By Michael Erman
Aug 12 (Reuters) – President Donald Trump’s order directing Americans to receive separate measles, mumps and rubella vaccines faces an immediate obstacle: none of the individual shots are licensed in the United States and experts say it could take years before any become available, if they ever do.
Two manufacturers – Merck & Co and GSK – are licensed to make combined measles, mumps and rubella shots for patients in the United States. Single disease shots for these diseases have not been available in the U.S. since Merck stopped making them in 2008. They are not routinely used in most other countries.
Merck and GSK said in statements there is no published scientific evidence supporting the separation of the vaccines and decades of evidence supporting the safety of their combined shots.
“Even under current expedited review pathways, it could take years – potentially as many as 10 – to meet the safety and efficacy requirements to obtain FDA approval and then begin manufacturing and commercialization” of single disease shots, Merck said.
Trump signed the executive order on Monday calling for fewer childhood vaccinations, which he said would give U.S. children “gold-standard” protection. According to the order, “the combined measles, mumps, rubella (MMR) vaccine should be administered in three separate single-disease shots once such products are domestically available.”
At a press conference on Monday, Trump suggested that vaccines cause autism, despite a lack of scientific evidence that there is a link. Some public health experts said the order could increase vaccine hesitancy, exposing more children to vaccine preventable illnesses.
The CDC and many major medical groups have long recommended the combined vaccine because it reduces the number of injections and lowers the risk that children will miss protection against one of the three diseases.
Dr. Andrew Racine, president of the American Academy of Pediatrics, said although it’s possible to separate out the MMR vaccine into its constituent components, each of those different components would have to be manufactured and have to be tested.
“They wouldn’t be able to do that probably for another 10 years, and there’s no indication that they have any interest in doing that.”
Establishing and receiving regulatory approval for just the manufacturing processes for the separate shots could be a timely and costly process, said Jesse Goodman, former Chief Scientist at the FDA.
“They’d be making three times as many vials or vaccines and filling three times as many,” Goodman said. “It’s not like they have facilities sitting around idle – so they might need to either change current facilities or even create additional capacity for them.”
Still, a White House official said on Monday the administration would work with the private sector to make the option of separate vaccines available for parents, relying on market-based solutions.
“Right now we have a lot of Americans and a lot of American parents who want to see additional options,” the official said.
Dorit Reiss, a professor of law at UC Law San Francisco who focuses on vaccine policy, said in the past it took at least 10 to 18 months to get new vaccines licensed. Given Trump is already more than a year-and-a-half into a four-year term, vaccine makers might try to hold off on following the order.
“It might not happen if the companies don’t really want it. The companies might say, ‘Well, we are going to wait this administration out… Maybe it’s not worth investing,” Reiss said.
(Reporting by Michael Erman in New Jersey; Additional reporting by Julie Steenhuysen in Chicago and Ahmed Aboulenein in Washington; Editing by Lincoln Feast.)
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