Merck’s current pneumococcal vaccine is usually only recommended for older adults.
Francois Lo Presti / AFP via Getty Images
Pneumococcal vaccines are big business for Pfizer, which sold $ 5.9 billion to Prevnar 13 in 2020. Now Merck wants to snatch the golden goose.
Merck (ticker: MRK) has its own pnuemococcal vaccine, called Pnuemovax 23, but sales were only $ 1.1 billion last year. The big gap between the two numbers is tied to the advice of the Centers for Disease Control and Prevention: The Pfizer (PFE) is recommended for children as part of their routine immunization schedules, while the Merck version is mainly recommended 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 leading indication for children.
On Thursday evening, Merck published data on a trial of the new version, called V114, in healthy babies. Some children had first received doses of Pfizer’s current vaccine (PFE) and some had skipped doses from the normal vaccination schedule.
The company said that the patients who received a mixed dosing schedule and the patients in the catch-up study had “generally similar” immune responses to children who received the full schedule of the Pfizer vaccine.
The new vaccines from Merck and Pfizer are designed to protect against more types of pneumococcal disease than the current Pfizer vaccine.
Cowen analyst Steve Scala said the data could put Merck in the lead for FDA approval of the new version in children. Still, he said the FDA’s stamp won’t be as important as an upcoming decision by a major CDC committee, the Advisory Committee on Immunization Practices, on adult use of vaccines, Scala wrote.
“MRK’s data lead in the pediatric setting may be positive, but ACIP’s adult use distinction may be more important in determining the 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 will decide on the Merck version in mid-July and the Pfizer version in early June. Scala said he expects ACIP to consider both by mid-September, and that efficacy and safety data for the two vaccines in adults appear similar.
But adults make up a smaller share of the market than infants and children, and most of the sales depend on the FDA and CDC decisions about the pediatric population.
Merck said it plans to file an application for children before the end of the year. According to a note from Cantor Fitzgerald analyst Lousie Chen, Pfizer won’t be filing its application for children until next year.
“MRK is still a leader in paediatrics [pneumococcal conjugate vaccine], ”Wrote Chen. “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 decision, and its ruling on adults this fall will provide important clues as to how it tends.
Shares of Merck were up 0.2% during morning trading, while shares of Pfizer were up 0.4%.
Write to Josh Nathan-Kazis at email@example.com