USA — In a recent development, the Food and Drug Administration (FDA) granted approval for Pfizer’s Penbraya, a groundbreaking meningococcal vaccine.

This approval extends the coverage of Penbraya to teenagers and young adults, safeguarding them against the five most common serogroups responsible for meningococcal disease.

The approval marks a significant milestone in the field of infectious disease prevention, offering a more comprehensive solution compared to existing options.

While meningococcal disease remains uncommon, it can pose severe health risks, even proving fatal in some cases.

Penbraya’s broad protection potential adds to Pfizer’s growing infectious disease portfolio, which also includes a recently approved vaccine for respiratory syncytial virus (RSV).

Despite these advancements, Pfizer is navigating declining sales for its COVID-19 vaccine and antiviral drug.

Presently, the United States has two types of meningococcal vaccines. Some safeguard against serogroups A, C, W, and Y, while others, like Trumenba, target serogroup B.

The Centers for Disease Control and Prevention (CDC) recommends that children aged 11 or 12 receive a MenACWY conjugate vaccine, followed by a booster at age 16.

People aged 10 and older at higher risk of meningococcal disease should receive a vaccine targeting serogroup B.

The existing multiple shots and spaced vaccination schedules have created a need for a vaccine like Penbraya, which caters to individuals between the ages of 10 and 25.

Pfizer’s infectious disease specialist, Jana Shaw, noted that nearly 9 out of 10 adolescents lack complete protection against invasive meningococcal disease from the dominant serogroups.

Pfizer anticipates that the routine use of Penbraya could lead to a reduction in cases of invasive meningococcal disease, as well as a decrease in related deaths and long-term effects.

The FDA’s approval of Penbraya stems from promising results obtained in Phase 2 and Phase 3 clinical trials conducted by Pfizer.

Despite the challenges presented by shifting demands in the COVID-19 market, Pfizer continues to focus on its infectious disease segment.

The company has cut its revenue forecasts by US$9 billion this year, yet it remains optimistic about the future success of its RSV vaccine, Abrysvo.

Early indicators following the vaccine’s launch suggest a robust demand, with high vaccination rates exceeding expectations.

Albert Bourla, Pfizer’s CEO, shared insights on the dynamics of the RSV market, stating, “It is a little bit early to see the dynamics of the RSV market, but it looks like it’s a really strong demand right now for RSV vaccines.”

Abrysvo initially gained approval for use in older adults earlier this year. In August, the FDA cleared the vaccine for safeguarding newborns through vaccination of their mothers during pregnancy.

Pfizer is also exploring the development of a combined influenza and COVID vaccine. The company envisions this combination vaccine as a regular option for fall vaccinations, emphasizing the convenience of a single visit for multiple vaccine doses.

In Bourla’s words, “Clearly, combinations are going to unlock a lot of potential because the convenience of getting one shot in one visit, zero co-pay, and full protection of respiratory vaccines is a very compelling proposition.”

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