Heading into what could be another bad RSV season, pediatricians share growing concerns about persistent shortages of a crucial new drug that was touted as a game-changer when it was approved in July.
Respiratory syncytial virus (RSV) is a common respiratory virus that kills hundreds of young children each year and hospitalizes thousands, according to the Centers for Disease Control and Prevention. Last year, the virus circulated in greater numbers and the CDC predicts a similarly bad season this year.
Newborn babies younger than 6 months, babies born prematurely, or those who have underlying health problems are most at risk. American Indian and Alaska Native children are at disproportionate risk, even in the second year of life, according to a recent study published in Pediatrics.
This year, a new tool was introduced that promises to turn the tide on childhood RSV hospitalizations: a monoclonal antibody injection called nirsevimab. In August, CDC Director Dr. Mandy Cohen hailed the recommendation as “a powerful tool.”
But now, doctors across the country say they are experiencing alarming shortages and are frustrated with the manufacturer, pharmaceutical company Sanofi. The shortage led the CDC to intervene on October 13 to help sort doses distributed through the federal Vaccines for Children (VFC) program.
Dr. Nirav D. Shah, principal deputy director of the CDC, told ABC News that a five-day temporary pause on nirsevimab orders for the VFC program was implemented to ensure all states had an equitable allocation of the shots. The VFC program offers vaccines to Medicaid-eligible children and those who are uninsured or uninsured, at no cost.
Shah said the CDC is continuing conversations with the shot’s manufacturer and state health agencies to try to find solutions. A Sanofi spokesperson told ABC News that they are “in close collaboration with the Centers for Disease Control and Prevention, which is working to ensure equitable distribution of available doses through the Vaccines for Children Program.”
On October 23, the CDC released a health alert setting out new recommendations to help ensure vulnerable children could be prioritized amid supply shortages. Those groups included infants younger than 6 months and American Indian and Alaska Native (AI/AN) children up to 19 months.
“We are frustrated. Pediatricians are frustrated by this constant change. [of recommendations]unequal access and lack of availability,” said Dr. Anita Henderson, a pediatrician at the Pediatric Clinic, a service of Hattiesburg Clinic and Forrest General Hospital in Hattiesburg, Mississippi, and immunization representative for the Mississippi Chapter of the American Academy. of Pediatrics.
“I feel like we were promised that the launch would be an adequate and on-time supply for the season,” said Dr. Julia Arana, medical director, hospitalist team and chief of staff at East Tennessee Children’s Hospital.
A Sanofi spokesperson told ABC News that the supply constraints were due to “truly unprecedented demand that exceeded our estimates.” In addition to suspending all orders for 100 mg doses of the shot, Sanofi said the lower 50 mg dose will also have allocation limitations in the private market.
“We previously reported that new orders for the 100 mg dose were no longer being accepted as demand exceeded the supply available for the season. Currently, due to demand, we are carefully managing the distribution of the 50 mg doses to the market private to “Meet existing orders and provide equitable access to remaining doses. “Sanofi is in contact with suppliers about distribution plans,” the Sanofi spokesperson said.
The high demand was partly due to the shot’s weight-based dosing.
At launch in September, most eligible babies younger than 8 months who were born before RSV season would need to receive the higher 100 mg dose instead of the 50 mg dose given to infants. that weigh less. of 11 pounds, leading to earlier higher demand for 100 mg doses.
“We knew there would be many barriers to the implementation of nirsevimab that we were anticipating, and pediatricians have been working hard to overcome those barriers, but the manufacturer assured us that supply would not be one of the barriers,” Sean said. T. O’Leary, MD, MPH, FAAP, chair of the AAP Committee on Infectious Diseases, said in an AAP news release.
Doctors have to reject some babies
Henderson said the Pediatric Clinic in Hattiesburg has only received supply through the VFC program, but has not yet received supplies of the vaccine for those with private insurance, meaning families with private insurance who want the vaccine have been turned away.
“[Parents] “They are calling our offices or messaging us daily and weekly asking for this product,” Henderson said. “We want to give it to their babies, but in some situations, in some cases, we can’t get that supply.”
Dr. Alice Phillips, a pediatrician and medical director of Ambulatory Quality at Cook Children’s Health Care System in Fort Worth, told ABC News that her VFC orders are still frozen due to allocation limits, so the supply is running low. in the clinics.
Some hospitals have decided to prioritize vaccines for their most vulnerable babies, regardless of cost or insurance status, and in some cases the $500 cost is absorbed by the hospital, including Cooke Children’s, Phillips said. But they say supplies may not meet demand for these high-risk babies.
“We still have supply, it remains to be seen how long it will last,” Phillips said.
East Tennessee Children’s Hospital has received vaccines allocated by the VFC program, but Arana said they only have enough supply to immunize babies discharged from the NICU. Still, it may not be enough. “I know that the numbers do not meet the demand at all.” Spider said.
Short-term solutions can leave gaps
A federal health official told ABC News that progress is being made and “tens of thousands” of doses are expected as early as this week.
Transparency on the part of the manufacturer has been an issue that likely prevented the CDC and the Indian Health Service (IHS) from forming an equitable allocation plan from the beginning, said Dr. Laura Hammitt, director of infectious diseases programs at the Center Johns Hopkins for Indigenous Health and a Principal Investigator on a clinical trial of nirsevimab.
“I think the company told us all that there would be enough supply. And I think the number of doses available is not publicly known. And that lack of transparency is a problem,” Hammitt said.
After speaking with several clinics serving children across the Navajo Nation, Hammitt says some sites are out of supply and estimates that less than half of these eligible children currently have access to the vaccine.
Dr. Sara Jager, head of the pediatrics department at the Tuba City Regional Health Care Corporation (TCRHCC) on the Navajo Nation, told ABC News that she estimates her health system has less than half the supply it they would need.
So far, TCRHCC has received 50 50 mg doses and 100 100 mg doses, but Jager said it is unknown when more supply will be available. “All over [Navajo Nation] We have trouble accessing more than that,” Jager said.
In a statement to ABC News, IHS said they are advocating for equitable allocation of nirsevimab for AI/AN children and are collaborating with stakeholders, including the CDC and the manufacturer, to do so.
“We are committed to exploring all options and contingencies to ensure access to nirsevimab for our vulnerable pediatric service population,” IHS said.
Dr. Jade A Cobern, MD, MPH is a neonatal hospitalist and member of the ABC News Medical Unit.