FDA advisers vote in support of new RSV vaccine to protect newborns

CNN
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The US Food and Drug Administration’s independent vaccine advisers voted Thursday in favor of recommending approval of a new vaccine to protect infants from respiratory syncytial virus, known as RSV.

The decision now goes to the FDA. If the agency ultimately approves the vaccine, it will be the first to protect babies against RSV – a goal scientists have been working toward for decades.

The maternal vaccine is a single-dose shot would be given to a pregnant people late in pregnancy. It would trigger the development of antibodies that are passed on to the fetus and provide protection for about the first 6 months of the baby’s life.

Trials show that the vaccine, made by Pfizer, cuts the risk that infants would need to see a doctor or be admitted to the hospital with a moderate to severe infection, according to a new analysis by government regulators.

Why there’s a need for a vaccine

Last year, children’s hospitals across the country were so busy with respiratory infections that some had to set up tents or temporary beds in their parking lots to accommodate the flood of patients. Covid-19 on top of the flu and RSV challenged hospitals, but even in a typical RSV season, hospitals stay busy.

RSV is ubiquitous, and although nearly every child will get the virus before they turn 2, most children will have mild cases. RSV infections often look like a cold. For some children, though, the virus can be quite serious.

RSV is the No. 1 reason for child hospitalizations in the US. In a single year, there are about 34 million episodes of RSV-associated lower respiratory tract infections in children under the age of 5, and about 10% need to go to the hospital for treatment, studies show.

Nearly 80% of children hospitalized with RSV before age 2 had no underlying medical conditions, the FDA said in its presentation to the committee Thursday.

Once at the hospital, most kids improve with supportive care, but there is no specific drug to treat RSV. In some cases, the infection can turn into pneumonia and become deadly.

The introduction of a monoclonal antibody developed in the 1990s, palivizumab, made RSV much more survivable for infants who are vulnerable to severe illness, but only a small number of infants qualify for it.

It also comes with some challenges. It has to be given once a month, and logistics can be difficult for parents. Monoclonal antibodies can also be expensive and are not available in every country. The FDA is considering new monoclonal antibodies for infants this year.

Globally, about 64 million people get sick with RSV each year, and at least 160,000 die, according to the National Institute of Allergy and Infectious Disease. RSV causes about 1 in 28 deaths among infants ages 28 days to 6 months worldwide, studies show. But because most RSV deaths don’t happen at the hospital, that number is probably an undercount, a 2022 study found.

RSV is costly, too. Every year, the US spends more than $709.6 million on hospitalization for infants with RSV alone, studies show.

Vaccine’s protection isn’t for life

The Pfizer vaccine is 82% effective at protecting newborns from severe lower respiratory tract infections in the first three months after birth, according to an FDA analysis published Tuesday. It was 57% effective at keeping babies from having to see the doctor for an RSV infection. By about six months after birth, the vaccine was 69% effective at preventing severe disease and 51% effective at keeping them out of the doctor’s office for breathing problems.

Pfizer told the FDA committee Thursday that maternal vaccination could prevent up to 16,000 hospitalizations and more than 300,000 visits to the doctor due to RSV among this age group each year if the vaccine is universally applied.

However, the vaccine does not offer protection throughout the child’s life like a measles vaccine does. After about six months, it was about as effective as a placebo at keeping babies from having to see the doctor.

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