Mike Derer/AP

Spain Recalls Batch of Gardasil Vaccine Following Serious Adverse Reactions

February 11, 2009 10:29 AM
by Cara McDonough
The country has withdrawn tens of thousands of doses of Gardasil after the hospitalization of two teenage girls, reinforcing critics’ doubts about the safety of the vaccine.

Serious Complications after Gardasil Vaccinations

Two teenage girls from the eastern Valencia region reportedly fell ill on Feb. 6 just hours after receiving the Gardasil vaccine, and they were hospitalized. One of the girls was released from intensive care this weekend, while the other remains there, according to a government statement. The girls, who received shots from the same batch of Gardasil, are in stable condition.

Gardasil is a vaccine used to prevent human papillomavirus, or HPV, which can cause cervical cancer.

AFP reports that both girls were vaccinated last weekend as part of a government vaccination program that is targeting adolescents.

Spain’s health ministry said that Gardasil will continue to be administered but that one batch of the vaccine—batch NH52670—has been recalled. About 76,000 vaccines from the affected batch have already been distributed throughout Spain, but chemists have been instructed to halt sales.

Reuters reports that Sanofi Pasteur MSD, the Sanofi-Merck partnership that sells the vaccine in Europe, has stated that it is investigating the incident, but that an adverse event following the shot did not necessarily mean that Gardasil had caused it.

Other details about the incident, including the girls’ names and the extent of their illnesses, have not yet been released.

Background: The Gardasil debate

Gardasil has been proven successful in preventing HPV, and thus cervical cancer, but a number of doctors, parents and medical experts have questioned the vaccine’s safety since the FDA approved it in 2006.

Despite reports of adverse reactions, including paralysis and even death, the vaccine continues to be marketed successfully to teenage girls. The FDA, after reviewing 9,700 cases of reported health problems following the injection, said the most serious health problems did not appear to be related to the vaccine.

The vaccine’s safety will most likely continue to be questioned as the government continues to recommend Gardasil for teenage girls. One of the researchers who helped develop the drug, Dr. Diane Harper, has been vocal in her concern that a push by several states and pharmaceutical company Merck to make the vaccine mandatory is happening far too fast, before clinical trials reveal any possible risks.

Additionally, the National Vaccine Information Center, a vaccine safety watchdog group, continues to issue periodic reports questioning Gardasil’s safety.

Other critics worry that Gardasil is targeting the wrong age group altogether, saying that middle-school-aged girls who receive the vaccine will be no more than 18 when they pass its five-year window of proven effectiveness. Furthermore, many young women’s immune systems clear the virus within one to two years of contracting it. And when detected early, HPV can be treated and rarely leads to cancer.

Merck recently sought approval to market Gardasil to males between 9 and 26. HPV causes some cancers in males.

Reference: Cervical cancer, STDs


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