Multinational pharmaceutical firms are gearing up to replace conventional pneumococcal vaccines with new ones to secure a larger market share.
Pfizer is leading the global pneumococcal vaccine market with established vaccine Prevnar 13. Shortly, the company aims to secure an adult market with experimental 20-valent conjugate vaccine PF-06482077, while MSD targets young children and pediatric patients with 15-valent V114.
According to the November forecast by pharmaceutical market research firm Evaluate Pharma, Prevnar 13 is expected to sell around $5.82 billion in 2019 and rank within 10 globally top-selling medicines. In the local market, Prevnar 13 accounts for about 90 percent of the pneumococcal vaccine market.
Other rivals are developing various polyvalent vaccines that have the serotype not included in Prevnar 13 to become a new market leader.
However, Pfizer’s defense is formidable, too.
Pfizer is working on PF-0648077, a 20-valent conjugate vaccine that complemented seven serotypes from Prevnar-13.
The drugmaker announced in December that it would begin a phase-3 trial on PF-0648077, which won the U.S. Food and Drug Administration’s Breakthrough Therapy Designation (BTD) in September. This means that the company is in the last stage of vaccine development.
In the phase-3 clinical trial, Pfizer is testing PF-06482077’s effectiveness on invasive diseases or pneumonia caused by the 20 pneumococcal serotypes in adults aged 18 or over.
Up to 3,880 adults will participate in Pfizer’s clinical program. The study will compare immune responses of one group aged 60 and over who are vaccinated with PF-06482077 with the control group aged 60 and over who receive the 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine. It will also evaluate the immunogenicity of PF-06482077 in adults 18-59 years of age, and describe the investigational vaccine’s safety profile in adults aged 18 and over.
Kathrin U. Jansen, senior vice president and head of vaccine R&D at Pfizer, said the experimental 20-valent vaccine would be a significant milestone to protect adults from invasive diseases and pneumonia caused by serotypes not included in Prevnar 13.
While Pfizer is to secure an adult market with the 20-valent vaccine, MSD is looking at different age groups – infants, young children, and pediatric patients.
V114, an investigational 15-valent conjugate vaccine, also received the FDA’s BTD status. The vaccine aims to protect infants from six weeks of age to 18 years old.
Even though V114’s BTD status covers six weeks to 18 years of age, MSD is also conducting a trial on adults. The two tests on both groups are phase-3, giving MSD high possibility that it could successfully develop the vaccine.
“The goal of our program in pediatric patients remains focused on providing additional serotype coverage versus currently available vaccines, while at the same time maintaining a strong immune response across all serotypes in the vaccine,” said Nicholas Kartsonis, senior vice president and head of the vaccine and infectious diseases clinical research at Merck Research Laboratories.