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FAQ: Voluntary Recall of One Lot of Gardasil® HPV (Human Papillomavirus Quadrivalent) Vaccine

 

Why is there a recall of the Gardasil® HPV vaccine?

On December 16, 2013 CDC was informed by Merck that the company planned to implement a voluntary recall of one lot (lot J007354) of Gardasil® [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant], due to the potential for a small number of vials to contain glass particles as a result of breakage during the manufacturing process.  These vials were distributed between August 20, 2013, and October 9, 2013. No other lots are affected.

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If my child received one of the affected HPV vaccine vial injections, what could happen?

 If a vaccine containing glass particles (tiny enough to get through a needle) is given to a patient, mild reactions routinely seen after vaccination may occur (for instance, redness or swelling at the injection site).  There are multiple safety systems in this country that track and monitor vaccine safety, including VAERS, which allows anyone to report an adverse event that may be associated with receiving a vaccine.  To date, no adverse events related to this lot of HPV vaccine have been reported other than mild reactions such as redness and swelling at the injection site.  It is not expected that delayed side effects will occur.

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If my child received the HPV vaccine injection from this affected lot, does he or she have to be vaccinated again?

If your child received HPV vaccination from this one affected lot, he or she does NOT have to be vaccinated again. The vaccine’s effectiveness is not impacted by this problem.  The HPV vaccine series is given in 3 shots over 6 months. Be sure that your child gets all 3 shots for full protection.

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How will I know if my child received one of the affected HPV vaccinations?

Merck is currently contacting its direct customers (doctors’ offices or clinics) who have purchased or received product from the affected lot.  People who have recently received an HPV vaccine, including those who received vaccine from the affected lot, do not need to take any action as a result of this recall.  Because no action is necessary, CDC is not asking doctors to notify patients who have received vaccine from the affected lot.  However, if you want to know if your child received a dose of vaccine from the affected lot, you can ask his or her doctor.

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How do I find out more information about this voluntary recall?

For questions about this recall or to report any adverse events following vaccination, please contact: Merck National Service Center at 800-672-6372, select prompt #2, and then prompt #3. Calls will be fielded Monday through Friday, 8 a.m. to 7 p.m. EST. For questions about the recall process, including how to return the recalled product and how to be reimbursed for the returned product), please contact: Stericycle, Inc. at 855-741-4996.

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Does CDC recommend HPV vaccination?

Yes. This recall was caused by an isolated problem in the vaccine manufacturing process. HPV vaccine continues to have a strong safety record, and CDC continues to recommend that all preteen girls and boys receive three doses of this cancer-preventing vaccine at age 11 or 12 years.   To learn more about HPV vaccine and the diseases it prevents, visit here: www.cdc.gov/vaccines/teens.

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What HPV vaccines are available in the United States?

Two HPV vaccines are licensed by the FDA and recommended by CDC. These vaccines are Cervarix® (made by GlaxoSmithKline) and Gardasil® (made by Merck).  Both vaccines are very effective against diseases caused by HPV types 16 and 18; HPV 16 and 18 cause most cervical cancers, as well as other HPV associated cancers.  Both vaccines are very safe.  Only one of the vaccines (Gardasil®) has been tested and licensed for use in males.  Only one of the vaccines (Gardasil®) has been tested and shown to protect against precancers of the vulva, vagina, and anus.

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For more important information regarding the safety of HPV vaccines and how they are actively monitored, please visit:

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