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Statement of the Committee on Infectious Diseases of the American Academy of Pediatrics, District II, New York State regarding thimerosal and the Measles/Mumps/Rubella (MMR) vaccine.

  
Pediatricians may once again face questions about thimerosal, autism, and the MMR vaccine, following the opening episode of “Eli Stone” on ABC, Thursday, January 31, 2008, in which the titular lawyer successfully argues in court that MMR caused a child’s autism, and wins a 5.2 million dollar settlement from the vaccine manufacturer.  The committee has compiled the information below, with references, to prepare and enable pediatricians to give detailed, accurate answers.

1.            At present, pediatric vaccines used for the recommended immunization of infants and children are already thimerosal free or significantly thimerosal reduced.  The producers have, over the last four years, completely removed or reduced thimerosal to trace amounts in all childhood vaccines.  The only routinely administered vaccines that contain thimerosal are adult tetanus boosters and some influenza vaccines.  Thimerosal reduced or thimerosal free pediatric influenza vaccines have recently been developed, but their mass production is more complicated, so quantities remain limited and the cost is much higher.

2.            Current scientific research indicates that thimerosal has no negative impact on infant or child health and development.  The committee is sympathetic to parental concerns regarding possible exposure of infants and children to a harmful substance.  However, the thimerosal controversy is largely based on misinformation, half-truths, and emotional but scientifically unsound personal stories.  The type of mercury contained in thimerosal is ethylmercury.  The known toxicity of mercury is based on human exposure to a different form of mercury, called methylmercury.  Methylmercury is a form of mercury that accumulates in the body.  It is true that in 1999, the American Academy of Pediatrics and the United Public Health Service recommended the removal of thimerosal from vaccines, but that recommendation was made as a precaution because there was inadequate data on effects of human exposure to ethylmercury.  In 2001, the Institute of Medicine (an impartial and highly respected unit of the National Academy of Science) concluded that the hypothesis of a causal relationship between thimerosal and developmental delay was biologically plausible; however, the evidence at that time could neither prove nor disprove the hypothesis.  Subsequent scientific data and studies on ethylmercury found that it was metabolized differently from methylmercury.  Unlike methylmercury, ethylmercury does not accumulate in the body.   The ethylmercury found in thimerosal is rapidly excreted from the body in the stool. In 2004, the Institute of Medicine reviewed the new data, and concluded that thimerosal has no negative impact on infant or child health and development  including no relationship whatsoever with autism.[1] A 2003 scientific study, based in Denmark, has shown that although Danish vaccines have been thimerosal free since 1990, during the period 1971-2000, the number of autistic children in Denmark has continued to increase, and that the increase continued in children born after the discontinuation of thimerosal. [2] A study of similar design of almost 28,000 children in Montreal born from 1987 to 1998 found the prevalence of pervasive developmental disorders to be high and increasing as in most other countries, but that this increase occurred despite a significant decrease in thimerosal exposure from vaccinations. [3] Finally, a 2007 study in the New England Journal of Medicine conducted by the Centers for Disease Control and Prevention’s Vaccine Safety Datalink found no pattern of association with thimerosal exposure and developmental outcome in 1047 boys and girls aged 7-10 years, and no support for a causal link between prenatal and postnatal thimerosal exposure and neuropsychological outcomes and functioning in childhood. [4]  

3.            The MMR vaccine is safe.  First of all, MMR vaccine in the U.S. has never contained any thimerosal.  Period. With regard to thimerosal, thimerosal reduced vaccines contain 0.0 – 0.5 mcg of rapidly excreted ethylmercury.  On the other hand, the average 6 ounce can of chunk light tuna contains over 20 mcg of mercury, in the concerning methylmercury form.  The same size can of solid white albacore tuna contains over 60 mcg of methylmercury. [5] By this rationale, those who seek to ban the annual pediatric influenza vaccine that contains 12.5 mcg of ethylmercury, should be banning the sale and consumption of canned tuna, and virtually all fish and shellfish.  By published EPA and FDA standards, all of these quantities of mercury are considered well below recommended exposure levels.[6][7]  

