The CDC advises the use of an initial vaccine to safeguard infants against RSV
23.09.2023 posted by Admin
The US Centers for Disease Control and Prevention (CDC) has made a crucial recommendation to safeguard infants against a severe respiratory virus known as RSV. According to CDC Director Dr. Mandy Cohen, this new measure is an additional tool available for use during the upcoming fall and winter seasons to save lives. Dr. Cohen encourages parents to consult with their healthcare providers about protecting their infants from RSV, either through a vaccine administered during pregnancy or an RSV immunization given to newborns.
The CDC's independent vaccine advisors voted overwhelmingly in favor of recommending the maternal RSV vaccine. The vote, which saw 11 in favor and 1 against, revolved around the recommendation that pregnant individuals receive the RSV vaccine between weeks 32 and 36 of gestation, following a seasonal schedule, to prevent lower respiratory tract infections caused by RSV in infants.
The vaccine, named Abrysvo and developed by Pfizer, will be administered as a single dose to pregnant individuals late in their pregnancy. The RSV season typically spans from September to January in most parts of the US. Pregnant individuals delivering outside of the RSV season will not receive the vaccine, but an alternative RSV prevention antibody called nirsevimab will be recommended to protect their infants.
In addition to the vaccine recommendation, the committee also voted 11 to 1 on adding the RSV vaccine to the Vaccines for Children program. The CDC plans to update its vaccine schedule, usually published in February, to incorporate all the committee's recommendations regarding vaccines, ensuring that insurance companies and healthcare providers are aware of the latest guidance.
Health experts serving on the committee emphasized the potential positive impact of the RSV vaccine on public health. Previously, RSV had limited treatment options, primarily consisting of supportive care. The vaccine is expected to provide infants with protection against RSV-related lower respiratory tract diseases for at least the first six months of their lives.
In August, the US Food and Drug Administration (FDA) granted approval to the Abrysvo vaccine, with unanimous agreement on its effectiveness and safety. Clinical trials involving over 7,000 pregnant participants and their infants demonstrated that the vaccine significantly reduced the need for doctor visits and hospitalizations among infants. Minor side effects, experienced by less than 10% of participants, included pain at the injection site, headaches, muscle pain, and nausea.
While the vaccine was initially administered earlier in pregnancy during trials, the CDC committee recommended its administration between weeks 32 and 36 to minimize the risk of extreme preterm birth, which was a concern with a similar RSV vaccine from GSK that had to be halted.
One point of contention was the vaccine's cost, with Pfizer revealing a price of approximately $295 per dose, nearly 50% higher than the initially projected cost. Some committee members expressed disappointment about the vaccine's expense, particularly since it may be recommended for all pregnant individuals. In comparison, the Tdap vaccine given to pregnant people costs between $46 and $52. The cost of the RSV vaccine could pose a significant barrier to access.
Despite potential cost challenges, committee members recognized the vaccine's value in protecting infants from RSV-related hospitalizations and doctor visits. Vaccine coverage among pregnant individuals has declined since the onset of the pandemic, making it uncertain how many people will choose to receive this new vaccine. However, if widely adopted, Pfizer estimates that this vaccine could prevent thousands of hospitalizations and RSV-related doctor visits annually.
In addition to the maternal vaccine, an alternative for protecting infants from RSV is the antibody treatment nirsevimab, which the FDA and CDC approved for use after birth. The committee did not recommend both nirsevimab and maternal vaccination; either option is considered suitable. Each has its advantages, with the vaccine providing immediate protection after birth and potentially being more resistant to virus mutations, while maternal vaccination eliminates the need for an infant injection. However, there is a slight risk of preterm birth with the vaccine, although this risk decreases when administered at 32 weeks or later.
Nirsevimab, on the other hand, offers longer-lasting protection compared to the vaccine. It delivers antibodies directly to the infant, without the risk of causing preterm birth since it is given to the infant rather than the pregnant person. Nevertheless, it is more expensive, costing $495, but insurance should cover the expense. Availability may be limited due to supply constraints.
Dr. Brenda Hughes from the American College of Obstetricians and Gynecologists expressed strong support for the maternal RSV vaccine, emphasizing its efficacy in reducing severe disease risk in infants. She noted that while nirsevimab is highly effective, it may not always be available or preferred by parents or healthcare facilities.
The FDA has mandated post-marketing studies for Pfizer to assess whether the vaccine is linked to preterm birth or hypertensive disorders in pregnancy, including pre-eclampsia. Pfizer intends to conduct a large trial once the vaccine is officially available on the market. The CDC will utilize V-Safe, a program originally designed to monitor COVID-19 vaccine safety, to track individuals' post-vaccine experiences with other vaccines.
