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Health & Fitness Ministers were urged to withhold vaccine trial data from the EU

02:25  19 september  2021
02:25  19 september  2021 Source:   dailymail.co.uk

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One of England's deputy chief medical officers proposed withholding information from the EU in the face of travel restrictions on jabbed UK trial volunteers.

Professor Jonathan Van-Tam sensationally told how he had suggested to the Government that the UK withhold clinical trial data if vaccine trial participants were not being allowed into European countries.

Almost 20,000 Brits have been effectively banned from travelling to Europe for work, holidays or to see friends and family as they took part in trials for Novavax and Valneva jabs - which were not recognised by UK medicine regulators.

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Those who 'selflessly volunteered' to take part in a UK trial for the Novavax vaccine are 'significantly disadvantaged' when it comes to travel because they have not had an approved jab, an online petition to the Health Secretary has stated.

The Observer reported that Prof Van-Tam had discussed the issue with trial participant Ffyona Dawber at an event on September 1.

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The paper said that she recalled: 'As soon as I said, "I'm on the Novavax trial", he put his head in his hands and went, "Oh God, that's a disaster".'

She added: 'I said, "I realise you can't influence international borders", and he said "no, no, no" - he said that he had proposed to the Government that the UK withhold all future clinical trial data from the EU if the EU did not let our clinical trials subjects who'd been vaccinated into their countries.'

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He said the proposal had been refused, she added.

In June, Professor Van-Tam wrote an open letter to trial volunteers in which he promised they would 'not be disadvantaged as global travel resumes'.

Phase III clinical trial data from Novavax released earlier this year showed its vaccine had an overall efficacy of 90.4% at preventing people from contracting COVID-19 across 113 sites in the U.S. and six in Mexico.

Of nearly 30,000 participants, just 14 people given the two-dose vaccine caught the virus compared to 53 people who received placebos.

But those who have received two jabs are not permitted to get any other jabs, despite Novavax not being an NHS-approved vaccine.

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The Government has not disputed the reported conversation between Van-Tam and Ms Dawber.

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A spokesperson said trial volunteers should not be disadvantaged when it comes to vaccine certification policies, and indicated that as part of efforts to address the issue, guidance could be reviewed to see if people can get other jabs while still involved in trials for unapproved vaccines.

The Government spokesperson said: 'Clinical trials of Covid-19 vaccinations have played an instrumental role in getting us to the point where we have safe, approved vaccines and they are providing critical data to help us respond to this pandemic.

'We are clear that volunteers in formally approved Covid-19 vaccine trials in the UK should not be disadvantaged in relation to vaccine certification policies, and we are committed to taking action on this issue, including reviewing guidance on additional vaccination for this group.'

The European Medicines Agency began a rolling review of the Novavax vaccine in February and, last month, the company said it is working to complete its rolling submission to the regulator in the third quarter of this year.

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