Immunization PolicyFrequently Asked Questions (FAQ)IntroductionThis FAQ is concerned with immunization and vaccination policies of United States government and medical authorities. It is intended to give background information so that official policies and recommendations can be better understood.Where can I find information on vaccines? For a nice general (but dated) FAQ, see misc.kids FAQ on Childhood VaccinationsFor official information, see:
Are vaccines controversial? Yes. For an example of vaccine criticism, see the Money magazine article and the CDC response.Why did you write this FAQ? I was faced with some vaccination decisions regarding my own daughter. While I found it easy to find information on the risks and benefits of individual vaccines, I had a hard time getting the higher-level information on immunization policy contained in this FAQ. Once I assembled it, I thought others would want it also. I published a related article titled, Official Vaccine Policy Flawed in the Medical Sentinel, Volume 4, No. 3, May/June 1999.Are you a medical doctor? No. I have a Ph.D. in Mathematics. I do not have the expertise to evaluate the medical aspects of vaccines, but I can judge the mathematical models used to justify vaccine policies.Role of MedicineAre pediatricians the best source of vaccine information? No. Pediatricians usually do not know much more than what is printed on the drug company label.Are you saying I cannot trust my pediatrician? Your pediatrician is only following the law which requires school-children to get vaccines according to official schedules. If he were personally opposed to the vaccine, he would be unlikely to tell you.Aren't the schedules determined by pediatricians? No. The American Academy of Pediatrics (AAP) no longer has the lead role in vaccine policy, and in 1995 it and other physician organizations agreed to endorse schedules determined by federal authorities. The feds do get some advice from pediatricians on the ACIP, and the AAP usually sends a couple of non-voting observers, but that's all. (See ACIP questions, below.)(Note added July 1999) The AAP has just withdrawn its endorsement of the CDC/ACIP recommendation that all newborn babies get hepatitis B vaccinations at birth, citing potentially hazardous levels of mercury in the vaccine. Here is the AAP press release. In Sept. 1999, the manufacturer announced a mercury-free version of the vaccine, and the recommendation is being reinstated. The AAP recommendations have also differed slightly in the pace of the switch from OPV to IPV, as explained here. Don't pediatricians and other physicians take an oath to "first, do no harm"? For centuries, all physicians took the Hippocratic Oath (see here for several versions) However, when abortion by physicians was legalized, medical schools phased out the Oath, and U.S. physicians no longer take it. Many medical students take a watered-down oath instead.But don't all physicians have an ethical obligation to do what they personally believe is best for their patients? Some old-fashioned physicians think that way. A more modern statement is:A physician shall respect the law and recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient. AMA Principles of Medical Ethics Do I have a right to informed choice of medical treatment? Traditional medical ethics require that physicians give the patient "informed choice" regarding any medical procedure. Ultimately, it is the responsibility of the patient (or parent or guardian) to make any vaccine decision. See Principles and Guidelines for Informed Choice and Consent for a typical statement of medical ethics and patient rights in this matter.Role of LawAre vaccines required by law? In the United States, all states have laws requiring children to be vaccinated according to CDC schedules, although some states are not always current with the latest recommendations.Do states have to follow the CDC schedules? No, if they are willing to forfeit federal funds. The states have usually adopted the CDC schedules but the rash of recent questionable vaccine recommendations for diseases like chicken pox has caused uncertainty in some states as to whether they will conform. A recent JAMA editorial has urged the states to make an independent decision, because sometimes the CDC recommends a vaccine in order to trigger some federal funds to buy vaccines.How is the law enforced? Most schools and day-care centers require vaccine certificates as a condition for enrollment. Even colleges and graduate schools now require them.Do schools administer vaccines? More and more. But in their zeal to promote vaccination, schools may present incomplete and biased information, as in this example:To win parental support for school-based immunizations [for hepatitis B], the programs have de-emphasized sex and drugs as risk factors for the disease, instead highlighting activities parents may not think of as risky, like ear piercing and contact sports, said Beth Rowe-West, who was the hepatitis B coordinator in North Carolina when the program began two years ago. "We didn't want to have to battle people's moral philosophy over children's vaccinations and having parents tell us, 'My sixth-grader doesn't have sex,;" Ms. Rowe-West said. [Lining Up for Hepatitis Shots, NY Times, July 30, 1997.] Are there exceptions? All states have exemptions for medical and/or religious purposes. For example, a child who has been brain-damaged by a vaccine can apply for a waiver to skip the booster shot. Some religious sects which avoid the military draft, such as Jehovah's Witnesses, can usually also avoid vaccines.In California and some other states, there is an exemption for "personal beliefs" which can be religious or otherwise. As a result, just about any objection to a vaccination which is grounded in a sincere belief qualifies, and vaccines should not be regarded as mandatory. (Link to California law on vaccines. Information on laws in other states can be found here or .) A recent Wyoming Supreme Court decision upheld the parents' right to claim a religious exemption to hepatitis B vaccine, even though the Health Dept. concluded that the objection was of a non-religious nature. Are physicians and HMOs legally liable for their vaccine policies? If a pediatrician fails to administer an officially recommended vaccine, and the child gets a preventable disease, the pediatrician could be sued for malpractice. If the child is injured as a side effect from such a vaccine, no