Merck & Co says it has voluntarily recalled over one million doses of vaccines that protect against pneumonia and meningitis, after equipment was found to be contaminated at the firm’s facility in West Point, Pennsylvania.
The New Jersey-based drugmaker said that it has initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine PedvaxHIB and its combination jab ComVax, which were distributed starting in April this year. Merck said the recall is necessary because it “cannot assure sterility of these specific vaccine lots”.
The firm added that the potential, and level, of contamination of any individual vaccine is low, but the batches are being pulled to be on the safe side. Merck said it is working closely with the US Food and Drug Administration and the US Centers for Disease Control and Prevention to inform affected healthcare providers of the recall.
The company and the regulatory bodies noted that there is no immediate health threat to children but the recall could lead to a supply shortage in the short-term. About 14 million doses of Hib vaccine are administered each year, said Anne Schuchat, director of CDC’s National Centre for Immunisation and Respiratory Diseases and that amount is fairly equally split between Merck and Sanofi-Aventis. The latter is working with the FDA and CDC to ease the problem of vaccine shortage.
Januvia filed in Japan
Better news for Merck came with the news that partner Ono Pharmaceutical Co and its own Banyu unit have applied for marketing approval of the diabetes treatment Januvia (sitagliptin) in Japan.
Approved in the USA in October 2006, Januvia, a dipeptidyl-peptidase-4 inhibitor, has achieved massive sales growth and Merck will be hoping for a similar strong performance in Japan. The file for approval of Januvia is based on Phase III studies jointly conducted by Ono and Banyu in Japan.
