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FDA Delays Cervarix Decision, Glaxo Says British Death Not Behind Delay

Sep 30, 2009 | Parker Waichman Alonso LLP

U.S. regulators have postponed an approval decision on GlaxoSmithKline's cervical cancer vaccine, Cervarix.  The Food & Drug Administration's (FDA) delay of the Cervarix decision came a day after news broke that a British girl had died only hours after receiving the vaccine.  

Cervarix protects against two strains of HPV that cause more than 70% of cases of cervical cancer in women. According to the Associated Press,  the FDA was supposed to announce its Cervarix ruling on Tuesday, but  needed additional data.  Earlier this month, an outside panel of health experts voted that Cervarix appears safe and effective for girls and women ages 10 to 25.   The vaccine is already approved in 100 other countries.

If approved in the U.S., Cervarix would compete with Merck & Co.'s Gardasil, which the FDA ok'd in 2006. Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. According to the Associated Press, Glaxo said the death in Britain did not play a role in the FDA's decision to postpone the Cervarix ruling.  

The death occurred Monday.  According to BBC News, the girl, aged 14, appeared to be healthy prior to receiving the vaccine at school in Coventry.  She died in the hospital, four hours after the shot was administered.  A small number of girls at the school had also reported mild symptoms such as dizziness and nausea but were not admitted to hospital.   The cause of death is unknown at this time, pending an autopsy report.

According to The Wall Street Journal, Glaxo has recalled the batch of Cervarix involved in the fatal incident.  Other batches of the vaccine remain available and are not affected by this recall.   The Cervarix vaccination program in Coventry has been paused for now.

According to the BBC report,  Britain's Medicines and Healthcare Regulatory Agency has received 2,137 adverse reaction reports involving Cervarix between April 14, 2008 and September 23, 2009.

In the U.S. Merck's Gardasil has also been the subject of safety concerns.  As of June 2009, 15 million girls had received Gardasil, with more than 14,000 recipients reporting adverse reactions. The complaints included reports of dizziness numbness, and blood clots. Health regulators are also looking at 43 reports of fatalities that occurred following Gardasil administration.

In June, the FDA announced that the Gardasil label had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to the agency, roughly 13% of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.