Pfizer’s Abrysvo becomes first vaccine to safeguard newborns against RSV in utero

USA — In a remarkable stride toward advancing maternal and infant health, Pfizer has achieved an exceptional feat by gaining FDA approval for Abrysvo, the first-ever vaccine to safeguard newborns against respiratory syncytial virus (RSV) while in utero.

This groundbreaking approval heralds a new era in protecting the most vulnerable members of our population.

Tailored to pregnant women at the gestational stage of 32 to 36 weeks, Abrysvo extends its protective shield to infants for their first six months of life.

This innovative vaccine offers a preemptive defense against RSV, a virus responsible for severe respiratory infections in infants and young children.

While Pfizer’s Abrysvo isn’t the first RSV prophylactic for infants—Sanofi and AstraZeneca secured approval for Beyfortus last month—its significance lies in its pioneering approach.

Annaliesa Anderson, Ph.D., Senior Vice President and Head of Pfizer’s vaccine Research and Development, expressed enthusiasm for the prospect of safeguarding newborns “from their first breath” and potentially reducing lung conditions in children.

RSV poses a significant threat to infants, annually causing hospitalizations and even fatalities. According to the CDC, the virus is responsible for hospitalizing infants and claiming the lives of nearly 300 children under the age of 5 in the U.S. each year.

However, Pfizer encountered some challenges in securing full endorsement for Abrysvo. While advisory committees recognized its efficacy in the second and third trimesters of pregnancy, the approved window of usage was restricted to just four weeks.

This limitation likely stemmed from trial results that indicated a higher occurrence of pre-term birth among vaccinated pregnant women.

Nonetheless, Pfizer’s commitment to addressing RSV extends beyond this groundbreaking vaccine. The company is actively testing Abrysvo in high-risk children aged 2 to 17 and in immunocompromised adults aged 18 to 59.

These efforts underscore Pfizer’s dedication to curbing the impact of RSV across various age groups.

Pfizer’s success is complemented by its concurrent achievements in different populations. Abrysvo is the first RSV vaccine to gain approval for both pregnant women and older adults, providing a comprehensive approach to safeguarding those at the highest risk.

As the RSV season approaches, Pfizer’s innovative strides pave the way for a transformative landscape in healthcare.

With multiple products entering the market, this upcoming season promises to witness competition for market share in a potentially lucrative field.

While challenges persist, including ongoing litigation initiated by GSK against Pfizer’s vaccine, the momentum toward preventing and treating RSV-related illnesses is palpable.

As Pfizer continues its efforts, the anticipation of Abrysvo’s public availability by late October or early November holds the promise of a safer and healthier future for infants and their families.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.