Nearly three-quarters of a million vials of the human papillomavirus (HPV) vaccine Gardasil were recalled Friday, following the discovery that the vials may contain glass shards that pose a potential health risk.
Merck & Co. and the U.S. Centers for Disease Control and Prevention (CDC) announced the Gardasil recall (PDF) on December 20, indicating that the glass particle contamination could cause injection site reactions.
According to a CDC FAQ on the recall, the vaccines were removed from the market because of a breakage during the manufacturing process, which allowed glass particles to enter the vials.
The risk of health problems from the Gardasil vaccines has been described as “remote”, and no injuries or adverse events have been linked to the recall. Merck states that the vaccines are still sterile and if doctors injected patients with the affected vaccines already, those patients do not have to be vaccinated again.
The recall affects one lot of Gardasil, affecting 743,360 single dose 0.5mL vials distributed in packages of 10 by Merck between August 20, 2013 and October 9, 2013. The lot number is J007354. No other vials are affected and Merck says that the recall will not affect its supply of the drug.
Gardasil is a widely used vaccine for the prevention of certain types of HPV that are sexually transmitted, and which can cause cervical cancer. It was approved by the FDA in 2006, and is widely given to young girls before adolescence and potential sexual activity.
Since it’s introduction, concerns about the safety of Gardasil have emerged after one of the lead researchers responsible for developing the HPV vaccine, Dr. Diane Harper, indicated that the drug’s protection may only last a few years, suggesting that the risks may outweigh the benefits for young girls.
Dr. Harper reportedly said at a conference in 2009, that while Gardasil was tested on 15 year old girls, it is commonly being given to girls as young as nine years old. She has called for more detailed warnings to parents about the Gardasil risks and to provide additional information about the unknown long-term benefits for girls who are not likely to be sexually active for several years.
The CDC noted in the recall announcement that it still recommends the drug for both young girls and boys, saying this was an isolated problem and that Gardasil has a strong safety record.
Merck says that it is in the process of contacting customers who purchased vials from the affected lot to instruct them on how to return the vials. Distributors and wholesalers are also contacting those who purchased the vaccine from their stocks to provide information on how to return them. Consumers with questions can call the Merck National Service Center at (800) 672-6372 and select prompt #2 and then prompt #3.