This summer, for the first time, there were two vaccines against respiratory syncytial virus, which is especially dangerous for the elderly and infants. Only one of them – Abrysvo, made by Pfizer – was Approved for pregnant womenAnd it was not for small children.
The distinction seems to have slipped by some clinicians and pharmacists.
At least 128 pregnant women were mistakenly given an alternative vaccine – Arexvy, by GSK – and at least 25 children under the age of 2 received the vaccine, according to the Centers for Disease Control and Prevention. warned.
Dr. Sarah Long, a pediatric infectious disease physician and consultant to the agency, said she was “blindsided” by the reports. “It’s very unfortunate that this happened,” she said.
Arexvi has not been studied in pregnant women or children, so information on its effects in those groups is limited. No serious injuries have yet been confirmed by the bugs, but in most reported cases the consequences are unknown.
Based on the available data, Dr. Long said she is more concerned about young children who receive the RSV vaccine than pregnant women or their children who receive Arexvi. Data from animal studies “strongly suggest” that ArexV may worsen rather than reduce RSV infection in children younger than 2 years of age. such as the Food and Drug Administration.
To prevent that, the CDC recommends that children who mistakenly receive both vaccines be given nirsevimab (marketed as Bayfortus). Strong defenseWhile RSV season lasts.
Up to 80,000 children Every year in the United States, children under the age of 5 are hospitalized with RSV infections, and the virus is a global killer of children.
In the year In 2022, GSK stopped clinical trials of a version of the vaccine in pregnant women after a safety assessment showed an increased risk of premature birth. The company stated that the death of newborns has increased, but these are the consequences of premature birth.
GSK is still tracking participants in those trials and sharing the data with the FDA, company spokeswoman Alison Hunt said.
In the Pfizer trial, Abrysvo also slightly increased the risk of preterm delivery up to 37 weeks’ gestation, but the increase was not statistically significant.
Still, concerned about the risk of premature birth, the FDA only approved Abrysvo for pregnant women between 32 and 36 weeks’ gestation. (The goal is to produce antibodies in the women that can be passed on to the babies, who will be protected immediately after birth.)
CDC advisors have narrowed the window further by recommending screening only for pregnant women. From September to JanuaryIt aims to protect babies born during peak RSV season.
“We were somewhat conservative in our evaluation of the data,” said Dr. Camille Cotton, a physician at Massachusetts General Hospital and one of the agency’s science advisors.
“If there is a problem with preterm labor, having it in the last eight weeks of pregnancy will have less of an impact than it did during pregnancy,” she said.
Some infants were mistakenly given the RSV vaccine to receive nirsevimab. The GSK vaccine appears to have been given to some pregnant women while the Pfizer vaccine was not available as often and pharmacists thought it could be exchanged.
Amy Gardner, 39, a former kindergarten teacher in Cleveland, Tenn., said she tried to find Pfizer’s RSV vaccine for her pregnant daughter at multiple pharmacies. In mid-September, the last day her daughter was eligible to receive the vaccine, she found a pharmacy that said it had the vaccine, Ms. Gardner said.
But her son accepted Arexvi instead.
“We’re all human, but there should be more checks and balances,” said Mrs Gardner. She believes the shot caused her baby to go into premature labor a few hours later.
The errors are reported to a federal database called the Vaccine Adverse Event Reporting System. Experts say those taking the vaccine may be confused by the similarity of the two names.
“It’s terrible – why, why did you do this?” Dr. Long said. A lot of people get paid a lot of money to come up with these names, but I don’t.
Dr. Cotton urged the FDA to encourage companies to give names that clearly distinguish similar products. “When joint vaccines are released, it would be good to have as many different names as possible,” she says.
Dr. Long said she was concerned about young children receiving RSV vaccines. Because they are not approved for children, pediatricians’ offices that routinely give vaccines should not have any in stock.
“It’s important to know how this happened, because we don’t want it to happen again,” she said.