Topline results from the PNEU-PED study evaluating MSD’s pneumococcal vaccine Vaxneuvance in healthy infants between 42-90 days of age have shown a “statistically superior” immune response compared to Pfizer’s Prevnar 13 (PCV13).
In the trial, 1,720 infants were given a four-dose regimen of either Vaxneuvance or Prevnar 13 at two, four, six and 12-15 months of age.
Primary endpoints showed the two vaccines had the same general safety profile, and at 30 days beyond the third and fourth doses, Vaxneuvance’s protection was equal to that of Prevnar 13 in all 13 shared serotypes based on serotype-specific response rates.
Secondary endpoints demonstrated superior immune responses for Vaxneuvance in comparison to Prevnar 13 for shared serotype 3 and unique serotypes 22F and 33F, MSD – known as Merck & Co in the US and Canada – said in a statement.
“By nature, pneumococcal disease is constantly evolving. Strains of the disease associated with invasiveness cause significant disease burden in children, calling for innovation to help protect this vulnerable population worldwide,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
“At Merck, our goal is to design pneumococcal vaccines that target strains causing the greatest proportion of disease while maintaining a strong immune response to these serotypes. With the inclusion of serotypes 22F and 33F, Vaxneuvance has the potential to play an important role in the prevention of invasive pneumococcal disease in children,” he added.
Vaxneuvance was approved by the US Food and Drug Administration (FDA) on 16 July for adults, and MSD has said it plans to submit a supplemental regulatory licensure application to the FDA for use in children before the end of the year.
