Chloe Ramirez
Respiratory Syncytial Virus (RSV) is a leading cause of hospitalisation for infants in the US. In 2023, the CDC recommended the first RSV vaccine for pregnant people to protect their newborns from severe RSV illness. The vaccine, Pfizer's bivalent RSVpreF (Abrysvo), has been shown to reduce the risk of RSV hospitalisation for babies by 57% in the first six months after birth. The Advisory Committee on Immunization Practices (ACIP) voted to recommend the maternal RSV vaccine for pregnant people during 32 through 36 weeks of gestation. In addition, the FDA approved the monoclonal antibody Beyfortus (nirsevimab) in 2023, which can be administered as a single injection to infants and provides protection during the RSV season.
| Characteristics | Values |
|---|---|
| Date | 22 September 2023 |
| Vaccine Name | Pfizer's bivalent RSVpreF vaccine (trade name Abrysvo TM) |
| Administration | One dose |
| Who Gets It | Pregnant people between 32 and 36 weeks of gestation |
| When | During the RSV season |
| Protection | 57% reduction in the risk of RSV hospitalisation for babies in the first six months after birth |
| Availability | The vaccine is available in some locations in the U.S. and is expected to become more widely available in the coming weeks |
| Alternative | Beyfortus (nirsevimab) or clesrovimab (Enflonsia) |
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What You'll Learn
- The CDC recommends Pfizer's bivalent RSVpreF vaccine for pregnant people
- The FDA approved AstraZeneca's Beyfortus for babies in 2023
- RSV vaccines for infants are not available in Australia
- The RSV season typically starts in the fall and peaks in winter
- RSV is the leading cause of hospitalisation for US infants
The CDC recommends Pfizer's bivalent RSVpreF vaccine for pregnant people
On September 22, 2023, the CDC recommended Pfizer's bivalent RSVpreF vaccine for pregnant people. The Advisory Committee on Immunization Practices (ACIP) voted 11-1 in favour of the vaccine, which is designed to prevent RSV lower respiratory tract infection in infants.
The CDC recommends seasonal administration of the vaccine, during weeks 32 through 36 of pregnancy. This strategy is designed to maximize benefits and cost-effectiveness. The RSV vaccine dosing should occur during September-January in most of the continental United States. The CDC recommends that jurisdictions in which RSV seasonality differs should have the flexibility to adjust the start and stop dates of the RSVpreF vaccine administration.
The RSVpreF vaccine is one of two new tools to protect babies from severe RSV illness. The other is a new RSV immunization for infants, which has been shown to reduce the risk of RSV-related hospitalizations and healthcare visits in infants by about 80%. The CDC recommends that parents talk to their doctors about how to protect their newborns against RSV illness, using either the vaccine given during pregnancy, or the RSV immunization given to the baby after birth.
The Pfizer vaccine is designed to reduce the risk of RSV hospitalization for babies by 57% in the first six months after birth. RSV is the leading cause of hospitalization for infants in the United States. The highest hospitalization rates are in the first months of life, and the risk declines with increasing age in infancy and early childhood.
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The FDA approved AstraZeneca's Beyfortus for babies in 2023
The U.S. Food and Drug Administration (FDA) approved AstraZeneca's Beyfortus for use in babies and toddlers on July 17, 2023. The drug is designed to protect against respiratory syncytial virus (RSV) lower respiratory tract disease in infants and children up to 24 months old. RSV is a common virus that causes acute respiratory infection in people of all ages, but it can be particularly severe in infants and young children, leading to hospitalizations.
Beyfortus is a monoclonal antibody, a laboratory-made version of an antibody that helps the immune system fight off RSV. It is the first preventive option approved to protect a broad infant population, including those born healthy at term or preterm, as well as those with specific health conditions that make them vulnerable to severe RSV disease. The approval was based on an extensive clinical development program, including three pivotal late-stage clinical trials.
One dose of Beyfortus, administered as a single intramuscular injection prior to or during the RSV season, may provide protection for the entire season. This is in contrast to other antibody drugs, such as Synagis, which require monthly injections. The approval of Beyfortus provides a longer-lasting option that is expected to improve uptake and help reduce the impact of RSV on children, families, and the healthcare system.
It is important to note that Beyfortus comes with warnings and precautions about serious hypersensitivity reactions, including anaphylaxis, and should be used with caution in infants and children with clinically significant bleeding disorders. The drug was already approved in Canada, Europe, and the U.K. prior to its approval in the U.S.
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RSV vaccines for infants are not available in Australia
RSV, or respiratory syncytial virus, is a virus that causes acute respiratory infection in individuals of all age groups. While most infants and young children experience mild, cold-like symptoms, some infants, especially with their first infection, develop lower respiratory tract disease such as pneumonia and bronchiolitis.
