Pfizer’s vaccine wins U.S. panel’s backing for safety in older people

Pfizer Inc.’s vaccine for respiratory syncytial virus received endorsement from a key panel of U.S. advisers for its safety in people 60 and older, a key endorsement for the drugmaker’s potential product.

Members of the panel that advises the Food and Drug Administration voted 7-4 Tuesday that the data presented by the drugmaker show the safety of the vaccine developed to prevent RSV. The same panel will next vote on whether the data show the vaccine is effective.

The FDA doesn’t have to follow the recommendations of the Vaccines and Related Biological Products Advisory Committee, but it usually does.

Pfizer has been vying with the United Kingdom’s GSK Plc over which drugmaker will become the first to reach the U.S. market with vaccines for the lung illness. GSK will face its own advisory committee hearing today for what infectious disease specialists call the last big respiratory virus without a vaccine.

People with weak immune systems are particularly at risk along with older people, with 177,000 hospitalizations and 14,000 deaths recorded among U.S. elderly each year from the disease, according to one 2005 study.

Both Pfizer and GSK have produced strong data showing the vaccines are effective in adults 60 and older, although there’s relatively little evidence on how much the vaccines reduce hospitalizations from RSV.

Several FDA advisory committee members raised safety questions because of two cases of Guillain-Barre syndrome among close to 20,000 trial participants who received the vaccine, which the FDA called an important potential risk before the hearing. GBS is a rare disorder in which the body’s immune system attacks the nerves, which could eventually lead to paralysis that is usually temporary.