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The CDC’s advisors on Friday recommended a maternal respiratory syncytial virus (RSV) vaccine to protect infants from serious infections.
By an 11-1 vote, the Advisory Committee on Immunization Practices (ACIP) recommended that pregnant women receive a single dose of Pfizer’s prefusion F protein (RSVpreF) vaccine (Abrysvo) at 32 to 36 weeks’ gestation to prevent lower respiratory tract RSV infection in infants.
After decades without an option for protecting most infants against the annual respiratory scourge, providers now have two options: the maternal vaccine and the monoclonal antibody nirsevimab (Beyfortus), which the ACIP last month recommended for all infants younger than 8 months born during or entering their first RSV season.
“RSV, throughout my career, has been a difficult disease with just supportive care treatment because there have been no options,” said committee member Katherine Poehling, MD, MPH, of Wake Forest School of Medicine in Winston-Salem, North Carolina, who voted yes. “So, today is an exciting day.”
The maternal vaccine will be covered under the Vaccines for Children program, which makes coverage free for uninsured or underinsured children.
Shortly after the meeting, CDC Director Mandy Cohen, MD, MPH, endorsed the recommendations, noting that the vast majority of infants whose mothers receive the RSV vaccine at least 2 weeks prior to birth will not need nirsevimab as well. The monoclonal antibody can be considered in rare circumstances when, per the clinical judgment of the healthcare provider, the potential incremental benefit of administration is warranted.
Prior to Friday’s vote, committee members discussed at length how a recommendation for the maternal RSV vaccine would coexist with the recent recommendation for the monoclonal antibody for RSV prevention in infants, delivered directly to babies as a singular muscular injection after birth.
“I think the complexity is that the mother and the healthcare provider, actually we have options,” said committee member Pablo Sanchez, MD, of Nationwide Children’s Hospital in Columbus, Ohio, who also voted yes. “I mean, if we only had the RSV vaccine to offer, it would be simple. We would just be saying, ‘yes,’ they should get it, but we do have options.”
“We as physicians, when we care for our patients, we do have some personal preferences,” Sanchez said. “I think that is part of [the] patient discussion. And so, I think that these options are great. We, as pediatricians, infectious disease specialists, neonatologists, have to prevent serious RSV disease in our babies.”
Ultimately, despite complexities acknowledged by a number of committee members, ACIP moved forward with its recommendation.
“There’s nothing simple about this RSV vaccine and nirsevimab, but they give us both hopes,” Poehling said. “We’ve done this before with [the] COVID vaccine. And I think if everybody’s willing to chip in and do their part that this is feasible and will improve the well-being of many families throughout our nation.”
Helen Talbot, MD, of Vanderbilt University in Nashville, Tennessee, was the sole committee member to vote no.
“I really want to reiterate how important it is that the medical societies work on this process,” said Talbot. “The pneumococcal vaccines have been complicated for years … And I worry that you have created another very complicated recommendation.”
“And what happened with pneumococcus is we have low immunization rates. So please, please, every society needs to talk. There needs to be massive education, and you need to do it better than what we did for pneumococcus,” she emphasized.
The FDA approved the maternal RSV vaccine in August. Though the vaccine was administered in trials starting at 24 weeks’ gestation, the agency approved giving it at 32 to 36 weeks’ gestation due to a possible risk for preterm birth.
As always, all ACIP recommendations are not considered final until they are published in the Morbidity and Mortality Weekly Report.
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Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.
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