UK approves Janssen COVID-19 Vaccine

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Janssen COVID-19 Vaccine conditional marketing authorisation (CMA). The approval allows the single-dose vaccine to be used in Great Britain for protection against COVID-19 in people aged 18 years and older.

Dr June Raine, MHRA Chief Executive, commented: “We have undertaken a thorough review of the conditional marketing authorisation application submitted by Janssen, including the information on quality, safety and effectiveness. I am pleased to confirm today that this authorisation has been granted. This is encouraging news for the public and the healthcare sector. We now have four safe and effective vaccines approved to help protect us from COVID-19.

“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 safety of the public will always come first – you can be absolutely sure of our commitment to this.”

In making the decision the MHRA also obtained independent scientific advice from the Commission on Human Medicines (CHM) and its COVID-19 Expert Working Group.

Professor Sir Munir Pirmohamed, Chair of the independent Commission on Human Medicines, said: “The independent Commission on Human Medicines 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. This is yet another win for the vaccination programme, which has saved thousands of lives so far.”

The National Institute for Biological Standards and Control, part of the Agency, is carrying out independent batch release on all of the approved COVID-19 vaccines to ensure that every batch meets the expected quality standards and will do so for the Janssen COVID-19 Vaccine.

The Janssen COVID-19 Vaccine was approved for emergency use by the US Food and Drug Administration and the European Commission in March 2021.