Hpv Vaccine Controversy Essay


HPV and How to Protect Against It

Human papillomavirus (HPV) infection is very common. Most people—about 9 in 10—will get an HPV infection at some point in their lives. HPV infections can cause health problems, including several kinds of cancer in both women and men. There are safe and effective vaccines recommended to prevent these health problems from happening.

HPV Vaccine Side Effects

The HPV vaccine is very safe, and it is effective at preventing HPV. Vaccines, like any medicine, can have side effects. Many people who get the HPV vaccine have no side effects at all. Some people report having very mild side effects, like a sore arm from the shot. The most common side effects are usually mild.

Brief fainting spells and related symptoms (such as jerking movements) can happen after any medical procedure, including vaccination. Sitting or lying down for about 15 minutes after a vaccination can help prevent fainting and injuries caused by falls.

On very rare occasions, severe (anaphylactic) allergic reactions may occur after vaccination. People with severe allergies to any component of a vaccine should not receive that vaccine.

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Available HPV Vaccines

There are three licensed HPV vaccines available in the United States. CDC recommends that anyone starting the series before their 15th birthday receives two doses of HPV vaccine at least six months after the first dose.  Adolescents who receive their two doses less than five months apart will require a third dose of HPV vaccine.

Teens and young adults who start the series at ages 15 through 26 years still need three doses three doses of HPV vaccine.   Also, three doses are still recommended for people with certain immunocompromising conditions aged 9 through 26 years.

  • Gardasil 9: FDA approved Gardasil 9 for use in 2014. The safety of Gardasil 9 was studied in clinical trials with more than 15,000 participants before it was licensed and continues to be monitored. Gardasil 9 protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
  • Gardasil: FDA approved Gardasil for use in 2006. The safety of Gardasil was studied in clinical trials with more than 29,000 participants before it was licensed and continues to be monitored. Gardasil protects against HPV types 6, 11, 16, and 18.

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How CDC Monitors the Safety of HPV Vaccines

CDC and FDA monitor the safety of vaccines after they are licensed. Any problems detected with these vaccines will be reported to health officials, health care providers, and the public.

CDC uses three systems to monitor vaccine safety:

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A Closer Look at the Safety Data

  • In 2014, before it was licensed by the FDA, the safety of Gardasil 9 was evaluated across seven studies. The safety findings from these pre-licensure studies show it has a similar safety profile to Gardasil. The main findings from these studies are:
    • The most common side effect reported was pain, swelling, and redness in the arm where the shot was given.
    • These mild side effects may occur more often after Gardasil 9 vaccination than after Gardasil. Women and girls who received Gardasil 9 reported higher rates of swelling and redness where the shot was given than those who received Gardasil. Reports of swelling and redness also increased with each following dose for those receiving Gardasil 9.
  • In 2014, CDC published a report analyzing health events reported to VAERS following Gardasil vaccination from June 2006 through March 2014. About 92% of the Gardasil reports were classified as non-serious.
  • The most common adverse events reported were:
    • Syncope (fainting)
    • Dizziness
    • Nausea
    • Headache
    • Fever
    • Injection site reactions (pain, swelling, and redness)

    Although rare, fainting was found to happen after HPV vaccination. In response, FDA changed Gardasil’s guidance for doctors to include information about preventing falls and injuries from fainting. CDC and the Advisory Committee on Immunization Practices included this guidance in the recommendations for HPV vaccination. Based on these recommendations, health care professionals should administer HPV vaccinations while the patient is seated or lying down. The patient should then remain seated and be observed for 15 minutes. CDC continues to remind doctors and nurses to observe this guidance and to share this information with all their patients.

  • In 2011, the Institute of Medicine (IOM) reviewed published and unpublished studies of the safety of eight vaccines, including HPV, and published a report, Adverse Effects of Vaccines: Evidence and Causality. This report concluded:
    • Syncope (fainting) may be caused by injected vaccines, including HPV vaccines.
    • Some people are allergic to certain ingredients in vaccines, and vaccines, including HPV vaccines, can cause anaphylaxis among people with severe allergies. This is very rare. People with severe allergies to any component of a vaccine should not receive that vaccine.

