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FDA committee recommends pneumococcal vaccine in adults
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The FDA’s Vaccines and Related Biological Products Advisory Committee today recommended use of the 13-valent pneumococcal conjugate vaccine for the prevention of pneumococcal disease in adults aged 50 years and older.
“The applicant has provided data that does indicate that [13-valent pneumococcal conjugate vaccine (Prevnar 13, Pfizer)] is immunogenic in adults who are treatment-naive,” Jose Romero, MD, chair of the committee, said during the meeting.
After some deliberation over phase 3 data from various trials, 14 out of 15 committee members voted that the efficacy and safety data provide substantial evidence to recommend that the indication for the vaccine be expanded under the FDA's accelerated approval system. Fourteen out of 15 members voted in favor of administering the vaccine to adults aged 50 years and older.
The vaccine is currently approved for use in children aged between 6 weeks and 5 years for the prevention of invasive disease caused by Streptococcus pneumonia serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V,14, 18C, 19A, 19F and 23F. The 23-valent pneumococcal polysaccharide vaccine (Pneumovax 23, Merck) is the only approved vaccine for the adult age group. However, is only effective for about 3 to 5 years and is not effective against non-bacterial pneumococcal pneumonia.
Pfizer submitted supplemental applications earlier this year seeking regulatory approval to expand the use of the 13-valent pneumococcal conjugate vaccine to adults aged 50 years and older in more than 40 countries.
Although the FDA is not required to follow the recommendations of the advisory committees, it usually does.
I have frequently said in the past that the 23-valent polysaccharide vaccine is least effective in those one might most want to protect. This includes the immunocompromised and elderly patients with underlying conditions, such as chronic cardio-pulmonary disease, liver disease, renal disease, etc. Happily, this situation may now change with the availability of the 13-valent pneumococcal conjugate vaccine. There is no question in my mind that this product will become the vaccine of choice for use in adults aged 50 years and older. I hope that further product development might include a modest number of additional capsular types tailored to the needs of the target adult and elderly population. Finally, the remaining role, if any, for the pure polysaccharide product (Pneumovax) will need to be clarified.
– Theodore C. Eickhoff, MD
Editor Emeritus of Infectious Disease News
Disclosure: Dr. Eickhoff reports no relevant financial disclosures.
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