The experts who advised their counterparts at the Food and Drug Administration recommended that the agency approve the first vaccine that will safeguard babies from RSV which is also known as respiratory syncytial disease. However, some experts expressed doubts about the quality of evidence in favor of vaccine’s efficacy.
In a two-part voting the experts agreed unanimously 14-0 that the evidence available supports the efficacy of Pfizer vaccine in the prevention of respiratory disease. Then they voted 10-4 in favor of evidence confirm the vaccine’s safety.
RSV is the leading cause of hospitalizations for infants across the U.S. Between 58,000 and 88,000 children less than five years old are admitted every year due to RSV illnesses, according to the Centers for Disease Control and Prevention. Infants aged 6 months and younger are more at risk of developing serious RSV disease.
The decision was made following an entire day of testimony and discussions at a public meeting of the FDA’s expert panel on vaccines. The FDA does not have to adhere to the recommendations of its panels of experts, however, it does so often. A decision on the vaccination for infants is expected in late August.
The vaccine is not given to infants. Instead, pregnant women get vaccinated in the third and second trimesters of pregnancy. The antibodies that they create against RSV are passed into the fetus within the womb, and then protect the infant.
A study conducted in a clinical setting with 7400 people showed that the vaccine showed 81.8 percent effectiveness in preventing serious respiratory illness due to RSV within 3 months of the birth, and 69.4 percent within during the initial six month.
There was evidence that people who were vaccines were more likely to have babies early. And committee members worried about pregnant people getting the vaccine at the same time as some other vaccines, such as TDAP (tetanus-diphtheria-pertussis), because it could interfere with their effectiveness.
“I am concerned that the preterm births could be at all a result due to this vaccine it could be a tragedy,” said Dr. Paul Offit, professor of pediatrics at The Children’s Hospital of Philadelphia. He was against the quality of safety data.
The identical Pfizer vaccine is currently under FDA examination to protect over 60 from RSV. Advisors voted in support of the an approval of the vaccine at a February’s meeting.
In a separate development in a series of firsts, the agency also approved an RSV vaccine made by GSK, the drugmaker GSK in May for individuals 60 and older.
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Transcript:
AILSA CHANG, HOST:
It’s all right. The first vaccine that protects infants from one of the most prevalent respiratory diseases took a huge leap forward today. Experts from the Food and Drug Administration endorsed the vaccine to protect newborns against RSV. NPR health reporter Rob Stein joins us now. Hey, Rob.
ROB STEIN, BYLINE: Hey, Ailsa.
Change: So I can remember when RSV was a major problem in winter months, and it was a huge issue in the moment. However, can you please bring us back to how huge of an issue RSV is during a typical year?
STEIN: Sure. It’s true, RSV came roaring back with a vengeance in the fall of last year and played a major part in the winter’s miserable tripledemic (ph) which is, as you know that it ravaged hospitals for children across the across the country. Even in normal years, RSV is a huge problem in winter and autumn. The majority of children will contract RSV during the first year of their lives. In the majority of cases, RSV just causes a cold. But, between 2 and three percent of newborns are likely to be admitted to hospitals due to RSV and it is the most frequent reason for hospitalizations for infants and toddlers. Around 80,000 newborns are admitted to hospitals every year due to RSV. Between 100 to 300 people die in the estimation of CDC. This is the doctor Dr. Eric Simoes from the Children’s Hospital of Colorado, who spoke on behalf of Pfizer who developed the latest vaccine.
ERIC SIMOES: Nothing is more stressful to parents than the terrified face of a 3-month-old child struggling to breathe and not able to feed.
Stein: The very first vaccine that protects older adults who are at risk of RSV is just being accepted by FDA. Yet, despite years of effort to discover a vaccine which could protect infants this marks the very first time that an RSV vaccine for infants has been approved to this point.
CHANG: Oh, really? There must be something unique in this vaccine that been able to make it this far?
STEIN: Yeah, it’s interesting. We usually consider vaccines to be shots we take to safeguard ourselves from for instance, influenza or COVID. But there’s an interesting twist to this one. This is a shot that pregnant women take between six and nine months into their pregnancy to safeguard their babies for at least the initial six months following they’re born. It does this by stimulating the woman who is pregnant to produce immune defense antibodies that can then be passed on to the fetus developing in the womb. In a large study of thousands of pregnancies people, conducted by Pfizer the drug proved to be nearly 82% effective in protecting infants from severe RSV during the initial three months. It was also 69% effective in defending the infant against serious illness in their first 6 months.
It sounds good. Are there any concerns with the vaccine? What are the potential risks?
STEIN: Yeah. There was a time when an experimental vaccine actually ended up creating RSV worse, without protecting infants. Although that was in the 1960s the specter of that vaccine has sort of thrown a shadow over the whole field. The truth is, there’s no sign of the issue in this vaccine, however there was some worry about a tiny suggestion that those who had been vaccinations might become more susceptible to have babies early. The following is the doctor. Paul Offit from the University of Pennsylvania.
PAUL OFFIT: I am concerned that if preterm births were in any way related to the vaccine, that could be a tragedy.
STEEN: However, it was Dr. William Gruber from Pfizer said that the obvious advantages of the vaccine far outweigh the unknown risks.
WILLIAM GRUBER The question is: are you sabotaging any potential advantages of a vaccine in order to gain something of no statistically significant?
Stein: In the final analysis in the end, FDA advisory committee unanimously voted that the vaccine was effective. The committee, however, approved 10-4 that the vaccine was secure.
CHANG: OK. The committee is happy with the features they find with this particular vaccine. What following?
STEIN Stein: Stephen Stein: FDA will now take into consideration the votes of the advisors and make a decision on what it will do next in the coming days, and must decide on the 21st of August. It is important to note that the FDA is looking at approving this vaccine for people who are older and also the monoclonal antibody for protecting infants. Also after years of frustration trying to discover ways to combat RSV it’s finally time to consider possibilities to be protected the population this fall and winter.
Change: That’s a great thing. That’s NPR health reporter Rob Stein. Thank you for everything, Rob.
STEIN: Oh, you bet.
(SOUNDBITE of MASEGO Song, “YOU NEVER VISIT ME”) Transcript supplied by NPR Copyright NPR.
