Merck Receives Highly-Anticipated FDA Approval for Pneumococcal Vaccine
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The U.S. Food and Drug Administration (FDA) approved Merck's Vaxneuvance, a vaccine against invasive disease caused by 15 Streptococcus pneumoniae serotypes, including 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F, in adults that are at least 18 years of age.
The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) is planning a meeting in October to make recommendations on the vaccine’s use in adults.
Different strains of the S. pneumoniae bacteria, called serotypes, are associated with varying degrees of illness. Invasive pneumococcal disease (IPD) is defined as when the bacteria infected organs or tissues are typically germ-free. IPD is most common in people 50 years of age and older, and serotypes 3, 22F, and 33F are the most common causes of IPD, with serotype 3 being the leading cause of the disease in the United States.
“At Merck, we are committed to helping protect more people from invasive pneumococcal disease,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
“The FDA approval of Vaxneuvance builds on Merck’s more than 40 years of experience in pneumococcal disease prevention with a new option that includes serotypes responsible for substantial disease burden in adults, like serotype 3, as well as serotypes 22F and 33F, which are associated with a high degree of invasiveness and antibiotic resistance.”
Vaxneuvance is a 15-valent pneumococcal conjugate vaccine. That means it is effective against and also uses materials from 15 different strains of bacteria. It is made up of purified capsular polysaccharides from the various bacterial serotypes that are individually attached to a CRM197 carrier protein.
In clinical studies, Vaxneuvance was comparable in terms of protection compared to Pfizer's Prevnar 13 pneumococcal vaccine. But Vaxneuvance had a superior immune response to Prevnar 13 against serotype 3. Vaxneuvance also protects against 22F and 33F, which Prevnar 13 does not protect against. However, the FDA approved Pfizer’s Prevnar 20 on June 8, which also offers protection against 22F and 33F.
Merck has sued Pfizer, specifically Pfizer’s subsidiary, Wyeth, over the pneumococcal vaccine patents. Merck contends that Wyeth’s ‘024 and ‘060 patents should be invalidated for failing to “provide an enabling disclosure or adequate written description,” arguing that the ‘708 patent did not “comply with the requirements for patentability.” This was filed in January 2021, but the two companies have been tied up in patent infringement and invalidity cases outside the U.S., in Australia, Canada, Europe, Japan, Korea, the Netherlands, and the UK for more than four years.
The Vaxneuvance approval was built on data from seven clinical trials. In the pivotal Phase III PNEU-AGE (V114-019) clinical trial, the study demonstrated superiority to Prevnar 13 for several primary and secondary measures.
“Some adults, including older adults or those with certain chronic medical conditions or immunocompromising conditions, are at increased risk for pneumococcal disease and its serious, sometimes life-threatening complications,” said Jose Cardona, Indago Research and Health Center, coordinating investigator of the PNEU-AGE trial.
“The FDA’s approval of Vaxneuvance is based on robust Phase II and III studies assessing immune responses in a broad range of adult populations and provides an important new option in protection from invasive pneumococcal disease.”