Up to 20,000 Britons who received unapproved Covid vaccines from Valneva and Novavax will receive two doses of Pfizer or Moderna so they can finally go on holiday
- Get two doses of the mRNA vaccines over a standard eight week period
- More than 20,000 British trialists were barred from leaving the country
- Most trialists participated in the study of Novavax (15,000) and Valneva (4,000) jabs
Britons who have participated in Covid vaccine trials for shots not recognized internationally 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 trials will be invited to the shots from next week.
They will receive two doses of the mRNA vaccines over the standard eight-week period, which will allow them to travel in time for Christmas.
Health officials had initially insisted that the subjects could go abroad without having to be revaccinated “because of the sacrifice they made.”
But the plans met resistance from EU countries that refused to recognize Novavax and Valneva, both of which are still awaiting regulatory approval.
There is no specific safety data on giving people four doses of Covid vaccines, but officials are confident it is safe based on booster studies looking at three doses.
About 15,000 Novavax and 4,000 Valneva subjects have been unable to fly to Europe, the US or elsewhere for vacation or business, despite resuming global travel months ago.
Pfizer and Moderna vaccines will be offered to Britons who have taken part in Covid shot shots not internationally recognized so they can finally travel (file)
Trialists will be faced with the choice of going ahead with four doses of vaccine or waiting to see if their original shots get approval from the UK’s drug watchdog.
Those waiting will be recognized for domestic vaccine passports if those policies are introduced in England as part of the government’s winter emergency plan for Covid.
Professor Jonathan Van-Tam, England’s deputy medical officer, said: “The measures we have taken will allow participants in the UK’s Covid vaccine trial to travel abroad freely once they have had the additional vaccinations.
‘These volunteers now have the flexibility to make their own decisions, so that they can visit relatives abroad, for example.
“We must be very clear that the results of these trials will benefit the whole world, and it must be said that if more countries around the world had responded by allowing British volunteers to be fully vaccinated before traveling to the abroad, these measures would not have been necessary.’
The move follows Health Minister Sajid Javid’s call to global health leaders last month at the G20 human subjects meeting to have their vaccination status recognized worldwide.
Letters will be sent to clinical trial participants next week, outlining further details and next steps.
Participants will be contacted by the research 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 in hospital hubs.
Principal 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 the field of international travel because this vaccine has not yet been approved for use.
“But trial participants now have the flexibility to receive booster doses, or additional doses for travel purposes, if they wish.”
Phase III clinical trial data from Novavax released earlier this year showed the vaccine had an overall efficacy of 90.4 percent in preventing serious disease.
The company has postponed the submission of research data to the UK medical regulator, with reports suggesting there are difficulties in collecting consistent manufacturing information.
Novavax still plans to submit full data to the Medicines and Healthcare Regulatory Authority (MHRA) before the end of the year.
Meanwhile, the UK cut its deal with French vaccine maker Valneva for 100 million doses last month.
The UK government cited a breach of the contact agreement, a claim the drugmaker denies, but it’s still unclear why the deal failed.
The results of the phase three trials are expected later this year.