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Trump’s vaccine plan would require millions of individual shots last used decades ago

Public health experts have been quick to condemn an executive order from President Trump aimed at upending childhood vaccinations in the U.S., but the biggest obstacles may be the unprecedented financial and logistical challenges it would impose on parents, health providers and drugmakers.

Monday’s announcement by the Republican president calls for separating combination shots — including the measles, mumps and rubella, or MMR, vaccine — into separate injections. Appointments for that and other vaccinations should be spaced out whenever possible, the order states.

To accomplish that, drugmakers would need to revive a slate of individual vaccines that have not been marketed separately 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.

For parents, unbundling the MMR vaccine and spacing out the shots would mean returning to the doctor’s 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.

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.

Health experts say there is no scientific basis for changing course.

“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 plan would require vaccine manufacturing overhaul

Under Trump’s executive order, federal officials are instructed to develop within 90 days plans for breaking up the MMR shot and spacing out other vaccines.

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.

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 are combination shots. That three-in-one approach has been the standard in the U.S. since the early 1970s.

Dr. Jesse Goodman, a former FDA vaccine chief, said companies would have to conduct large studies showing new individual shots produced immune system-boosting reactions in children similar to the current versions.

Companies might also have to demonstrate the safety of new manufacturing facilities and procedures, given that individual measles shots haven’t been widely produced in the U.S. for roughly a half-century.

“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.

Designing, constructing and getting federal sign-off for new vaccine plants typically takes about five years, according to industry experts.

Additionally, Goodman said the FDA would have to review and license each unbundled vaccine separately, a process with no 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,” he said.

Individual shots for measles and related diseases tend to be used by lower-income countries that can’t afford the MMR shot. Merck, GSK and the handful of other companies that supply U.S. childhood vaccines make only the combination shot.

In separate statements, Merck and GSK said they stand by the safety and effectiveness of their products. Neither discussed plans to unbundle their shots.

“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.

Parents would need to make many more trips to the doctor

The MMR shot is currently delivered in two doses — 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.

As the number of visits goes up, parents are more likely to miss appointments or stop making them, according to Durbin.

“It’s going to be less convenient, more expensive and you’re going to have fewer people getting vaccinated,” she said.

Since last year, Trump has repeatedly expressed concern about the number of vaccinations U.S. children are receiving and called on Health Secretary Robert F. Kennedy Jr. to reduce the number. Kennedy and other officials have pointed to smaller countries, such as Denmark, that recommended slightly fewer vaccines than the U.S.

But breaking up combination shots will result in kids receiving many more individual shots than other comparable nations, Durbin notes.

White House spokesman Kush Desai said the Trump administration’s efforts on 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.”

Vaccine order is not legally binding

Despite the precedent-breaking nature of Trump’s order, some experts are skeptical it will result in meaningful changes.

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.

“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.

While Trump’s 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’s approach.

“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.”

Perrone writes for the Associated Press. AP videojournalist Mary Conlon in New York contributed to this report.

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Sen. Darline Graham tests value of famous name in South Carolina primary

Few people have anything bad to say about Darline Graham, who was catapulted from obscurity last month when she was appointed to replace her late brother Lindsey Graham in the U.S. Senate.

“I think Darline’s wonderful,” said Kathy Bustos of Mount Pleasant after attending a Republican forum recently.

But that doesn’t mean Bustos wants to vote for her in the state’s special primary Tuesday.

“I think it’s a very nice gesture for her to have the rest of his term to complete, but I’m not sure that she’s really qualified or ready to be elected to the Senate,” she said.

It’s a common sentiment among Republican voters pondering an unexpected decision about replacing Lindsey Graham, who was nominated for a fifth term before he died last month from a tear in his aorta. Darline Graham was often by his side throughout his career, but she remains largely unknown in South Carolina’s clubby political circles.

President Trump has endorsed her, and she’s backed by the National Republican Senatorial Committee, which is running television advertising to support her candidacy.

However, Graham has been largely absent from the campaign trail, spending most of her time in Washington as an interim senator. Her appointment to the role, instead of giving her a leg up over the competition, may ultimately hold her back by preventing her from getting to know voters during a weeks-long sprint to Tuesday.

A crowded field

She is up against several well-known Republicans, including Reps. Russell Fry and Ralph Norman, as well as former Gov. Mark Sanford. The crowded field makes a runoff more likely, and it would be held Aug. 25.

All of them spoke at a Friday meeting of the Fourth District Republican Club in Greenville, but Graham sent a video message, saying she was “in Washington working hard for you.” She promised to be “a great friend and ally” to Trump and that she wanted to “earn your vote.”

And at a candidates event in Florence on Saturday, where Graham spoke, some of her supporters said they backed the interim senator’s decision to stay in Washington, even if it meant not campaigning.

“She committed to not missing votes or not being there to push forward with those bills,” said Teresa Castrinos, who made the hours-long drive from Bluffton to see Graham. “I feel like she’s putting South Carolina first. She’s wanting to fulfill her time as a senator right now, so I really admire her for that.”

A low profile

While Lindsey Graham was single and well-known around the world, his sister lived a relatively quiet life with her husband and daughters in Lexington, S.C. She spent years in state government, working with people with disabilities and as an agency head of the South Carolina Commission for the Blind.

Before participating in Saturday’s event in Florence, her only public campaign event had been a candidates forum in Lexington. Charles Brentnell of Greenville County, who said he was still considering whom to vote for, liked her decision to stay in Washington when the Senate was in session.

“Let’s keep the Senate at the Senate instead of taking a month off for no good reason,” he said.

Appearing alongside other contenders Saturday, Graham apologized for reading from notes from a lectern, pointing to the Senate votes that kept her in Washington until just hours before she headed to meet voters in South Carolina.

“Yes, I have some notes. You know why? Because I haven’t slept in two days, so I’m going to keep my thoughts straight,” Graham said, adding that she opposed Senate recess but lost out to others who wanted to end votes and go home. “I wanted to stay there, and I wanted to get things done.”

Graham also participated in one of two televised debates, where she backed Trump’s plan to change filibuster rules to make it easier to pass the president’s bill for strict voter ID requirements.

While other candidates came to speak to the media gathered afterward, Graham skipped the session and merely gave a thumbs-up outside when asked how she felt the debate had gone.

In contrast to her loquacious late brother, Graham has not spoken with reporters in Capitol Hill hallways or fielded questions on the stump.

She’s spoken at length to Fox News personalities Sean Hannity and Trey Gowdy, both of whom eulogized Lindsey Graham at memorial services last month, and granted two interviews to local news outlets.

On Saturday, in her first gaggle with reporters, Graham addressed some of voters’ concerns, reiterating her commitment to do Senate work when the chamber is in session.

“I feel like my job is to be in D.C. working for everyone right now. I hate that I can’t be here. I want to be here,” she said. “That’s why I left and didn’t sleep at all last night, so I could attend today’s event.”

As to the skepticism in sending her to Washington for six years, Graham cited her state government experience, plus the last several weeks she’s had serving as interim senator.

“Trust me, I have learned a lot already, so I think I have experience,” she said.

A second debate took place while Graham was in Washington on Tuesday, a date her campaign pointed out had been scheduled despite the senator’s conflict.

Gigi Bray of Charleston said the idea of Darline Graham serving in the interim makes sense, but electing her to a full term does not.

“I think it’s a great honor for her to hold her brother’s spot till November, but it’s time for a change,” said Bray, who backs Sanford. “I don’t think she has a lot of government experience, and I think right now, with the state of our country, I think it’s very important that somebody has experience.”

Kinnard writes for the Associated Press.

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