In the first nine months of 2007, 3345 adverse reactions to the vaccine Gardasil have been reported to the CDC. Deciding whether to require this expensive and controversial vaccination is proving difficult. While it would be completely unnecessary in a society that practiced sexual abstinence before marriage and monogamy afterwards, the reality is that the virus HPV is causing cancer at alarming rates.
The vaccine is effective against two strains of the HPV virus that are responsible for 70% of cervical cancers. The virus is transmitted through sexual contact and is the nation’s most common sexually transmitted disease with about 6 million cases per year which lead to an estimated 9,700 cases of cervical cancer. It is also effective against two different strains of HPV that cause genital warts.
Various watch-dog groups have been warning against Gardasil for several months because of adverse effects. Nevertheless, some states are making the vaccines mandatory for girls as young as 9 years old in an effort to prevent HPV from spreading. The vaccine costs $300 to $500.
The CDC reported on August 15, 2007 that over 7 million doses of Gardasil had been distributed. Their report states that the number of reported adverse reactions is about half of the number normally reported for a new medication. It goes on to say that the deaths are being investigated.
According to CDC records, of the 3,345 adverse reports in the first nine months of 2007, five deaths were reported from Gardasil vaccinations:
Since the CDC reporting system for adverse drug reactions is voluntary, estimates range from 1 to 10% of actual events are reported. It’s possible, therefore that the actual number of adverse reactions is in the 30,000 to 300,000 range.
Hundreds of the more serious adverse effects, some immediately after the vaccination while the patient was still in the doctor’s office, were associated with irregularities in the circulatory system. They included fainting, being unresponsive, pallor, dizziness, falls, seizures, tremors, facial spasms, being short of breath, temporary deafness, and vision irregularities. Similar reactions have been reported in Australia where the government is requiring girls to be vaccinated.
The majority of the less serious reactions reported to the CDC involved itching, pain, nausea, headaches—the sort of reactions that are common in many medications.
Two of the ingredients in the vaccine are known to cause fainting. Histidine is a precursor of histamine which can decrease blood pressure and cause fainting. The other ingredient, polysorbate 80 is used in lotions and creams. It can cause anaphylaxis, a drop in blood pressure and breathing difficulties.
Studies are continuing about the effectiveness of Gardasil. It has been suggested that the vaccine is more effective when given to virgins since they’ve never been exposed to the HPV virus.
A cautious approach is recommended by George Sawaya who is an associate professor of OBGYN at UC-San Francisco. He wrote in an article for the New England Journal of Medicine on May 10, "A cautious approach may be warranted in light of important unanswered questions about overall vaccine effectiveness, duration of protection, and adverse effects that may emerge over time. HPV vaccination has the potential for profound public health benefit if the most optimistic scenario of effectiveness is realized."
Resources:
The vaccine is effective against two strains of the HPV virus that are responsible for 70% of cervical cancers. The virus is transmitted through sexual contact and is the nation’s most common sexually transmitted disease with about 6 million cases per year which lead to an estimated 9,700 cases of cervical cancer. It is also effective against two different strains of HPV that cause genital warts.
Various watch-dog groups have been warning against Gardasil for several months because of adverse effects. Nevertheless, some states are making the vaccines mandatory for girls as young as 9 years old in an effort to prevent HPV from spreading. The vaccine costs $300 to $500.
The CDC reported on August 15, 2007 that over 7 million doses of Gardasil had been distributed. Their report states that the number of reported adverse reactions is about half of the number normally reported for a new medication. It goes on to say that the deaths are being investigated.
According to CDC records, of the 3,345 adverse reports in the first nine months of 2007, five deaths were reported from Gardasil vaccinations:
- A 19-year old woman was vaccinated with Gardasil on 3/12/07; she collapsed and died from a pulmonary embolism on 3/26/07.
- Two females of unknown age died of thrombosis after being vaccinated with Gardasil.
- A 15-year old girl died of respiratory failure after she was vaccinated with Gardasil; details are unavailable.
- An 11-year old girl died of thrombosis within a month of vaccination with Gardasil.
Since the CDC reporting system for adverse drug reactions is voluntary, estimates range from 1 to 10% of actual events are reported. It’s possible, therefore that the actual number of adverse reactions is in the 30,000 to 300,000 range.
Hundreds of the more serious adverse effects, some immediately after the vaccination while the patient was still in the doctor’s office, were associated with irregularities in the circulatory system. They included fainting, being unresponsive, pallor, dizziness, falls, seizures, tremors, facial spasms, being short of breath, temporary deafness, and vision irregularities. Similar reactions have been reported in Australia where the government is requiring girls to be vaccinated.
The majority of the less serious reactions reported to the CDC involved itching, pain, nausea, headaches—the sort of reactions that are common in many medications.
Two of the ingredients in the vaccine are known to cause fainting. Histidine is a precursor of histamine which can decrease blood pressure and cause fainting. The other ingredient, polysorbate 80 is used in lotions and creams. It can cause anaphylaxis, a drop in blood pressure and breathing difficulties.
Studies are continuing about the effectiveness of Gardasil. It has been suggested that the vaccine is more effective when given to virgins since they’ve never been exposed to the HPV virus.
A cautious approach is recommended by George Sawaya who is an associate professor of OBGYN at UC-San Francisco. He wrote in an article for the New England Journal of Medicine on May 10, "A cautious approach may be warranted in light of important unanswered questions about overall vaccine effectiveness, duration of protection, and adverse effects that may emerge over time. HPV vaccination has the potential for profound public health benefit if the most optimistic scenario of effectiveness is realized."
Resources:
- Vaccine Adverse Event Reporting System (VAERS) http://vaers.hhs.gov/info.htm
- George F. Sawaya, M.D. and Karen Smith-McCune, M.D., Ph.D., "HPV Vaccination--More Answers, More Questions," New England Journal of Medicine, May 10, 2007, http://content.nejm.org/cgi/content/full/356/19/1991
- Coors, EA. Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions. Ann Allergy Asthma Immunol. 2005 Dec;95(6):593-9. PMID: 16400901
- CDC, Office of the Chief Science Officer, HPV: Gardasil and GBS, factsheet issued on 8/15/2007.
- CDC, HPV Vaccine: Q&A Concerning Safety and efficacy of Gardasil, downloaded from http://www.cdc.gov/vaccines/vpd-vac/hpv/downloads/vac-faqs-vacsafe-efficacy.pdf
