FDA OKs Pfizer’s RSV Vaccine for Expectant Mothers

First Vaccine Approved for Pregnant Women to Protect ⁤Babies from RSV

Exciting⁤ news from the U.S. ⁤Food and Drug Administration (FDA) on Aug. 21! They⁤ have approved the first vaccine for pregnant women to prevent respiratory syncytial virus (RSV) infections in⁣ babies and toddlers.

The vaccine, called ‍Pfizer’s Abrysvo, is ⁤a groundbreaking single-dose⁢ injection administered into the muscle. It has been approved for ⁣use between 32 and‌ 36‌ weeks of pregnancy.

What makes this vaccine even more remarkable is⁣ that pregnant women who⁣ receive it will⁣ pass on immunity to their unborn babies, protecting them​ from⁢ lower respiratory​ tract disease (LRTD) and severe LRTD caused by RSV until ⁢they are ⁣at ⁢least 6 months ​old.

This approval‌ comes after a unanimous vote by 14 ⁤members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) in May, recommending the use of⁤ this drug in pregnant women to ‍safeguard newborns and infants.

Abrysvo has also received approval for use ⁣in individuals aged 60 and older to protect against RSV.

RSV: A Common Virus with Serious Consequences

RSV is a respiratory virus that usually causes mild‍ illness⁣ in healthy adults,‌ with symptoms like a runny‍ nose, coughing, and fever. However, it‍ is ‍particularly common and dangerous in children, often leading to serious conditions such as pneumonia and bronchiolitis.

Each year, RSV results in millions of⁢ outpatient visits and hundreds of deaths‌ among children under ⁤5 years old in the ‍United States.

Longevity and Potential Side Effects

The FDA has announced ⁢that clinical studies evaluating the effectiveness of Abrysvo ‌have shown‍ promising results. ⁣The⁣ drug reduced the risk⁤ of ​severe LRTD by ⁣81.8% within 90 days after​ birth and by 69.4%⁤ within 180 days after birth.

In​ a study involving approximately 3,500 pregnant women, ⁤Abrysvo led to ⁤a 34.7% reduction in LRTD risk and a 91.1% reduction in severe‍ LRTD risk within 90 days after birth.

While the vaccine has shown great⁤ potential, there have ⁢been some reported side⁣ effects‍ among pregnant women⁤ who ⁢received it, including pain at the injection site, headache, ⁢muscle pain, and nausea.

It’s important to note that‍ although rare, a serious hypertensive disorder known as pre-eclampsia has been ‌associated with the⁣ vaccine.