Hep B Vaccines for Infants: MHRA Reaffirms Strong Safety Record

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reaffirmed the strong safety profile of hepatitis B vaccines routinely given to all babies. These shots, part of the national program since August 2017, provide long-term protection against the virus, with high-risk newborns vaccinated within 24 hours of birth and others starting at eight weeks.

Chief Safety Officer Dr. Alison Cave emphasized that patient safety drives rigorous assessments of all authorized vaccines for quality, efficacy, and risks. Continuous surveillance via the Yellow Card scheme, large datasets, and international data confirms benefits outweigh any potential issues, with no evidence linking vaccines to autism from extensive studies.

Pregnant women undergo early hepatitis B testing, enabling prompt action for at-risk infants. The Joint Committee on Vaccination and Immunization (JCVI) and NHS recommend this schedule, aligned with WHO standards, to shield children from serious diseases. MHRA urges reporting suspected side effects through Yellow Card for ongoing vigilance

As an executive agency of the Department of Health and Social Care, MHRA ensures medicines meet strict standards and acts swiftly on new evidence.

Learn more: Hepatitis B vaccines for babies