Sunday 10 October 2021

Up to 20,000 Brits given unapproved Covid vaccines made by Valneva and Novavax will get two doses of Pfizer or Moderna so they can finally go on holiday

 Britons who took part in Covid vaccine trials for jabs that are not internationally recognised will be offered doses of Pfizer or Moderna so they can finally travel. 

The UK Government announced today that more than 20,000 participants in the Novavax and Valneva studies will start to be invited for the jabs from next week.

They will be given two doses of the mRNA vaccines over the standard eight-week period, which should allow them to travel in time for Christmas.

Health officials had originally pushed for the trialists to be able to go abroad without needing to be revaccinated 'because of the sacrifice they made'.

But the plans were met with resistance by EU countries which refused to recognise Novavax and Valneva, both of which are still waiting on approval from regulators.

There is no specific safety data on giving people four doses of Covid vaccines but officials are confident it is safe based on booster trials which looked at three doses. 

About 15,000 Novavax and 4,000 Valneva trialists have been unable to fly to Europe, the US or elsewhere for holiday or business despite global travel resuming months ago.

Pfizer and Moderna’s vaccines will be offered to Britons who took part in Covid jab trials for shots that are not internationally recognised so they can finally travel (file)

Pfizer and Moderna's vaccines will be offered to Britons who took part in Covid jab trials for shots that are not internationally recognised so they can finally travel (file)

Children take part in vaccine study as Pfizer seeks FDA approval
Loaded: 0%
Progress: 0%
Current Time0:00
Duration Time2:24
Need Text

Trialists will be faced with the choice of going through with four vaccine doses or waiting to see if their original jabs get approval from the UK medicines watchdog.

Those who wait will be recognised for domestic vaccine passports if that policy is introduced in England as part of the Government's winter Covid contingency plan.

Professor Jonathan Van-Tam, England's deputy chief medical officer, said: 'The measures we have taken will allow UK Covid vaccine trial participants to travel freely overseas once they have had the additional vaccinations.

'Those volunteers now have the flexibility to make a decision for themselves so they can, for example, visit loved ones abroad.

'We should be very clear that the results from these trials benefit the whole world, and it has to be said that if more countries around the world had reciprocated by allowing UK volunteers to enjoy fully vaccinated status for overseas travel, these measures would not have been necessary.'

The move follows Health Secretary Sajid Javid's appeal to global health leaders last month at the G20 meeting for trialists to have their vaccination status recognised globally.

Letters will be sent out to clinical trial participants next week, outlining further details and next steps.

Participants will be contacted by the trial team, who can respond to any questions they may have, and should not contact their local NHS or GP.

Vaccinations will most likely take place at hospital hubs.

Principle Investigator of the Novavax clinical trial Professor Paul Heath said: 'I very much welcome this development on behalf of the more than 15,000 participants in the Novavax trial and my colleagues in the 35 UK trial sites.

'For too long the participants have been disadvantaged in terms of international travel because this vaccine is not yet approved for deployment.

'But trial participants now have the flexibility to receive booster doses, or additional doses for travel purposes, if they wish to.'

Phase III clinical trial data from Novavax released earlier this year showed its vaccine had an overall efficacy of 90.4 per cent at preventing severe disease. 

The firm has delayed its submission of trial data to the UK medical regulator, with reports suggesting issues with collating consistent manufacturing information. 

Novavax still plans to submit the full data to the Medicines and Healthcare Regulatory Authority (MHRA) before the year is out. 

Meanwhile, the UK scrapped its deal with French vaccine maker Valneva for 100million doses last month.

The UK Government cited a breach of contact agreement, an allegation the drugmaker denies, but it is still unclear why the deal fell out. 

Results from its phase three trials are due later this year.

There are around 52,000 people currently taking part in trials across the UK for other experimental vaccines.

They will not qualify for the standard two-dose Pfizer or Moderna schedule until those studies come to an end - unless the trial vaccines get approved.

They include studies of GlaxoSmithKline and Sanofi's vaccine and the CureVac mRNA jab.

Post a Comment

Start typing and press Enter to search