President Donald Trump's executive order aimed at splitting the combined measles, mumps and rubella vaccine faces a major hurdle because none of the individual disease shots are currently licensed in the U.S. Only Merck and GSK are licensed to make combined MMR shots for U.S. patients, and Merck stopped manufacturing individual vaccines for these diseases nearly two decades ago. Merck said even under current expedited review pathways it could take years, potentially as many as 10, to meet safety and efficacy requirements for FDA approval and begin manufacturing and commercialization of single-disease shots. Andrew Racine, president of the American Academy of Pediatrics, said each constituent would have to be manufactured and tested, and that drugmakers probably could not do that for another 10 years. The American College of Physicians warned the order could increase costs to patients and families and place a greater burden on families needing multiple appointments.
Merck & Company IncExecutive order to split MMR vaccine faces decade-long regulatory hurdles, delaying potential new product.
GSK plcGSK also licensed for combined MMR, but order could increase costs and burden without clear benefit.
Merck KGaA