Biologics

Lawmakers Question Plan to Split MMR Vaccine

Congressional Democrats are questioning the Trump administration's proposal to replace combination childhood vaccines with separate injections, a policy that could require new FDA regulatory reviews because single-disease measles, mumps and rubella vaccines are not currently available in the U.S.

In a 10/7 letter to CDC head Erica Schwartz, Sen. Michael Bennet (D-CO), Rep. Kim Schrier (D-WA) and 29 colleagues demanded scientific justification for the administration's August executive order (see earlier story) calling for changes to childhood immunization recommendations.

The order recommends reducing the number of diseases covered by routine childhood vaccination recommendations from 18 to 11, separating the combined MMR vaccine into individual injections once those products become available, and administering vaccines at separate medical visits to the maximum extent feasible.

The MMR proposal has potential implications for FDA. Introducing separate measles, mumps and rubella vaccines would require manufacturers to obtain the necessary agency approvals before marketing those products in the U.S.

The executive order directs HHS, through its Task Force on Safer Childhood Vaccines, to develop plans within 90 days for offering single-disease vaccines while maintaining the availability of combination products.

The lawmakers questioned why the administration was recommending products that are not currently available and requested evidence demonstrating that separating combination vaccines would improve health outcomes. They also asked whether spacing vaccinations across additional visits could leave children susceptible to infection for longer periods.

The letter additionally sought explanations for CDC's handling of measles-associated deaths reported in Pennsylvania and delays in making updated COVID-19 vaccines available through the Vaccines for Children program.

The lawmakers requested written responses by 10/16.

The White House has characterized its vaccine initiative as an effort to expand parental choice and align U.S. recommendations with international practices. The congressional letter challenges the scientific basis for several of those changes.

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