FDA Gives Green Light to RSV Vaccine for Expectant Mothers to Shield Newborns

by Sophia Chen
RSV vaccine

On Monday, U.S. regulators granted approval to the inaugural RSV vaccine for expectant mothers, aimed at providing newborns with immunity against the dreaded respiratory infection.

Respiratory syncytial virus, or RSV, is infamous for resulting in a surge of hospitalized babies with wheezing problems each autumn and winter. The Food and Drug Administration sanctioned Pfizer’s maternal immunization to defend against serious instances of RSV, during the time babies are at their most susceptible—namely, from the moment of birth until they reach 6 months.

The ensuing stage: The Centers for Disease Control and Prevention is tasked with furnishing guidelines for administering the vaccine, called Abrysvo, throughout pregnancy. (Vaccinations intended for the elderly, who are also at significant risk, are commencing this autumn, utilizing the identical Pfizer injection along with another one from rival GSK.)

Dr. Elizabeth Schlaudecker of Cincinnati Children’s Hospital, involved in Pfizer’s international trial of the vaccine, stated that “maternal immunization is a remarkable means to safeguard infants.” Should immunizations commence promptly, she believes that “an effect on this RSV season” could be discernible.

RSV, while merely a coldlike annoyance for the majority of healthy individuals, poses fatal risks to the very young, as it can inflame infants’ diminutive airways, making breathing arduous, or even lead to pneumonia. Each year in the U.S., the respiratory syncytial virus causes the hospitalization of 58,000 to 80,000 children under 5, with several hundred fatalities.

The previous RSV season in the U.S. was exceptionally brutal, beginning its toll on infants in the summertime, much earlier than typically observed.

With an underdeveloped immune system at birth, infants rely on maternal protection during their first months. The function of the RSV vaccine: Administered as a single shot later in pregnancy, it allows sufficient time for the mother-to-be to produce antibodies against the virus, which are then transferred through the placenta to the fetus, becoming active upon birth.

This method is akin to how pregnant women confer immunity against other infections. They have long been encouraged to receive vaccines against the flu and whooping cough, and more recently, the COVID-19 vaccine.

Pfizer’s research encompassed roughly 7,400 pregnant women and their newborns. While the maternal vaccine did not avert mild RSV infection, it demonstrated 82% efficacy in preventing severe cases during the first three months of life and 69% efficacy at six months.

Adverse reactions to the vaccine were predominantly localized pain at the injection site and fatigue. In the research, a minor difference in premature birth was observed—only a few weeks early—between vaccinated mothers and those receiving a placebo, a discrepancy Pfizer attributed to randomness. The FDA consequently stipulated that the vaccine should be administered solely between the 32nd and 36th weeks of gestation, slightly later than in the clinical trial.

Pfizer anticipates that with sufficient vaccinations among pregnant women, the U.S. could avert as many as 20,000 infant hospitalizations and 320,000 doctor visits annually.

The sole alternative for protecting infants from RSV is through the administration of synthesized antibodies. The FDA has newly approved a first-of-its-kind one-dose drug, Beyfortus from Sanofi and AstraZeneca, anticipated to be accessible this fall.

Both the novel antibody medication and the maternal vaccine are keenly awaited, opined Cincinnati’s Schlaudecker, a pediatric infectious disease specialist. She foresees that physicians may employ a combination of the two to offer the optimal protection for infants depending on their age and risk during the RSV season.

Another doctor from Cincinnati Children’s, who has treated gravely ill RSV patients, volunteered for Pfizer’s vaccine trial during her pregnancy.

Dr. Maria Deza Leon remarked, “The last thing a parent wants to see is their kid struggling to breathe.” She received her immunization in January 2022, and her son Joaquin was born the next month. Although she has not yet determined whether she was given the actual vaccine or a placebo, Joaquin is currently a healthy toddler with no RSV diagnosis.

The Health and Science Department of The Big Big News receives backing from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP holds exclusive responsibility for all content.

Frequently Asked Questions (FAQs) about RSV vaccine

What is the newly approved RSV vaccine and who is it intended for?

The U.S. Food and Drug Administration has approved Pfizer’s RSV vaccine called Abrysvo, intended for pregnant women. This vaccine aims to provide newborns with immunity against respiratory syncytial virus (RSV), which can lead to severe respiratory infections in infants.

When will the RSV vaccine be administered during pregnancy?

The FDA has recommended that the vaccine be administered between the 32nd and 36th weeks of gestation, allowing enough time for the mother to develop virus-fighting antibodies that are passed to the fetus.

How effective is Pfizer’s RSV vaccine in preventing severe RSV infection?

Pfizer’s study has shown the vaccine to be 82% effective at preventing a severe case during babies’ first three months of life and 69% effective at age six months.

What are the alternative methods for protecting babies from RSV?

The only other option to guard babies from RSV is through lab-made antibodies. The FDA recently approved a one-dose drug called Beyfortus from Sanofi and AstraZeneca, expected to be available this fall.

What were the observed side effects of the RSV vaccine in the study?

Vaccine reactions were mostly injection-site pain and fatigue. A slight difference in premature birth was also observed between vaccinated mothers and those given a dummy shot, though this was attributed to chance by Pfizer.

How many infant hospitalizations and doctor visits could be prevented with widespread vaccination?

Pfizer predicts that if enough pregnant women are vaccinated, the U.S. could prevent as many as 20,000 infant hospitalizations a year and 320,000 doctor visits.

More about RSV vaccine

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James Tylor August 22, 2023 - 12:20 pm

Its about time someone came up with a solution for RSV. Glad to see Pfizer stepping up, hope this really saves lives. go science!

Sarah Wills August 22, 2023 - 8:59 pm

Can anyone tell me if there’s side effects?? my sister’s pregnant and we’re both worried about new vaccines

GeorgeP August 23, 2023 - 12:08 am

Will this be a required vaccine or optional? I have mixed feelings about it, but its good to have more options for keeping our kids safe.

Martin.K August 23, 2023 - 12:43 am

Didnt know RSV was such a big problem. Scary to think so many babies get hospitalized every year.

Linda Fields August 23, 2023 - 1:17 am

I work in a children’s hospital and see the impact of RSV firsthand. this is good news, but we need to be cautious with new vaccines i think.


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