Massachusetts is among at least 40 states that received vials from a recalled lot of Gardasil vaccine, health officials announced late Friday, but they were unable to say how many health care providers may have received doses from this batch.
The vaccine is given to protect against human papillomavirus, or HPV, which can cause cervical cancer in women.
Federal health officials said Merck, which manufactures the vaccine, informed them on Dec. 16 that it would voluntarily recall one lot of the drug because it was believed to have been contaminated with glass particles during the manufacturing process.
The US Centers for Disease Control and Prevention said in a statement that there were 743,360 vials in the affected lot, and that Merck estimates that approximately 10 of those vials could contain glass particles.
Vaccines from the affected lot were distributed between Aug. 20 and Oct. 9
CDC spokeswoman Barbara Reynolds said the agency has received no reports of injuries or adverse health effects related to the vaccine. Reynolds was unable to say, however, how the company determined that only 10 of the vials in that lot may have been affected.
Merck spokesman Imraan Munshi said the company calculated the number based on a “level of sophisticated inspection of in-house material, combined with a rigorous statistical analysis.”
Reynolds said officials do not know if the glass particles are small enough to be drawn into a needle when the vaccine is given, but they believe the only adverse effect would be swelling and redness at the injection site.
She said patients who may have received shots from this lot do not need to be revaccinated, and there is no reason to believe the vaccine’s effectiveness would have been impacted by the manufacturing problem.
The recall comes as the CDC and Massachusetts health officials are trying to encourage parents to have their 11- and 12-year-olds vaccinated against HPV.
“We want everyone to understand that this is a vaccine that is safe and effective, that prevents cancer in men and women, if they receive it early enough,” Reynolds said.
The Massachusetts Department of Public Health recently received one of 13 grants from the CDC to develop and administer programs aimed at boosting the HPV vaccination rate.
The recalled lot is J007354.
More information is available on the CDC’s website.
Consumers may also call Merck National Service Center at 800-672-6372, select prompt #2, and then prompt #3.