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Ongoing Safety Monitoring and Studies

Ongoing HPV vaccine safety monitoring efforts include:

  • Review of reports to VAERS to search for unusual adverse events or changing patterns of adverse events
  • Continued monitoring and research in VSD, including the new Gardasil 9 vaccine
  • Regular consultation with CISA experts, as needed, on clinically complex adverse events

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More Resources

 

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Related Scientific Articles

Gee J, Naleway A, Shui I, Baggs J, Yinc R, Lic R, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink, Vaccine. 2011;29(46)8279-8284.
Markowitz LE, Dunne EF, Saraiya M, Chesson HW, Curtis CR, Gee J, et al. Human papillomavirus vaccination: Recommendations of the Advisory Committee on Immunization Practices (ACIP).MMWR. 2014;63(RR05);1-30.
Petrosky E, Bocchini JA Jr, Hariri S, Chesson H, Curtis CR, Saraiya M, et al. Use of 9-Valent human papillomavirus (HPV) vaccine: Updated HPV vaccination recommendations of the Advisory Committee on Immunization Practices. MMWR. 2015;64(11):300-304.
Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua J, Sutherland A, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine.JAMA. 2009;302(7):750-7.
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Common Side Effects of HPV Vaccine:

  • Pain, redness, or swelling in the arm where the shot was given
  • Fever
  • Headache or feeling tired
  • Nausea
  • Muscle or joint pain

The recognition that invasive carcinoma of the uterine cervix is the end result of some genital tract human papillomavirus (HPV) infections and the development of prophylactic vaccines to prevent these infections are major recent achievements of public health medicine.

Learning ObjectiveUnderstand how the argument for mandatory vaccination to prevent human papillomavirus (HPV) infections differs from justification for mandatory vaccination against more easily transmitted diseases.

The quadrivalent Gardasil HPV vaccine from Merck & Co., Inc., was licensed by the Food and Drug Administration (FDA) in June 2006 and was subsequently recommended by the Advisory Council on Immunization Practices (ACIP) for vaccination of adolescent girls and young women. Gardasil is designed to protect against infections with four of about 40 genital tract HPVs, types 16, 18, 6, and 11. HPV 16 and HPV 18 are responsible for about 70 percent of invasive cervical cancers and for a larger majority of the HPV-related cancers at other sites [1,2]. Worldwide, about 500,000 cervical cancers annually and about 100,000 cancers at other sites, including vulva and vagina, anus, penis, and oropharynx, are attributable to genital tract HPV [1].

HPV 6 and HPV 11 account for over 90 percent of genital warts, which are very common, with millions of cases annually worldwide, and for nearly 100 percent of a rare disease, recurrent respiratory papillomatosis of juvenile or adult onset. A second HPV vaccine, Cervarix, is expected to be available in the U.S. in the near future. Cervarix, from GlaxoSmithKline, is a bivalent vaccine designed to prevent infections with the oncogenic HPV types 16 and 18 [3].

Both vaccines have been shown to be well tolerated, safe, and highly immunogenic in clinical trials [1-3]. Over a 4- to 5-year period of observation, they have been nearly 100 percent effective in preventing incident persistent infections and cervical intra-epithelial neoplasia by HPV types in the vaccine. Gardasil was also nearly 100 percent effective in preventing genital warts associated with HPV 6 and HPV 11. It is not yet known whether the vaccine will provide decades-long protection over the sexual life of a woman immunized when young, or a girl immunized in her preteen years.

It is anticipated that vaccinated women will have significantly fewer Pap smear abnormalities and therefore less need for treatment of cervical precursor lesions. Pap smear screening will still be required, but at lengthier intervals.

Because HPV is sexually transmitted, the vaccine is recommended for use in early adolescents prior to the initiation of sexual activity. The effort by several state legislators and aggressive lobbying by Merck to make the Gardasil vaccine mandatory for school attendance produced a backlash. The controversy has been comprehensively described in a recent issue of CQ Researcher [4].

Mandating vaccination as a public health policy measure has a long history in the U.S., dating back to the middle of the 19th century, and it invariably creates tension between public health policy and individual rights [3]. In the past 30 years, every state in the union has mandated vaccines for school-aged children. The most compelling case for doing so can be made when the vaccine prevents a serious infectious disease that is spread by casual contact in the age group for which it is mandated, and when that disease can be effectively controlled only by vaccination of a high proportion of the population. Examples of vaccines in this category are those that protect against polio, measles, mumps, rubella, diphtheria, and pertussis. Exemptions are available, but, if widely used, exemptions result in a lowering of what is called "herd immunity" and a resulting increase in disease incidence [4].