MMR was originally linked to autism, because of a controversial 1998 study led by British surgeon, Andrew Wakefield, which studied bowel symptoms in 12 autism spectrum children and concluded ,”We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers.”  Although no causal connection had been shown in the study, Wakefield called for suspension of MMR, and recommended administration of single doses of each component.  Numerous follow-up studies by investigators around the world failed to show any causal connection between increasing rates of autism and introduction of the MMR vaccine.  By 2004, 10 of 13 co-authors published a retraction that read, "We wish to make it clear that in this paper no causal link was established between (the) vaccine and autism, as the data were insufficient. However the possibility of such a link was raised, and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent."  The General Medical Council, regulator of the British medical profession, has brought charges against Wakefield for serious professional and scientific misconduct.  

4.            The MMR vaccine is still important.  Measles is a highly contagious viral illness, and prior to the introduction of the vaccine in 1963, virtually everyone got measles.  Over half of children aged 6 had measles, and by 15, 90% had it.  There were 3-4 million cases every year, with about 500 deaths.  Complications are common and include pneumonia and diarrhea, as well as rare complications like encephalitis (1/1000 cases) and corneal ulcerations.[10] In the 45 years since the introduction of measles vaccine, the incidence of measles in the U.S. population has fallen by 99.9% to just 30 cases for all of 2007.[11]  Many of these cases were imported from other countries.  Globally, measles remains a significant problem.  Over half a million deaths from measles occur annually, or about 5% of all childhood mortality, especially in those less than 5 years old.[12]  In less than two generations, we in the United States have forgotten how contagious and potentially dangerous measles is.  

5.            Television shows that imply vaccines and thimerosal are harmful send the wrong message to the population and potentially create major health risks and unnecessary health costs.  Shows like “Eli Stone” suggest to the public that there are safety problems with current routine vaccinations.  This is not the case and such an unfounded implication undermines the critical role the immunization program plays in public health.  It needlessly frightens parents, as well as all Americans who face a real health threat from vaccine preventable infections, rather than thimerosal.  Shows like “Eli Stone” are junk science with an agenda masquerading as entertainment, and are as irresponsible and reprehensible as encouraging people not to use condoms because a latex allergic reaction is worse than contracting sexually transmitted infections like syphilis, gonorrhea, or HIV.  

We ask that parents, guardians, and families carefully review the facts, and not be swayed by their emotions or the hype involved with the thimerosal controversy.  Mercury exposure from thimerosal is not the same as mercury exposure from fish or other environmental sources of mercury.  Receiving the MMR vaccine cannot result in mercury exposure levels exceeding either EPA or FDA guidelines, since MMR contains zero mercury.  

We empathize with the parents of children with developmental delays, who only want answers and to ensure their children are safe from harm.  As pediatricians and parents, we share the same goal for the children under our care.  But we also have a responsibility to advocate for the children and protect them from the devastating and potentially life-threatening complications of measles, mumps, and rubella.  

We urge parents and families to boycott “Eli Stone” and other shows of its ilk.  It only contributes to, rather than minimizes, public fears and concerns by legitimizing anti-thimerosal pseudo-science. It undermines the effectiveness of immunization programs that protect the public health.  It is an insult to healthcare professionals who work tirelessly on behalf of children. And it is clearly pandering to parents’ fears, manipulating the public to create controversy and buzz all in the name of ratings, free publicity, and advertising dollars for ABC.  We should not reward or legitimize ABC and its programs for such crass behavior.  

Committee Members:

Paul J Lee, MD, FAAP, Co-Chair                Leonard R. Krilov MD, FAAP, Co-Chair
David Annunziato MD, FAAP                     Howard J. Balbi MD, FAAP
Kenneth Bromberg MD, FAAP                   David DiJohn MD, FAAP
Brinda Doriswamy MD, FAAP                   Abby J. Greenberg MD, FAAP
Donald S. Gromisch MD, FAAP                 Margaret R. Hammerschlag MD, FAAP
Marc Lashley MD, FAAP                          Sharon Nachman MD, FAAP  
Sujatha Rajan MD, FAAP                         Lorry G. Rubin MD, FAAP
Sunil K. Sood MD, FAAP                                                      

REFERENCES

1.            Institute of Medicine.  Immunization Safety Review: Vaccines and Autism.  Washington, DC: National Academies Press; 2004.

