FDA approves first RSV vaccine for use in pregnancy to protect newborns

Expectant parents could soon have another new way this fall to protect their newborns from RSV, or respiratory syncytial virus, the leading cause of hospitalizations in American infants, after the Food and Drug Administration announced on Monday that it was extending its approval for Pfizer's Abrysvo vaccine to include expectant mothers.

Pregnant women gain immunity to the injection during pregnancy and pass it on to their baby before birth, providing protection for the infant in the first few months of life.

“This approval offers healthcare providers and pregnant women an opportunity to protect infants from this potentially life-threatening disease,” said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in one release Notification of Approval.

Pfizer's new approval follows a positive vote by the FDA's external vaccine advisors in May after results find The shot was 69.4% effective in reducing the risk of serious lower respiratory tract disease in babies up to six months after birth.

If the Centers for Disease Control and Prevention agree, vaccination would be added to one list of “maternal immunizations” recommended before birth, increasing the chances of newborns safely surviving some of their most vulnerable months.

“Today a long-awaited goal was achieved of providing a maternal vaccine that will help protect infants six months of age and younger – when they are at greatest risk for potentially serious consequences from RSV -” said Annaliesa Anderson, Director of Pfizer's scientific director of vaccine research and development said in a statement.

While almost all children have survived at least one RSV infection by age 2, the virus can be particularly dangerous for babies who first contract the disease in their youngest months.

The FDA had previously only approved Pfizer's Abrysvo vaccine for Use in older adults. adults over the age of 60 recommended to talk to their doctors about a possible vaccination.

The CDC's Advisory Committee on Immunization Practices is due to meet again to consider updated recommendations for vaccinations during pregnancy.

While physicians are not legally required to follow the panel's recommendations, they play a key role in decision-making Requirements for vaccine insurance.

A second way to protect newborns

The latest approval follows another option that was recently given the green light to protect babies from RSV: nirsevimab, an antibody injection now being marketed by drugmakers Sanofi and AstraZeneca under the name Beyfortus.

After a meeting in early August, the CDC had passed new recommendations urging parents of babies born into their first RSV season this fall and winter to do so Get them the Beyfortus shot.

But officials at the agency acknowledged that if Abrysvo were also approved by the FDA, the committee would need to meet again to vote on new recommendations and how that might affect their new guidance.

Both Abrysvo and Beyfortus appeared safe and effective in trials to curb RSV hospitalizations in infants, according to a working group convened by the agency reported earlier this year.

However, preliminary calculations demonstrated According to the committee, it would not be cost-effective to recommend giving both shots, which would add up to a combined cost of $700 for each child before insurance.

Instead, the CDC may endorse recommendations to offer Abrysvo first.

Beyfortus would be practically a backup among them draft guidelinesis mostly offered only to babies whose parents were not infected with Abyrsvo during pregnancy or who are at higher risk of serious illness.

Questions about very rare preterm births

The new recommendations are further complicated by a handful of very rare preterm births that have been observed in babies born to mothers who received Abrysvo during pregnancy.

While the number in the Pfizer study was too small to be statistically significant, it came after a larger surge in preterm births was large enough to force GSK to abandon a separate RSV vaccine trial in pregnant women earlier this year.

“We've debated for a long time whether or not there might be biological plausibility for this,” CDC's Katherine Fleming Dutra told ACIP meet in June.

This also puzzled some members of the FDA's vaccine panel earlier this year. While they voted unanimously for efficacy, the panel voted 10-4 on whether there was enough data on the safety of Abrysvo to support its approval.

“I, like everyone else, am concerned about the problem of preterm birth. And I'm not sure it's going to give us an answer if we maybe play another season. And I think we've heard these observational studies over time. “If there's a problem there, it'll give us an answer pretty quickly,” said Dr. Arnold Monto, one of the FDA committee members. said at the conference.

The FDA said Monday it will require Pfizer to “perform post-marketing studies” to assess the risk of preterm birth and include a warning about the “numerical imbalance.”

“The available data are insufficient to establish or rule out a causal relationship between preterm birth and abrysvo,” the agency said.

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