Pfizer ($PFE), which has big expectations for its pneumococcal conjugate vaccine, got a boost toward its goals with a prequalification from the World Health Organization (WHO) for use of Prevenar 13 in adults over 50.
That means WHO countries can now order it for older people. To meet demand, Pfizer says it is increasing its manufacturing capacity for the vaccine and also investing in a multi-dose vial which, if approved, would be a benefit in developing countries.
It also is approved in more than 110 countries worldwide for use in infants and young children. In addition, Prevenar 13 for pediatric use is available in 16 of the 18 countries that have launched national immunization programs with a pneumococcal conjugate vaccine through the Advance Market Commitment (AMC) program. The company says it intends to provide nearly half billion doses of the vaccine through 2023 to infants and young children in the poorest countries through the AMC for pneumococcal vaccination.
Analysts, on average, have forecast Prevenar 13 to reach $4.42 billion this year and they expect it to increase to $6.75 billion by 2016. Pfizer says Prevenar 13, or Prevnar 13 as it is called in the United States, Canada and Taiwan, is approved for adults 50 years of age and older in more than 70 countries.
That includes the U.S., but it hit a speed bump here after the Centers for Disease Control and Prevention committee said it will wait for more data before deciding whether to recommend that older adults add the vaccine to their regimens. The data the CDC's vax group is awaiting will come next year from a Dutch study, CAPiTA. It's designed to assess whether the vaccine actually does prevent pneumonia in adults.
That hasn't kept Pfizer from moving forward with its marketing campaigns for the vaccine.
- here's the release
CDC delay could temper adult uptake of Pfizer's Prevnar shot
FDA extends Prevnar review on additional data
Pfizer's next top seller aces trials for new use