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Pfizer announces promising developments for first maternal RSV vaccine

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(NEW YORK) — After decades of researching respiratory syncytial virus, an illness especially dangerous for newborns and the elderly, scientists this week announced a major development in plans for a possible vaccine that could be available as soon as next year.

“Among very young children, particularly those [younger] than 6 months of age, we have a high probability now of protecting against serious illness and hospitalization,” Pfizer’s Dr. William Gruber told ABC News.

Gruber is responsible for the company’s vaccine development programs and has been personally working on the RSV vaccine for over 40 years.

Pfizer announced Tuesday that given promising preliminary data on their maternal RSV vaccine for newborns, the Food and Drug Administration granted a green light to stop enrolling new patients in the study. The company said it will move forward with the vaccine approval process.

Pfizer’s traditional protein-based RSV vaccine works by vaccinating a pregnant person, who then passes on some protective antibodies to the infant. The company also said that the same vaccine has also shown promising data in adults 65 and older.

According to data collected from the preliminary studies, Pfizer said, the vaccine was 82% effective at protecting newborns, within the first three months of life, from severe RSV illness. Within six months of an infants’ life, the vaccine effectiveness dropped to 69%.

“To be able to be in a position where we have the potential to provide 80% or more protection against serious disease is a dream fulfilled,” Gruber said.

Pfizer plans to submit the vaccine for official FDA approval by the end of the year and, if greenlit by the FDA and recommended by the Centers for Disease Control and Prevention, the maternal RSV vaccine could be available as soon as next year.

Currently, there is no approved RSV vaccine. If Pfizer’s vaccine is approved, it would be the first RSV vaccine given to pregnant people to protect infants. The company said that there were “no safety concerns” for vaccinated pregnant participants and their newborns during the trial.

The news comes as pediatric hospitals across the country are experiencing a rise in the number of patients admitted with RSV. Infections due to RSV have spiked by 69% over the last four weeks and are appearing earlier than usual this year, according to the CDC.

Pediatric bed occupancy in the U.S. has reportedly hit its highest in two years, with 75% of the estimated 40,000 beds filled, according to an ABC News analysis.

RSV usually causes mild, cold-like symptoms, and is the most common cause of bronchitis and pneumonia in kids under the age of 1 in the U.S., according to the CDC.

The CDC also states that premature infants and young children with weakened immune systems, congenital heart or chronic lung disease are the most vulnerable to complications from RSV.

Dr. William Linam, a pediatric infectious disease doctor at Children’s Healthcare of Atlanta, told ABC News last year that parents can help protect their kids from RSV by following the three W’s of the coronavirus pandemic: wear a mask, wash your hands and watch your distance.

“Pretty much all kids have gotten RSV at least once by the time they turn 2, but it’s really younger kids, especially those under 6 months of age, who can really have trouble with RSV and sometimes end up in the hospital,” Linam said at the time.

“If you have a child who has significant underlying health conditions, you probably need to sort of maintain some of those precautions you were following during the worst of the pandemic, like continuing to wear masks more when you’re in enclosed spaces, being diligent about keeping hand sanitizer with you and using it a lot and avoiding crowds,” he added.

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