pediatrician will be sued. HMOs cannot be sued.Are drug companies legally liable for the safety and efficacy of their vaccine products? No. Vaccine manufacturers and others are sheltered from product liability lawsuits by a special 1986 act of Congress. (See the US Code 42 USC 300aa for details.) This act set up a fund to compensate those who can prove serious injury from vaccines. For payments to date and other information, see the National Vaccine Injury Compensation Program (VICP).Vaccine recommendationsWho decides on the official vaccine schedule? In the U.S., the Centers for Disease Control (CDC), an agency of the federal government. The schedule is based primarily on recommendations of the Advisory Committee on Immunization Practices (ACIP).What is the ACIP? The ACIP is a committee sponsored and managed by the CDC to recommend and document vaccine policy decisions. Here is its charter, ACIP Policies and Procedures (HTML, WordPerfect, MSWord, Text).The ACIP has apparently passed a new charter and put it online here. How is the ACIP chosen? Members of the ACIP are chosen by the CDC based on nominations from vaccine manufacturers and others. They are primarily vaccine researchers and enthusiasts. Many have financial ties to vaccine manufacturers.What is the purpose of the ACIP? The purpose of the ACIP is to increase use of vaccines, not to promote health. According to its charter:
The overall goals of the ACIP are to provide advice which will assist the Department and the Nation in reducing the incidence of vaccine preventable diseases and to increase the safe usage of vaccines and related biological products, including active and passive immunoprophylaxis. What's the difference? Won't increased vaccine usage promote health? Maybe, and maybe not. Increased usage of a vaccine might reduce the incidence of a vaccine-preventable disease, but still be a bad idea, because:
What is the purpose of the ACIP recommendations? No purpose is ever revealed. The recommendations discuss rationales, but not the objective of the recommendation. The objective, or purpose, of the immunization policy recommendation is not as obvious as it might appear. For example, is it optimizing individual or population health? Is it looking for what is best in an average, or worst-case, sense?Is the ACIP and CDC influenced by political and pragmatic aspects of implementing their recommendations? Yes. In the case of hepatitis B, high-risk groups (including IV drug abusers) do not voluntarily get vaccinated in high numbers, and it is politically infeasible to force them, so the ACIP recommends that all babies be vaccinated at birth. Hepatitis B is primarily a venereal disease, but is also common among IV drug abusers and others. "Infants are considered the easiest to immunize, said Dr. Walter Ornestein, directory of the National Immunization Program at the C.D.C." [Lining Up for Hepatitis Shots, NY Times, July 30, 1997.]Why is hepatitis B (HBV) vaccine given to all newborn babies? HBV vaccine for newborns has been controversial. If the mother has HBV, as is common in certain Asian communities, then a vaccine at birth can help prevent the baby from getting it.But why is it given to others at birth? Now that a mercury-free vaccine is available, it is being given to healthy newborn babies again. A recent JAMA exchange has clarified the reason for hepatitis B vaccination. A letter said: There is no scientific evidence to justify HBV vaccination before the age when those risk factors associated with the HBV transmission (sex, needles, etc) become relevant. Recent risk-benefit analyses show HBV vaccination among children carries one of the largest unjustified risks ...In response, the vaccine policy defenders gave these alleged benefits:
Does the ACIP do a cost/benefit analysis for each recommendation? No. Sometimes a manufacturer will present some risk/benefit information, but the ACIP does not weigh costs and benefits in any systematic way. For example, in Feb. 1998, the ACIP approved a recommendation for a rotavirus vaccine even though the vaccine was not yet on the market and the manufacturer had not yet set a price on it. Obviously, no cost/benefit analysis could have even included the price of the vaccine.Dr. Glode asked about the procedural issues. Should the Committee establish a standard that precludes recommendations without knowledge of vaccine costs? Dr. Orenstein argued that ACIP decisions are based on public health and that holding vaccines hostage to price is a mistake. Cost decisions are negotiated later; data are always incomplete, and costs change. Dr. Helms agreed that the Committee's job is to decide on what is best for children. The universality argument is compelling; a decision need not rest on cost. Dr. Guerra also felt strongly that the levels of morbidity and risk justify a recommendation regardless of cost. [ACIP meeting minutes, Feb. 1998](But see also the CDC gastroenteritis FAQ, which admits that "A statement on cost-benefit cannot be made without a price.") In July, 1999, the rotavirus vaccine was withdrawn from the market because of evidence that it causes intussusception (bowel obstruction). Aren't there models which quantify the costs and benefits in such a way that the overall cost can be compared to the overall benefit? Yes, but the ACIP and CDC do not use them. From the above quote, it appears that most of the ACIP members do not even believe they have an obligation to determine that the benefits outweigh the costs. Sometimes the ACIP makes statements about weighing risks and benefits, such as,"Infants known to be living in households with persons known or suspected to have an impaired immune status may be vaccinated. On the basis of the available data, the benefits of vaccinated infants in such households probably outweigh the potential risk of transmission of vaccine virus to immunocompromised persons." [ACIP meeting minutes, Feb. 1998]But never is any sort of mathematical model presented which indicates how such risks and benefits are weighed. Such a model is crucial because it clarifies the assumptions and analysis which leads to the conclusion. Otherwise, there is no clue as to how they compare an infant with diarrhea with an adult dying of AIDS. How is the ACIP supposed to make policy decisions? According to its charter, "Many of the issues addressed by the Committee are not technical but policy issues." For a policy analysis decision, it recommends a process that it outlines as follows.
