Advisers for the U.S. Food and Drug Administration (FDA) have voted in support of recommending a new Pfizer vaccine to protect infants from respiratory syncytial virus, or RSV. Here’s everything parents need to know about this vaccine as it inches closer to becoming available.
As CNN reported, the FDA’s advisory panel convened last week to weigh in on the vaccine’s safety and efficacy. The group of independent health experts voted to approve the vaccine, which is given to pregnant people during the late stages of pregnancy to promote infants’ immunity while in utero.
The FDA isn’t obliged to follow its advisers’ advice, but it often does. If this vaccine is formally approved, it will become the first on the market specifically designed to prevent RSV infection in infants. That could be a major public-health win: According to the Centers for Disease Control and Prevention (CDC), babies born prematurely and those younger than 6 months old are at a higher risk for severe illness from RSV, which can lead to hospitalization.
“This is great news for kids and moms everywhere in the U.S.,” Dr. David Kim, flexeril indications use a member of the panel and division of vaccines director at the U.S. Department of Health and Human Services (HHS), told CNN. “The burden of RSV disease is high, and there’s a definite need for preventive care.”
Here’s how this RSV vaccine works.
Although this vaccine is designed to boost immunity in infants, it is administered to pregnant people, not babies themselves. It’s a single-dose shot that induces RSV immunity in the receiver, who then passes on those antibodies to their baby.
This mode of delivery doesn’t seem to impede its efficacy. According to an FDA report, the Pfizer vaccine is 82 percent effective at preventing lower respiratory tract infections in infants during the first three months after birth.
It’s worth noting that this protection does not last for the rest of a baby’s life. However, RSV is much less serious for toddlers, older children, and adults, so lifelong immunity is not the main concern.
Some experts have questions about the vaccine’s safety.
FDA advisers unanimously agreed that this vaccine is effective. However, some members of the panel had reservations about its safety. These concerns were driven by the slightly elevated proportion of pregnant people who gave birth prematurely after getting the vaccine in trials versus people who received a placebo (5.7 percent versus 4.7 percent).
“I’m still wrestling with the totality of evidence,” Dr. Holly Janes, a fellow panel member and professor at the Fred Hutchinson Cancer Center, told CNN. “I sort of wish that we could have some more discussion and more data on how to put these benefits and potential risks together.”
TL;DR: The Pfizer vaccine works, but some experts want to see more data before signing off on its safety. It’s now up to the FDA itself to decide whether to formally approve this vaccine for the American public.
After last winter’s surge in pediatric hospitalizations from RSV, a vaccine could be a major boon.
Immunologists have been working for years to develop a safe and effective vaccine to protect infants from RSV. That’s in large part because this virus is so ubiqutous. According to the CDC, almost all children contract RSV before they turn 2.
In the vast majority of children and adults, RSV causes mild, cold-like symptoms that resolve in a week or two. However, it is also the most common cause of bronchiolitis and pneumonia in children under the age of 1 in the U.S. Depending on the severity of their illness, very young patients may need to be hospitalized for their symptoms, which include runny nose, coughing, fever, and difficulty breathing.
Parents of young or immunocompromised children will recall last winter’s “tripledemic” of COVID-19, the flu, and RSV. RSV season started early and resulted in medication shortages and staggeringly high rates of pediatric hospitalizations throughout the U.S. The outbreak was so alarming, it prompted children’s hospital officials across the country to ask the Biden administration to declare a state of emergency.
A vaccine to protect infants from RSV could help prevent another surge in pediatric hospitalizations nationwide — which is great news for babies, their parents, and children’s hospitals alike.
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