Pfizer’s RSV vaccine to protect infants gets approval from FDA

The US Food and Drug Administration (FDA) has granted approval to the very first RSV vaccine designed specifically for expectant mothers to safeguard their newborns. Administered during the final trimester of pregnancy, Pfizer’s novel vaccine, named Abrysvo, is said to shield infants from lower respiratory tract issues triggered by RSV, also known as respiratory syncytial virus, for their initial six months of life.

What is RSV and why is it dangerous for newborns?

RSV, a common respiratory virus often causing mild symptoms, can pose serious risks for infants, young children, and older adults. According to the Immunisation Coalition, RSV infection creates around 6000 hospitalisations per year with 95% of the hospitalisations reported in children under 5 years of age. 5-10% of the people hospitalised end up in the intensive care unit. 

There are less than five deaths per year in Australia from RSV.  However globally, RSV is a leading cause of death.

A long time coming

As mentioned in an earlier blog post, making a vaccine for RSV (Respiratory Syncytial Virus) has been tricky because the virus has a part on its surface called the F protein that changes shape when it infects cells. The best antibodies, whether made by our body or in a lab, attack a specific part of this F protein that is only exposed before the shape change happens. This has made it challenging to create a vaccine that works effectively against RSV.

The US Food and Drug Administration (FDA) previously approved Glaxo SmithKline and Pfizer’s vaccines for RSV in May 2023, both for use in adults over the age of 60.

Pfizer’s RSV vaccine (Abrysvo) has also been approved as a maternal vaccine. Meaning it is administered to pregnant women, to help them develop and pass on protective antibodies to their babies. Administered in a single shot at 32 to 36 weeks of pregnancy, the vaccine significantly protects children from birth to age 6 months, when they are at highest risk of RSV-related complications.

Late-stage clinical trials published in The New England Journal of Medicine showed that infants born to women who had received the vaccine had an 81.8% lower risk of developing severe lower respiratory tract illness within 90 days after birth and a 69.4% lower risk within 180 days after birth.

These RSV vaccines are not yet approved in Australia. But this could change in the near future!

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