FDA Greenlights Merck's Capvaxive Vaccine for Adult Pneumococcal Disease Treatment

On June 17, 2024, U.S. Food and Drug Administration (FDA) granted approval to the first invasive pneumococcal disease and pneumococcal pneumonia treatment vaccine in adults. Merck's Capvaxive vaccine shot showed significant effects in its clinical trials against 21 strains of the bacteria known to cause pneumococcal disease.

Capvaxive made history as the first-ever FDA-cleared pneumococcal conjugate vaccine specifically designed for adults and is expected to give robust competition to Pfizer’s Prevnar 20.

Capvaxive: First Vaccine to Deliver Protection Against 21 Serotypes of Pneumococcal Bacteria

CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine), primarily developed to protect against pneumococcal pneumonia caused by the bacteria, Streptococcus pneumoniae, can also prove to be effective against infections that lead to the rarer but more fatal invasive pneumococcal disease (IPD). Such life-threatening conditions can progress into a bloodstream infection or pneumococcal meningitis and are reported to cause death in around 1 out of 6 older adults who contract the infection.

Merck’s shot has garnered significant attention in the healthcare community as it is the first pneumococcal vaccine specifically designed to deliver protection against the 21 strains or serotypes of Streptococcus pneumoniae. Capvaxive has a competitive advantage as it includes protection against eight of the pneumococcal bacterial strains not covered by the existing vaccines in the market. The company claims that the new vaccine shot targets serotypes that cause around 84% of invasive pneumococcal disease cases that are found among adults aged 50 and above. The Capvaxive vaccine is also poised to give strong competition to the dominant Pfizer vaccine Prevnar 20 which has covered most of the serotypes until now.

Entry of Merck's New Vaccine Poised to Benefit Pneumococcal Vaccine Market

The arrival of Merck’s pneumococcal conjugate vaccine is anticipated to shape the pneumococcal vaccine market dynamics, with its potential for higher overall protection rates against pneumococcal disease within the elderly population. According to Expert Market Research estimates, the pneumococcal vaccine market size was valued at USD 8.61 million in 2023 across the 7 major markets and is expected to grow at a CAGR of 4.9% during the forecast period of 2024-2032. Additionally, the market size is likely to rise from USD 9.03 million in 2024 to USD 13.21 million by 2032, driven by the rising pneumococcal disease burden and the growing aging population.

Given its broader coverage, the Capvaxive vaccine is expected to combat the alarming mortality rate associated with pneumococcal disease. Recent data from Centers for Disease Control and Prevention (CDC) indicates that approximately 150,000 hospitalizations in the United States are a result of pneumococcal pneumonia. The disease kills 1 in 20 or 5-7% of the infected individuals, with the death rate reported to climb higher among people aged 65 or above, particularly the ones with immunocompromising health conditions or other risk factors. Moreover, with the increasing aging population, estimated to reach over 2.1 billion by 2050, the demand for infectious disease therapeutics, such as the pneumococcal vaccine, is set to witness a surge in the upcoming years.

Novel Pneumococcal Vaccine’s FDA Win Based on Positive Clinical Data from Multiple Phase 3 Trials

In December 2023, Merck & Co., Inc. announced that the FDA granted priority review to its new Biologics License Application (BLA) for its population-specific vaccine V116 (Capvaxive) based on the pivotal Phase 3 trial results. Fast forward to June 2024, the United States regulatory body cleared Merck’s pneumococcal vaccine for adults 18 and older. The impressive clinical performance of the investigational candidate V116 across multiple Phase 3 studies, where it showed robust immune responses in both vaccine-experienced and vaccine-naïve adult populations, resulted in its approval.

The company reported that it secured the primary and secondary endpoints for the biologic pneumococcal vaccine across the Phase 3 STRIDE-3 and STRIDE-6 trials in July 2023. The STRIDE-3 study, which enrolled 2,600 vaccine-naïve adults, demonstrated that V116 delivers statistically significant immune responses in a single shot after a span of 30 days in comparison to another FDA-approved Prevnar 20 pneumococcal vaccine. In the STRIDE-6 clinical trial, more than 700 patients aged 50 years and above were recruited, who were already vaccinated against pneumococcal disease at least a year prior. The patients were dosed with either V116, Prevnar 20 or Merck’s Vaxneuvance. The findings exhibited V116 immunogenicity against all 21 pneumococcal strains included in the vaccine.

The STRIDE-3 and STRIDE-6 clinical trials also revealed a comparable safety profile of the new vaccines against the reference pneumococcal shots included in the study. Additionally, the regulatory win is also supported by the findings from the Phase 3 STRIDE-5 trial conducted in adults 50 years of age and older.

Merck's Capvaxive Shot Likely to Outperform Existing Pneumococcal Vaccines

Merck intends to launch the new pneumococcal vaccine as soon as late July. The introduction depends on the recommendations from the Centers for Disease Control and Prevention (CDC). The Advisory Committee on Immunization Practices which advises the Centers for Disease Control and Prevention on vaccination policy is scheduled to meet on June 27.

The eagerly anticipated conjugate vaccine is also being seen as a key growth driver for Merck’s revenue. The firm has set the price of the drug at USD 287 for a single dose. Besides this novel Capvaxive shot, Merck has two other pneumococcal vaccines in its portfolio, including Pneumovax 23 indicated for adults aged at least 50 years and children aged over two years who are prone to infection. The other pneumococcal vaccine, Vaxneuvance, is designed for children aged six weeks and older.

Following Capvaxive’s regulatory nod, Merck is set to compete with Pfizer’s 20-valent shot Prevnar 20 which currently enjoys market dominance. Pfizer’s pneumococcal vaccine was cleared by the FDA in June 2021 for adults aged 18 years and above against pneumonia and invasive pneumococcal disease. In April 2023, the regulatory agency expanded the vaccine’s label for use in infants and children from six weeks to 17 years of age.

The launch of Capvaxive is likely to change the revenue performance of Prevnar 20 and other established pneumococcal vaccines. Additionally, Merck’s vaccine shot is projected to intensify competition in the pneumococcal vaccine market owing to its ability to offer protection against additional serotypes and its potential to improve public health outcomes.