Pfizer Inc (NYSE: PFE) and Merck & Co., Inc (NYSE: MRK) are in race to expedite the launch of next-gen pneumococcal vaccines by the end of this year. However, Merck gains an upper hand for kids’ vaccines.
In a communiqué, Merck said its V114 completed the efficacy and safety thresholds in two phase 3 clinical trials and gains an advantage over Pfizer in the timing of the launch. As a result, Merck could submit for kids’ vaccines by the end of this year. On the other hand, Pfizer expects its readout of pneumococcal candidate’s late pediatric data in 2022.
FDA to promulgate its decisions soon
However, both Pfizer and Merck are in the race in adult vaccines by completing the FDA reviews. Merck expects a reply from FDA in July 2021 for its 15-valent candidate whereas Pfizer will receive the decision of the regulator in June 2021 for its 20-valent shot.
Merck said its drug V114 achieved its primary immunogenicity and safety endpoints in an interchangeability study conducted in healthy infants aged between 42 and 90 days.
As part of the Pneu-Plan catch-up clinical trial, investigators conducted tests in healthy kids aged between seven months and 17 years using V114. Those kids and adolescents have not previously received pneumococcal vaccines. Both Prevnar 13 and V114 demonstrated similar immune responses in the clinical trial. Merck will share the clinical trial outcome at the forthcoming medical congress.
Merck said the trial outcomes help it to tell the parents of infants to switch to its 13-valent vaccine. It could also suggest this vaccine for children, who have not previously been given a pneumococcal shot.
Pfizer amassed significant revenues for several years by offering its Prevnar 13, a pneumococcal stalwart and the best-selling vaccine worldwide. However, it will add significant revenues from COVID-19 vaccines from this year changing the history.
Merck is in the race for almost 10 years using its pneumococcal conjugate vaccine after posting success in 2011 with its first formulation. However, it is not optimal for kids. Therefore, Merck halted the program and incorporated several changes over several years to unveil a high-quality product in the market.
Cantor Fitzgerald analysts in February 2021 said Pfizer’s 20-valent candidate could be a better option compared to Merck’s 15-valet shot. They also said Merck has an advantage in V114 in serotype 3. The team said Merck could significantly increase its revenues because of blockbuster opportunities in the lucrative pneumococcal field.