In September 2023, the CDC recommended the first respiratory syncytial virus (RSV) vaccine for pregnant people to protect their newborn from severe RSV illness. The vaccine, Pfizer's bivalent RSVpreF vaccine, has been shown to reduce the risk of RSV hospitalization for babies by 57% in the first six months after birth.
However, it is important to note that RSV vaccines for infants are not available in Australia. The Australian Immunisation Handbook, which provides information on vaccines, dosage, and administration, specifically states that "neither RSV vaccine should be given to infants or children, and there are no vaccines currently licensed in this age group."
Instead, Australia offers the RSV monoclonal antibodies nirsevimab and palivizumab to provide passive immunization in infants and children aged less than 2 years. These antibodies are given to infants and children who are at increased risk of severe RSV disease, regardless of their mother's vaccination status.
While there is no licensed RSV vaccine for infants in Australia, the maternal RSV vaccine (Abrysvo) is free under the National Immunisation Program (NIP) and is recommended for pregnant women at 28-36 weeks of pregnancy to protect their babies. The process of providing antibodies from mother to baby is a form of passive immunization and can provide protection to the infant for up to six months from birth.
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The RSV season typically starts in the fall and peaks in winter
In September 2023, the CDC recommended the first respiratory syncytial virus (RSV) vaccine for pregnant people to protect their newborns from severe RSV illness. The RSV season typically starts in the fall and peaks in the winter. In most parts of the US, RSV circulation is seasonal, usually starting in the fall and peaking in winter. It is transmitted from person to person through close contact with infected individuals.
Pfizer's bivalent RSVpreF vaccine, or Abrysvo, has been shown to reduce the risk of RSV hospitalization for babies by 57% in the first six months after birth. The CDC recommends seasonal administration of one dose of the RSV vaccine for pregnant people during weeks 32 through 36 of pregnancy.
The RSV vaccine is not the only tool available to protect babies from severe RSV illness. Nirsevimab, a monoclonal antibody, is also recommended for infants and young children at high risk of severe RSV disease. It is administered as a single intramuscular injection before or during the RSV season and may offer protection throughout the season. Nirsevimab is recommended for infants younger than eight months of age who are entering their first RSV season if their mother did not receive the RSV vaccine during pregnancy or within two weeks of delivery.
The optimal timing for nirsevimab administration is shortly before the RSV season begins, typically in October or November. In most of the US, nirsevimab is administered during October through March.
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RSV is the leading cause of hospitalisation for US infants
Respiratory Syncytial Virus, or RSV, is a highly contagious virus that can cause severe respiratory infections, especially in infants and young children. While RSV usually causes mild, cold-like symptoms, it can sometimes lead to more severe complications, such as bronchiolitis and pneumonia, which are lower respiratory infections that can be life-threatening and require hospitalisation.
RSV is the leading cause of hospitalisation among infants in the United States. According to the American Academy of Pediatrics, approximately 1-3% of children under 12 months of age in the US are hospitalised each year due to RSV. This equates to about 58,000 to 80,000 children under the age of 5 requiring hospital care annually. RSV is particularly dangerous for infants under 6 months of age, with 2 to 3 out of every 100 infants in this age group being hospitalised with RSV each year.
The virus is transmitted through close contact with infected individuals and is highly contagious. The CDC recommends two tools to protect newborns from severe RSV illness: a vaccine given to pregnant people during weeks 32 to 36 of pregnancy and an RSV immunisation given to infants and some older babies. The maternal vaccine, Pfizer's bivalent RSVpreF vaccine, has been shown to reduce the risk of RSV-related hospitalisations in babies by 57% in the first six months after birth. The infant immunisation, Beyfortus, is a monoclonal antibody that can be administered as a single injection prior to or during the RSV season and may provide protection for the duration of the season.
While RSV is a significant health concern for infants in the US, the recent development of vaccines and immunisations offers hope for reducing the impact of this virus on children, families, and the healthcare system.
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Frequently asked questions
The first RSV vaccine for babies was approved in 2023. The FDA approved the monoclonal antibody Beyfortus (nirsevimab) for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season.
The RSV vaccine for babies is given as a single intramuscular injection prior to or during the RSV season. One dose of the vaccine may provide protection for the duration of the RSV season.
The RSV vaccine for babies is manufactured by AstraZeneca and was granted approval by the FDA.
The RSV vaccine for babies has been shown to reduce the risk of RSV-related hospitalisations and healthcare visits in infants by about 80%. The vaccine provides protection for up to 6 months from birth.
The RSV vaccine for babies is generally safe, with possible side effects including rash and injection site reactions. However, it should not be given to infants with a history of serious hypersensitivity reactions to its active ingredients or excipients.
