Trump’s vaccine overhaul could bring more shots, higher costs for US families

President Donald Trump’s plan to overhaul childhood vaccinations in the United States could face major financial and logistical hurdles, even as public health experts question the scientific basis for the changes.

An executive order signed by Trump on Monday calls for combination vaccines to be separated into individual shots, including the measles, mumps and rubella (MMR) vaccine. It also directs officials to encourage greater spacing between vaccinations wherever possible, as per an Associated Press report.

The move would require drugmakers to bring back individual vaccines that have not been marketed separately in the US for decades. Companies would also need to develop manufacturing capacity for millions of additional doses, while parents and healthcare providers would face more appointments and higher costs.


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Studies in the US and other countries have found that combination vaccines make it more likely that children will be fully vaccinated against infectious diseases before they start school.

Public health experts say there is no scientific evidence supporting a move away from combination shots.

“There is no good justification for this,” said Dr. Anna Durbin of the Johns Hopkins Bloomberg School of Public Health, calling the policy a bad public health decision.

Drugmakers face years of work

The executive order gives federal agencies 90 days to develop plans for separating the MMR vaccine and spacing out other childhood shots. But pharmaceutical scientists and former regulators say putting such a system into practice could take years.

The US currently has no separately marketed vaccines for measles, mumps or rubella. FDA-approved vaccines for the three diseases are combination products, a system that has been standard in the country since the early 1970s.

Drugmakers would likely have to conduct large clinical studies to establish that individual vaccines generate immune responses in children comparable to existing combination products, said Dr. Jesse Goodman, a former FDA vaccine chief who is now a professor at Georgetown University.

Companies could also have to demonstrate the safety of manufacturing facilities and processes, particularly because individual measles vaccines have not been widely produced in the US for about 50 years.

Building, validating and securing federal approval for new vaccine manufacturing plants typically takes around five years, industry experts said.

The FDA would also need to review and license each individual vaccine separately, creating a regulatory process for which there is no clear precedent.

“I don't think there's any comparable example of removing hugely effective public health measures that protect babies for no documented scientific reason,” Goodman said.

Individual vaccines for measles and related diseases are more commonly used in lower-income countries that cannot afford combination MMR vaccines. In the US, Merck, GSK and other companies supplying childhood vaccines produce combination versions.

Merck and GSK said separately that they continue to stand behind the safety and effectiveness of their vaccines. Neither company outlined plans to split its products.

Merck said there is currently no published scientific evidence showing a benefit from separating the MMR vaccine into three individual shots.

More appointments for parents and doctors

The MMR vaccine is currently administered in two doses — the first at age 1 and the second after age 4.

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If measles, mumps and rubella vaccines were given separately while retaining the same two-dose schedule, children would need six vaccination appointments instead of two. Spacing out other childhood vaccines, including those protecting against pertussis and other infectious diseases, could increase the number of visits further.

That could create additional pressure on pediatricians and increase spending on syringes and other medical supplies.

More appointments could also make it harder for children to complete their vaccination schedules. Parents may be more likely to miss appointments or stop bringing their children for shots as the number of visits rises, Durbin said.

The result, she warned, could be lower vaccination rates rather than higher ones.

Trump has repeatedly raised concerns about the number of vaccines given to US children and has called on Health Secretary Robert F. Kennedy Jr. to reduce the number.

Kennedy and other administration officials have cited countries such as Denmark, which recommend slightly fewer childhood vaccines than the US.

But Durbin said separating combination vaccines would actually leave American children receiving more individual injections than children in comparable countries.

White House spokesman Kush Desai said the administration's approach to the MMR vaccine would give parents greater flexibility over the timing and frequency of vaccinations and ultimately increase vaccination rates against all three diseases.

Order may not force drugmakers to act

The executive order could also face limits because the federal government cannot force pharmaceutical companies to develop or seek approval for new vaccines.

From a commercial standpoint, drugmakers may have little incentive to develop individual versions of vaccines they already sell successfully as combination products.

“They'd be competing against themselves, and there's no reason to do that,” said Dr. Paul Offit, a vaccine researcher at Children's Hospital of Philadelphia and former government adviser.

The order calls for additional federal research and recommendations, but it does not give the White House or FDA authority to require states to change school vaccination rules.

States retain the legal authority to mandate vaccines for children attending school. The order only asks states to consider changes that would align their laws with the administration's approach.

Offit said he expects states to largely disregard the recommendation.

The combination of regulatory hurdles, years of manufacturing work, increased costs and the absence of a clear scientific rationale could therefore make Trump's proposed vaccine overhaul difficult to implement.

(With inputs from AP)