2.            Madsen KM, Lauritsen MB, Pedersen CB, et al. Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data. Pediatrics. 2003;112:604–606

3.            Fombonne E, Zakarian R, Bennett A, Meng L, McLean-Heywood D. Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations.  Pediatrics 2006 Jul;118(1):e139-50.

4.            Thompson WW, Price C, Goodson B, et al, for the Vaccine Safety Datalink Team. Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years.   N Engl J Med 2007;357:1281-92.

5.            http://www.cfsan.fda.gov/~frf/sea-mehg.html, accessed Jan 30, 2008.

6.            http://www.cfsan.fda.gov/~dms/admehg3.html, accessed Jan 30, 2008.

7.            http://www.fda.gov/CBER/vaccine/thimerosal.htm, accessed Jan 30, 2008.

8.            Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998. 351 (9103): 637–41.

9.            Murch SH, Anthony A, Casson DH, et al. Retraction of an interpretation. Lancet 2004; 363 (9411): 750.

10.         Pickering LK, Baker CJ, Long SS, McMillan JA, eds.  Red Book: 2006 Report of the Committee on Infectious Diseases. 27th ed.  Elk Grove Village, IL: American Academy of Pediatrics; 2006.

11.         Centers for Disease Control and Prevention.  MMWR 2008;56:1360.

12.         Brenzel L, Wolfson LJ, Fox-Rushby J, et al.  Disease Control Priorities in Developing Countries (2nd Edition).  New York: Oxford-University Press; 2006.
 


Talking Points on Gardasil (posted 7/11/2008)

Human Papillomavirus (HPV) Vaccination:

  • CDC continues to recommend HPV vaccination because of its importance for the health of women. CDC maintains this is a safe and effective vaccine.  However, as with all vaccines, we will continue to review the safety of this vaccine and take appropriate action if there are issues with the vaccine.
  • Parents and providers are encouraged to report any adverse events to the Vaccine Adverse Event Reporting System http://vaers.hhs.gov/ (phone 1-800-822-7967).
  • Parents are encouraged to discuss HPV vaccination with their pre-teen's doctor.  The routine recommendation is to administer HPV vaccine at ages 11 and 12 years.
  • People who miss vaccination at those ages can get the vaccine through age 26.
  • Syncope, or fainting, is a common event occurring with needle injections and vaccinations, especially in adolescents.  CDC recommends that patients who receive HPV vaccine remain in the clinic for 15 minutes after vaccination to avoid potential injury from a fall.
  • HPV disease and vaccine information is available at http://www.cdc.gov/vaccines/vpd-vac/hpv/default.htm 

HPV Disease

  • HPV is a common virus.  It is the major cause of cervical cancer in women.
  • HPV infection usually occurs in people in their teens and early 20s.
  • There are about 20 million people currently infected with HPV.
  • Each year in the U.S., about 11,000 women will be diagnosed with cervical cancer and 3,600 will die.
  • Women have an 80% chance of developing HPV by the time they are 50.
  • Because the vaccine is a preventative and not a cure, it is important that the vaccine be given prior to beginning sexual activity.

