FDA approves RSV vaccine for expectant mothers to protect their newborns

WASHINGTON (AP) – U.S. regulators on Monday approved the first RSV vaccine for pregnant women to help their babies be born with protection from the scary respiratory infection.

RSV is notorious for filling hospitals with panting babies every fall and winter. The Food and Drug Administration has approved Pfizer's maternal vaccine to protect against a severe case of RSV Babies are the most vulnerable — from birth to 6 months of age.

The next step: The Centers for Disease Control and Prevention must issue recommendations for the use of the vaccine called Abrysvo during pregnancy. (Vaccinations for older adults, who are also at high risk, begin this fall with the same Pfizer shot and one more shot Competitor GSK.)

“Maternal vaccination is an incredible way to protect infants,” said Dr. Elizabeth Schlaudecker of Cincinnati Children's Hospital, a researcher in Pfizer's international study of the vaccine. If recording starts soon, “I think we could see an impact on this RSV season.”

RSV is a common cold-like nuisance for most healthy people, but can be life-threatening in the very young. It inflames the baby's tiny airways, making it difficult for them to breathe or causing pneumonia. In the United States alone, between 58,000 and 80,000 children under the age of five are hospitalized and several hundred die each year as a result of respiratory syncytial virus.

Last year's RSV season The disease was extremely harsh in the US and started getting sick in the little ones in the summer, much earlier than usual.

This image provided by Pfizer shows the RSV vaccine.
This image provided by Pfizer shows the RSV vaccine.

Babies are born with an immature immune system and need their mother's protection for the first few months. How the RSV vaccination works: A single injection late in pregnancy gives the expectant mother enough time to develop virus-fighting antibodies that can cross the placenta to the fetus and work there at birth.

In the same way, pregnant women pass on protection from other infections. Pregnant women have long been urged to get vaccinated against the flu and whooping cough — and more recently, against COVID-19.

Almost 7,400 pregnant women and their babies took part in Pfizer's study. Maternal vaccination did not prevent mild RSV infection – but was 82% effective in preventing a severe case in the baby's first three months of life. At the age of 6 months, the effectiveness against serious diseases was still 69%.

Most of the vaccine reactions were pain at the injection site and fatigue. In the study, there was a slight difference in preterm birth — just a few weeks earlier — between vaccinated mothers and those given a sham vaccine, which Pfizer said was due to chance. The FDA said to avoid this possibility, the vaccine should only be given between weeks 32 and 36 of gestation, a few weeks later than during the clinical trial.

If enough pregnant women were vaccinated, the US could prevent up to 20,000 infant hospitalizations and 320,000 doctor visits a year, according to Pfizer.

The only other way to protect babies from RSV is to give them lab-made antibodies. The FDA recently a new drug This is the first single-dose version recommended for all infants under 8 months prior to the start of their first RSV season. Beyfortus by Sanofi and AstraZeneca is expected to be available in the fall.

Cincinnati-based Schlaudecker, a specialist in pediatric infectious diseases, said both the new antibody drug and the maternal vaccine are highly anticipated and that doctors are expected to try a combination to give the babies the best doses based on age and risk during RSV season to offer protection.

Another Cincinnati pediatrician who cares for seriously ill RSV patients volunteered to participate in Pfizer's vaccine trial when she became pregnant.

“The last thing parents want to see is their child having trouble breathing,” said Dr. Maria Deza Leon. “I also ran the risk of being the person who could get RSV and give it to my son without even realizing it.”

Deza Leon received her vaccination in late January 2022 and their son Joaquin was born the following month. Although she has not yet learned whether she received the vaccine or a sham, Joaquin is now a healthy toddler who has never been diagnosed with RSV.

The Associated Press Health and Science Division receives support from the Howard Hughes Medical Institute's Science and Educational Media Group. The AP is solely responsible for all content.

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