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Matthew Perrone Associated Press
The Food and Drug Administration (FDA) approved this Monday the first long-acting drug to protect infants and children under 2 years of age against the respiratory syncytial virus (RSV), which infects millions of adults and children in the United States every year: for most, it feels like a cold, but can sometimes be deadly for the smallest, and for older or sick people.
“This approval is in response to an urgent need for drugs that help reduce the impact of RSV on children, families and the healthcare system,” FDA spokesman John Farley said in a statement.
(What is RSV, why are hospitals flooded with it, and why do doctors and parents worry about it, given that almost all children will be infected)
Last year, a surge in RSV cases flooded U.S. children’s hospitals with respiratory complaints. There is no vaccine for infants yet, although Pfizer and other drug makers are working on developing one.
AstraZeneca’s new drug, which will be sold under the name Beyfortus, is a laboratory version of an antibody that helps the immune system fight RSV.
With FDA approval, babies (including preterm babies) can get one shot to protect themselves from the early part of the RSV season, which usually lasts about five months. Children under 2 years of age may also receive another dose to protect them during the second season from the virus.
Beyfortus, which will be sold in the US by Sanofi, has already been approved in Canada, Europe and the UK. Sanofi did not say what the price of the drug would be in the US.
The FDA approved the drug based on three studies showing the drug reduces the risk of RSV infection by 70-75% in infants and children under 2 years of age.
(FDA approves world’s first respiratory syncytial virus vaccine for people aged 60 and over)
Centers for Disease Control and Prevention consultants will meet early next month to recommend who should get the drug.
A similar antibody received FDA approval over 20 years ago, but it is only recommended for high-risk children and requires monthly injections.
Pediatricians say the drug is underutilized and hope that the longer-lasting effect of the AstraZeneca shot will improve absorption.
In the United States, about 58,000 children under 5 years of age are hospitalized with RSV each year, and several hundred die.
(FDA committee recommends that pregnant women be vaccinated to prevent RSV in infants)
After decades of failures in RSV research, drug makers have made great strides this year by releasing the first vaccines against the virus. In May, the FDA approved two senior drugs developed by GlaxoSmithKline and Pfizer. The FDA is expected to make a decision on the Pfizer vaccine for pregnant women who want to protect their babies in August.
