Updated: February 12, 2009
The development of immunization schedules and recommendations is a complex process that includes the regulation of vaccine manufacturing and the review of data about vaccine safety and efficacy by medical and policy experts.
Here we answer some of the most common questions regarding indications, recommendations and laws for vaccine use.
Before a vaccine is licensed, the Food and Drug Administration (FDA) evaluates its safety and efficacy (how well it works). Once the vaccine has been licensed, the FDA establishes indications (uses), contraindications (when it shouldn’t be used) and precautions for the use of that vaccine.
As more information is learned, the FDA may require the manufacturer to revise these from time to time. Thus, the indications, contraindications and precautions are developed as a part of the regulatory process that leads to vaccine licensure and are dependent on how the vaccine was tested and the vaccine producer’s requested license application for the intended marketing of the vaccine.
Recommendations for vaccine use are made by a number of groups including the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), The American Academy of Family Physicians (AAFP) and others.
These groups consider the benefits and risks of the vaccine compared to the risks of disease to determine how the vaccine should be used to obtain the greatest benefit. As experience is gained with a particular vaccine or when there is more than one vaccine available, recommendations may need to be changed.
The CDC seeks advice about its recommendations from vaccine experts, regulatory authorities, manufacturers, consumers and others at public meetings of its Advisory Committee on Immunization Practices. The CDC recommendations are then published in the Morbidity and Mortality Weekly Reports that CDC publishes. These are available at www.cdc.gov/mmwr .
In addition to the CDC recommendations, many health professionals consult the Redbook Report of the Committee on Infectious Diseases of the AAP.
Information about vaccines, the diseases they prevent and recommendations for their use are available here at NNii (www.immunizationinfo.org) and also at www.cdc.gov/vaccines, www.aap.org and other sites. It is important for parents who are seeking information about vaccines and their use to recognize that many web sites have incorrect or misleading information. (See Evaluating Information on the Web about immunizations).
The Food and Drug Administration (FDA), through the Center for Biologics Evaluation and Research (CBER), regulates all aspects of the testing and licensure of vaccine products intended for humans. All products regulated by FDA, including vaccines, undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products.
Because the numbers of people who have received the vaccines during the pre-licensure phase may be relatively small (for example, 10,000), frequently the FDA may also require additional studies after licensure to further evaluate the vaccine as well as to address specific questions about the vaccine’s safety, effectiveness, or possible side effects.
CBER often consults with its Vaccines and Related Biologics Advisory Committee, a group of scientific advisors and consumer representatives who are selected by the Commissioner of the FDA and the Secretary of Health and Human Services. They also often include other consultants and representatives from other government agencies.
The law mandates strict guidelines regarding conflict of interest for all members of advisory committees. Industry representatives and the public may attend these meetings, except when proprietary information is to be discussed.
After a new vaccine is reviewed and licensed by the Food and Drug Administration (FDA), several committees of experts make recommendations to health care providers and public health programs for use of the vaccine in specified target groups (for example, in children, elderly people or travelers).
The committees of experts include: the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention, the Committee on Infectious Diseases (COID) of the American Academy of Pediatrics, and the American Academy of Family Physicians (AAFP). These committees independently assess the evidence to recommend when people should receive the vaccine, how many doses are needed, and how frequently the doses should be given.
For each vaccine, the expert committees evaluate a broad range of research data, including reports on the safety and efficacy of the vaccine, the vaccine’s indications, precautions and contraindications, and the severity of the disease that the vaccine will prevent.
They also develop strategies for how the vaccine could be most effectively used, estimate how new recommendations would impact other health care issues, including the immunization schedule.
If there will be more than one vaccine available for the same infection, they must consider the impact, and make recommendations about how to immunize if the child has been partially immunized with one manufacturer’s vaccine (or how to immunize an individual when it is unknown which vaccine was received first) when the immunizer has available only a different vaccine. They also consider cost effectiveness, particularly as it applies to the public health.
