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Merck wins speedy FDA review for 15-valent pneumococcal vaccine

Pfizer's rival 20-valent candidate was granted priority review in December 2020

Merck & Co (MSD) has been given a fast-track designation for its next-generation 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.

Merck submitted V114 to the FDA in November 2020 – at the same time, the pharma company also filed the vaccine candidate with the European Medicines Agency (EMA). Following the fast-track designation, the FDA will plan to reach a decision on Merck's vaccine by 18 July.

In phase 2 studies, V114 has been shown to 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, V114 met its primary immunogenicity objective in healthy adults aged 50 years or older by demonstrating equivalent immune responses across all 15 serotypes for three different lots of the vaccine.

If approved, Merck’s V114 will be a close competitor of Pfizer's Prevnar-13, although Pfizer 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 – also known as 20vPnC – which found that all 20 vaccine serotypes induced robust responses across all age 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.

Pfizer’s 20-valent candidate was given a priority review by the FDA in December 2020, with the goal of announcing a decision in June this year.

Article by
Lucy Parsons

13th January 2021

From: Regulatory



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