12/8/99

Jane M. Orient, M.D.
Executive Director
Association of American Physicians and Surgeons, Inc.
1601 N. Tucson Boulevard, Suite 9
Tucson, Arizona 85716-3450

Dear Dr. Orient:

I am responding to your lefter to Health and Human Services Secretary, Donna E. Shalala, regarding the Association of American Physicians and Surgeons' concerns regarding Federal and State vaccination policies and vaccine safety. I apologize for the delay in responding.

Enclosed are specific responses to the issues addressed in your letter.

Please be assured that the Centers for Disease Control and Prevention is collaborating with a wide range of organizations to ensure the safety and effectiveness of all vaccines so that disease can be prevented with the least possible risk. We appreciate your interest in this important public health issue, and hope this information is helpful.

Sincerely,


Centers for Disease Control and Prevention
Comments to Issues Raised by
the Association of American Physicians and Surgeons, Inc.
Regarding Vaccines

December 1999

Issue 1

The Association of American Physicians is deeply concerned that federal vaccine policy results in the violation of informed consent, and is based on incomplete studies of efficacy and potential adverse effects of the vaccines.

Response 1

The National Childhood Vaccine Injury Act (42 USC 300aa-26) requires that all health professionals who administer vaccines discuss the known benefits and risks with parents and guardians of children receiving the vaccine and provide parents and guardians with the Vaccine Information Statement (VIS) prepared by the Centers for Disease Control and Prevention (CDC). This statement includes information about the vaccine, the disease it is preventing, the contraindications to vaccination, and adverse events that have been documented to be associated with the vaccine. As new scientific information is accumulated regarding a vaccine, the VIS may be changed and there is a public comment period for each new or revised VIS. The specific requirements for informed consent are determined by State law. We are aware that the VIS is not always provided, as required, and we are working with professional medical societies such as the American Academy of Pediatrics to improve compliance and to assure that all parents are appropriately informed about the benefits and risks of vaccination.

Although extensive studies involving thousands of persons are required to demonstrate both safety and effectiveness of a vaccine before it is licensed, research and monitoring are subsequently necessary to identify very rare safety issues, which may only arise or be detected following vaccination of millions of persons. These rare side effects may not come to light before licensure or, if noted, the evidence may not be adequate to prove that a reported health event in preclinical trials is due to the vaccine. This surveillance and targeted research extends to all reported adverse reactions potentially due to vaccination, regardless of the length of time that has elapsed from administration of the vaccine. At present, there are multiple studies underway to address questions raised about the safety of various vaccines.

Issue 2

If children do not receive all the mandated vaccines, because of their beliefs or individual medical circumstances, they may be deprived of their liberty to associate with others or of their supposed "right" to a public education. Parents may give "consent" to the vaccine under duress, such as the threat of having their children taken from them.

Response 2

Control of infectious diseases by a State within its borders is a constitutional right of sovereignty. The Federal government does not promulgate school entry laws; such laws are passed under the States' authority. The Federal government does, however, recommend vaccines based on advice received from the Advisory Committee on Immunization Practices (ACIP). The Federal government may also recommend strategies that States can use to increase vaccination rates to achieve disease prevention goals.

All States have exemptions to vaccination for medical conditions that are known to increase the risk of an adverse reaction; 48 States have exemptions for religious beliefs and 15 States have exemptions for philosophical beliefs. CDC is not aware of any "threats" made to parents who do not consent to having their children immunized.

High rates of vaccination coverage have several advantages to families and society. First, vaccination protects children against a range of serious and, sometimes, fatal diseases. Secondly, in communities where vaccination coverage is high, there is decreased transmission agents that cause disease resulting in "community immunity," which protects even those children who are not vaccinated or who cannot be vaccinated because of medical contraindications.

Issue 3

Many questions have been raised about the use of hepatitis B vaccine in groups at low risk for the disease....

Response 3

Several studies have documented high rates of early childhood hepatitis B virus transmission among children born in the United States to mothers who are not infected. Before hepatitis B vaccine was given universally to infants, each year there were approximately 33,000 infants and children infected who were not exposed to hepatitis B virus-infected mothers. Other than for infants born to hepatitis B virus-infected pregnant women who are tested prior to delivery, which does not always happen, there is no way to identify and selectively vaccinate most of those children who will acquire hepatitis B virus infection in early childhood. More than 90 percent of young children who become infected with hepatitis B virus are asymptomatic and, therefore, would not be reported. Hepatitis B virus-infected children are at greatest risk of chronic infection, and they contribute disproportionately to the number of adults with chronic hepatitis B, cirrhosis, and liver cancer. CDC has estimated that one-third of the chronic hepatitis B virus infections in the United States come from such infected infants and young children. If childhood infections are not prevented, especially the early childhood infections, hepatitis B liver disease in the United States cannot be effectively controlled.

Reported cases of possible adverse events related to vaccines are tracked by CDC and the Food and Drug Administration (FDA) through the Vaccine Adverse Event Reporting System (VAERS). The VAERS system is unique in that there is no other drug monitoring system on the market as extensive as VAERS. This system provides "signals" for further investigation and research; however, VAERS numbers are not reflective of actual side effects associated with vaccines and cannot be used in this way. The numbers quoted in the constituent's correspondence are misleading in that VAERS accepts ALL reports, regardless of whether the report is causally related to receipt of a vaccine or a chance occurrence unrelated to the vaccine. VAERS data are available to the public and are often misinterpreted. The vast majority of deaths reported to VAERS and investigated by FDA are found to be related to other health conditions unrelated to vaccination. To date, anaphylaxis is the only serious adverse event for which scientific data indicate a causal relationship with hepatitis B vaccine, and no deaths from anaphylaxis have been reported in the United States.

In addition to VAERS, CDC's Vaccine Safety Data-Link Project provides the ability to conduct carefully controlled studies of potential vaccine-adverse events among persons enrolled in certain managed care plans. For example, this system was used to determine that no association exists between rubella vaccination and arthritis. Similarly, ongoing studies are analyzing whether an association exists between hepatitis B vaccination and SIDS, multiple sclerosis, or diabetes mellitus.

Issue 4

There is also increasing concern about the safety and efficacy of the vaccines so mandated. The rotavirus vaccine is a case in point

Response 4

The Federal government is very concerned that the vaccine program be as safe as possible so that disease can be prevented with the least possible risk. Changes in the vaccination schedule such as the transition to inactivated polio virus vaccine and to acellular pertussis vaccine demonstrate that commitment to the safest program, even at increased costs. At its October 1999 meeting, the ACIP recommended that Rotashield, the only U.S.-licensed rotavirns vaccine, no longer be recommended for infants in the United States. This action is based on the results of an expedited review of scientific data presented to the ACIP by CDC in cooperation with FDA, the National Institutes of Heath, and Public Health Service officials, along with Wyeth-Lederle. Use of the vaccine was suspended in July pending the data review by the ACIP.