Vaxneuvance triggered superior immune responses for serotypes 3, 22F and 33F compared to Merck’s 13-valent pneumococcal vaccine PCV13
Merck Life Science site in Burlington, US. (Credit: Merck KGaA, Darmstadt, Germany.)
Merck has received the US Food and Drug Administration (FDA) approval for Vaxneuvance, its pneumococcal 15-valent conjugate vaccine, for active immunisation in adults.
The vaccine is indicated for the prevention of invasive pneumoniae disease (IPD) caused by pneumococcus serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.
Vaxneuvance is not advised for people with a history of severe allergic reaction to any component of the vaccine or to diphtheria toxoid.
The drugmaker previously received the US FDA Breakthrough Therapy designation for the vaccine, and Priority Review designation in January 2021.
Merck Research Laboratories senior vice president, global clinical development head and chief medical officer Roy Baynes said: “At Merck, we are committed to helping protect more people from invasive pneumococcal disease.
“That’s why we set out to develop a conjugate vaccine that includes pneumococcal serotypes that pose the greatest threat and elicits a strong immune response to each serotype covered.
“The FDA approval of Vaxneuvance builds on Merck’s more than 40 years of experience in pneumococcal disease prevention with a new option that includes serotypes responsible for substantial disease burden in adults.”
The US FDA approval was based on data from seven randomised, double-blind clinical studies that evaluated the safety, tolerability, and immunogenicity of Vaxneuvance in adults.
The studies enrolled 7,438 individuals from different adult populations and clinical circumstances, of whom 5,630 received the 15-valent vaccine.
According to clinical data, Vaxneuvance elicited immune responses that were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13).
The superiority was for 13 shared serotypes, as evaluated by opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs).
In the Phase 3 PNEU-AGE trial, Vaxneuvance demonstrated immune responses superior to PCV13 for shared serotype 3 and two unique serotypes 22F and 33F.
The superiority was based on statistically significant OPA GMT ratios for serotypes 22F and 33F, along with the key secondary objective assessing serotype 3.
The most commonly reported adverse reactions include injection site pain, fatigue, myalgia, headache, injection site swelling, injection site erythema and arthralgia.
PNEU-AGE trial coordinating investigator Jose Cardona said: “Some adults, including older adults or those with certain chronic medical conditions or immunocompromising conditions, are at increased risk for pneumococcal disease and its serious, sometimes life-threatening complications.
“The FDA’s approval of Vaxneuvance is based on robust Phase 2 and 3 studies assessing immune responses in a broad range of adult populations and provides an important new option in protection from invasive pneumococcal disease.”
Furthermore, the US Centres for Disease Control and Prevention (CDC) advisory committee on immunization practices (ACIP) is expected to make recommendations on the use of Vaxneuvance in adults.