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MHRA approves Novavax Covid jab for 12-17-year-olds

MHRA approves Novavax Covid jab for 12-17-year-olds

The Novavax Covid-19 vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in 12-17-year-olds.

Nuvaxovid, the Covid-19 vaccine developed by US biotech company Novavax, was approved by the MHRA for those aged 18 and over in February following a series of delays and was tipped to ‘replace’ Pfizer and Moderna this coming winter due to its lower cost.

However, patients are set to receive Moderna’s new Omicron booster jab under NHS England plans for the autumn booster programme launching next month.

The MHRA today announced that it has concluded that the vaccine is also ‘safe and effective’ in 12-17s.

MHRA chief executive Dr June Raine said: ‘Following our review of the safety, quality and effectiveness of Nuvaxovid in 12- to 17-year-olds, I am pleased to confirm that the vaccine has now been authorised in this age group. 

‘In reaching this decision, we have taken advice from the Government’s independent scientific advisory body, the Commission on Human Medicines.’

JCVI advice states that Novavax can be used off-label as a Covid booster dose for over-18s ‘in exceptional circumstances’, when no alternative clinically suitable UK-approved Covid-19 vaccine is available.

But the Government stressed last week that getting a booster in good time before the winter season is more important for those eligible than the type of vaccine that is received.

It was previously announced that around 60 million doses of the Novavax Covid vaccine were ordered by the UK Government, with delivery expected this year.

Novavax sought regulatory approval back in March 2021, after the vaccine was found to be ‘100% effective’ against severe Covid.

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

Meanwhile, GP leaders have warned they have ‘serious concerns’ about the financial and workload implications of the upcoming autumn booster programme.

GPs have been told to start delivering the autumn Covid booster campaign from 5 September, with patients set to receive Moderna’s new Omicron booster jab.

Covid booster vaccines will be extended to people aged 50 and over from September alongside other at-risk groups, following a final recommendation from the JCVI last month.


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Patrufini Duffy 26 August, 2022 3:23 pm

Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland. Yes, “independent scientific advisory body”.