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Merck submits 15-valent pneumococcal vaccine candidate to EMA and FDA

If approved, this vaccine will closely challenge Pfizer's Prevnar-13

Merck HQ

Merck & Co (MSD) has submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for its 15-valent pneumococcal conjugate vaccine candidate V114.

V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease (IND) in older adults.

In phase 2 studies, V114 has shown it can match Pfizer’s Prevnar-13 on the 13 serotypes covered by Pfizer’s vaccine in adults, with the added bonus of tackling the additional pair.

However, it fell a little short in infant studies, failing to meet the non-inferiority mark for three of Prevnar’s serotypes.

In September, Merck announced the top-line results from two phase 3 studies evaluating the safety and immunogenicity of V114.

In one study, PNEU-AGE, V114 demonstrated non-inferiority compared to Prevnar in adults aged 50 years or older for the 13 serotypes targeted by both vaccines and superiority for the additional serotypes 22F and 33F.

In another phase 3 study, PNEU-TRUE, in healthy adults aged 50 years or older, V114 met its primary immunogenicity objective by demonstrating equivalent immune responses across all 15 serotypes for three different lots of the vaccine.

“For more than a century, Merck inventors have developed vaccines that help tackle some of society’s biggest public health challenges, and that heritage is reflected today in our pneumococcal vaccine portfolio,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

“These submissions for V114 help to bring us closer to offering more options to help protect against pneumococcal disease,” he added.

If approved, Merck’s V114 will most closely compete with Pfizer's Prevnar-13, although the latter company is seeking to defend its franchise with its new generation 20-valent pneumococcal vaccine.

In October, Pfizer revealed the full analysis from a phase 3 study of its 20-valent vaccine candidate PF-06482077, which found that all 20 vaccine serotypes induced robust responses across all aged groups.

Pfizer also announced results from a proof-of-concept trial in infants aged 42 to 98 days, with the vaccine eliciting pneumococcal immune responses to all 20 serotypes one month after dose 3.

This early-age subgroup could help Pfizer to take on Merck’s challenge, if PF-06482077 continues to prove effective in this population.

Article by
Lucy Parsons

24th November 2020

From: Regulatory

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