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2021-07-20| Trials & Approvals

Merck’s FDA approval for Pneumonia Vaccine Sets Up Collision Course with Pfizer

by Daniel Ojeda
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On July 16th, Merck (known as MSD outside the United States and Canada) announced Vaxneuvance, its vaccine against pneumococcal disease, was approved by the FDA. Vaxneuvance protects against more variants than the standard of care vaccine, the 13-valent pneumococcal conjugate vaccine (PCV13), owned by Pfizer. The news arrives just a month after the FDA approval of Pfizer’s pneumococcal vaccine, setting up a battle for market dominance among the two pharma giants.

Pneumococcal diseases are bacterial infections caused by Streptococcus pneumoniae. They can be life-threatening in adults and children, particularly if they evolve into pneumonia, meningitis, or bloodstream infections.

There are vaccines approved to prevent severe disease and hospitalization. Two vaccines are currently approved in the US. 1) PCV13, and 2) pneumococcal polysaccharide vaccine (PPSV23 or Pneumovax 23®). PCV13 is the most common since the protection lasts longer. In 2020, the sales of PCV13 reached almost $6 billion.

Although effective, the current vaccines do not protect against all strains of the Streptococcus pneumoniae bacteria. Therefore, there is a need for vaccines that protect against more strains.

 

Vaxneuvance’s Edge Over Pfizer’s Vaccine

Originally developed by Ligand Pharmaceuticals, Vaxneuvance consists of purified capsular polysaccharides from 15 variants (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) of the Streptococcus pneumoniae. These are conjugated to the CRM197 carrier protein produced using Ligand’s proprietary Pelican Expression Technology. Vaxneuvance protects against the same variants as PCV13 and an additional two variants.

The safety and efficacy of Vaxneuvance were tested in seven randomized, double-blind clinical trials. The results showed that Vaxneuvance treatment produced a comparable or superior immune response than PCV13, as measured by opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs). For two of the 13 variants shared between both treatments, Vaxneuvance produced a superior response. Additionally, Vaxneuvance protected against two more strains.

“At Merck, we are committed to helping protect more people from invasive pneumococcal disease. That’s why we set out to develop a conjugate vaccine that includes pneumococcal serotypes that pose the greatest threat and elicits a strong immune response to each serotype covered,” said Dr. 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.”

 

Market Battle with Pfizer

Vaxneuvance is now approved for the treatment of adults over 18 years or older. Pfizer’s PCV20 vaccine was also approved for the treatment of adults last month. One area where Merck outpaces Pfizer is clinical trials in children. Back in May, Merck announced its vaccines are effective and safe for children between 42 days and 17 years. This is crucial because children make up almost 80% of the market for pneumococcal vaccines.

Related Article: Merck’s Pneumonia Vaccine Candidate Blossoms in Phase 3 Trial

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