ATLANTA (CBS ATLANTA) — The Centers for Disease Control and Prevention issued a voluntary recall for an isolated HPV vaccine that it says contained tiny glass particles as a result of a breakage during the manufacturing process.
The CDC states that mild reactions such as redness and swelling at the site of the needle injection are the only “adverse events” that have been reported from the approximately 10 affected vials of the cancer-preventing Human Papillomavirus Quadrivalent vaccine, Gardasil.
The glass particles in the affected vials were tiny enough to push through the needles.
The CDC was notified by the Merck pharmaceutical manufacturer on Dec. 16 that the company planned to implement a voluntary recall of a single lot (lot J007354) of the Gardasil vaccine. Merck states that it’s in the process of directly contacting clinics and doctors’ offices who purchased the affected lot.
The affected vaccines were distributed between Aug. 20 and Oct. 9 of this year.
The CDC recommends that concerned recipients of the drug contact the Merck National Service Center, or contact their doctor. The center states that the HPV vaccine continues to maintain a strong safety record, as well as its recommendation that all preteen boys and girls receive three doses of the vaccine between ages 12 and 13.
According to the CDC, from June 2006 through March 2013, approximately 57 million doses of HPV vaccines were distributed in the United States.
VAERS received approximately 22,000 adverse event reports occurring in girls and women who received HPV vaccines. An adverse event is an undesired side effect or health problem that occurs after someone receives a vaccine or medicine. It may — or may not — have been caused by the vaccine or medicine.
Of the reports to VAERS, 8 percent were classified as “serious”.
If a parent or child has recently received an HPV vaccination, the CDC states there is no need to take any action as a result of the recall, and also no reason to be revaccinated.
The Gardasil vaccine is one of two CDC-recommended and FDA-licensed HPV products for 6, 11, 16 and 18 virus strains (the other being Cervarix) found to cause most cervical cancers among other diseases. Gardasil also protects against genital warts.
The CDC states that the safety of both Gardasil and Cervarix were licensed after clinical trials with nearly 30,000 females.