CNN
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On Monday, the U.S. Food and Drug Administration approved antibody injections to protect newborns from the respiratory syncytial virus known as RSV. Nilsevimab, also known by the brand name Bayfortus, is expected to go on sale this fall unless the U.S. Centers for Disease Control and Prevention also gives it the go-ahead.
It is FDA-approved and CDC-recommended. Two new respiratory syncytial virus vaccines Adults over the age of 60 will also be able to use it this fall. CDC is also considering an RSV vaccine given to pregnant women during pregnancy.
Why are vaccines and treatments that protect against RSV so important? How effective are vaccines for older people? When will they be available? Who are they for?
To answer these questions, we spoke with CNN Medical Analyst Dr. Liana Wen. Wen is an emergency physician and George She is a professor of health policy and management at the University of Washington’s Milken Institute School of Public Health. She is a former Baltimore City Health Commissioner and mother of two young children.
CNN: Why are vaccines and treatments to prevent RSV so important?
Dr. Liana Wen: RSV is a very common virus that infects virtually all children by the age of two. According to the CDC. Most people who get RSV have mild, cold-like symptoms, but some people experience very severe symptoms. Approximately 58,000 to 80,000 children under the age of five are hospitalized for her RSV in the United States. Newborns and young children are particularly susceptible. Among infants under 6 months of age, the rate of hospitalization for respiratory syncytial virus infection is as high as 1 to 2 in 100.
RSV also poses a significant health risk to older people.as much as you want 159,000 adults Each year, people over the age of 65 are hospitalized with RSV and about 10,000 to 13,000 die from RSV.
Precautions such as hand washing and masks can reduce the risk of contracting RSV, but given the spread of the virus, developing vaccines and treatments that can reduce the severity of the disease, especially among the most vulnerable, is a big step forward.
Courtesy of AstraZeneca
What you see is a rendering of Beyfortas. be A recently approved drug that protects newborns from RSV infection.
CNN: How effective is the vaccine for the elderly? Will it be available to everyone, or only to those over a certain age?
Wen: There are two types of vaccine GlaxoSmithKline’s Alexie and Pfizer’s Abrisvohas already received clearance from both the FDA and the CDC. Both are for people over the age of 60. People under that age are ineligible.
Two vaccines include Equivalent Effectiveness. Alexi has an 88% efficacy rate for RSV requiring medical attention, and Pfizer has an 85% efficacy rate. It has strong durability. It is not yet known if the vaccine will need to be vaccinated every year, but the vaccine will last at least 8 months or more, so it will likely last through this year’s RSV season (which would be this fall/winter, if the previous season was a guideline).
CNN: When will these vaccines be available and how will older people access them?
Wen: The CDC said an RSV vaccine could be available as soon as possible. End of July. Eligible people over the age of 60 should talk with their doctor about vaccines and plan to get the vaccine at other places, such as pharmacies and doctors’ offices, where they can get it.
CNN: Can the RSV vaccine be given with other vaccines such as influenza, COVID-19, and shingles?
Wen: Yes, the RSV vaccine can be co-administered with other vaccines. But I don’t advise people to wait. The next Covid-19 booster won’t be released until the end of his September. Since the RSV vaccine has a strong persistence, it is better to get vaccinated early in advance of the expected surge in RSV infections in the fall.
CNN: What’s the difference between vaccines and prophylactic antibody shots?
Wen: Vaccines induce the body to produce antibodies that can protect against viruses. Prophylactic antibody injections provide ready-made antibodies, so the immune system does not need to produce them.
CNN: What’s next in the approval process for newborn antibody injections and RSV vaccines?
Wen: The FDA has just approved nircevimab, an injectable antibody that can be given as a single dose to infants prior to RSV season. The Advisory Board of The CDC then reviews and issues recommendations. The group could recommend nilsevimab across the board for all newborns, or limit it to, for example, premature infants or those with chronic lung or heart disease.
according to Data from FDAnircevimab was approximately 70% effective in reducing the risk of requiring RSV medical attention and 78% effective in preventing RSV hospitalization.
Another antibody injection called is worth noting. Palivizumab or brand name Synagis, is already approved and available, but only for premature births under 6 months. This injection should be given once a month. Nilsevimab has the advantage that he only needs one injection each season, and FDA approval is broader to allow it to be given to babies born at term. that too.
There are other products under consideration. Pfizer’s vaccine is now called the RSVPreF vaccine and is FDA-approved. Awaiting CDC decision. The vaccine is given to pregnant patients in hopes that maternal antibodies will help protect the newborn. CDC has not issued final guidance on which groups are recommended for this maternal vaccine and whether nircevimab is preferred over maternal vaccine or vice versa.
There’s a lot going on right now when it comes to RSV prevention in newborns, and I think it’s all great news. RSV can be a very serious illness, and it’s really good to finally have tools that can prevent serious illness from RSV, especially for vulnerable people.