How does the ACIP make policy decisions? Unknown. It publishes some information about its rationale in its official recommendations, but it does not include a policy analysis anything like what is outlined above.Does the ACIP consider alternative recommendations? Probably. But the published recommendations do not contain a discussion of all the advantages and disadvantages of the various alternative policies considered.Are vaccines safe and effective? According to the CDC, no vaccine is 100% safe or 100% effective. See CDC Vaccine Safety site or CDC Questions and Answers about Vaccine Safety.Are vaccines chosen in an open process? No. Some of the ACIP meetings which decide on vaccine recommendations are open to the public. The minutes of those meetings are public records, but are not on the web and the Freedom Of Information Act (FOIA) must be used to get the older minutes. (Contact Ms. Gloria Kovach, ACIP secretary, gak1@cdc.gov, 1-404-639-7250, or Dr. Dixie Snider, Office of the Director, CDC.) But there are also closed portions of meetings, and ACIP members are forbidden to discuss those sessions without CDC approval. Also, drug companies provide the ACIP with secret information which the ACIP uses to make its decisions but which the ACIP never reveals. According to the ACIP charter:The Department's Standards of conduct prohibit "speaking" on matters related to an ACIP member's official duties outside committee or working group meetings. Members may discuss the public meeting and their views, but should be careful not to disclose any proprietary information. Regarding closed portions of committee meetings, only the topic of discussion may be made public. Prior to discussing any matter, the member should consult with the Executive Secretary or a knowledgeable CDC staff member. Shouldn't we just trust experts to make technical medical decisions for us? We don't let generals decide whether we go to war. We don't let astronauts decide how much funding the space program gets. Some of the pitfalls of relying on vaccine experts are described in a NY Times article on a military anthrax vaccine.Do the vaccine officials have any incentive to mislead us? Vaccination is a multi-billion dollar industry. Drug companies, pediatricians, government officials, and researchers all profit from it, directly or indirectly. A salesman giving a pitch for aluminum siding or vacation timeshares might genuinely believe that he is giving the customer a good deal. Maybe it is a good deal, but maybe also it is something the customer does not want or need. Similarly, vaccines may have been oversold by vested interests.Do they have any monetary conflicts of interest? Yes. There are laws against it, but they are routinely waived. Vaccine officials sometimes change their positions after payments from vaccine makers, as explained in the Money magazine article.The US Congress (House Committee on Government Reform) recently held hearings on the subject, and discovered that those who voted for the rotavirus vaccine at the FDA and CDC had a financial stake in it. See the June 15, 2000 statements and staff report. Eg, ACIP member Paul Offit admitted under oath that he is actually a paid lobbyist in behalf of a vaccine manufacturer. Do they have any non-monetary ulterior motives? Many in the Clinton administration and elsewhere believed that the federal government should manage the health care industry, and that all Americans should carry national ID cards which link them to a national medical database. Portions of this plan were passed by Congress in the 1996 Health Insurance Portability and Accountability Act (also known as Kennedy-Kassebaum) which mandated a national ID number for tracking personal medical histories. The pilot project for this Orwellian scheme is the CDC Immunization Registry. The Clinton administration was lobbying to repeal state privacy laws so that government officials will have unfettered access to private medical records.Do the ACIP recommendations have any direct legal effect? The ACIP recommendations cause federal funds to be made available to buy vaccines under the Vaccines For Children program. Most states periodically revise their compulsory vaccination laws in order to synchronize them with the ACIP. A recent JAMA editorial suggests that the ACIP endorse as many vaccines as possible in order to maximize the federal subsidies, but that the states apply stricter standards and not mandate so many vaccines.Where can I get the ACIP recommendations? The ACIP recommendations are published by the CDC in the Morbidity and Mortality weekly report, and posted on the CDC site. (Search for "ACIP recommendation".) You can find pointers to them at immunofacts.com.Scientific basis for vaccinesHow do vaccines work? Vaccines contain mild doses of agents causing disease, or fragments of such agents. They are taken in the hope of triggering the body's immune system to making antibodies to the disease. The hope is that the antibodies will ward off a later exposure to the disease.Do vaccines always cause antibodies? No, but they do about 95% of the time, depending on the vaccine. Sometimes people get the disease they were vaccinated against.Are the