The Food and Drug Administration approved the drug, called nilsevimab, in July, making it the first widely available prophylactic antibody treatment to protect healthy infants from respiratory syncytial virus, the leading cause of infant hospitalization in the United States. However, demand for RSV drugs far exceeds supply.
“It’s very frustrating for parents and pediatricians alike to know that this treatment is available and not available,” said Krupa Playforth, a Virginia-based pediatrician. She said, “Pediatricians are struggling with dosage limitations, and it’s been especially difficult to come up with dosage limitations and fielding phone calls from frustrated parents.”
The CDC said additional 100-milligram doses of Nilsevimab will be immediately distributed to hospitals and physicians through the federally-funded Pediatric Vaccine Program and private payers.
“CDC and FDA are committed to expanding access to this important vaccination to give more parents peace of mind during the winter virus season,” said Nirav D. Shah, CDC Principal Deputy Director. said in a statement.
“We communicated the demand and urgent need for additional doses to manufacturers, which allowed us to quickly provide these additional shots to health care providers,” the agency said in an email to The Washington Post. . [and] We were able to identify batches awaiting final clearance and work with FDA to expedite processing. ”
RSV is a highly contagious respiratory disease that can send as many as 80,000 children under the age of five to the hospital each year. According to the CDC.
Nilsevimab, sold under the brand name Bayfortas, is not a vaccine. Instead, the single-dose shot provides similar protection by delivering lab-made antibodies that block invading viruses from entering cells.Experimental data from the manufacturer indicates that nilsevimab Reduced risk of hospitalization due to RSV It decreases by about 80% in infants under 1 year of age.
In August, a CDC advisory panel recommended the drug for healthy infants younger than 8 months during their first RSV season and for children up to 2 years of age if they are at risk of developing severe disease.
But due to low supplies, authorities tightened recommendations in October. Updated recommendations Priority will be given to babies under 6 months of age and those with underlying health conditions. The CDC said American Indian and Alaska Native infants should also be vaccinated if they are under 8 months old.
Some doctors say problems with RSV treatment may be related to low interest in coronavirus vaccines. Many doctors thought he would have little interest in receiving the RSV vaccination, so his health care providers chose not to order too many doses.
“Many practitioners were really afraid to buy these doses in bulk when they actually needed to buy them in advance. [which] That’s what happened with the coronavirus vaccine,” said Anita Patel, a pediatric critical care physician at Children’s National Hospital in Washington.
Cost is a major barrier for doctors to pre-order doses. The Children’s Vaccine Program pays $395 per 100-milligram dose, while the private sector costs $495 per dose.
“I think it was just a little reluctance on the part of the doctors to use guns…they didn’t want to use them.” [cover] …These vaccines are expensive,” Patel said.
Experts say the extra doses likely won’t be enough to fully address the shortage, but many believe it will have a positive impact on communities disproportionately affected by RSV. I’m looking forward to it.
“I think this will certainly make a difference, and I hope that distribution through VFC will allow for more equitable access,” Playforth said. “We hope that with increased supply, more babies who meet the original criteria will be able to receive treatment.”
RSV epidemics usually occur from late fall to early spring, with a peak in winter.The number of infected people has already started to increase this year. some southern statesbut experts say the rise is typical.
“While the number of respiratory syncytial virus infections is rising, we don’t expect a season like last year,” said Sean T. O’Leary, a pediatric infectious disease expert at the University of Colorado and chairman of the committee. Stated. Researched infectious diseases at the American Academy of Pediatrics. “We’re hoping for a normal season. Seasons are always bad, but not as bad as last year’s unprecedented nature.”
