USDA panel recommends OK for Pfizer kids' vaccine: Prevnar 13 meant to fight strep and ear infections

The U.S. Food and Drug Administration panel voted 10-1 to recommend Prevnar 13's use to fight ear infections and other maladies caused by strep bacteria.

The panel downplayed a previous report that the new vaccine failed to meet goals for controlling three of the strep strains it was meant to target as Pfizer experts testified that the medicine's effect was still pretty similar to what had been expected.

While the vaccine would be aimed at young children, one expert testified that immunizations would help adults exposed to the H1N1 virus, previously known as swine flu. The immunologist said that autopsies of those who have died from H1N1 found that about one-third of the victims had invasive pneumococcal disease, which is one of the conditions targeted by Prevnar 13.

"An important new data point that the presenter discussed was that FDA has seen an increase in IPD cases coincident with peak H1N1 activity, particularly within the last 10 days in the U.S. and (Prevnar 13) would play an important role in helping to mitigate the H1N1 outbreak," according to an on-site report by Seamus Fernandez, a drug-company analyst for Leerink Swann in Boston.

Fernandez said experts reported that "vaccination of infants/children would help to prevent IPD in adults" as well. He added that three of the strep strains covered by Prevnar 13 are prevalent in adults today and that one of those strains accounted for about 40 percent of all invasive pneumococcal disease cases in the United States last year, according to the FDA.

Prevnar 13 is a follow-up vaccine to Prevnar, developed by Wyeth Pharmaceuticals before its merger with Pfizer. Prevnar 13 adds six new bacterial strains to those targeted by the original formulation.

The FDA estimates that the new strains of bacteria targeted by Prevnar 13 account for more than 60 percent of U.S. pneumococcal cases in young children.

The FDA granted priority review to the vaccine earlier this year because it appeared to be a significant health advance. The agency is expected to rule on the vaccine's final approval next month, and it usually follows the expert panel's advice.

Prevnar sales were in line to contribute $3 billion a year in sales to Pfizer's financial performance. The new formulation is expected to extend Prevnar's sales life by several years.

Pfizer's stock price closed Wednesday at $18.19 a share on the New York Stock Exchange, up 25 cents or 1.4 percent.

l.howard@theday.com

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