FDA advisors vote to support new RSV vaccine to protect newborns | CNN


Independent vaccine advisors for the U.S. Food and Drug Administration voted Thursday in favor of recommending approval of a new vaccine to protect children against the respiratory syncytial virus known as RSV.

The decision now goes to the Food and Drug Administration. If the agency eventually approves a vaccine, it will be the first to protect children against respiratory syncytial virus—a goal scientists have been working towards for decades.

The maternal vaccine is a single dose of the vaccine that is given to a pregnant woman late in the pregnancy. It may lead to the development of antibodies that pass to the fetus and provide protection for about the first six months of the baby’s life.

Trials have shown that the vaccine, made by Pfizer, reduces the risk of children needing to see a doctor or being hospitalized with moderate to severe infections, according to a new analysis by government regulators.

Why is a vaccine needed?

Last year, children’s hospitals across the country They were very busy with Respiratory infections Some have had to erect tents or makeshift beds in their parking lots to accommodate the influx of patients. Covid-19 tops flu and RSV hospitalizations, but even in a typical RSV season, hospitals stay busy.

Respiratory syncytial virus is ubiquitous, and although almost every child will contract the virus before the age of two, most children have mild cases. RSV infection often feels like a cold. For some children, the virus can be very dangerous.

RSV is the number one cause of hospitalization in children in the United States. Studies show that in one year, there are about 34 million episodes of RSV-related lower respiratory tract infections in children under the age of five, and about 10% need to go to hospital for treatment.

In its submission to the committee Thursday, the Food and Drug Administration said that nearly 80% of children hospitalized with RSV before the age of two had no underlying medical conditions.

Once in the hospital, most children improve with supportive care, but there is no specific medication to treat RSV. In some cases, the infection can turn into pneumonia and become fatal.

The introduction of a monoclonal antibody developed in the 1990s, palivizumab, has made RSV more survivable for infants at high risk of severe disease, but only a few infants are eligible.

It also comes with some challenges. It has to be given once a month, and the logistics can be difficult for parents. Monoclonal antibodies can also be very expensive and not available in every country. The US Food and Drug Administration (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 people die, according to the National Institute of Allergy and Infectious Diseases. Studies show that RSV causes about 1 in 28 deaths in babies between the ages of 28 days and 6 months worldwide. But since most RSV deaths don’t occur in the hospital, that number is likely an undercount, according to a 2022 study.

RSV is also expensive. Studies show that each year the United States spends more than $709.6 million on hospitalization of infants infected with RSV alone.

Vaccine protection is not for life

Pfizer’s vaccine is 82% effective in protecting newborns from acute lower respiratory tract infections in the first three months after birth, according to a US Food and Drug Administration analysis published Tuesday. It was 57% effective in preventing children from seeing a doctor for a respiratory syncytial virus (RSV) infection. About six months after birth, the vaccine was 69% effective in preventing severe disease and 51% effective in keeping them away from the doctor’s office due to breathing problems.

Pfizer told the Food and Drug Administration committee Thursday that a mother’s vaccination could prevent up to 16,000 hospitalizations and more than 300,000 doctor visits for RSV among this age group each year if the vaccine were implemented universally.

However, the vaccine does not provide protection throughout a child’s life like the measles vaccine. After about six months, it was as effective as a placebo at preventing children from seeing a doctor.

Overall, the vaccine was considered safe, and in the trials, the number of people who had serious adverse reactions or events was balanced between the group that got the vaccine and the group that didn’t get the vaccine.

Safety conversation

One of the topics that came up in the FDA advisory discussion Vaccine safety data.

The most common side effects reported in the trials were minor and included fatigue, headache, muscle aches, and pain at the injection site.

The data also showed a slightly higher rate of preterm birth in infants whose mothers received experimental RSV compared with those given placebo: 5.7% versus 4.7%, respectively. The difference is not considered statistically significant, so it may be due to chance.

Premature birth rates in both groups were lower than reported in the general population, and are about 10%. Most babies, even when born prematurely, are born after 34 weeks of gestation, a few weeks before they are due.

Late-stage trials of a different maternal vaccine against respiratory syncytial virus created by pharmaceutical company GSK were halted in February due to safety concerns. There was a greater risk of premature births among mothers given the GSK RSV vaccine in the study, compared with those given a placebo, according to a report published in the BMJ.

In the case of the Pfizer RSV vaccine, Dr. William Gruber, Pfizer’s senior vice president of vaccine research and development, told the FDA committee Thursday that “there is no conclusive evidence to suggest there is an increased risk” of prematurity. ”

Pfizer said it plans to conduct a large aftermarket safety study that will use large databases of commercial claims data, including Medicaid data, to help assess safety endpoints — including premature delivery — in everyone who gets the vaccine.

With the Pfizer RSV vaccine, there were 17 deaths in the main study, the government analysis found: five in the group that got the vaccine and 12 in the group whose mothers got a placebo.

The FDA agreed with Pfizer’s analysis that four of the five deaths in the vaccinated group may not have been related to the vaccine. With one of the deaths, a baby born prematurely 10 days after the baby’s mother was vaccinated, the agency said it could not rule out the possibility that it was related to the vaccine.

One infant in the placebo group died of RSV infection.

next steps

An FDA advisory panel will go on Thursday debating the pros and cons of the vaccine and voting on whether to recommend that the agency approve the vaccine for people in their second or third trimesters.

The FDA takes the committee’s vote into consideration, but doesn’t have to follow suit.

The only approved RSV vaccine, made by GSK, is for seniors. Pfizer’s RSV vaccine for seniors is being considered for approval.

Many pediatricians say they hope this vaccine will be approved.

Anything that reduces RSV infection would be a “welcome intervention,” said Dr. Bill Mueller, an infectious disease physician at Ann & Robert H. Lurie Children’s Hospital in Chicago.

“Just reducing the amount of disease that we see would be a really important advance in pediatrics,” said Mueller, who is also a professor of pediatrics at Northwestern University Feinberg School of Medicine.

“This can make a huge difference,” said Dr. Amy Edwards, associate medical director for pediatric infection control at UH Rainbow Children’s and Children’s Hospital in Cleveland. The trick, she said, is to educate people about why they need this vaccine.

“RSV is an underreported disease, unless you are one of the people who has had a child who has been affected by it or know someone in your family, I think it flies under the radar. But any pediatrician will tell you, RSV puts a number of people in the hospital each year It does the flu and kills as many as possible,” Edwards said. “If you look at the protection the vaccine provides for newborns, it’s tremendous, and you can ask any mother of any child to be in the ICU for RSV. They’ll tell you how much they would have given to get that vaccine even though they were pregnant to protect their newborns. .

“If the mother is vaccinated during pregnancy and the babies do better, which means fewer ICU admissions, that would be a complete game-changer.”

CNN’s Brenda Goodman contributed to this report.

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