FDA Panel Supports Pneumococcal Vaccine for Adults 50 and Older

Megan Brooks

November 16, 2011

November 16, 2011 — The Vaccines and Related Biologics Advisory Committee of the US Food and Drug Administration (FDA) has voted in favor of expanding the indication for the pneumococcal 13-valent conjugate vaccine (Prevnar 13, Pfizer) to adults aged 50 years and older.

The vote of the 15-member panel was 14 in favor and 1 against. The FDA usually follows the advice of its advisory committees.

Prevnar 13 is currently approved only for use in children. The advisory committee recommended an expanded indication for Prevnar 13 under the FDA's accelerated approval regulation, which applies to biologics that are intended to treat serious or life-threatening illnesses and that provide a meaningful benefit over existing treatments.

Unmet Need

Pneumovax 23 from Merck is the only pneumococcal vaccine currently licensed in the United States for use in adults aged 50 and older. A briefing document posted on the FDA Web site notes that Pneumovax 23 "has not been demonstrated to be effective in the prevention of non-bacteremic pneumococcal pneumonia, [which] continues to be a more common pneumococcal disease manifestation than invasive pneumococcal disease (IPD) in adults.

"The Center for Biologics Evaluation and Research (CBER), therefore, considers protection of adults/elderly from non-bacteremic pneumococcal pneumonia or non-bacteremic pneumococcal pneumonia combined with protection from IPD to be a 'meaningful therapeutic benefit over existing treatments,'" the document reads.

Pneumococcal infections "remain an important cause of morbidity and mortality among older adults," the FDA briefing document notes. "There remains an unmet medical burden" of pneumococcal disease in older adults, William C. Gruber, MD, Pfizer's senior vice president of Vaccine Clinical Research, added in comments to the advisory committee.

The advisory committee recommendation to expand Prevnar 13's indication follows a review of clinical safety and immunogenicity data from 6 studies involving more than 5600 adults aged 50 years and older.

Jose Romero, MD, professor of pediatrics and chief of pediatric infectious diseases, Arkansas Children's Hospital, Little Rock, who chaired the meeting, said he saw "no safety concerns in the studies" and noted that the data provided to the committee "do support the immunogenicity of Prevnar 13" in older adults.

The 13 pneumococcal serotypes in Prevnar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are responsible for causing a substantial proportion of invasive pneumococcal disease in older adults, including disease caused by antibiotic-resistant serotypes.

As previously reported by Medscape Medical News, the European Commission last month extended approval of Pfizer's 13-valent pneumococcal conjugate vaccine to adults aged 50 years and older. In Europe, the vaccine is known as Prevenar 13.


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