For the second time in five weeks, the FDA Officially recognized A new pneumococcal vaccine, this time agrees with Merck.
The Vaxneuvance vaccine is designed to prevent 15 pneumococcal strains. This is two more strains than Prevnar 13, which brings more than $5.8 billion in annual sales to rival Pfizer. But the total number of strains covered by Vaxneuvance is 5 less than the successor of Prevnar 13. Prevnar 20, FDA approved in June.
These vaccines can prevent pneumococcal infections caused by Streptococcus pneumoniae. Young children and the elderly are particularly susceptible to these bacteria, which can cause infections such as pneumonia and meningitis. Infections of parts of the body that are usually free of bacteria can lead to invasive pneumococcal disease (IPD). According to Merck, headquartered in Kenilworth, New Jersey, approximately 80% of IPD occurs in people 50 years and older.
There are more than 90 pneumococcal strains; pharmaceutical companies have been working to develop vaccines that can prevent more and more. Like Prevnar vaccine, Vaxneuvance is a combination vaccine. The antigen of the vaccine is a polysaccharide, which is a chain of sugar molecules from the outer layer of the bacteria. These chains bind to the carrier protein. The more polysaccharides bound to the protein, the more strains the vaccine can prevent.
Merck tested Vaxneuvance in seven randomized, double-blind phase 2 and 3 clinical trials. These studies are not placebo-controlled. For some diseases, it is unethical to keep patients out of treatment, so the experimental therapies are compared with existing therapies. Vaxneuvance tested Pfizer’s Prevnar 13 and evaluated it against 13 strains shared by both. The results show that Vaxneuvance is “non-inferior”, and in jargon it is no worse than Pfizer injections. The most common side effects in the study included pain at the injection site, fatigue, muscle pain, and headache.
The clinical study is not intended to evaluate the clinical efficacy of Vaxneuvance compared to Prevnar 13. But in one of the strains, serotype 3, Merck said the immune response to its vaccine was better than Pfizer’s.Merck added that serotype 3 is the leading cause of IPD in adults in the United States
Vaxneuvance’s approval covers the use of the vaccine in adults 18 years of age and older.The shooting test is still in progress processing In healthy babies, children and adolescents.
The Centers for Disease Control and Prevention’s Immunization Practice Advisory Committee is expected to meet in October to discuss the use of the newly approved Merck and Pfizer pneumococcal vaccines and make recommendations. The commercial market is not the only place where the two vaccines clash. Merck said it has been challenging multiple Pfizer patents related to pneumococcal vaccine technology.
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