Key facts
- President Donald Trump's executive order aims to separate combination vaccines, such as MMR, into individual shots.
- The order also suggests spacing out vaccine appointments.
- Experts warn of significant financial and logistical hurdles for parents, healthcare providers, and drug manufacturers.
- Reviving individual vaccines not marketed in the U.S. for decades and building new manufacturing facilities would be necessary.
- Public health experts state there is no scientific basis for the proposed changes and that it could lead to lower vaccination rates.
- The FDA would need to undertake a novel review and licensing process for these unbundled vaccines.
President Donald Trump's executive order mandating the separation of childhood vaccines, such as the measles, mumps, and rubella (MMR) shot, into individual injections and spacing them out, has drawn sharp criticism from public health experts. The order, announced Monday, faces substantial logistical and financial obstacles, according to health officials and pharmaceutical scientists.
Experts argue that fulfilling the order would require drugmakers to revive individual vaccines that have not been marketed separately in the U.S. for decades. This would necessitate significant investment in new studies and manufacturing facilities, potentially costing tens of millions of dollars and taking years to implement. The current standard of care in the U.S. since the early 1970s involves combination shots, which studies show increase the likelihood of children being fully vaccinated.
For parents, the proposed changes would mean more frequent doctor visits, potentially straining pediatricians' resources and increasing costs associated with supplies. Dr. Anna Durbin of Johns Hopkins Bloomberg School of Public Health stated that such measures are less convenient, more expensive, and likely to result in fewer children receiving vaccinations, calling it "very bad public health policy."
Pharmaceutical scientists and former regulators like Dr. Jesse Goodman, a former FDA vaccine chief, highlighted that companies would need to conduct extensive studies to demonstrate that individual shots elicit immune responses comparable to combination vaccines. The FDA would also face the unprecedented task of reviewing and licensing each unbundled vaccine separately. Industry experts estimate that designing and building new vaccine plants can take about five years.
Merck and GSK, major suppliers of U.S. childhood vaccines, stated they stand by their current combination products and noted the lack of scientific evidence supporting the separation of the MMR vaccine. White House spokesman Kush Desai, however, contended that the administration's efforts would provide parents with more options, ultimately increasing vaccination rates.