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Gardasil vaccine has 'good safety record'

August 20 2009: Medical opinions divided over vaccine designed to prevent virus associated with the development of cervical cancer

 

The HPV vaccine Gardasil has a good safety record, according to research published in the Journal of the American Medical Association.

Gardasil is licensed in the US to prevent infection with the human papillomavirus (HPV). HPV is associated with the development of diseases including cervical cancer. The researchers looked at reports about Gardasil made to the Vaccine Adverse Event Reporting System (VAERS) between June 2006, when it was licensed, and December 2008. They only looked at reports from the US.

Medical professionals are divided in their opinions over the safety of Gardasil with some US doctors saying they will no longer administer the vaccine until there is more evidence of its safety. However, given the risks associated with HPV infection and cervical cancer, many medical professionals believe its benefits outweigh the risks.

It is estimated that over this period the vaccine was given to more than 23 million people in the US. During this time the VAERS received almost 12,500 reports of side-effects after people had the vaccine. The most common were fainting, a reaction at the site of the injection, dizziness and feeling sick.

Other rarer, more serious side-effects included severe allergic reactions (anaphylaxis) and the development of blood clots. Of the total adverse reactions reported, 772 were classed as serious. This was defined as causing death, permanent disability, birth defects or hospitalisation, or needing medical treatment to prevent one of these.

However, the researchers found that most of the serious side-effects were not directly related to Gardasil and were likely to have been caused by other factors. These included having other vaccines at the same time and taking the contraceptive pill.

Apart from fainting and blood clots, the number of serious side-effects that occurred was not statistically different from results of safety trials done before the vaccine was licensed.

Bupa International medical director, Dr Sneh Khemka, said: “Although these results are limited and don’t provide any information about possible long-term effects, they are reassuring. Gardasil can provide protection against the types of HPV that are most often responsible for causing cervical cancer, one of the most common forms of cancer in women.”

Key facts

  • HPV can cause diseases including cervical cancer and genital warts
  • Gardasil protects against four types of HPV – 6, 11, 16 and 18
  • It is thought that the vaccine provides protection from these types of HPV for at least six years
  • The vaccine is given as three separate injections within a 12-month period
  • The vaccine doesn’t protect against all types of HPV so it’s important to have regular cervical screening tests (pap tests) after the age of 21

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