Friday, September 22

The FDA approves the first vaccine to safeguard newborns from RSV infections.


The US Food and Drug Administration approved the first RSV vaccine, which is a type of vaccine that protects newborns from respiratory syncytial virus. Pfizer’s vaccine is given to mothers who are late in their pregnancies and provides protection to infants for the initial six months of life.

The vaccine, Abrysvo, was used in a trial with over 7,000 pregnant women and their infants to decrease the need for visits from doctors or hospitals.

RSV is a prevalent sickness that results in hospitalization of both young and old individuals annually. It is most frequently observed in the winter season, and the last RSR season was more extended than usual, causing significant delays in access to children’s hospitals.

According to a statement by Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, RSV is primarily contracted by children, and infants are at the highest risk of contracting the disease, which can result in hospitalization and possibly lead to death.

Despite decades of research and unsuccessful attempts to develop RSV vaccines, there are now multiple options for protecting against the virus, such as a new antibody shot that can be administered to all infants after birth and new vaccine offerings for people aged 60 and over.

Annaliesa Anderson, Pfizer’s senior vice president and chief scientific officer for vaccine research and development, announced that the approval of ABRYSVO as the first and only maternal immunization to protect newborns immediately at birth through six months from RSV represents a significant milestone for the scientific community and public health.

According to Pfizer, if the vaccine were universally administered, maternal vaccination could prevent up to 16,000 hospital visits and over 300,000 doctor visits per year due to RSV.

The maternal vaccine for Pfizer to safeguard newborns from RSV has been approved by the FDA. Photo courtesy of Ppfiser.

The vaccine is effective for three months after birth, but it lacks long-term protection. It was found to be 82% effective in preventing severe RSV disease and 57% effective from reducing the need for doctor visits for RSPs.

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The FDA’s vaccine advisers voted in favor of the RSV vaccine earlier this year, with a 10-4 vote on whether data showed it was safe and indicating that there was fewer preterm birth cases among children receiving the vaccine.

Pfizer has announced that a significant postmarket safety investigation will utilize extensive commercial claims data databases, including Medicaid data, to assess safety criteria for all vaccine recipients, such as preterm birth.

The company is also investigating the use of the vaccine in children and adults aged 2 to 18 who are at greater risk for RSV infection due to underlying medical conditions or immune system weakness.

The report was aided by CNN journalists Jen Christensen and Amanda Sealy.

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