antibodies harmful? No one knows for sure.Are vaccines scientifically tested? Manufacturers of new vaccines must conduct clinical trials testing safety and efficacy in order to gain FDA approval to market the vaccine. However, these are usually small scale, short term, and narrowly focussed, and so are only able to find adverse effects which are severe and common. Most vaccine knowledge is based on epidemiological studies. For example, no large-scale clinical trial was ever done for the safety of the hepatitis B on infants, just epidemiological research, according to the official recommendation.What is the difference between clinical trials and epidemiological studies? Clinical trials are the "double-blind" controlled studies which are the most scientific of the various medical tests. See Guide to scientific studies (or another copy) for a nice explanation of the difference between epidemiological research and clinical trials. Epidemiological studies are a lot less reliable.Is anyone killed or seriously injured by vaccines? Yes. There is a VAERS program for reporting vaccine injuries. See Surveillance for Adverse Events Following Vaccination (or the FDA link). Over $1 billion has been paid in damages under the VICP program. As a result of the Freedom Of Information Act, the database of injuries is now available online at FedBuzz.com.Does the CDC give a balanced picture of vaccine risks and benefits? No. The CDC gives a wealth of information, but also slants it to favor its vaccine policies. For example, it has a chart comparing "Risk from Disease" to "Risk from Vaccines", but gives no risk/benefit analysis for healthy children. The chart is misleading because it is not comparing any choice available to any real person. One can choose to vaccinate, and be faced with the risk from vaccines (and the risk of getting the disease in spite of the vaccine), or choose not to vaccinate, and be faced with the risk of getting the disease and being injured by the disease.For example, the chart says the risk from diphtheria is "Death: 1 in 20", but the risk from the vaccine varies from "1 in 100" for continuous crying to a much lower risk for brain damage. But it does not mention that the risk of getting diphtheria is virtually zero, because there are only a couple of cases a year in the U.S. As a result, the risk of being unvaccinated appears much worse than it really is. Are vaccines in the best interests of the child being vaccinated? Uncertain. The ACIP, CDC, and AAP conspicuously avoid addressing this question. In some cases, it is hard to see how it possibly could be. For example, Polio has been declared eradicated from the western hemisphere. The last case "in the wild" was in Peru in 1991. Yet, a live oral polio vaccine was still being recommended until June 1999, and some people still get polio from the vaccine. (See medical article on oral polio vaccine tradeoffs. See also this map. of progress towards the WHO goal of eliminating polio worldwide by the year 2000.) Measles has now also been declared exterminated from the indigenous US population, but the measles vaccine is still recommended.Is there a difference between what is good for the individual child and what is good for society at-large? Yes. Society may benefit by having a large proportion of the population immunized so that outbreaks of disease are unlikely, and yet an individual may not need to be immunized if most of the others are. This point, and some others, are nicely explained in a speech by a Stanford professor. For example, the risk of rubella (aka german or 3-day measles) is primarily that it might be transmitted to a pregnant woman and cause birth defects, because it is relatively harmless in children.But what if no one got vaccinated? Then we would see a return to some of the childhood diseases. With highly contagious diseases like measles, we only have herd immunity if at least 90% or so the population is immune. If no one were vaccinated, then most of the population would be exposed, once an epidemic started. There is little or no herd immunity for some other diseases like tetanus and pertussis, but incidence of these diseases would also go up if no one were vaccinated.Vaccination rates are at an all-time high and increasing, so there is no likelihood that everyone will suddenly stop using vaccines. Do vaccines cause autoimmune disease? Unknown. There is some theoretical and epidemiological evidence that they do, but there have been no scientific studies completed. For example, there has been an alarming increase in childhood asthma in the U.S. over past 25 years, coinciding with an increase in vaccination. Some officials believe that it is better not to raise the issue or study the matter, because people might be unduly alarmed. Here are some mainstream media articles on the subject:
Where can I get info about the pros and cons of individual vaccines? The following are reliable sources of information:
Last revised: July 19, 2002 Latest version: Immunization Policy FAQ home page This is a work in progress. If you have any comments, corrections, or additions, please send a message to the FAQ author.
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