Hepatitis B vaccines for babies
All babies in the UK get the hepatitis B vaccine. It has a well-established safety record and ensures long-term protection against the virus.
Dr Alison Cave, Chief Safety Officer at the MHRA, said:
“Patient safety is our top priority, which is why all vaccines authorised for use in the UK undergo rigorous assessment for safety, quality and effectiveness.
“The UK has been providing universal hepatitis B vaccination for all babies since August 2017. It has a well-established safety record and ensures long-term protection against the virus.
“All pregnant women in the UK are routinely tested for hepatitis B during the very early stages of pregnancy.
“Any babies born to mothers who are found to be infected with hepatitis B, who are considered to be at high-risk of contracting the virus, will be vaccinated within 24 hours of birth. All other babies will be routinely vaccinated from eight weeks of age.
“Extensive safety monitoring in the UK and internationally continues to show that the benefits of these vaccinations outweigh any risks.
“We continue to monitor the safety of all vaccines through robust surveillance, including the Yellow Card scheme, and encourage anyone to report any suspected side effects so that we can investigate them and act where necessary.”
Notes to Editors:
-
As with the Advisory Committee on Immunization Practices’ recommendation in the US, in the UK any babies born to mothers infected with hepatitis B - and therefore considered at high-risk of contracting the virus - are vaccinated within 24 hours of birth. All other babies are routinely vaccinated from eight weeks of age.
-
Childhood vaccination is recommended by the NHS, the World Health Organization, and public health authorities globally as the most effective way to protect children from serious infectious diseases.
-
Before approval, all vaccines undergo robust independent assessment by the MHRA to ensure they meet strict standards of safety, quality, and efficacy.
-
The UK childhood vaccination schedule is informed by evidence-based recommendations from the Joint Committee on Vaccination and Immunisation (JCVI) and supported by NHS clinical guidance.
-
Multiple large, well-conducted international studies, including national registry studies and sibling-controlled studies, have found no evidence that vaccines cause autism in children.
-
The MHRA conducts continuous safety surveillance through the Yellow Card scheme, analysis of large healthcare datasets, review of international safety data, and there is ongoing review by independent scientific experts.
-
Should new evidence indicate a change in vaccine safety, the MHRA will act promptly to update guidance and information for healthcare professionals and the public.
-
Parents and carers should continue to follow NHS vaccination guidance to protect children from preventable diseases such as measles, meningitis, and whooping cough. An MHRA Factsheet on vaccine safety is also available.
-
Members of the public and healthcare professionals are encouraged to report any suspected side effect from medicines and vaccines through the MHRA’s Yellow Card scheme.
-
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All work is underpinned by robust and fact-based judgements to ensure that benefits justify any risks.
-
The MHRA is an executive agency of the Department of Health and Social Care.
For media enquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.