Following the news that Merck & Co.’s V114 (15-valent pneumococcal conjugate vaccine) received FDA Breakthrough Therapy designation for the prevention of invasive pneumococcal disease in infants, children, and adolescents,

Arafa Salam, PhD, Pharma Analyst at GlobalData, offers her view on the impact this will have on Pfizer’s market dominance:

“Pfizer currently leads the pneumococcal vaccine marketplace with Prevnar 13, which achieved global sales of $5.8bn in 2018. Along with their late-stage, 20-valent conjugate pneumococcal vaccine, 20vPnC, which has also received an FDA Breakthrough Therapy designation in adults, these latest developments will increase the already fierce competition between Pfizer and Merck as both companies attempt to reach the market first with their latest pneumococcal vaccines.

“At the end of February 2019, the CDC’s Advisory Committee on Immunization Practices (ACIP) plans to meet, and has suggested that it may vote on changes following a re-evaluation of the recommendation for Prevnar 13 for all adults ages 65 years or older. This change is being proposed because only 5% of pneumococcal infections in this population are caused by Prevnar 13 serotypes, due to the herd immunity resulting from pediatric vaccination.

“Any change could have an impact on the Prevnar 13’s sales and may also affect the future market uptake for 20vPnC. This, in addition to Merck’s V114 Breakthrough Therapy designation for infants, means that Pfizer’ Prevnar 13 could stand to lose its grip on the lucrative infant segment of the pneumococcal vaccine market. Although 20vPnC is also likely achieve a CDC recommendation for infants, V114’s coverage of 22F and 33F serotypes could result in a more favorable recommendation.

“Both candidates have commenced pivotal Phase III trials, with Merck’s V114 trial expected to be complete in December 2019 and Pfizer’s trial for 20vPnC set to finish only one month later. Although Merck’s V114 may beat Pfizer’s 20vPnC to market, and currently looks poised to be a strong future player in the lucrative infant population based on its inclusion of the 22F and 33F serotypes, that broader overall serotype coverage of 20vPnC combined with Pfizer’s extensive experience and strong reputation in the pneumococcal vaccines space will result in stiff competition. At the end of February, the focus will be on any changes made to the CDC recommendations that could be detrimental to Merck’s or Pfizer’s future earnings.”