FDA Approves Merck Vaccine to Prevent Shingles
BOSTON (Reuters) – Merck & Co. said on Friday that U.S. regulators have approved its vaccine to prevent shingles, a painful disease characterized by a blistering rash.
Shingles is caused by the reactivation of the virus that causes chickenpox, which can lay dormant after childhood and strike again when the immune system weakens with age or illness.
The U.S. Food and Drug Administration approved the vaccine, Zostavax, to prevent shingles in people aged 60 and older.
Everyone who has been infected with chickenpox — about 90 percent of American adults — is at risk of developing shingles, Merck said.
The company also plans to try to win approval for use of the vaccine in individuals as young as 50.
"We’ll be working with the FDA to talk about an indication beginning at age 50 and what it is specifically the FDA would like to see in addition," said Dr. Jeffrey Silber, Merck’s senior director of clinical research, in an interview.
Of the roughly 1 million cases of shingles that occur in the United States each year, 40 percent to 50 percent affect people over the age of 60, Merck said.
Shingles can cause intense pain that lasts weeks, or in extreme cases, months or years. Treatment often involves use of antiviral drugs to relieve pain and shorten the duration of the disease.
Merck studied the vaccine, which is given as a single dose by injection, in more than 40,000 people, of whom about 21,000 received the vaccine. It said Zostavax reduced the risk of developing shingles by 51 percent, compared with placebo.
Merck said it will create a new patient assistance program to provide free vaccines to adults who are uninsured and who are unable to afford vaccines.