An FDA advisory committee has voted 14-1 in favor of expanding the indication for the pneumococcal 13-valent conjugate vaccine (Prevnar 13) to include use in adults 50 and older.
Currently the Pfizer vaccine is approved only for use in children.
The FDA's Vaccines and Related Biologics Advisory Committee voted for accelerated approval, reserved for biologics or drugs that are intended to treat serious or life-threatening illnesses and that provide a meaningful benefit over existing treatments.
At the end of a day-long meeting, the panel also voted 14-1 that the vaccine appears to be effective in adults, and 14-1 that it appears to be safe.
There is currently only one other pneumococcal vaccine for adults -- a free polysaccharide vaccine from Merck called Pneumovax 23 -- but its protection lasts only three to five years and it's unclear whether it's effective at preventing nonbacteremic pneumococcal pneumonia, which is the more common type of pneumococcal disease in adults.
If approved, Prevnar 13 would be the first conjugate vaccine approved for adults. It is longer-lasting than the polysaccharide vaccine and triggers a memory response in the immune system that may make it more effective than Pneumovax 23.
The FDA does not have to follow the advice of its advisory committee, but it often does.
Currently the Pfizer vaccine is approved only for use in children.
The FDA's Vaccines and Related Biologics Advisory Committee voted for accelerated approval, reserved for biologics or drugs that are intended to treat serious or life-threatening illnesses and that provide a meaningful benefit over existing treatments.
At the end of a day-long meeting, the panel also voted 14-1 that the vaccine appears to be effective in adults, and 14-1 that it appears to be safe.
There is currently only one other pneumococcal vaccine for adults -- a free polysaccharide vaccine from Merck called Pneumovax 23 -- but its protection lasts only three to five years and it's unclear whether it's effective at preventing nonbacteremic pneumococcal pneumonia, which is the more common type of pneumococcal disease in adults.
If approved, Prevnar 13 would be the first conjugate vaccine approved for adults. It is longer-lasting than the polysaccharide vaccine and triggers a memory response in the immune system that may make it more effective than Pneumovax 23.
The FDA does not have to follow the advice of its advisory committee, but it often does.
