H1N1 vaccination of children can require reasoning with concerned parents

Scenario: How can you get the message out about the safety and efficacy of the novel flu vaccine?

Mrs. Jones arrives at your office with her 3-year-old daughter and 9-month-old son for the children's routine health maintenance visits. As she waits, Mrs. Jones scans your practice's monthly newsletter and its lead article on the influenza A(H1N1) virus. She notes that the Centers for Disease Control and Prevention and your practice recommend immunization for all children older than 6 months. When you step into the room, she immediately voices her concerns about yet another vaccine, especially one that has had so little time to be tested. She asks whether the new vaccine contains "the preservative with mercury in it," alluding to the ongoing public worry about mercury and autism.

Reply:

When the H1N1 virus, which has achieved pandemic status, emerged last spring, it frightened U.S. and World Health Organization authorities because of its rapid spread, its puzzling association with high morbidity and mortality in typically healthy populations (young adults, especially pregnant women), and the concern that, like the 1918 influenza virus, it could return in the fall with even greater virulence.

World authorities mobilized to arrange rapid manufacture and testing of a vaccine in the hope of preventing a public health disaster. The Centers for Disease Control and Prevention has issued priority immunization recommendations and arranged for distribution of vaccine through state and major metropolitan public health departments. According to the CDC, pregnant women, children -- especially those with chronic illnesses -- and health care workers should receive the first available doses of the vaccine.

Manufacturers have produced two forms of the vaccine, just as they have done with seasonal influenza vaccine: an injectable form made of killed virus components and an intranasal spray made of attenuated live virus. The injectable agent, in turn, comes in multidose vials and single-dose ampules. The multidose vials do contain the preservative thimerosal to prevent bacterial growth from accidental contamination. The single-dose ampules do not have thimerosal, nor does the nasal spray live-virus vaccine. The amount of ethyl mercury delivered in the thimerosal from one or two doses of the vaccine is well below that considered possibly harmful by toxicology experts. Moreover, none of the many studies with hundreds of thousands of vaccine recipients examining a possible link between thimerosal-containing vaccine and the apparently rising incidence of autism has shown any statistical correlation between vaccine receipt and risk of a subsequent diagnosis of autism in immunized children.

The H1N1 vaccine available in the U.S. has been produced in the same manner as the seasonal influenza vaccines. Therefore, we have the excellent safety record of many years of influenza immunization to point to as grounds for confidence in the H1N1 vaccine. Because chicken embryos are used as part of the vaccine manufacturing process, people with known allergy to chicken eggs do have an increased risk for hypersensitivity reactions. (See correction)

Many people have raised concerns about a repeat of the incidence of Guillain-Barré syndrome and other polyneuropathies that were reported in association with the 1976 "swine flu" immunization campaign.

Several factors provide confidence that the H1N1 vaccine will not have that effect: The H1N1 virus differs from the 1976 virus. In retrospect, while it seems possible that the 1976 vaccination did produce a small increase in the incidence of Guillain-Barré syndrome, the lack of good epidemiologic data about the occurrence of that disorder in the population and the low incidence of any adverse reaction (perhaps one in a million doses of the vaccine) make it impossible to draw a conclusive link between the vaccine and the neurological disorder.

No evidence links the seasonal vaccine, produced for some time in the same way as the H1N1 vaccine, with Guillain-Barré syndrome. While the H1N1 antigens could, in theory, produce Guillain-Barré-like reactions, there has been no apparent rise in the incidence of Guillain-Barré observed with natural infection by H1N1.

Physicians confronted with resistance or questions about the use of the H1N1 vaccine for children should:

• Begin by acknowledging the seriousness of the parent's concern and the difficulty of sorting through media exaggeration of hazards and opponents' strident, though often professionally produced materials.
• Review our obligations to protect children -- and others -- who cannot make medical decisions for themselves and remind parents that younger-than-usual individuals were vulnerable during last spring's outbreak.
• Review the excellent safety record of the recently produced seasonal influenza vaccine.
• Address the worry about thimerosal. For many, this concern goes beyond scientific rationality, and the inability to prove a negative (i.e., to demonstrate conclusively that mercury has not contributed to autism) will continue to inflame parental anxiety. For practices and physicians who can obtain single-dose ampules or the nasal spray form of the vaccine, providing those options to avoid thimerosal-containing immunization may overcome fears.
• Present the ethical argument for vaccinating children based on public health considerations, over and above parents' duty to protect their own offspring. In recent years, epidemiologists and infectious disease experts have come to see children, especially young ones in child care settings, as a community reservoir of influenza virus that tends to perpetuate outbreaks. These children, with little or no natural immunity and limited immunity from the few influenza antigens they may have received in prior vaccines, become infected with influenza easily. Their own behavior, such as lack of attention to hand washing or prevention of droplet spread when coughing or sneezing, and the difficulties of maintaining careful attention to hygiene by workers in early childhood facilities, contribute to rapid spread of virus among peers, child care center workers and back to the families of the children. High vaccination rates among young children may mean significant reduction in the impact of influenza on a community.
• Mention the effects on the family of having a sick child. Parents may respond to reminders about how their children's influenza, even if clinically mild, can disrupt the family routine. In most settings, children with flu-like illnesses must remain at home, perhaps up to seven days after resolution of fever or cough. For many families, such a situation means loss of parental work time as the mother or father needs to stay home with the child, with loss of income or other serious employment consequences. The H1N1 vaccine may help parents avoid such problems with work or at least shorten the lost work time.
• Emphasize that timing matters. Some families may want more time to think about H1N1 vaccine before initiating the process. In response, it seems fair and important to point out that many children will need two doses of vaccine, separated by a month. And since the H1N1 season already has begun in the U.S., delay may mean failure to protect the child. We also do not yet know if the U.S. will have enough vaccine to immunize everyone categorized as high risk. Delay in administration may mean having to forgo one or both administrations of the vaccine, preventing protection of the child.

In the end, absent a declared public health emergency and officials' invocation of mandatory vaccination under existing laws, parents have the legal authority to refuse H1N1 vaccination of their children. Acknowledging and accepting parents' right not to vaccinate their children will go further toward building trust between the physician and the parents than threatening to exclude the family from the practice, and it may make attempts at education and immunization promotion easier in the future. Medical practices also may want to provide families with references to responsible and scientifically valid information about the H1N1 immunization program and other vaccines such as that available via Web sites of the CDC and the American Academy of Pediatrics.

--Joel Frader, MD, professor, pediatrics and medical humanities and bioethics, Northwestern University Feinberg School of Medicine; chief, Division of General Academic Pediatrics at Children's Memorial Hospital, Chicago

Ethics Forum discusses questions on ethics and professionalism in medical practice. Readers are encouraged to submit questions and comments to philip.perry@ama-assn.org or to Ethics Group, AMA, 515 N. State Street, Chicago, IL 60654; fax 312-464-4613. Opinions in Ethics Forum reflect the view of the author and do not constitute official policy of the AMA.

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