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Two-dose Novavax Covid vaccine approved for use in UK

Two-dose Novavax Covid vaccine approved for use in UK


UK regulators have approved the Novavax Covid vaccine after a series of delays to the approval process.

The vaccine developed in the US and also known as Nuvaxovid is the fifth to be approved in the UK and is licensed as a two-dose schedule for over-18s.

It follows approval by European regulators in December. The vaccine differs from those currently in use in the UK in that it is based on recombinant protein-based technology, similar to that already in use in hepatitis B and other vaccines.

The Medicines and Healthcare products Regulatory Agency (MHRA) said it based its decision on data from two large clinical trials of almost 50,000 people, one of which was done in the UK and found an effectiveness of around 90%.

It has previously been announced that around 60 million doses of Novavax have been ordered by the UK Government with expected delivery in 2022.

In September, Novavax began early clinical trials of a combined Covid and flu vaccine in Australia.

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.

She added: ‘We also carry out independent batch testing on all the approved Covid-19 vaccines to ensure that every batch meets the expected quality standards.’

Health and social care secretary Sajid Javid said the vaccine approval was testament to the ‘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’.

He added that the Joint Committee on Immunisation and Vaccination would now consider its use as part of the UK vaccination programme.

Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, said they had 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.’

A version of this story was originally published on Nursing in Practice’s sister title Pulse.

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