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Drugmakers, feds plan to avert second infant RSV shot shortage

BY: CHELSEA CIRRUZZO, DAVID LIM | 05/29/2024 05:00 AM EDT

New parents should have easier access to a shot that protects against a common respiratory virus this fall after widespread shortages last year, according to manufacturers and federal officials.

As the shot heads into its second year on the market, more parents have heard about it and demand is expected to be stronger than last year. Top Biden administration health officials have repeatedly met with vaccine-makers AstraZeneca and Sanofi in recent months to ensure there is enough supply early in the season.

“We all know that last year there was a supply-demand mismatch,” said Demetre Daskalakis, director of the CDC’s National Center for Immunization and Respiratory Diseases. He added that CDC is working with CMS to ensure that providers receive reimbursement when shots are administered, and efforts are being made to get private insurance plans to cover the shots.

RSV, or respiratory syncytial virus, hospitalizes 58,000 to 80,000 children under age 5 each year, and in severe cases can be fatal. In recent winter seasons, parents have been fighting the triple threat of RSV, flu and Covid-19, and this year will likely be no different.

Last year, enough doses were available to immunize nearly 40 percent of U.S. infants, and manufacturers plan to more than double the number of available U.S. doses this upcoming season, according to Ayanna Santos, head of the RSV franchise in Sanofi’s U.S. vaccines unit.

“We see demand being pretty high this year,” said Chan Harjivan, who works on domestic preparedness in the White House’s Office of Pandemic Preparedness and Response Policy. “Our goal is to work with the pharmaceutical companies to make sure that they can meet that demand with their supply.”

AstraZeneca’s monoclonal antibody shot Beyfortus cuts by about 90 percent the risk of RSV-associated hospitalization for infants in their first respiratory virus season — but shortages of the drug last year left many families without the immunization.

“Last year, CDC pivoted to only giving the shot to high-risk kids. That was scary for us,” said Stacey Bartell, medical director for career and practice at the American Academy of Family Physicians.

Sanofi, which leads commercialization efforts for the therapy, said that efforts to expand manufacturing are progressing as planned.

“Based on this, and assuming regulatory validations are delivered in due time by regulatory agencies, Sanofi and AstraZeneca are confident to meet global commitments and build inventory that can be used in future RSV seasons,” Santos said in an email. “In addition, the companies are producing Beyfortus well in advance of the RSV season, with the vast majority of doses planned to be available by October.”

CDC Director Mandy Cohen and agency officials recently visited a Thermo Fisher Scientific manufacturing plant in Greenville, North Carolina, that handles what is known as fill and finish for Beyfortus. CDC spokesperson Kathleen Conley said the visit was one of many meetings the agency is having to prepare for the RSV season.

Still, there could be surprises. A manufacturing insider familiar with AstraZeneca’s production efforts granted anonymity to speak candidly about the upcoming season said that while manufacturing capacity is stronger, the shot is complicated to make.

“If there were any hiccups along the way, that would potentially cause a disruption,” the person said, adding that pivoting to produce more in the moment is not a surefire solution.

The FDA last summer approved the first shot to protect babies against the virus but the unanticipated demand for it forced the CDC to urge providers to ration the shots.

According to providers, avoiding last year’s shortages will depend on having adequate supply early — with shots in freezers ideally by Sept. 1 — and transparency from officials and manufacturers about how many doses are available.

“Last year was the early adopters,” said Nathaniel Beers, executive vice president of community and population health at Children’s National Hospital.

Unlike last year, hospitals can order the shots at the same time they order their flu shots, said Terri Wilson, vice president of pharmacy at the Children’s Hospital Association. That will help keep up with demand.

“My hope is that the federal government can work in lockstep with Sanofi in hopes they overproduce. There’s a two-year expiration on these vaccines, so even if they overproduce, there’s no great risk,” Wilson said.

The CDC has been working to increase the number of birthing hospitals enrolled in the Vaccines for Children program, which provides free vaccines to kids whose parents may not be able to afford them. That means some newborns might receive the shot before they leave the hospital.

But some providers are still a bit wary of how to manage the number of shots they carry, particularly given the high price of the medication, which can run over $500 per dose.

“This medication is quite expensive. It’s not something [providers] want extra supply of,” Beers said.

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