HPV Vaccine

  • On June 8, 2006, the Food and Drug Administration (FDA) licensed the first vaccine developed to prevent cervical cancer and other diseases in females caused by certain types of genital human papillomavirus (HPV).  The quadrivalent vaccine, Gardasil®, protects against four HPV types (6, 11, 16, and 18), which are responsible for 70% of cervical cancers and 90% of genital warts.  On June 29, 2006, the Advisory Committee on Immunization Practices (ACIP) voted to recommend routine vaccination of females 11 and 12 years of age. Catch up vaccination is recommended for females 13 though 26 years who have not been previously vaccinated.  Gardasil was tested in over 11,000 females (9 through 26 years of age) in many countries around the world, including the U.S.  These studies found that the HPV vaccine was safe and caused no serious side effects.  Adverse events were mainly injection site pain.  This reaction was common but mild.
  • Since licensure, more than 12 million doses of Gardasil vaccine have been distributed in the U.S. In 2006, a total of 2,151,000 doses were distributed and in 2007, another 11,317,902.  At this time, the U.S. does not have a national registry for immunization and vaccination and therefore cannot report the total number of people who have received Gardasil.
  • The number of serious adverse events reported to VAERS following HPV vaccine is less than 7% of the total number of reports received.  In comparison, the overall average in VAERS for any serious adverse event ranges from 10%–15%; thus, the percentage of serious reports for Gardasil is less than the overall average.

VAERS REPORT – A Case Currently in the News

  • In late March 2008, a 14 year old girl's physician submitted a report to the Vaccine Adverse Event Reporting System (VAERS) describing progressive muscular weakness which occurred approximately four months after the patient received her third dose of Gardasil.  In addition, the patient's physician directly contacted the CDC to follow-up on the case.
  • Upon receipt of the inquiry, CDC's Clinical Immunization Safety Assessment (CISA) Network began a review of the case.  Through the CISA Network, CDC and the FDA have received permission from the family to collect medical history from the treating physician, the family, and the medical records.  CDC and FDA, in collaboration with internal and external clinical experts, continue to follow the child's clinical course.
  • Because the patient has symptoms of peripheral motor neuropathy, CDC and FDA scientists reviewed the VAERS database and found no other reports describing lower motor neuron lesion, amyotrophic lateral sclerosis, or peripheral motor neuropathy occurring after Gardasil vaccination.

Other Gardasil Reports in VAERS

  • CDC and FDA are conducting an ongoing study of VAERS reports describing other adverse events after Gardasil. For more information visit: http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm 
  • As of April 30, 2008, VAERS received 7,802 reports after Gardasil vaccination in the U.S. Less than 7% of reported adverse events were considered serious, about half of the average for reports for other vaccines.  A report to VAERS does not mean there is a connection between the vaccine and the report.  It means the event took place following vaccination.
  • VAERS data are updated continuously and the number of reports and the type of adverse events will vary depending on the date of analysis.
  • VAERS defines serious adverse events by the Code of Federal Regulations as adverse events involving hospitalization, death, permanent disability, and life-threatening illness.
  • Between the date of its licensure in June 2006 and April 30, 2008, VAERS has received 15 reports of death following Gardasil vaccination in the U.S. Only 10 reports contained the level of information adequate for further analysis.  After careful review of those reports, we could not establish the causal relationship between vaccination and death.  For the remaining 5 reports of death, we were unable to obtain any patient identifying information; therefore we could not confirm death.
  • 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.
  • Information on Gardasil vaccine reports to VAERS can be found on the Immunization Safety Office's web page at http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm.

Vaccine Safety Monitoring: Vaccine Adverse Event Reporting System (VAERS)

General Description of VAERS and the CISA Network

     The Vaccine Adverse Event Reporting System (VAERS) is part of a larger system that helps to make sure vaccines are safe and work as intended. VAERS is managed by CDC and FDA.  To ensure vaccines are safe, vaccines are developed in accordance with the highest standards of safety.  FDA requires extensive safety testing before a vaccine is licensed and distributed to the public.  After licensing, VAERS is used to continually monitor vaccines for safety and efficacy.

     VAERS receives reports of many events that occur after immunization.  Some of these events may occur coincidentally following vaccination, while others may truly be caused by vaccination.  It is important to remember that many adverse events reported to VAERS may not be caused by vaccines.  More in depth studies are usually required to investigate the association between a vaccine and an adverse event. Since 1990, most of the reported adverse events describe mild side effects such as fever and rash.  Through continued monitoring, VAERS helps to ensure that the benefits of vaccines are far greater than the risks.  More information about VAERS can be found at http://www.cdc.gov/vaccinesafety/vaers/ .