In addition to making recommendations on new vaccines, the committees of experts also review and update recommendations on existing vaccines. For example, the policies for vaccines frequently change along with changes in the threat of disease, the availability of new vaccines, and new information about the safety and effectiveness of the vaccine.
The recommendations are regularly reviewed, revised, and updated. Often the different organizations try to make similar recommendations so that healthcare providers and families don’t become confused. Descriptions of three of the committees are below:
Yes. However, sometimes practical issues make this more complex. For example, each manufacturer develops and manufactures vaccines by its own methods, according to FDA regulations.
FDA indications are specific to that vaccine. Often when more than a single manufacturer produces vaccine for prevention of specific disease (such as Hepatitis B or whooping cough), the various manufacturers’ vaccines have not been tested for their interchangeability. Thus the advisory groups must recommend how the healthcare provider should manage a child who has received a dose of vaccine but it is either a different brand or an unknown brand of vaccine.
Universal recommendation means that all persons in the recommended group should receive the vaccine, except for people who have medical conditions that prevent them from being immunized.
No; recommendations are not mandatory.
Committees of experts make recommendations on the use of vaccines in the United States, but it is the responsibility of the individual State to determine which vaccines should be required for school and daycare entry based on the public health needs of the State.
School immunization laws were first established to control outbreaks of smallpox and have subsequently been used to avoid epidemics of vaccine-preventable contagious diseases, such as measles, pertussis (whooping cough), and polio. Currently, all 50 states have school immunization laws— although there are differences in what may be required in different states.
States require vaccines because they have a responsibility to protect both individuals and the entire population of their state.
Vaccine requirements for day care and school entry help ensure that most people are protected through immunization. Because contagious diseases spread among susceptible people (those who have not been immunized and the small percentage of people for whom the vaccine was not fully effective), vaccination reduces the chance of infection and outbreaks of disease in schools and communities by reducing the number of unprotected people who may be infected and subsequently transmit the disease.
Interestingly, some other countries such as Canada and Mexico do not utilize mandates and have generally higher immunization rates than in the United States. However, in Canada there is universal health care coverage, including immunizations, and in Mexico very successful countrywide immunization weeks three times per year reach almost all of the children.
Parents should not solely rely on mandatory immunizations at school entry to protect their children because a number of the vaccines are critical for the younger child. Also, unless immunization laws are enforced vigorously it is not likely that sufficient numbers of children will be immunized to protect the community immunity.
It is difficult to give a yes or no answer to this question because the issues are so complex. It is up to each parent to decide whether to protect their child through immunization or take the chance that the child might develop a vaccine preventable disease.
However, that decision should be made after discussion with their healthcare provider. The State’s obligation is to understand the risks and perils facing their citizens and then to develop laws and regulations to best protect the public health.
In the United States, mandatory immunizations have proven to be an extremely effective means to limit a number of diseases, particularly diseases that are highly contagious with serious outcomes, such as measles, congenital rubella and diphtheria.
From a societal perspective, mandatory immunization for some diseases which are not communicable from person to person, such as tetanus, has been seen as important by most states as a means to protect children from this terrible, painful and frequently fatal illness.
Currently, 48 states allow religious exemptions to vaccination and 20 allow philosophical exemptions, in addition to the medical contraindications that are the same in all 50 States. Parents who choose to exempt their children either for religious or philosophical reasons need to be aware that their children are many times more likely to both acquire and spread vaccine preventable diseases.
High vaccine coverage rates today have almost eliminated diseases that used to kill thousands of people every year in the U.S. Before vaccines were introduced there were over 175,000 cases of diphtheria annually (1920-22), over 147,000 cases of Pertussis (1922-25), and over 503,000 cases of measles (1951-54). Very high vaccine coverage (>94%) is needed to prevent the spread of measles.
High vaccine coverage also seeks to protect those who cannot be vaccinated because of illnesses such as cancer. (See Community Immunity).
As of February, 2009, all 50 states allow vaccination exemptions for medical reasons; 48 states allow exemptions for religious reasons; and 20 states allow exemptions for philosophical reasons. (See Exemptions from Immunization Laws).