaccines at no cost to patients. A new, temporary Bridge Access Program will provide no-cost access to the vaccines for adults without insurance or whose insurance will not provide no-cost coverage.

The FDA also is reviewing an updated protein subunit COVID-19 vaccine from Novavax. In the meantime, the original Novavax COVID vaccine remains authorized as a two-dose primary series or a booster in limited situations.




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