Trump Vaccine Plan Requires Millions of Long-Unused Shots
President Donald Trump’s executive order calling for major changes to the childhood vaccination system could face formidable practical and financial barriers, with experts saying drugmakers would potentially need years to develop separate vaccines while families could be forced to make substantially more visits to pediatricians.
The order announced Monday directs federal officials to pursue the separation of combination vaccines, including the measles, mumps and rubella, or MMR, vaccine, into individual injections. It also calls for appointments involving other childhood vaccinations to be spaced apart whenever possible.
Putting those directives into practice would require pharmaceutical manufacturers to bring back individual vaccines that have largely disappeared from the American market over the past several decades. Companies could also need new production facilities capable of manufacturing millions of additional doses.
Families would face their own logistical challenges. Separating the three components of the MMR vaccine and spreading out other immunizations could require parents to make numerous additional trips to doctors’ offices. Pediatric practices could face increased workloads, while the greater number of injections would increase spending on syringes and other medical supplies.
Research conducted in the United States and abroad has found that combination vaccines make it more likely that children will receive full protection against infectious diseases before reaching school age.
Public health experts opposed to Trump’s plan argue that there is no scientific justification for abandoning the current approach.
“We do things that are less convenient and more expensive if there’s a good reason to do it,” said Dr. Anna Durbin, of the Johns Hopkins Bloomberg School of Public Health.
“There is no good justification for this. I think it’s very bad public health policy.”
Trump’s order gives federal officials 90 days to formulate plans for separating the MMR vaccine and increasing the intervals between other vaccinations.
Scientists in the pharmaceutical industry and individuals who previously served as federal regulators say implementing those changes could take years rather than months, potentially requiring manufacturers to spend tens of millions of dollars on research and new production infrastructure.
There are currently no individual measles, mumps or rubella vaccines available in the United States.
Every vaccine for those three diseases currently approved by the Food and Drug Administration is administered as a combination product. The three-in-one MMR vaccine has been standard practice in the United States since the 1970s.
Dr. Jesse Goodman, who previously headed the FDA’s vaccine division, said manufacturers could be required to undertake extensive studies demonstrating that newly produced standalone vaccines generate immune responses in children comparable to those produced by existing products. How much additional research would be necessary could depend on the quality of historical data involving the older standalone vaccines and how FDA officials assess that evidence.
“The question is how much has changed since then and how comfortable will the FDA and the companies be relying on those comparisons,” said Goodman, who is now a professor at Georgetown University.
Manufacturers could also be required to establish that new production facilities and manufacturing methods are safe, particularly because individual measles vaccines have not been produced on a large scale in the United States for decades.
Industry experts say designing and building a vaccine manufacturing facility and securing the necessary federal approvals generally takes approximately five years.
Goodman said another challenge would involve the FDA individually reviewing and licensing each vaccine separated from an existing combination product, something regulators have not previously been called upon to do on this scale.
“I don’t think there’s any comparable example of removing hugely effective public health measures that protect babies for no documented scientific reason,” he said.
Standalone vaccines for measles and similar illnesses are more commonly used in lower-income countries where combination MMR vaccines can be less affordable. Merck, GSK and the small group of other manufacturers supplying childhood vaccines in the United States currently produce only combination versions for the American market.
Merck and GSK each issued statements defending the safety and effectiveness of their existing vaccines. Neither company indicated that it intended to begin producing separate versions.
“To date, there has been no published scientific evidence that shows any benefit in separating the combination MMR vaccine into three individual shots,” Merck said in an emailed statement.
Under the current vaccination schedule, children receive two MMR injections, with the first generally administered at age 1 and the second after age 4. Administering measles, mumps and rubella vaccines separately could turn those two injections into six separate office visits.
If vaccines protecting against pertussis and other infectious illnesses were similarly separated and spaced apart, the number of appointments required for a fully vaccinated child could increase substantially further.
Durbin said requiring additional appointments would make it more likely that families miss scheduled visits or eventually stop returning for subsequent vaccinations.
“It’s going to be less convenient, more expensive, and you’re going to have fewer people getting vaccinated,” she said.
Trump has argued for more than a decade that American children receive too many vaccines and that immunizations should instead be administered in smaller numbers over a longer period, a position that has conflicted with recommendations from major medical organizations.
Last year, Trump asked Health Secretary Robert F. Kennedy Jr. to examine whether the number of recommended childhood vaccinations could be reduced. Kennedy and other administration officials have cited countries such as Denmark, whose recommended vaccination schedules include somewhat fewer immunizations than those in the United States.
Durbin noted, however, that separating combination vaccines could ultimately produce the opposite result in terms of individual injections, leaving American children receiving considerably more shots than children in comparable countries.
White House spokesman Kush Desai defended the administration’s approach, saying its work regarding the MMR vaccine “will give parents more options on timing and frequency for their children, which ultimately will increase vaccination rates for all three diseases.”
Despite the sweeping nature of the executive order, some specialists question whether it will ultimately produce significant changes to the vaccines available to American families.
Neither the White House nor the FDA has the power to force pharmaceutical manufacturers to develop new standalone vaccines and submit them for regulatory approval. Companies could also have little commercial reason to invest heavily in separate versions of vaccines that they already successfully market as combination products.
“They’d be competing against themselves, and there’s no reason to do that,” said Dr. Paul Offit, a Children’s Hospital of Philadelphia vaccine researcher and former government adviser.
The executive order also calls for additional federal research and recommendations, but decisions requiring vaccinations for children attending school are made by state governments rather than the federal government. The administration’s directive therefore recommends that states consider revising their laws to conform with its proposed approach rather than requiring them to do so.
“I think states will ignore this,” Offit said. “I think that bottom line is that we don’t need to look to Donald Trump for our medical advice.”
{Matzav.com}
