USA — Pfizer has received an expanded approval from the US FDA for its pneumococcal vaccine candidate, Prevnar 20, which is a conjugate vaccine designed to protect against invasive pneumococcal disease (IPD) caused by 20 different serotypes of Streptococcus pneumoniae.
Prevnar 20 offers additional protection against seven more serotypes, including those linked to antibiotic resistance, invasive potential, and disease severity.
The vaccine has now been approved for use in infants and children aged six weeks to 17 years, in addition to its prior approval for adults.
The vaccine’s approval is based on results from Phase 2 and Phase 3 clinical trial programs that evaluated the vaccine in the pediatric population.
Prevnar 20 also offers protection against otitis media, a type of ear infection caused by the original seven serotypes in the vaccine for infants aged six weeks through five years.
Annaliesa Anderson, Pfizer’s Vaccine Research and Development Senior Vice President and Chief Scientific Officer, expressed the company’s excitement over the expanded approval.
She noted that Prevnar 20’s approval builds on more than two decades of real-world impact with Prevnar and Prevnar 13.
Anderson further highlighted Pfizer’s leadership in developing ground-breaking pneumococcal conjugate vaccines to protect infants and their families from life-threatening infections.
With Prevnar 13 and 20, Pfizer has the dominant franchise on the market, generating $5.3 billion in sales in 2021.
The expanded approval of Prevnar 20 now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in US infants and children.
The Centers for Disease Control and Prevention recommends that infants receive doses at ages 2 months, 4 months, 6 months, and 12 through 15 months. Children make up 80% of the pneumococcal vaccine market.
Merck gained an advantage with its pediatric approval seven months ago for Vaxneuvance, which offers protection against 15 serotypes of the virus versus the 13 strains covered by Prevnar.
However, Prevnar’s next-generation vaccine protects against 20 serotypes, offering an edge over Merck.
Competition in the pneumococcal vaccine market is on the horizon for Merck and Pfizer. In an effort to crack the market, GSK acquired Affinivax and its 24-valent vaccine in a US$3.3 billion buyout.
A phase 3 trial is underway for AFX3772. Just recently, California biotech Vaxcyte received FDA breakthrough therapy designation for its pneumococcal vaccine VAX-24, which is in phase 2 testing for adults.
In August, Seattle-based Inventprise launched a phase 1/2 trial of its 25-valent vaccine IVT PCV-25.
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