Gardasil® gets 7,802 adverse reports to CDC by VAERS system

On June 8, 2006, the FDA licensed Gardasil®, the first vaccine developed to prevent cervical cancer caused by certain kinds of human papillomavirus (HPV) and was licensed for use in the United States by the FDA on June 8, 2006

More than 12 million doses of the 3 stage vaccine have been distributed, 2,151,000 in 2006 and a further 1,317,902 by the end of 2007. AS there is no national registry the number of people vaccinated is unknown.

Initial tests, only performed on females were undertaken on 11,00 people between 9 and 26 worldwide and found the most common side effect was injection site pain. While Gardasil was being tested in the U.S. before it was licensed, 10 people in the group that received the HPV vaccine and 7 people in the placebo group died during the trials. None of the deaths was considered vaccine-related.

The US national Vaccine Adverse Event Reporting (VAERS) system has received 7,802 reports after Gardasil vaccination in the U.S. (June 8, 2006 through April 30, 2008) Less than 7% reported serious side effects, about half of the average for vaccines overall.

An adverse event by the Code of Federal Regulations as adverse events involving hospitalization, death, permanent disability, and life-threatening illness.

VAERS received 15 reports of death following Gardasil vaccination in the U.S and only 10 reports contained the level of information adequate for further analysis none could establish the causal relationship between vaccination and death. The details of the other 5 reports of death were insufficient to make any judgement.

Guillain-Barré Syndrome (GBS)

Note: GBS cases take longer to verify because each case must be confirmed manually by CISA staff after reviewing the patient's medical record.

VAERS received 31 reports of Guillain-Barré Syndrome (GBS) after Gardasil vaccination in the U.S. Ten have been confirmed. Of the 10 confirmed GBS cases, 5 reported vaccination with Menactra ( A meningococcal vaccine) and Gardasil at the same time. Of the remaining 21 reports, 7 did not meet the case definition for GBS (when evaluated by the Clinical Immunization Safety Assessment (CISA) group), 1 had symptoms of GBS prior to vaccination, 4 are unconfirmed reports, and 9 are pending additional follow-up.

Because GBS occurs at a rate of 1 to 2 per 100,000 person-years during the second decade of life, it is likely that some cases occur after vaccination by chance alone and are not caused by vaccination. Among 9 to 26 year-olds, the number of reports of GBS received by VAERS are within the range that could be expected to occur by chance alone after a vaccination. Studies are underway to evaluate the risk of GBS that may be associated with receipt of Menactra vaccine.

Merck shares (MRK:NYSE) dropped nearly US$2 (5%) but recovered slightly today to close at US$36.60 as analysyst and TV companies digested the news. FOX CBS WKBW CBC

Canada

Health Canada approved Gardasil® on July 18, 2006. Since then, all 10 provinces have started or said they would be starting vaccination programs. Nova Scotia were the first province offering vaccinations to girls in Grade 7 from JUne 2007.

As of Jan. 8, 2008, the Public Health Agency of Canada had received a total of 145 reports of adverse events following vaccination with Gardasil®, none of which were of death or Guillain-Barré syndrome, according to the agency.