HPV vaccine does not meet the high threshold for mandating. HPV is spread by intimate sexual contact and therefore is not an epidemic infectious disease among school-aged children. Most infections are harmless, and screening methods (Pap smear and HPV testing) are available to identify individuals who are at risk of cervical cancer, which occurs 10 to 20 years following initial infection. Treatment of precursor lesions by minor surgical procedures is completely effective in preventing cervical cancer. Thus, there is no compelling public health rationale for mandating HPV vaccine in school-aged children.

Because vaccines are an economical and effective way to prevent many infectious diseases, mandates have sometimes been used more broadly, as in the instances of tetanus and hepatitis B. While a case for mandating HPV vaccine can be made on grounds of good medical and public health practice, the arguments against its use also have merit. The autonomy of the individual to make his or her own decisions about medical care can be disregarded only when the public health is threatened. While this might be the case during an influenza epidemic, for example, it is certainly not the case for HPV. Moreover, when the public health is not threatened, vaccine safety is of paramount importance.

Despite the promising results from clinical trials, the number of vaccinated individuals is still too small to exclude rare serious adverse effects, and more experience with the HPV vaccine is advisable before its mandatory use comes up for consideration. The availability of alternative strategies for detection and control of cervical cancer, discussed above, must also be factored in to the recommendation for the HPV vaccine. But these strategies are less economical than vaccination, potentially less effective, and medically and psychologically more burdensome for women.

The controversy surrounding the HPV vaccine has also raised questions about the appropriate procedures for making vaccination against a given illness or disease mandatory and about possibly restricting lobbying on the part of the manufacturer. While laws mandating vaccine use have to be passed by legislatures, and while manufacturers should be free to make the case for their product, recommendations are best made by state health departments after soliciting input from diverse sources.

The high cost of Gardasil is a deterrent for its use for many families. It has been suggested that Merck would profit substantially even if it cut the cost of Gardasil by 90 percent [5]. In any case, economic considerations should not drive the decision. Many existing government programs provide needed vaccines to children at low cost or no cost. Vaccines that are either mandated or "officially recommended" are covered by the federally funded Vaccines for Children program in the United States.

HPV vaccine provides us an opportunity to reduce the cancer burden for women in all parts of the world, however. We think the widespread use of the vaccine by men and women and availability of the vaccine in the developing world will be the best use of this resource.



References

  1. Parkin DM, Bray F. Chapter 2: the burden of HPV-related cancers. Vaccine. 2006;24(Suppl 3):S11-S25.
  2. Future II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007;356(19):1915-1927.
  3. Paavonen J, Jenkins D, Bosch FX, et al. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet. 2007;369(9580):2161-2170.
  4. Bristol N. HPV vaccine: should it be mandatory for school girls? CQ Researcher. 2007;17(18):409-432.
  5. Malone KM, Hinman AR. Vaccination mandates: the public health imperative and individual rights. In: Goodman RA, Rothstein MA, Hoffman RE, et al, eds. Law in Public Health Practice. New York, NY: Oxford University Press; 2003: 262-284.
  6. Offitt PA. Fatal exemption. Wall Street Journal. January 20, 2007:A10.
  7. McGee G. How much should Gardasil cost? Scientist. 2007;21(8):26.

Raphael P.Viscidi, MD, is a professor of pediatrics in the Johns Hopkins University School of Medicine in Baltimore. He is an infectious diseases specialist with a primary research interest in human papillomavirus infections.

Keerti V.Shah, MD, DrPH, is a professor of microbiology and immunology in the Johns Hopkins University Bloomberg School of Public Health in Baltimore. He is a virologist with a primary research interest in human papillomavirus and polyomavirus infections.

Disclosure

Keerti V. Shah, MD, DrPH, served in a scientific capacity on expert committees for GlaxoSmithKline and Merck that met one time each.

Related in VM

Development of the Human Papillomavirus Vaccine and Guidelines for Its Use, January 2007

The viewpoints expressed on this site are those of the authors and do not necessarily reflect the views and policies of the AMA.

© 2007 American Medical Association. All Rights Reserved.

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