Pneumococcal disease kills millions worldwide and the largest affected groups are children and the elderly. Federal health scientists now assure that the popular pneumococcal vaccine Prevnar is at least as effective as a rival vaccine at protecting adults from the sometimes-deadly infection.
The CDC currently recommends Pneumovax for all adults 65 or older. Only about two-thirds of eligible seniors get the injection. Prevnar 13 is intended to block infection by 13 strains of the disease, which causes ear infections, meningitis, and pneumonia. Vaccination with Prevnar is urged for all infants and young children, because of their vulnerability to infection. But the disease also strikes 36,000 older adults a year, killing 5,000, the CDC says.
Prevnar's maker, drug giant Pfizer, has appealed to the FDA to expand the vaccine's approval for adults age 50 and older. In a review posted online Monday, scientists from the agency said Prevnar triggered an immune system response comparable to Merck's Pneumovax, the only pneumococcal vaccine now approved for adults.
In the review of six studies involving more than 6,000 adults it was found that Prevnar vaccination generated at least as many antibodies against pneumococcal disease as Pneumovax. Side effects for the vaccines were comparable, including swelling and redness at the injection site as well as fever, chills, and fatigue.
Two trials from Pfizer tested Prevnar 13 against the standard vaccine, Merck & Co's Pneumovax, which is currently the only vaccine for pneumococcal bacteria approved in the United States for adults.
On Wednesday the FDA will ask a panel of outside experts whether Prevnar is safe and effective for adults. The group's recommendation isn't binding, but the agency often follows its advice.
Currently used Pneumovax has not been shown to protect against pneumococcal pneumonia, one of the most dangerous infections associated with the disease. Because of its potential to defend against pneumonia, the FDA agreed to give Prevnar an accelerated six-month review, as opposed to the usual nine months.
Pfizer is conducting an 85,000-patient study in the Netherlands to assess Prevnar's strength against pneumonia in adults. The company must submit the results to the FDA after the study concludes, which is expected in the next two years.
Additionally Pneumovax is approved only for children older than two years of age and adults over 65. Prevnar is approved for babies as young as six weeks. Pneumovax sells for about $50 a shot on average, while Prevnar 13 costs $114 on average. Adults need one or two Pneumovax shots and then a booster after age 65. Pfizer hasn't determined how many Prevnar boosters will be needed after the first dose.
A competing vaccine for children is Synflorix by GlaxoSmithKline, which protects against 10 strains of the bacteria that causes the pneumococcal infection.
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