Pfizer (PFE) Issues Statement Following Favorable FDA Committee Vote on Prevnar 13
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Pfizer Inc (NYSE: PFE) issued the following statement in response to today’s Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) vote to recommend the use of Pfizer’s Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) for adults 19 years of age and older with immunocompromising conditions. The ACIP defines immunocompromised as those people who have functional or anatomic asplenia, HIV infection, cancer, advanced kidney disease, or other immunocompromising conditions.
Pfizer believes that Prevnar 13 offers a significant health benefit and compelling value proposition for the U.S. health care system. We are committed to continuing discussions with the ACIP with the aim of expanding the recommendations to include all adults 50 years of age and older – a population rapidly increasing in the United States and at risk for developing vaccine-type pneumococcal pneumonia and invasive disease.
In December 2011, Prevnar 13 was approved by the U.S. Food and Drug Administration (FDA) under an accelerated approval pathway for adults 50 years of age and older for active immunization for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 serotypes contained in the vaccine. This indication is based on immune responses elicited by Prevnar 13. There have been no controlled trials in adults demonstrating a decrease in pneumococcal pneumonia or invasive disease after vaccination with Prevnar 13. Prevnar 13 is not FDA-approved for patients 6 through 49 years of age.
Pfizer is conducting a variety of clinical studies using Prevnar 13 in immunocompromised individuals and expects results at the end of 2012 and into 2013. Data on the safety and effectiveness of Prevnar 13 when administered to immunocompromised individuals are not available. These individuals may have reduced antibody response to active immunization due to impaired immune responsiveness.
Pfizer is conducting the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) and will share results with the ACIP once complete. The ACIP will consider these results and other available evidence before developing a recommendation regarding routine use of Prevnar 13 in adults aged 50 years of age and older. CAPiTA is an efficacy trial involving more than 84,000 subjects 65 years of age and older designed to evaluate whether Prevnar 13 is effective in preventing the first episode of community-acquired pneumonia (CAP) caused by the 13 pneumococcal serotypes contained in the vaccine. Pfizer estimates that the primary outcome measures for this event-driven study will be available in 2013.
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Pfizer believes that Prevnar 13 offers a significant health benefit and compelling value proposition for the U.S. health care system. We are committed to continuing discussions with the ACIP with the aim of expanding the recommendations to include all adults 50 years of age and older – a population rapidly increasing in the United States and at risk for developing vaccine-type pneumococcal pneumonia and invasive disease.
In December 2011, Prevnar 13 was approved by the U.S. Food and Drug Administration (FDA) under an accelerated approval pathway for adults 50 years of age and older for active immunization for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 serotypes contained in the vaccine. This indication is based on immune responses elicited by Prevnar 13. There have been no controlled trials in adults demonstrating a decrease in pneumococcal pneumonia or invasive disease after vaccination with Prevnar 13. Prevnar 13 is not FDA-approved for patients 6 through 49 years of age.
Pfizer is conducting a variety of clinical studies using Prevnar 13 in immunocompromised individuals and expects results at the end of 2012 and into 2013. Data on the safety and effectiveness of Prevnar 13 when administered to immunocompromised individuals are not available. These individuals may have reduced antibody response to active immunization due to impaired immune responsiveness.
Pfizer is conducting the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) and will share results with the ACIP once complete. The ACIP will consider these results and other available evidence before developing a recommendation regarding routine use of Prevnar 13 in adults aged 50 years of age and older. CAPiTA is an efficacy trial involving more than 84,000 subjects 65 years of age and older designed to evaluate whether Prevnar 13 is effective in preventing the first episode of community-acquired pneumonia (CAP) caused by the 13 pneumococcal serotypes contained in the vaccine. Pfizer estimates that the primary outcome measures for this event-driven study will be available in 2013.
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