The Hepatitis B vaccine has been safety-tested as well as tested for efficacy by many expert scientists under the auspices of ACIP sub-committee on vaccines of American Academy of Pediatrics. It has been tested and approved for administration to infants as young as 2-3 days old, and at scheduled 2 and 4 month check-ups. Safety testing includes testing for adverse reactions like fever or rash or not feeling well, lack of transmission of blood-borne infections. Efficacy testing means the vaccine has been shown to prevent Hep B in exposed infants and toddlers after vaccination.
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Louise Sivak, Pediatrics, answered
Vaccines have been evolving since the late 1700s. Since that time, we have achieved eradication of some serious illnesses and dramatically reduced many others that used to cause severe, long-term complications and even death. The hepatitis B vaccine has been routinely recommended for all children and adults since 1991; since this, the number of new cases of hepatitis B has decreased by more than 95%. This being said, all vaccines have some small risks. The hepatitis B vaccine contains noninfectious material, which means it is impossible that your child will get hepatitis B from the vaccine. Children who should not get the vaccine include anyone who has had a life-threatening reaction to yeast, any other component of the vaccine, or a history of a reaction to a previous dose. There have been no medical studies that have proved any link between the vaccine and the risk of developing other illnesses later in life, including autism or multiple sclerosis.
Brigham and Women's Hospital answeredThe hepatitis B vaccine is very safe. The most common side effect is soreness in the thigh, where the shot is given. No serious illness has been related to the vaccine. Your pediatrician can answer other questions you may have about the importance of this vaccine.