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February 20, 2019updated 21 Feb 2019 9:46am

Merck’s infant vaccine breakthrough threatens Pfizer’s dominance

Merck & Co’s V114 received breakthrough therapy designation by the US Food and Drug Administration.

By GlobalData Healthcare

On 30 January, Merck & Co’s V114 (15-valent pneumococcal conjugate vaccine) received breakthrough therapy designation by the US Food and Drug Administration (FDA), for the prevention of invasive pneumococcal disease in infants, children and adolescents.

The current leading pneumococcal vaccine is Pfizer’s Prevnar 13, which achieved global sales of $5.8 billion in 2018, and Merck will be looking to capture as much of this market share as possible. However, Pfizer also has a late-stage, 20-valent conjugate pneumococcal vaccine, 20vPnC, which has also received FDA breakthrough therapy designation in adults.

Competition in pneumococcal vaccines

GlobalData believes 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.

Currently, Prevnar 13 is recommended by the US Centers for Disease Control and Prevention (CDC) guidelines alongside Merck’s Pneumovax 23.

However, Pneumovax 23 is an older polysaccharide vaccine and is not indicated for use in children under 24 months old. Therefore, Prevnar 13 currently dominates the large market for the primary pediatric series of pneumococcal vaccinations included in the US routine immunisation schedule.

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.

Lucrative infant vaccine market

Therefore, GlobalData expects that any change could have an impact on the Prevnar 13’s sales and may also affect the market uptake for 20vPnC, as it has received an FDA breakthrough designation for adults.

This, in addition to V114’s breakthrough therapy designation for infants, means that Pfizer’ Prevnar 13 could stand to lose its grip on the lucrative pneumococcal vaccine market in infants.

Prevnar 13 contains 13 different serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), while V114 contains the same serotypes as well as 22F and 33F.

Serotypes 22F and 33F are two of the most prevalent serotypes in infant infections, and they are not covered by Prevnar 13. 20vPnC contains seven additional serotypes compared to Prevnar 13, but it does not contain the 22F and 33F serotypes that are of high importance for the infant population.

This gives Merck a head start in the push for the CDC recommendation for infants. Although 20vPnC is also likely to achieve a CDC recommendation for infants, V114’s coverage of 22F and 33F could potentially result in a more favourable recommendation.

Both candidates have commenced pivotal Phase III trials, with Merck’s V114 trial expected to be complete in December 2019. However, Pfizer’s trial for 20vPnC is set to finish only one month later.

Topline data may, therefore, be published at a similar time, which means the race to file for approval and be the first to reach the market will be close.

GlobalData expects that although Merck’s V114 may beat Pfizer’s 20vPnC to market, and currently looks posed 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.

Further reading:
GlobalData (2019). Pneumococcal Vaccine Opportunity Analysis and Forecasts to 2028, to be published.

GlobalData (2018). World Pneumonia Day 2018: Pfizer’s Future in the Pneumococcal Vaccines Space Looks Bright, November 2018, GDHC2111EI.

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