Mercedon submits a 15-price pneumonia vaccine listing application! Impact Pfizer's $6 billion heavyweight product

If approved for listing, the V114 will have an impact on the market landscape of Pfizer's 13-price pneumococcal polysaccharide-binding vaccine, Prevenar 13.
because V114 contains not only all 13 serotypes of Prevenar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), while adding 2 serotypes 22F and 33F, which are common in invasive pneumococcal diseases in the elderly, are not covered by the pneumonia vaccine products currently on the market.
7/13 is Pfizer's home product, with global sales of nearly $6 billion in 2019 and an 11% contribution to Pfizer's overall sales revenue.
Pfizer Prevenar 7/13 Vaccine Global Annual Sales Source: NextPharma V114 was awarded FDA-granted breakthrough therapy in January 2019 to prevent invasive pneumococcal disease in pediatrics ages 6 to 18 and adults over the age of 18.
's application is based on the results of a number of Phase II and III studies conducted in different populations, including healthy and high-risk groups (e.g., people with chronic diseases, HIV infections, people over 65 years of age).
pneumococcal disease is a type of disease caused by pneumococcal infections, including non-invasive diseases such as pneumonia, sinusitis and otitis middle, as well as meningitis.
more than 90 different types of pneumococcal bacteria, which affect adults and children differently.
study found that invasive pneumococcal diseases caused by serotypes 22F and 33F were associated with higher death rates and longer hospital stays in adults.
September, Mercadon announced the first-line results of two Phase III studies evaluating the safety and immunogenicity of V114.
in the Phase III PNEU-AGE study, the immune response rate of V114 was not inferior to that of PCV13 in people over 50 years of age, and V114 was better in response to 22F and 33F serotypes.
in another Phase III PNEU-TRUE study, healthy subjects over the age of 50 had a consistent immunological response to the 15 serotypes they covered after being vaccinated in different batches of V114, reaching the primary endpoint of immunogenicity.
October, Mercedon announced the success of two other Phase III studies of V114.
PNEU-PATH study included 652 healthy adults over the age of 50 who were randomly vaccinated against V114 or PCV13, and who were vaccinated against Pneumovax 23 a year later.
results showed that two vaccination groups responded equally to 15 serotypes of V114 after being vaccinated against Pneumovax 23.
addition, on the 30th day of vaccination V114 or PCV13, two groups of subjects responded equally to the 13 serotypes of the vaccine, and the V114 group responded more highly to 22F and 33F serotypes.
PNEU-DAY study included 1,512 subjects aged 18-49 who had an increased risk of pneumococcal disease due to underlying or lifestyle conditions.
were randomly vaccinated against V114 or PCV13 and Pneumovax 23 after 6 months.
results showed that the V114 group had the same immune response to the total 13 serotypes as the PCV13 group, and the V114 group had a higher immune response to 22F and 33F serotypes.
Dr Roy Baynes, chief medical officer, global clinical program leader and senior vice president of Mercado, said: "For more than a century, Mercado's researchers have developed vaccines that help address some of the major public health challenges in society, a tradition reflected in our pneumococcal vaccine portfolio.
V114 helps us have more options when it's time to prevent pneumococcal disease.
" faced with the challenge of V114, Pfizer is naturally not ready to die, it is vigorously developing a new generation of 20-price pneumococcal binding vaccine PF-06482077 (20vPnC).
20vPnC vaccine contains all 13 serotype pneumococcal strains contained in Prevnar 13, as well as seven additional common serotype pneumococcal strains that cause invasive pulmonary disease and pneumonia worldwide, so 20vPnC covers almost all of the U.S. and global The 20 major serotype pneumococcal strains prevalent in pneumonia, an upgrade to Pfizer's ace prevnar 13, were identified by the FDA as breakthrough therapies on September 20, 2018 to prevent pneumococcal invasive diseases and pneumonia in adults over the age of 18.
March 18, Pfizer released the top-line results of a Phase III clinical study of 20vPnC.
The randomized, double-blind study (NCT03760146) included 3,880 adults over the age of 18 with no history of pneumonia vaccination, with the main endpoint being differences in immunization effectiveness of 20vPnC, Prevnar 13 or PPSV23 for people over 60 years of age, and 20vPnC for people over 18 years of age.
end point was the difference in immune effectiveness of 20vPnC, Prevnar 13 or PPSV23 in people aged 18 to 59.
results showed that one month after the 20vPnC vaccine was given to adults over 60 years of age, the immune effectiveness of the 13 strains containing prevnar containing 13 serotype pneumococcal strains was no less effective than that of prevnar 13. PPSV23 contains 6 of the 7 additional serotype pneumococcal strains produced no less immune effectiveness than vaccination PPSV23, and the immune effectiveness of one of the serotype strains did not meet the non-inferior standards, but the gap is very small.
20vPnC vaccine was given to adults aged 18-59, the immune effectiveness of 20 serogroup strains reached a non-inferior standard compared to the control group.
the safety and tolerance of people over 18 years of age after 20vPnC vaccination.
also published the conceptual validation results of 20vPnC in newborns between 42 and 98 days, indicating that all 20 serotypes had an immune response after the 3rd dose of 20vPnC.
earlier age group coverage is also one of Pfizer's responses to the Mercedon challenge.
also announced plans to submit a 20vPnC listing by the end of the year.
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