Novavax COVID-19 vaccine Nuvaxovid approved by MHRA
The vaccine has been approved after meeting the required safety, quality and effectiveness standards.
Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA).
Nuvaxovid becomes the fifth COVID-19 vaccine authorised by the UK’s independent medicines regulator.
Health and Social Care Secretary Sajid Javid said:
It is great to see our world renowned medicines regulator approve another COVID-19 vaccine.
I want the UK to be the best place in the world to conduct clinical trials. It’s a testament to the country’s first-rate research and development capabilities for vaccines – with tens of thousands of people taking part in clinical trials here in the UK, contributing to the invaluable research that shows our vaccines are safe and effective.
The next step will be for the independent Joint Committee on Immunisation and Vaccination to consider its use as part of the UK COVID-19 vaccination programme
June Raine, MHRA Chief Executive, said:
Our approval of Nuvaxovid today follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines.
I am pleased to confirm today that this authorisation has been granted, providing access to a fifth vaccine that can be used to help protect us from COVID-19.
We are continuing our vital safety work in monitoring the use of all COVID-19 vaccines, to ensure that their benefits in protecting people against COVID-19 disease continue to outweigh any risks. We also carry out independent batch testing on all the approved COVID-19 vaccines to ensure that every batch meets the expected quality standards.
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 has carefully considered the available evidence on safety, quality and effectiveness. We are pleased to say that we have advised that the benefit risk balance of Nuvaxovid is positive.
Nuvaxovid is distinct from other COVID-19 vaccines currently in use in the UK as it uses recombinant protein-based technology which has been used for many years in the development of vaccines to prevent other illnesses, for example Hepatitis B. In reaching its decision, the MHRA considered the results of 2 large clinical trials involving nearly 50,000 participants.
Who can have this vaccine
The approval authorises the use of this vaccine in people aged 18 and over for a first and second dose. As with all vaccines. People with an allergy to one of the components of the vaccine listed in the patient information leaflet should not receive the vaccine.
Notes to Editor
- The Conditional Marketing Authorisation (CMA) granted by the MHRA is valid in Great Britain only. Nuvaxovid is authorised in Northern Ireland under an Emergency Use Authorisation granted by the European Medicines Agency on 20 December 2021.
- The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK. All work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- The Commission on Human Medicines (CHM) advises ministers and the MHRA on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
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