FDA Approves Pfizer’s Abrysvo As First Vaccine for Pregnant Women to Protect Babies From RSV
Already approved for adults, Pfizer’s vaccine, “Abrysvo,” protects pregnant women and their newborns against respiratory syncytial virus (RSV).
The FDA has approved Abrysvo for mothers 32 to 36 weeks pregnant. This shot protects the baby for the first six months.
Pfizer’s vaccine does not protect children from their first RSV infection. Last month, Sanofi and AstraZeneca released a controversial vaccine for children called “Beyfortus.” However, “Abrysvo” provides protection one step earlier.
Doctors are excited that this can start from the baby’s first breath and have a chance to protect babies. RSV is the leading cause of childhood hospitalizations and deaths in nearly 300 children under 5 years of age in the United States each year.
It wasn’t all good news for Pfizer, with Maternal approval for expectant mothers and newborns. In May, an FDA advisory panel unanimously agreed that there was an increased risk of preterm delivery among those given Abrisvo in the first and second trimesters of pregnancy.
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In addition to Abrisvo, the first vaccines are available in two separate groups to protect against RSV infection. Three months ago, the FDA approved a shot for people aged 60 and older.
“It’s really a supplement to older adult vaccines,” said doctor Annalisa Anderson. “It’s relatively risky to reach bookings for children and adults, I think, very surprising and breakthrough progress.”
For older adults, Pfizer’s approval comes a few weeks after GSK released “ArexV,” a vaccine for the RSV shot. Available at both Pfizer and GSK US-based pharmacies.
Earlier this month, GSK filed a patent infringement lawsuit alleging that Pfizer infringed four patents related to its vaccine “ArexV.”
However, Pfizer is still testing “Abrisvo” in children ages 2 to 17. It is being tested in elderly people aged 18 to 59 who are immunocompromised. Those with conditions such as asthma, diabetes, and COPD may be at increased risk for RSV infection.
The proposed vaccine, called Sanofi and AstraZeneca BeiFortus, is shown to offer the greatest protection against first RSV infection in children. This protects them when they are at high risk for RSV.
RSV infections generally begin in the winter and are at their peak in late winter, so new products may arrive at this time that may be profitable during the season.
