(NaturalNews) The Health Ministry of Spain has ordered an emergency recall of a batch of the human papillomavirus (HPV) vaccine Gardasil, manufactured by Merck and jointly marketed by Merck and Sanofi-Aventis.
Gardasil is marketed as preventive against cervical cancer and genital warts. It is designed to immunize the body against HPV stains 16 and 18, which are believed to be responsible for 70 percent of cervical cancer cases, and 6 and 11, believed to cause 90 percent of cases of genital warts. GlaxoSmithKline produces a similar vaccine, Cervarix, that produces against strains 16 and 18 but not against 6 or 11.
The recall order came after two adolescent girls became seriously ill and went into convulsions immediately after being vaccinated with the same batch, NH52670. Both girls were taken to intensive care, and were eventually pronounced stable. Merck and Sanofi-Aventis announced plans to investigate the reactions.
Authorities initially believed, after the first girl became sick in Valencia, that her reaction was unrelated to the vaccine. After a second girl had the same reaction immediately after receiving an injection from the same batch, however, the Health Ministry ordered a halt to all use of batch NH52670. Almost 80,000 doses of the batch had already been distributed and were in use all over Spain. Eventually, the government issued an outright recall.
The two girls had been vaccinated as part of a government program aimed at teenagers, similar to those being proposed in many parts of the United States.
Widescale HPV vaccination programs for children have been criticized both on grounds of potential risk and suspect benefit. Neither HPV vaccine has been tested on children, or has been clinically shown to reduce the risk of cervical cancer or genital warts.
Other health advocates have questioned the vaccines' usefulness in saving lives or even lowering medical costs, since regular Pap smears have already greatly improved the prognosis for cervical cancer. Since the HPV vaccine is not failsafe, women who are vaccinated must still continue to get regular Pap smears.