CDC urges RSV shot for pregnant women before virus season
A federal advisory panel recommended on Friday that expectant mothers get an RSV vaccine to protect their newborns from the potentially deadly respiratory disease. The vaccine is recommended for people who are between 32 and 36 weeks pregnant and who will give birth during the fall and winter, when RSV cases usually spike.
The maternal RSV vaccine represents the latest tool health care providers have to safeguard infants during their most vulnerable stage, right after birth, when their immune systems are still developing.
Most infants will be infected with respiratory syncytial virus in their first year of life. According to data from the Centers for Disease Control and Prevention, it’s the leading cause of hospitalizations in babies, sending more than 500,000 infants to the emergency department annually and hospitalizing 58,000 to 80,000 children younger than 5 each year.
Produced by Pfizer
Abrysvo, the RSV vaccine produced by Pfizer, was approved for maternal use by the Food and Drug Administration in August but needed approval from the CDC before the shots could be administered. CDC Director Mandy Cohen endorsed the recommendation from an independent advisory panel that voted earlier in the day to approve the vaccine.
Of the 12 panel members, only one, Helen Keipp Talbot, voted no on the recommendation, citing concerns regarding real-life administration. Unlike other vaccines given to larger populations, the RSV vaccine is for a specific subset of people during a few months of the year.
“This is the most complicated vaccine for young adults that we’ve had in a long time,” said Keipp Talbot during the advisory panel meeting. “I feel like this is going to be incredibly complicated and expensive.”
The CDC recommendation comes at pivotal time of year, when the spread of viral illness is beginning to ramp up. A CDC report reveals that RSV cases have already begun rising in certain parts of the United States, with an earlier onset than in previous years.
“Using this RSV vaccine for pregnant moms ... we can now keep our children safer than ever before,” said Cohen. “As a parent, I know nothing is scarier than seeing your child in the hospital, which is why getting this new vaccine if you’re pregnant — or getting the RSV antibody for your baby — is so important.”
More than 80% effective
In clinical trials, researchers found that the vaccine was more than 80 percent effective at protecting babies from severe illness during their first few months of life. The most common side effect for the parent was pain at the injection site. People who received the vaccine in the trials saw a slight increase in the likelihood of preterm births compared to those who did not.
Similar to the coronavirus and flu vaccines, protection against RSV wanes after three months, but that should be sufficient to protect babies during their first virus season.
The single shot is given to mothers, and protects their babies by passing on antibodies through the placenta. This type of passive immunity works similarly to other vaccines that are given to pregnant patients, such as the flu shot and Tdap, the vaccine that protects against tetanus, diphtheria and pertussis.
“The idea that we can vaccinate moms in their third trimester so that they can pass on their antibodies and protect the babies in the most vulnerable months — given the experience with RSV last year, this is very exciting,” said Colleen Denny, an associate professor in the department of obstetrics and gynecology and director of family planning at NYU Langone Hospital.
This is the second approved pharmaceutical aimed at protecting babies against RSV. Nirsevimab, sold under the brand name Beyfortus, is a monoclonal antibody treatment developed by Sanofi and AstraZeneca that was approved in July for healthy babies. While not a vaccine, the treatment works similarly and is a recommended protection for infants born outside the height of RSV season. The advisory panel also recommended that preterm babies born before 34 weeks receive the monoclonal antibody treatment.
The agency foresees the vaccine being administered during a patient’s prenatal visit at their provider’s office. Simultaneous administration of the RSV vaccine with other vaccines such as Tdap, coronavirus and the flu may happen at the same office visit.
The RSV shot will be added to adult and pediatric immunization schedules and will be released next week.
The cost per dose is $295, which is the same price as Pfizer’s RSV vaccine given to adults older than 60. That vaccine was recommended by the CDC in June. The CDC says it is taking steps to ensure broad access for both uninsured and insured patients.
Per the Affordable Care Act’s implementing regulations, vaccines recommended by the CDC and included in the immunization schedule are usually required to be covered by health insurance plans without co-pays, coinsurance or deductibles.
“Using this RSV vaccine for pregnant moms ... we can now keep our children safer than ever before. As a parent, I know nothing is scarier than seeing your child in the hospital, which is why getting this new vaccine if you’re pregnant — or getting the RSV antibody for your baby — is so important.”
CDC DIRECTOR MANDY COHEN