CDC advisors recommend RSV medication to protect babies before the virus’ expected fall spread

The drug is an antibody injection given to infants up to 19 months old ahead of RSV season. Next, the CDC director is expected to recommend the shot.

A committee of the Centers for Disease Control and Prevention unanimously voted on Thursday in favor of recommending an RSV injection for two groups infants.

First, babies under 8 months of age who were born in or during the first respiratory syncytial viruses season (which usually starts around October). Second, infants aged between 8-19 months are at a higher risk of developing severe RSV and will be entering their second RSV. The committee recommended that newborns who were born during or shortly before the RSV season receive the vaccine in the first week of their lives.

Beyfortus is a drug that works similarly to a vaccination, but it does not stimulate the immune system into developing antibodies against the virus, which is known as “active immunotherapy.” Instead, the antibody-producing cells are delivered directly to the bloodstream through passive immunization.

In the U.S., until now, no RSV vaccine or drug has been approved to be used by all infants. Only an injection can protect high-risk babies.

RSV is a serious illness for children.

The committee’s vote on Thursday clears the path for CDC director Mandy Cohen, who can now formally recommend this shot to the public — the final step before it is available to the general population.

Parents should be relieved to know that they will not have to worry about their child being hospitalized for RSV. We believe this is a major breakthrough, said Dr. Sarah Long. She is a pediatrics professor and member of the CDC advisory committee.

The Food and Drug Administration has approved beyfortus. It is also approved in Europe, Canada and United Kingdom.

AstraZeneca makes the shot and Sanofi markets it. Beyfortus will be available to the U.S. before the RSV season of 2023-2024.

Beyfortus reduced the risk that RSV would cause a respiratory infection that required a visit to a doctor by 75% in a study of 1,500 babies. This was for at least 5 months. In a study on premature babies, the percentage was a little lower. Premature births increase the risk of severe RSV infections.

In the clinical trials, the most common side effects were rashes or reactions at the injection site.

Last month, the FDA announced that Beyfortus would come with a warning regarding extreme immune reactions such as anaphylaxis.

FDA says that the drug should be given “with caution” to children and infants with clinically significant bleeding problems.

The CDC committee stated Thursday that children who have already received Beyfortus shouldn’t receive Synagis for the same RSV Season.

Beyfortus will be priced at $495. However, the price for individual consumers depends on their insurance plan.

Long was “extraordinarily dissatisfied” by the price. The CDC’s Vaccines For Children Program will cover the cost of the shot. This program offers free vaccines to children who do not have insurance, are underinsured or eligible for Medicare.

RSV is a common infection in children under the age of 2. RSV is a virus that causes lower respiratory illnesses. In most cases, the illness is mild. However, in severe cases, it can cause pneumonia or bronchiolitis. This inflames the airways and clogs with mucus.

Babies under 6 months of age and older adults are at greater risk for severe outcomes.

Recently, the FDA approved two RSV vaccinations for older adults: one from Pfizer, and another from GSK.

In May , a committee of the FDA recommended that Pfizer’s maternal RSV vaccination be approved by the agency. This vaccine is administered to mothers to protect their children. Next month, the FDA will decide whether or not to approve this shot.

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