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WASHINGTON (AP) \u2014 Public health experts have been quick to condemn an executive order<\/a><\/span> from President Donald Trump<\/a><\/span> aimed at upending childhood vaccinations<\/a><\/span> in the U.S., but the biggest obstacles may be the unprecedented financial and logistical challenges it would impose on parents, health providers<\/a><\/span> and drugmakers.<\/p>\n Monday\u2019s announcement by the Republican president calls for separating combination shots<\/a><\/span> \u2014 including the measles<\/a><\/span>, mumps and rubella, or MMR, vaccine \u2014 into separate injections. Appointments for that and other vaccinations should be spaced out whenever possible, the order states.<\/p>\n To accomplish that, drugmakers would need to revive a slate of individual vaccines that have not been widely used in the U.S. for decades. They would also have to build new manufacturing plants capable of producing millions more vaccine doses than the nation currently uses.<\/p>\n For parents, unbundling the MMR vaccine and spacing out the shots would mean returning to the doctor\u2019s office many more times than is currently needed. Those appointments could also strain pediatricians who typically administer the shots, while driving up costs tied to syringes and other medical supplies.<\/p>\n Studies in the U.S. and other countries have shown that combination vaccines increase the likelihood that children will be fully protected from infectious diseases before starting school.<\/p>\n Health experts say there is no scientific basis for changing course.<\/p>\n \u201cWe do things that are less convenient and more expensive if there\u2019s a good reason to do it,\u201d said Dr. Anna Durbin, of the Johns Hopkins Bloomberg School of Public Health. \u201cThere is no good justification for this. I think it\u2019s very bad public health policy.\u201d<\/p>\n Under Trump\u2019s executive order, federal officials are instructed to develop within 90 days plans for breaking up the MMR shot and spacing out other vaccines.<\/p>\n But pharmaceutical scientists and former regulators say those changes would likely take years and require drugmakers to spend tens of millions of dollars on new studies and manufacturing facilities.<\/p>\n Currently, there are no individual vaccines in the U.S. for measles, mumps or rubella. All the vaccines approved for those viruses by the Food and Drug Administration<\/a><\/span> are combination shots. That three-in-one approach has been the standard in the U.S. since the 1970s.<\/p>\n Dr. Jesse Goodman, a former FDA vaccine chief, said companies may have to conduct large studies showing their new individual shots produce immune system-boosting reactions in children similar to the current versions. The specifics would depend upon the quality of data from the original standalone vaccines and how it\u2019s viewed by FDA regulators.<\/p>\n \u201cThe question is how much has changed since then and how comfortable will the FDA and the companies be relying on those comparisons?\u201d said Goodman, who is now a professor at Georgetown University.<\/p>\n Manufacturers may also have to demonstrate the safety of new manufacturing facilities and procedures, given that individual measles shots<\/a><\/span> haven\u2019t been widely produced in the U.S. for decades.<\/p>\n Designing, constructing and getting federal sign-off for new vaccine plants typically takes about five years, according to industry experts.<\/p>\n Additionally, Goodman said the FDA would have to review and license each unbundled vaccine separately, a process with no precedent.<\/p>\n \u201cI don\u2019t think there\u2019s any comparable example of removing hugely effective public health measures that protect babies for no documented scientific reason,\u201d he said.<\/p>\n Individual shots for measles and related diseases tend to be used by lower-income countries that can\u2019t afford the MMR shot. Merck, GSK and the handful of other companies that supply U.S. childhood vaccines make only the combination shot.<\/p>\n In separate statements, Merck and GSK said they stand by the safety and effectiveness of their products. Neither discussed plans to unbundle their shots.<\/p>\n \u201cTo date, there has been no published scientific evidence that shows any benefit in separating the combination MMR vaccine into three individual shots,\u201d Merck said in an emailed statement.<\/p>\n The MMR shot is currently delivered in two doses \u2014 the first at the age of 1 and the second dose after age 4. Splitting up the shot into its three separate components would mean six office visits. Spacing out other shots for pertussis and other infectious diseases could multiply the number of visits many more times.<\/p>\n As the number of visits goes up, parents are more likely to miss appointments or stop making them, according to Durbin.<\/p>\n \u201cIt\u2019s going to be less convenient, more expensive and you\u2019re going to have fewer people getting vaccinated,\u201d she said. <\/p>\n For well over a decade, Trump has expressed his view \u2014 against medical groups\u2019 guidance<\/a><\/span> \u2014 that American children receive too many vaccines and that they should be given in smaller doses over a longer period of time. Last year he called on called on Health Secretary Robert F. Kennedy Jr.<\/a><\/span> to look at reducing the number<\/a><\/span>. Kennedy and other officials have pointed to smaller countries, such as Denmark, that recommended slightly fewer vaccinations than the U.S.<\/p>\n But breaking up combination shots will result in kids receiving many more individual shots than other comparable nations, Durbin notes.<\/p>\n White House spokesman Kush Desai said the Trump administration\u2019s efforts on the MMR vaccine \u201cwill give parents more options on timing and frequency for their children, which ultimately will increase vaccination rates for all three diseases.\u201d<\/p>\n Despite the precedent-breaking nature of Trump\u2019s order, some experts are skeptical it will result in meaningful changes.<\/p>\n Neither the White House nor the FDA can compel drugmakers to develop and seek approval for new vaccines. And from a business perspective, companies have little incentive to develop individual versions of vaccines they already sell in combination shots.<\/p>\n \u201cThey\u2019d be competing against themselves, and there\u2019s no reason to do that,\u201d said Dr. Paul Offit, a Children\u2019s Hospital of Philadelphia vaccine researcher and former government adviser.<\/p>\n While Trump\u2019s order calls for more federal research and recommendations, only state governments have the legal authority to require vaccinations for schoolchildren. The order simply advises states to consider updating their laws to reflect the Trump administration\u2019s approach.<\/p>\n \u201cI think states will ignore this,\u201d Offit said. \u201cI think that bottom line is that we don\u2019t need to look to Donald Trump for our medical advice.\u201d<\/p>\n ___<\/p>\n AP videojournalist Mary Conlon in New York contributed to this report.<\/p>\n ___<\/p>\n The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute\u2019s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.<\/p>\n ___<\/p>\n Follow the AP\u2019s coverage of immunizations at https:\/\/apnews.com\/hub\/immunizations<\/a><\/span>.<\/p>\n<\/p><\/div>\nTrump\u2019s plan would require vaccine manufacturing overhaul<\/h2>\n
Parents would need to make many more trips to the doctor <\/h2>\n
Vaccine order is not legally binding<\/h2>\n