Last reviewed 2 June 2021
The one-dose Janssen Covid-19 vaccine has been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in Great Britain.
It was already authorised for use in Northern Ireland under a Conditional Marketing Authorisation (CMA) granted by the European Medicines Agency.
This is the fourth Covid-19 vaccine to be authorised by the UK’s independent regulator and is the first to be approved for protection against Covid-19 with a single dose.
Dr June Raine, MHRA Chief Executive, said: “Our work does not end here. We are continually monitoring all Covid-19 vaccines in use once they have been approved to ensure that the benefits in protecting people against the disease continue to outweigh any risks.”
The MHRA also obtained independent scientific advice from the Commission on Human Medicines (CHM).
CHM Chairman, Professor Sir Munir Pirmohamed, said: “The independent CHM and its Covid-19 Expert Working Group have carefully considered the MHRA’s evaluation of the application submitted by Janssen and are pleased to say that we have given the vaccine a positive recommendation.”
The MHRA approval authorises the use of the vaccine in people aged 18 and over with the proviso that use for pregnant or breast-feeding women should be made in consultation with a healthcare professional after considering the benefits and risks.
People who have an allergy to one of the components of the vaccine listed in s.6.1 of the Janssen Patient Information Leaflet (available at GOV.UK) should not receive the vaccine.