Pfizer's Dr. Luis Jodar, the company's chief medical affairs officer for vaccines, antivirals, and evidence generation, lauded the CDC's recommendation for maternal immunization with Abrysvo, highlighting the broader positive impact that vaccines can have on protecting infants from severe and life-threatening RSV complications.
The CDC's independent vaccine advisors voted overwhelmingly in favor of recommending the maternal RSV vaccine. The vote, which saw 11 in favor and 1 against, revolved around the recommendation that pregnant individuals receive the RSV vaccine between weeks 32 and 36 of gestation, following a seasonal schedule, to prevent lower respiratory tract infections caused by RSV in infants.
The vaccine, named Abrysvo and developed by Pfizer, will be administered as a single dose to pregnant individuals late in their pregnancy. The RSV season typically spans from September to January in most parts of the US. Pregnant individuals delivering outside of the RSV season will not receive the vaccine, but an alternative RSV prevention antibody called nirsevimab will be recommended to protect their infants.
In addition to the vaccine recommendation, the committee also voted 11 to 1 on adding the RSV vaccine to the Vaccines for Children program. The CDC plans to update its vaccine schedule, usually published in February, to incorporate all the committee's recommendations regarding vaccines, ensuring that insurance companies and healthcare providers are aware of the latest guidance.
Health experts serving on the committee emphasized the potential positive impact of the RSV vaccine on public health. Previously, RSV had limited treatment options, primarily consisting of supportive care. The vaccine is expected to provide infants with protection against RSV-related lower respiratory tract diseases for at least the first six months of their lives.
In August, the US Food and Drug Administration (FDA) granted approval to the Abrysvo vaccine, with unanimous agreement on its effectiveness and safety. Clinical trials involving over 7,000 pregnant participants and their infants demonstrated that the vaccine significantly reduced the need for doctor visits and hospitalizations among infants. Minor side effects, experienced by less than 10% of participants, included pain at the injection site, headaches, muscle pain, and nausea.
While the vaccine was initially administered earlier in pregnancy during trials, the CDC committee recommended its administration between weeks 32 and 36 to minimize the risk of extreme preterm birth, which was a concern with a similar RSV vaccine from GSK that had to be halted.
One point of contention was the vaccine's cost, with Pfizer revealing a price of approximately $295 per dose, nearly 50% higher than the initially projected cost. Some committee members expressed disappointment about the vaccine's expense, particularly since it may be recommended for all pregnant individuals. In comparison, the Tdap vaccine given to pregnant people costs between $46 and $52. The cost of the RSV vaccine could pose a significant barrier to access.
Despite potential cost challenges, committee members recognized the vaccine's value in protecting infants from RSV-related hospitalizations and doctor visits. Vaccine coverage among pregnant individuals has declined since the onset of the pandemic, making it uncertain how many people will choose to receive this new vaccine. However, if widely adopted, Pfizer estimates that this vaccine could prevent thousands of hospitalizations and RSV-related doctor visits annually.
In addition to the maternal vaccine, an alternative for protecting infants from RSV is the antibody treatment nirsevimab, which the FDA and CDC approved for use after birth. The committee did not recommend both nirsevimab and maternal vaccination; either option is considered suitable. Each has its advantages, with the vaccine providing immediate protection after birth and potentially being more resistant to virus mutations, while maternal vaccination eliminates the need for an infant injection. However, there is a slight risk of preterm birth with the vaccine, although this risk decreases when administered at 32 weeks or later.
Nirsevimab, on the other hand, offers longer-lasting protection compared to the vaccine. It delivers antibodies directly to the infant, without the risk of causing preterm birth since it is given to the infant rather than the pregnant person. Nevertheless, it is more expensive, costing $495, but insurance should cover the expense. Availability may be limited due to supply constraints.
Dr. Brenda Hughes from the American College of Obstetricians and Gynecologists expressed strong support for the maternal RSV vaccine, emphasizing its efficacy in reducing severe disease risk in infants. She noted that while nirsevimab is highly effective, it may not always be available or preferred by parents or healthcare facilities.
The FDA has mandated post-marketing studies for Pfizer to assess whether the vaccine is linked to preterm birth or hypertensive disorders in pregnancy, including pre-eclampsia. Pfizer intends to conduct a large trial once the vaccine is officially available on the market. The CDC will utilize V-Safe, a program originally designed to monitor COVID-19 vaccine safety, to track individuals' post-vaccine experiences with other vaccines.
Pfizer's Dr. Luis Jodar, the company's chief medical affairs officer for vaccines, antivirals, and evidence generation, lauded the CDC's recommendation for maternal immunization with Abrysvo, highlighting the broader positive impact that vaccines can have on protecting infants from severe and life-threatening RSV complications.