This is the fourth COVID-19 vaccine to be cleared 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, Executive Director of the MHRA, said:
We have undertaken an in-depth review of the conditional marketing authorization application submitted by Janssen, including information on quality, safety and efficacy. I am pleased to confirm to you today that this authorization 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 stop there. We continuously monitor all COVID-19 vaccines used once they have been approved to ensure that the benefits of protecting people from disease continue to outweigh the risks.
Public safety will always be the priority – you can be absolutely sure of our commitment to this.
The MHRA has also obtained independent scientific advice from the Commission for Medicinal Products for Human Use (CHM) and its COVID-19 expert working group.
Professor Sir Munir Pirmohamed, Chairman of the Independent Commission for Human Medicines, said:
The Independent Commission for Medicinal Products for Human Use and its COVID-19 expert working group have carefully reviewed the MHRA’s assessment of Janssen’s application and are happy to say that we have given the vaccine a positive recommendation.
This is yet another victory for the immunization program, which has saved thousands of lives so far.
The National Institute for Biological Standards and Control, part of the Agency, conducts independent batch release on all approved COVID-19 vaccines to ensure that each batch meets expected quality standards, and the will do for the COVID-19 Janssen vaccine.
Who can get the COVID-19 Janssen vaccine
MHRA approval allows the vaccine to be used in people 18 years of age and older. The decision to use the vaccine in pregnant or breastfeeding women should be made in consultation with a healthcare practitioner after considering the benefits and risks. People who are allergic to any of the vaccine components listed in section 6.1 of the patient information leaflet should not be given the vaccine.
See the Summary of Product Characteristics and the Janssen COVID-19 Vaccine Patient Information Leaflet.
Notes to editor
- The Conditional Marketing Authorization (CMA) granted by the MHRA is only valid in Great Britain and has been approved by decision of the European Commission (EC). This is when the marketing authorization application submitted by the company refers to the decision taken by the Committee for Medicinal Products for Human Use (CHMP) of the EMA. The MHRA reviews this request, with due regard to the EC decision, before making an independent decision on the quality, safety and efficacy of the vaccine. The COVID-19 Janssen vaccine is authorized in Northern Ireland under the MAC granted by the European Medicines Agency on March 11. This CMA has similar requirements to those granted by the MHRA.
- The Medicines and Health Products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK. All work is supported by solid, factual judgments to ensure that the benefits justify the risks.
- The Medicines and Health Products Regulatory Agency (hereinafter the “Agency”) has three centers. The MHRA, the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The agency is an executive agency of the Ministry of Health and Social Affairs.
- The Commission for Medicines for Human Use (CHM) advises ministers and the MHRA on the safety, efficacy and quality of medicines. The CHM is a non-ministerial public advisory body sponsored by the Ministry of Health and Social Affairs.