Friday September 22, 2023, the Centers for Disease Control and Prevention recommended the first maternal RSV vaccine be administered during the third trimester of pregnancy to protect newborns.
Shortly after the CDC's advisory committee voted 11-1 on Friday to recommend that pregnant women between 32 and 36 weeks of gestation receive the Pfizer-made Abrysvo vaccine, which would provide infants with protection for the first six months of life, the agency's director signed off on the recommendation.
Dr. Mandy Cohen, director of the CDC, said in a statement, "This is another new tool we can use this fall and winter to save lives." "I encourage parents to speak with their doctors about protecting their children from serious RSV illness with either a vaccine administered during pregnancy or an RSV immunization administered after birth."
According to the CDC, the vaccine is already available in certain U.S. locations, and its availability will increase in the coming weeks.
Dr. Michelle Taylor, health commissioner of the Shelby County Health Department in Memphis, Tennessee, told ABC News, "Every family wants their children to have a good start in life, and to hear that we are finally going to have some additional protection against a major respiratory illness that has caused problems for families for years is a huge advance in medicine and a huge advance in public health."
According to the CDC, RSV hospitalizes between 58,000 and 80,000 infants under 5 years old annually in the United States. According to research published in The Lancet Infectious Diseases, in 2016, over 650,000 children younger than five perished from RSV infections of the lower respiratory tract worldwide. This virus is most dangerous to infants younger than six months and those born prematurely.
According to the CDC, young children with certain underlying health conditions, such as heart, lung, or neuromuscular diseases, are also at risk of developing severe complications from this virus.
According to Dr. Michael Caldwell, associate vice president of vaccine research and education at Meharry Medical College in Nashville, "this vaccine could have a significant impact on populations with disproportionate rates of prematurity, such as African-Americans, American Indians, and Alaska Natives, whose rates of prematurity are approximately 50 percent and 30 percent higher than white infants, respectively. Prematurity is the greatest risk factor for severe RSV disease. If you could reduce the severity of RSV in these infants, you would have a greater impact on those racial and ethnic groups with higher prematurity rates", he said.
This shot joins another recently approved tool called nirsevimab, a monoclonal antibody injection that is recommended for all neonates under 8 months of age, as a seasonal option.
During the meeting on Friday, the committee laid out clinical considerations for how these products should be used together. But said that most babies who are born to mothers who receive the RSV shot in pregnancy will not need the additional protection with nirsevimab unless they are born less than 14 days after the mother received their RSV shot.
In August, the Food and Drug Administration approved Pfizer's Abrysvo for expectant women and issued a warning that this injection should not be administered before 32 weeks gestation, citing a lack of evidence linking the drug to an increase in preterm births in clinical trials. The FDA requires Pfizer to conduct post-marketing studies to continue monitoring the shot's safety.
Dr. Julie Morita, executive vice president of the Robert Wood Johnson Foundation, told ABC News that this warning should not prevent expectant women who are eligible from receiving the vaccine. When these vaccines become available for expectant women, according to Morita, ensuring equality will be of the utmost importance. "While this is exciting news, I am concerned about how it will be implemented to ensure that all pregnant women have access to these vaccines so that they can reap their full benefits," Morita said.
Caldwell referred to this shot as "historic" and stated that this is the first time that studies have been conducted specifically for the purpose of submitting an application to the FDA for licensing with the indication for expectant women.
Dr. Laura Riley, chair of the American College of Obstetricians and Gynecologists' (ACOG) Immunization, Infectious Disease, and Public Health Preparedness Expert Work Group, told ABC News, "As an obstetrician, I am thrilled that a maternal vaccine has finally been developed. I believe that our experience with other vaccines indicates that maternally derived antibodies can swiftly traverse the placenta and protect the infant from vaccine-preventable diseases."
The interim CEO of the American College of Obstetricians and Gynecologists, Dr. Christopher Zahn, issued a statement in support of the vaccine, stating, "The national and global burden of RSV disease demonstrates how crucial it is to prevent this virus in neonates. The American College of Obstetricians and Gynecologists (ACOG) believes that the maternal RSV vaccine is effective and that parents must have the option to protect their infants from RSV after birth. ACOG is presently updating its clinical recommendations, which will be published in the coming days.
"This maternal RSV vaccine is also recommended during pregnancy, along with the COVID-19, influenza, tetanus, diphtheria, and pertussis, or Tdap, vaccines.
Riley reported that her patients are also enthusiastic about this development and began requesting the injection as soon as it was approved by the FDA in August. "I was at the office yesterday, four people out of twenty requested the vaccine, but none inquired for information. They desired the vaccine, said Riley.
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