Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Romper, in “The RSV Shot for Babies Was Supposed to Save Lives. Then Nobody Could Get It,” by Bryce Covert.
Following is an excerpt:
This virus season was supposed to be different: For the first time, there is a shot that protects young babies from respiratory syncytial virus, or RSV, the leading cause of hospitalization for children under a year old. In July, the Food and Drug Administration approved a new drug to not only reduce the rate of infections but protect babies from the very serious complications of RSV, such as bronchiolitis, inflammation of the small airways in the lungs, and pneumonia.
“It seemed like this advent of this new vaccine was the blessing we were praying for for decades,” says Dr. Rhea Boyd, a pediatrician and public health advocate.
But that blessing has failed to materialize for too many families. Sanofi and AstraZeneca, the companies that make the newly approved drug, called nirsevimab — a monoclonal antibody treatment that goes by the commercial name Beyfortus — grossly underestimated the intense demand from parents, and supplies have all but dried up. The shot is part of the federal Vaccines for Children (VFC) program, which is meant to ensure equitable access to vaccines for children of all income levels, but parents have had to spend hours on the phone and in some cases hundreds of dollars out of pocket just to get it, ensuring there will be vast disparities in who is able to actually obtain it this season.
Dr. Elias Kass’ two-person pediatric practice in Washington state is a case study in how the rollout has gone. The practice received just 25 doses from the state through the VFC program. “That was gone in like five minutes,” Kass says. So many parents wanted the shot that he started asking those who could to pay the $495 private market cost up-front, and he then went on Sanofi’s online store and bought doses directly. He simply didn’t have the cashflow to pay for the doses himself and then hope that insurance would reimburse him, and he was told by his state that Medicaid couldn’t pay for the shots up-front. He was able to get one box, or five doses, that way.
Then even that patchwork system failed. “It just immediately stopped being available,” he says.
“It’s exactly like last year and the year before and the year before. The only difference is that now we know it could have been different.”
A Sanofi spokesperson confirmed in a statement on Nov. 10 that the company is not currently taking orders for 100-milligram doses for children more than 11 pounds because “demand exceeded the available supply for the season.” It is “carefully managing distribution” of 50-milligram doses in the private market and has capped how many a provider can order based on an allocation system. Kass created a bot that refreshes the Sanofi store every four minutes to monitor for when it comes back in stock, and when Romper spoke to him in November, he was expecting one more five-dose shipment that month, which he was going to prioritize for existing patients whose babies were recently born. He had a list of about 50 children waiting to get the shot, some of whom aren’t even his patients, but he has no way to serve them.
Parents’ eagerness to secure the shot for their babies isn’t just driven by an urge to protect them from RSV, which hospitalized huge numbers of people last year. There’s also a short window when infants are eligible to get it at all. The 50-milligram doses are only meant for babies who are at or less than 11 pounds, and the Centers for Disease Control and Prevention (CDC) has urged providers to prioritize babies under six months old and those who are at highest risk. Even if the 100-milligram doses were available, they are only meant for children who are less than eight months old. “They can age out,” Kass says. For some parents, that’s creating “a dire sense of desperation,” says Fatima Khan, co-founder of Protect Their Future, which advocates for equitable access to pediatric vaccines.
Without protection from the new shot, by early November Kass already had pediatric patients testing positive for RSV. Rates are currently climbing. “It’s exactly like last year and the year before and the year before,” he says. “The only difference is that now we know it could have been different.”
Some good news came in mid-December: Sanofi announced that it would make approximately 230,000 additional doses of both 50-milligram and 100-milligram shots available in January. The announcement came after an intense pressure campaign from the White House, but the extra doses will arrive deep into the midst of RSV season, after an increasing number of young children have already been hospitalized.
The botched rollout is especially heartbreaking because Beyfortus held so much promise, particularly after the CDC’s Advisory Committee on Immunization Practices voted in August to include nirsevimab in the Vaccines for Children program. The program ensures free shots for underserved children by contracting with vaccine manufacturers to buy them at a discount and give doses to states. About half of all American children qualify: those on Medicaid, the uninsured, the underinsured, and Alaska Natives and Native Americans. The program has greatly improved vaccination rates, and by including nirsevimab, the CDC ensured that low-income parents wouldn’t face the $495 sticker price per dose.
Some states quickly ordered a lot of doses through VFC, but others were slower and got left behind, so access has become a patchwork depending on where parents live and even which provider they use. “It’s going to depend entirely on the specific location and how much stock was ordered for private and public supply,” says Richard Hughes IV, partner at Epstein, Becker & Green and lecturer at the George Washington University Law School. (Hughes is an advocate for vaccine access.)
“How did Sanofi get this so wrong?” Kass asks. “And also why are they not making more?”
In its statement, the Sanofi spokesperson said there “has been unprecedented demand” despite “an aggressive supply plan built to outperform past pediatric immunization launches.” In an American Academy of Pediatrics webinar in November, Ayanna Santos, head of RSV Franchise in the United States for Sanofi, said, “Obviously, that approach was not sufficient for the demand that we’re seeing.”
