Mike Derer/AP

Gardasil Not to Blame in Hospitalization of Spanish Teens

February 20, 2009 10:56 AM
by Cara McDonough
Officials are once again recommending the vaccine for young women following a health agency’s announcment that the shot is most likely not the reason two girls fell ill.

Fears Subside in Spain Gardasil Scare

When two teenage girls from the eastern Valencia were hospitalized on Feb. 6, just hours after receiving the Gardasil vaccine, health officials assumed the shot was the cause of their illness.

Spain’s health ministry immedialtely recalled batch NH52670 of the vaccine; both girls had received doses from that batch. They continued to administer the vaccine—used to prevent human papillomavirus (HPV), which can cause cervical cancer—from other batches. Italian authorities also discontinued vaccinating from the supposedly tainted batch.

But the European Medicines Agency, a pharmaceutical watchdog group in Europe, has investigated the situation and says Gardasil was unlikely the cause of the reaction in the two girls.

In a statement, the agency stated that “the cases are unlikely to be related to vaccination with Gardasil and that the benefits of Gardasil continue to outweigh its risks.” The Daily Telegraph reports that they are recommending that health officials continue with vaccinations as planned.

Both girls were vaccinated as part of a government vaccination program that is targeting adolescents. They were in stable condition shortly after being hospitalized.

The European Medicines Agency’s Committee for Medicinal Products for Human Use plans to investigate the case further and ensure further action is not needed.

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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