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The U.S. Centers for Disease Control and Prevention announced Friday that it is recommending a new vaccine to help protect infants from severe respiratory syncytial virus (RSV).
“This is another new tool we can use to protect lives this fall and winter,” said CDC Director Dr. Mandy Cohen. “We encourage parents to talk to their doctors about how to protect their young children from serious RSV disease by vaccinating them during pregnancy or by giving their babies the RSV vaccine after birth.”
The CDC’s independent vaccine advisors voted Friday to recommend vaccinating mothers.
The vote to recommend the vaccine was 11-1. The specific questions that advisors voted on were: “Seasonally administered maternal RSV vaccine is recommended for pregnant women from 32 to 36 weeks of gestation to prevent RSV lower respiratory tract infections in infants.”
The vaccine, called Abrysvo, is made by Pfizer and will be given in a single dose to pregnant women in the third trimester. The RSV season typically runs from September to January in most parts of the United States. Mothers of infants born outside the RSV season will not be vaccinated, but a new RSV prophylactic antibody called nilsevimab will be recommended to protect these infants.
The committee also voted 11-1 in favor of a resolution to add respiratory syncytial virus vaccine to the pediatric vaccination program. The CDC told the committee on Friday that it will update its vaccine schedule next week to include all of this year’s recommendations from the Independent Committee on Vaccines, including this one.
Vaccine schedules are typically published in February and do not reflect the latest recommendations from this committee. Experts said it’s important to keep schedules up to date because insurance companies often use them to decide which vaccines to cover. This is also important for clinicians, as they rely on this information to know what vaccines to administer to their patients. There are two vaccine schedules, one recommended for adults and one recommended for children and adolescents.
The committee’s experts said the RSV vaccine could make a huge difference to the country’s health.
“Throughout my career, this has been a difficult disease and only supportive care was available because there were no options. So today is an exciting day,” said the Wake Forest School of Medicine pediatrician who voted in favor of the vaccine. said committee member Dr. Katherine Poling, professor of epidemiology and prevention.
Studies have shown that the vaccine can protect infants from RSV lower respiratory tract disease and severe lower respiratory tract disease for at least the first 6 months of life.
In August, the U.S. Food and Drug Administration approved the vaccine, unanimously finding it effective and safe. In a trial involving more than 7,000 pregnant women and their infants, the vaccine reduced the risk of infants needing medical attention or hospitalization. Side effects were minor. Pfizer said the most common side effects felt by less than 10% of participants were injection site pain, headache, muscle pain and nausea.
In the trial, the vaccine was given to pregnant women even earlier than recommended by a CDC independent panel, but experts recommend giving the vaccine between 32 and 36 weeks into pregnancy to avoid the risk of extremely premature birth. I was hoping to. GSK’s trial of a similar RSV vaccine was halted due to the risk of premature birth.
Another adjustment was vaccine prices. Pfizer told the committee its vaccine will cost about $295 per dose, nearly 50% more than the expected price it offered in June. Some members of the CDC committee questioned why the vaccine is so expensive. By comparison, the Tdap vaccine given to pregnant people costs about $46 to $52. Research shows that the cost of the new RSV vaccine is likely to be one of the biggest barriers to people getting vaccinated.
Dr. Jamie Lauer, owner of Cayuga Family Medicine in Ithaca, New York, and a member of the committee, said, “The cost of this vaccine could lead to a recommendation specifically to offer the vaccine to all pregnant women.” Considering that, I feel very sorry.”
Dr. Grace Lee, chair of the committee and professor of pediatrics at Stanford University, said the vaccine is “an excellent option for protecting infants from hospitalization,” but also said it is “one of the better interventions we have recommended.” “It is one of the more expensive methods,” he added.
Since the pandemic, vaccination rates among pregnant women have declined overall; According to the CDC, so it’s not entirely clear how many people will get this new vaccine. Pfizer told the committee that if the vaccine is widely accepted, the newly approved vaccine could prevent up to 16,000 hospitalizations and more than 300,000 RSV-related doctor visits per year.
This is not the only option to protect infants from RSV. For years, premature babies have been given antibodies to protect them from infections, but they were targeted at children thought to be most susceptible to the most serious types of infections. This year, the FDA and CDC also approved an antibody treatment called nilsevimab that can be given to all infants after birth.
This group did not feel that infants needed both nisevimab and maternal vaccination. I recommend either one. There are benefits to getting either option, according to a presentation the CDC gave to the committee. Vaccines provide protection soon after birth and may become more resistant to mutations in the virus, and using maternal vaccines eliminates the need to inject infants. However, the vaccine carries a small risk of premature birth, but this risk is reduced if the vaccine is given after 32 weeks of pregnancy.
Studies have shown that the advantage of nirsevimab over vaccines is that protection may decline more slowly than protection provided by vaccines.
The treatment also provides antibodies directly to the infant, but because antibody treatments are administered directly to the infant and not to the pregnant person, there is no risk of causing premature birth. However, treatments are more expensive than vaccines. The cost is $495, but insurance should cover that cost. Another drawback to this treatment is that nicevimab is in limited supply and may not be available.
Dr. Brenda Hughes, president of the American College of Obstetricians and Gynecologists (ACOG), told the committee that she “unequivocally supports” the full recommendation of maternal RSV vaccine for pregnant people.
“This RSV vaccine is effective and has the potential to reduce the risk of severe disease in many infants. Also, while nilsevimab is clearly very effective, it may not be available or parents or health care facilities may not be able to provide the primary intervention. “We may not like it as such,” Hughes told the committee.
The FDA asked Pfizer to conduct a post-marketing study to assess whether the vaccine could cause hypertensive disorders during pregnancy, such as preterm birth or preeclampsia.
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Pfizer said it plans to conduct large-scale clinical trials once the vaccine is officially on the market. They plan to use a large database of commercial claims data to trial and evaluate safety endpoints. The CDC also plans to use it. V safea program developed specifically to monitor the safety of Covid-19 vaccines, has been redesigned to track other people’s post-vaccination experiences with other vaccines.
In the rare case someone has a bad reaction to a shot, you can also report it. Vaccine adverse event reporting system.
“Today’s ACIP recommendations for maternal immunization with Abrysvo include protecting infants immediately after birth from serious and life-threatening complications that can develop with RSV,” said Pfizer’s Dr. Louis Jodard. “This reinforces the far-reaching impact that vaccines can have.” the company’s chief medical officer responsible for vaccines, antivirals and evidence generation;