Merck, a leading pharmaceutical company, has received approval from the Food and Drug Administration (FDA) for its new vaccine, Capvaxive, designed to protect adults from the bacteria pneumococcus. This bacteria can lead to serious illnesses such as pneumonia and invasive pneumococcal disease. Unlike existing vaccines on the market, Capvaxive specifically targets 21 strains of the bacteria, providing broader protection for adults.
While pneumococcal disease can affect healthy adults, it poses a higher risk to older patients and those with chronic or immunocompromising health conditions. Invasive pneumococcal disease can result in complications such as meningitis and bacteremia. The impact of this disease on individuals’ quality of life, including hospitalization and time off work, is significant.
According to Heather Platt, Merck’s product development team lead for Capvaxive, around 150,000 U.S. adults are hospitalized with invasive pneumococcal disease each year. The highest death rates from the severe form of the disease are seen in adults aged 50 and above. Therefore, the approval of Merck’s vaccine is a crucial development in addressing this public health concern.
However, before the vaccine reaches patients, an advisory panel to the Centers for Disease Control and Prevention (CDC) will convene on June 27 to determine the eligibility criteria for receiving the shot. Merck is prepared to supply the vaccine by late summer and will support the committee’s decision.
Analysts view Capvaxive as a significant growth driver for Merck, particularly as the company prepares for the loss of exclusivity of its blockbuster cancer drug Keytruda in 2028. The market for pneumococcal conjugate vaccines is currently valued at around $7 billion and is projected to exceed $10 billion in the coming years. Merck’s new vaccine positions it competitively in this market segment, alongside Pfizer, a key player in this space.
Merck’s competitive edge lies in Capvaxive’s ability to protect against eight strains of the bacteria that are not covered by any other approved vaccine for pneumococcal disease. These eight strains account for approximately 30% of invasive pneumococcal disease cases in patients aged 65 and above. In contrast, Merck’s vaccine covers 21 strains, which represent approximately 85% of cases in this age group. Pfizer’s Prevnar vaccine targets strains that account for only about 52% of cases.
The FDA approval of Capvaxive is based on the results of Merck’s late-stage trial, STRIDE-3. This trial compared the vaccine against Pfizer’s Prevnar 20 in adults aged 18 and above who had not previously received a pneumococcal vaccine. The data from this trial, along with the broader coverage provided by Capvaxive, is expected to resonate with clinicians and policymakers, leading to rapid uptake of the vaccine.
In conclusion, the approval of Merck’s Capvaxive vaccine represents a significant advancement in protecting adults from pneumococcal disease. The vaccine’s broader coverage and unique ability to target strains not covered by other vaccines position Merck competitively in the market. The potential for rapid uptake and the projected growth of the pneumococcal conjugate vaccine market further solidify Capvaxive as a key growth driver for the company. With Merck’s commitment to supply the vaccine and support the CDC’s eligibility criteria, the availability of Capvaxive is eagerly awaited to address the health risks associated with pneumococcal disease.
