MMR Vaccine Recall Issued by Merck in Canada After 5 Injuries
Canadian Action Came on Same Day Merck Issued Hib Vaccine Recall in USDec 14, 2007 | Parker Waichman LLP
Another vaccine recall, this time in Canada, has been issued by a subsidiary of Merck. Earleir this week, Merck issued a recall for more than 1 million doses of Hib vaccine in the US. But unlike the US action, the Canadian recall of the measles, mumps and rubella (MMR-II) involves serious injuries to several people.
Canada suspended use of three batches of a MMR=II Wednesday after five people fell ill in the midst of a vaccination campaign in Alberta. Health Canada advised against the use of the three lots of measles, mumps, and rubella vaccine sold by MerckFrosst Canada, while it investigates suspected cases of anaphylaxis, a potentially life-threatening allergic reaction characterized by swelling and difficulty breathing. All five cases involved adults aged 20 to 30 with a history of allergy; all have fully recovered.
The vaccine is normally administered to children twice in their second year of life; however, due to mumps outbreaks across Canada, a catch-up campaign was under way in Alberta, primarily for young adults in post-secondary schools. A national advisory committee urged all Canadians up to about age 40 to receive two doses of the vaccine. Mumps can cause sterility, meningitis, and deafness.
Canadian officials are trying to determine if the vaccine may be having the same adverse reaction elsewhere. A joint investigation by Health Canada—the Public Health Agency of Canada—and Health Alberta with distributor MerckFrosst Canada is underway to solicit reports of adverse effects from other countries using MMR-II. Because parent Merck & Co. Inc. markets the vaccine worldwide, they are reaching out globally. Canadian officials will be contacting regulatory authorities in other countries.
It is expected to be several weeks before a complete analysis of the adverse events, the product, and product production is complete. MerckFrosst Canada Ltd. Claims this is a very unusual event and many millions of doses of this vaccine have been administered globally and the vaccine is very safe.
Over 500 million doses of MMR-II have been distributed worldwide since 1978 and MMR-II is on the regular childhood and baby vaccination schedule in Canada. The adverse events are related to one lot in Alberta and affected young adults; there have been no reported cases affecting babies.
The same day the Canadian MMR-II recall was issued, Merck & Co. Inc. recalled about 1.2 million doses of vaccines—11 lots of PedvaxHIB vaccine and two lots of Comvax vaccine—when quality control checks revealed that production equipment might not have been properly sterilized. The vaccines involved protect against Hib—or Haemophilus influenzae type b—disease and other conditions; Comvax also prevents hepatitis B. Hib was the leading cause of bacterial meningitis in children under five years of age, according to the US Centers for Disease Control and Prevention (CDC).
The vaccines were manufactured in West Point, Pennsylvania, and distributed beginning April 2007. All but one lot was distributed in the United States, the company said, adding that the potential for contamination of any individual vaccine is low—and—if present, the contamination level would be low. Sterility tests of the recalled vaccine lots did not reveal any contamination, according to Merck, which added that the recall does not affect any other vaccines it manufactures.
Children who have received the affected vaccine need not be re-vaccinated as efficacy was not compromised, according to the CDC's National Center for Immunization and Respiratory Diseases.