   The Clinical Immunization Safety Assessment (CISA) Network was established in 2001 as a collaborative project between CDC's Immunization Safety Office (ISO) and six medical research centers. CISA studies the pathophysiologic basis of adverse events after immunization, studies risk factors (including genetic) associated with developing an adverse event after immunization (AEFI), and provides clinicians with evidence-based guidelines when considering immunization of those at risk for AEFIs.  CISA is uniquely suited to study post-licensure vaccine safety in special populations due to its clinical access to both the special populations and the specialists who care for them.  More information about CISA can be found at http://www.cdc.gov/vaccinesafety/cisa/ .

*****************************************************************************************************

CDC Health Advisory

Distributed via Health Alert Network 
April 02, 2008, 20:55 ED T (08:55 PM ED T) 

Measles outbreaks in the United States: Public health preparedness, control and response in healthcare settings and the community

     A measles outbreak linked to an importation from Switzerland currently is ongoing in Arizona. The first case, with rash onset on February 12, 2008, occurred in an adult visitor from Switzerland who was hospitalized with measles and pneumonia.  This hospital admission prompted verification of the measles immune status of approximately 1800 healthcare personnel and vaccination of those without evidence of immunity.  Through March 31, 2008, nine confirmed cases have been reported to the Arizona Department of Health Services, and there are two suspected cases (one in a Colorado resident) and hundreds of contacts under investigation. The nine case-patients range in age from 10 months to 50 years.  All but one were infected in healthcare settings, one of the five adult case-patients is a healthcare worker, and all cases were unvaccinated at the time of exposure.

     In January and February 2008, San Diego experienced an outbreak of 11 measles cases, with an additional case-patient who was exposed in San Diego but became ill in Hawaii . The index case was an unvaccinated child who had recently traveled to Switzerland , where a measles outbreak is ongoing (see http://wwwcdc.gov/mmwr/preview/mmwrhtml/mm5708a3.htm). Transmission in this outbreak occurred in a doctor's office as well as in community settings. Measles genotype D5 was identified from more than one case in the San Diego and Arizona outbreaks; this genotype is currently circulating in Switzerland (see http://www.eurosurveillance.org/edition/v13n08/080221_1.asp). Confirmed measles cases also have been reported from New York City (involving genotype D4, which is identical to the genotype responsible for a large ongoing measles outbreak in Israel ; see http://www.eurosurveillance.org/edition/v13n08/080221_3.asp) and from Virginia (importation from India ). In addition, two measles cases recently confirmed in unvaccinated siblings from Michigan may have resulted from exposure during a long stop-over in the Atlanta airport.

     Although measles is no longer an endemic disease in the United States , it remains endemic in most countries of the world, including some countries in Europe . Large outbreaks currently are occurring in Switzerland and Israel . In the United States from January 1 through March 28, 2008, 24 confirmed cases of measles resulting from importations from endemic countries have been reported to the Centers for Disease Control and Prevention (CDC). These cases highlight the ongoing risk of measles importations, the risk of spread in susceptible populations, and the need for a prompt and appropriate public health response to measles cases. Because of the severity of the disease, people with measles commonly present in physician's offices or emergency rooms and pose a risk of transmission to other patients and healthcare personnel in these and in inpatient hospital settings. Healthcare providers should remain aware that measles cases may occur in their facility and that transmission risks can be minimized by ensuring that all healthcare personnel have evidence of measles immunity and that appropriate infection control practices are followed.

     Transmission and case definition

     Measles is a highly contagious disease that is transmitted by respiratory droplets and airborne spread. The disease can result in severe complications, including pneumonia and encephalitis. The incubation period for measles ranges from 7 to 18 days. The diagnosis of measles should be considered in any person with a generalized maculopapular rash lasting > 3 days, a temperature  >101ºF (38.3ºC), and cough, coryza, or conjunctivitis. Immunocompromised patients may not exhibit rash or may exhibit an atypical rash.

