Merck’s current pneumococcal vaccine is mostly recommended only for older adults.
Francois Lo Presti/AFP via Getty Images
Pneumococcal vaccines are big business for
which sold $5.9 billion worth of its Prevnar 13 in 2020. Now,
wants to snatch away the golden goose.
Merck (ticker: MRK) has its own pnuemococcal vaccine, called Pnuemovax 23, but sales totaled just $1.1 billion last year. The big gap between the two figures is tied to advice from the Centers for Disease Control and Prevention: The
(PFE) one is recommended for children as part of their routine immunization schedules, while the Merck one is mostly recommended mostly for older adults.
Now, both companies are waiting for the Food and Drug Administration to rule on their applications for new versions of the vaccines, and Merck is aiming for the key childhood indication.
On Thursday evening, Merck put out data on a trial of its new version, called V114, in healthy infants. Some of the children had received doses of Pfizer’s (PFE) current vaccine first, and some had missed doses from the normal vaccine schedule.
The company said the patients who received a mixed dosing schedule, and the patients in the catch-up trial, had “generally comparable” immune responses to children who had received the full schedule of the Pfizer vaccine.
The new Merck and Pfizer vaccines are designed to protect against more strains of pneumococcal disease than the current Pfizer vaccine.
Cowen analyst Steve Scala said the data may give Merck the lead for FDA approval of its new version in children. Still, he said the FDA’s stamp won’t be as important as a coming decision by a key CDC committee, the Advisory Committee on Immunization Practices, on adult use of the vaccines, Scala wrote.
“MRK’s data lead in the pediatric setting may be a positive but ACIP’s distinctions on adult use may be more important to determining extent/differentiation of use for each vaccine in pediatrics,” Scala wrote in a note late Thursday.
Both Pfizer and Merck have already filed for approval in adults. The FDA is set to rule on the Merck version by mid-July, and the Pfizer one by early June. Scala said that he expects ACIP to consider both in mid-September, and that efficacy and safety data for the two vaccines in adults seems comparable.
But adults make up a smaller proportion of the market than infants and children, and the bulk of sales hinge on the FDA and the CDC’s decisions about the pediatric population.
Merck said it plans to submit its application for children before the end of the year. Pfizer won’t submit its application for children until next year, according to a note from Cantor Fitzgerald analyst Lousie Chen.
“MRK still leading for pediatric [pneumococcal conjugate vaccine],” Chen wrote. “Neck and neck with PFE for adult indication.”
But Scala pointed out that speed alone won’t be the deciding factor. ACIP will make the determination, and its ruling on adults this fall will give key clues as to how it’s leaning.
Shares of Merck were up 0.2% in morning trading, while Pfizer shares were up 0.4%.
Write to Josh Nathan-Kazis at firstname.lastname@example.org