What if a parent has concerns about a child receiving a hepatitis A vaccine, such as Havrix (inactivated hepatitis A vaccine) or Vaqta (inactivated hepatitis A vaccine)?

Addressing Parental Concerns About Hepatitis A Vaccination

Parents should be reassured that hepatitis A vaccines (Havrix and Vaqta) are extremely safe, highly effective, and recommended by the American Academy of Pediatrics for all children in the United States starting at 12 months of age. 1

Safety Profile of Hepatitis A Vaccines

The safety record of hepatitis A vaccines is excellent and should be emphasized when discussing with concerned parents:

• Extensive safety data: Since licensure in 1995, approximately 188 million doses of hepatitis A vaccine have been sold worldwide, including 50 million doses in the United States, with an outstanding safety profile 1

• Mild side effects only: The most common adverse events are mild and include:

  • Pain at the injection site (10-15% of recipients)
  • Redness and swelling at the injection site
  • Fever (less commonly)
  • Mild headache or rash 1

• No serious adverse events: In prelicensure clinical trials of both Havrix and Vaqta, no serious adverse events were definitively associated with either vaccine 1

• Post-licensure safety: A study of over 36,000 children who received the vaccine showed no serious adverse events 1

Effectiveness of the Vaccine

When discussing with parents, highlight the high effectiveness of the vaccine:

• The vaccine is highly immunogenic with >95% of recipients developing protective antibody within 4 weeks of receiving the first dose 2

• Clinical trials demonstrated 94-100% efficacy in preventing hepatitis A infection 1

• Protection begins as early as 2 weeks after the first dose, with reliable protection by 4 weeks 1

• Mathematical models predict that protective antibody levels will persist for more than 25 years after completing the recommended 2-dose series 1

Addressing Specific Parental Concerns

For parents concerned about vaccine ingredients:

• The vaccine is an inactivated (killed) virus vaccine, not a live vaccine 1
• The vaccine should not be administered only to children with a history of severe allergic reaction to a previous dose or to vaccine components such as aluminum hydroxide and phenoxyethanol 1

For parents concerned about medical conditions:

• Immunocompromising conditions are NOT a contraindication to receiving hepatitis A vaccine 1
• The vaccine is an inactivated virus preparation and has not been shown to result in any increased safety risks for people with primary or secondary immunodeficiencies 1

For parents concerned about pregnancy:

• While data on administration during pregnancy is limited, the theoretical risk to a developing fetus is extremely low to nonexistent since it is an inactivated vaccine 1

Importance of Hepatitis A Vaccination

Explain to parents why vaccination is important:

• Hepatitis A is a vaccine-preventable disease of the liver 3
• Before vaccine availability, approximately 30,000 symptomatic cases were reported annually in the US, with actual numbers estimated at nearly 300,000 per year 1
• The vaccine has dramatically reduced hepatitis A rates in the US to the lowest ever reported 1
• The vaccine has eliminated regional, ethnic, and racial differences in hepatitis A incidence 1

Vaccine Schedule and Administration

• The vaccine is given as a 2-dose series:

  • First dose at 12-23 months of age
  • Second dose 6-12 months later for Havrix or 6-18 months later for Vaqta 1, 4

• The vaccine can be safely co-administered with other childhood vaccines without decreasing immunogenicity 1

Conclusion

When addressing parental concerns about hepatitis A vaccination, provide clear information about the vaccine's excellent safety profile, high effectiveness, and the importance of protection against hepatitis A. Emphasize that the American Academy of Pediatrics recommends this vaccine for all children in the United States as part of the routine childhood immunization schedule.