     Recommendations

     Rapid and aggressive public health action is needed in response to measles cases. Case investigation and vaccination of household or other close contacts without evidence of immunity should not be delayed pending the return of laboratory results. Preparation for other control activities may need to be initiated before laboratory results are known. Control activities include isolation of known and suspected case-patients and administration of vaccine (at any interval following exposure) or immune globulin (within 6 days of exposure, particularly contacts < 6 months of age, pregnant women, and immunocompromised people, for whom the risk of complications is highest) to susceptible contacts. For contacts who remain unvaccinated, control activities include exclusion from day care, school, or work and voluntary home quarantine from 7 to 21 days following exposure. Persons who are known contacts of measles patients and who develop fever and/or rash should be considered suspected measles case-patients and be appropriately evaluated by a healthcare provider. If healthcare providers are aware of the need to assess a suspected measles case, they should schedule the patient at the end of the day after other patients have left the office and inform clinics or emergency rooms if they are referring a suspected measles patient for evaluation so that airborne infection control precautions can be implemented prior to their arrival.

     Healthcare providers should maintain vigilance for measles importations and have a high index of suspicion for measles in persons with a clinically compatible illness who have traveled abroad or who have been in contact with travelers. They should assess measles immunity in U.S. residents who travel abroad and vaccinate if necessary. Measles outbreaks are ongoing in Switzerland and Israel , and measles outbreaks are common throughout Europe . Measles is endemic in many countries, including popular travel destinations, such as Japan and India . Suspected measles cases should be reported immediately to the local health department, and serologic and virologic specimens (serum and throat or nasopharyngeal swabs) should be obtained for measles virus detection and genotyping. Laboratory testing should be conducted in the most expeditious manner possible.

     Preventing transmission in healthcare settings

     To prevent transmission of measles in healthcare settings, airborne infection control precautions (available at http://www.cdc.gov/ncidod/dhqp/gl_isolation.html) should be followed stringently. Suspected measles patients (i.e., persons with febrile rash illness) should be removed from emergency department and clinic waiting areas as soon as they are identified, placed in a private room with the door closed, and asked to wear a surgical mask, if tolerated. In hospital settings, patients with suspected measles should be placed immediately in an airborne infection (negative-pressure) isolation room if one is available and, if possible, should not be sent to other parts of the hospital for examination or testing purposes.

     All healthcare personnel should have documented evidence of measles immunity on file at their work location. Having high levels of measles immunity among healthcare personnel and such documentation on file minimizes the work needed in response to measles exposures, which cannot be anticipated. Recent measles exposures in hospital settings in three states necessitated verifying records of measles immunity for hundreds or thousands of hospital staff, drawing blood samples for serologic evidence of immunity when documentation was not on file at the work site, and vaccinating personnel without evidence of immunity.

     Recommendations for vaccination

     Measles is preventable by vaccination. MMR vaccine is routinely recommended for all children at 12–15 months of age, with a second dose recommended at age 4–6 years. Two doses of MMR vaccine are recommended for all school students and for the following groups of persons without evidence of measles immunity: students in post–high school educational facilities, healthcare personnel, and international travelers who are > 12 months of age. Other adults without evidence of measles immunity should routinely receive one dose of MMR vaccine. To prevent acquiring measles during travel, U.S. residents aged > 6 months traveling abroad should be vaccinated or have documentation of measles immunity before travel. Infants 6–11 months of age should receive one dose of monovalent measles vaccine (or MMR vaccine if monovalent vaccine is not available) prior to travel.

     During a measles outbreak, additional vaccine recommendations should be considered: 1) children > 12 months of age should receive their first dose of MMR vaccine as soon after their first birthday as possible and their second dose 4 weeks later, 2) healthcare facilities should strongly consider recommending one dose of MMR vaccine to unvaccinated healthcare personnel born before 1957 who do not have serologic evidence of immunity or physician documentation of measles disease, and 3) one dose of measles or MMR vaccine should be considered for infants > 6 months of age.

     Further information on measles and measles vaccine is available at state health departments' websites and at http://www.cdc.gov/vaccines/vpd-vac/measles/default.htm.

     Additional Sources of Information The Centers for Disease Control and Prevention maintains a website with many informative articles and references on measles and the MMR vaccine.  Several links are listed below.

 

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