The rollout hasn’t just been bumpy, Boyd, the pediatrician, argues; “I’d call it the rollout that never existed.” At her urgent care clinic in California, she had started telling patients that the shot was coming once it was approved and was prepared to give it to anyone who showed up. But her clinic hadn’t gotten any shots when we spoke in early November. “It’s not like we’re even picking and choosing who to give it to,” she says. “Nobody’s getting it.” She saw no signs that the shots would be coming to her clinic anytime soon.
Kass and Boyd’s experiences aren’t isolated. Khan is “hearing from families across the country who want to protect their babies,” she says, but “they are so frustrated that despite having a great option to protect their babies, they still can’t access these treatments.”
Parents are repeatedly calling their pediatricians and other clinics and practices, spending hours and hours on the phone, only to be told there are no available doses. Some have driven hours only to find out that there were no more shots left. “You just have a lot of panic from a lot of new parents,” she says, many of whom are already in the throes of the sleeplessness and chaos of having a newborn.
“It’s not like we’re even picking and choosing who to give it to. Nobody’s getting it.”
“If it’s that hard to get a vaccine, most people are just going to give up,” Khan notes. Many families don’t have $495 lying around to throw at the problem, nor the time to call around and drive long distances to get it from the few clinics that have it. “They don’t have to be anti-vaxxers; they are just tired; they can’t figure it out.”
Had there been enough available doses, the RSV shot’s inclusion in VFC would go a long way toward ensuring equal access. But there are still problems within that longstanding program, and if and when the drug becomes more widely available, they will rear their heads too. Some states — Alaska, Connecticut, Idaho, Maine, Massachusetts, New Hampshire, New Mexico, Oregon, Rhode Island, Vermont, and Washington — employ a universal model where all children can be vaccinated from the CDC-provided stock of vaccines, whether they qualify for VFC or have private insurance. Such a system helps providers enormously, as it means they don’t have to maintain two separate stocks of shots, which can be expensive, especially for such a costly drug like nirsevimab. “It really improves access because it’s a lot easier to run a vaccine program when we’re not paying tens of thousands of dollars for vaccines out of pocket,” Kass says.
But in all other states, doctors who want to participate in the program have to maintain two separate stockpiles, laying out their own funds to buy enough private supply to match the public supply — vaccines are typically the second biggest expense behind staffing faced by pediatric practices. The $495 per dose cost of nirsevimab is a huge financial burden, and private insurers have a year to decide whether and how much they’re going to cover it, so pediatricians still don’t know how much they’ll get reimbursed for the private supply. Plus doctors have to store all the doses, which is another challenge. “It costs a tremendous amount of money to provider practices to do the outlay to purchase all of the product and store the product and manage the inventory,” Hughes says. There are also stringent rules that dictate that providers can’t borrow from one stock to cover children who qualify for the other — so, for example, if a VFC child shows up but that designated supply has run out, the provider can’t give him a shot from the private supply, or vice versa.
And in all states, there is a federal ceiling on what states can pay providers to reimburse them for administering the shots. “So many states pay well below $10 for administration,” Hughes says. That only adds to the financial hardship of participating in the program. Medicare, by comparison, pays $45 for administering the flu shot. “We’re not paying pediatricians enough to vaccinate,” he says. That starves pediatric practices, which already have slim margins, of money they need. Some doctors decide it’s not worth it to participate in the program at all.
If parents can’t get to a nearby pediatrician that participates in VFC, they face either coming up with the means to travel further to one that does or simply giving up. “There is potential for patient attrition,” Hughes says. Privately insured children are vaccinated at a rate that’s up to 38 percentage points higher than those on Medicaid or without insurance.
“The more difficult we make this to access when it comes out, the more people will just remember that something was off, something was wrong.”
Some parents can’t reach a pediatrician to administer vaccines at all — 1 in 4 Americans don’t have a relationship with a primary care doctor. The numbers are even worse for people of color and the gap is widening. Many shots, such as the flu and Covid vaccines, are now being administered through pharmacies, which typically don’t serve young children. “It doesn’t make a lot of sense to have a squirming baby in the pharmacy,” Hughes noted. There used to be a network of public health clinics across the country to fill that void, but long running reductions in public health funding have eaten away at it such that many communities don’t have one.
Nirsevimab has its own unique problem on top of the existing infrastructure challenges: the shots are meant for very young babies born during or just before their first RSV season and, ideally, would be given in the hospital right after delivery. But “hospitals by and large don’t participate in the VFC program,” Hughes says; only about 12% do. Hospitals administer so few pediatric vaccines that maintaining the VFC supply typically isn’t worth it.
One way to ease these challenges would be to give doctors more flexibility in the VFC program. They could be allowed to give any doses, either VFC or private, to administer shots for whichever children walk through the door. “If you have a patient before you that fits the bill for one or the other and you can’t do it because of this supply, that’s silly,” Hughes says. The CDC has given doctors the flexibility to borrow from one supply or the other to give RSV shots, but the doses have to be replaced within one month and the CDC warned that doctors shouldn’t use their VFC stock if they’re unsure about whether they can get more doses from the private market.