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Friday, October 30, 2020

UK to host ‘human challenge’ trials for COVID-19 vaccines -FT

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(Reuters) – Britain is planning to host clinical trials where volunteers are deliberately infected with the new coronavirus to test the effectiveness of vaccine candidates, the Financial Times reported yesterday, citing people involved in the project.

So-called “challenge trials” are expected to begin in January at a quarantine facility in London, the report https://on.ft.com/2G5o0jP said, adding that about 2,000 participants had signed up through a U.S.-based advocacy group, 1Day Sooner. (https://on.ft.com/2G5o0jP)

Britain said it was working with partners on the potential for human challenge trials without commenting on a specific plan.

“We are working with partners to understand how we might collaborate on the potential development of a COVID-19 vaccine through human challenge studies,” a government spokeswoman said.

“These discussions are part of our work to research ways of treating, limiting and hopefully preventing the virus so we can end the pandemic sooner.”

The FT reported that the studies will be government funded, although 1Day Sooner said it would also launch a petition for public funding of a biocontainment facility big enough to quarantine 100 to 200 participants.

Open Orphan, a pharmaceutical services company cited in the FT report, confirmed in a statement early on Thursday that it is in “advanced negotiation with the UK Government and other partners for a coronavirus challenge study in the UK”.

“There can be no certainty that these discussions will lead to a new contract,” it added.

Imperial College London, cited by the FT as the academic lead on the trials, did not confirm the report.

“Imperial continues to engage in a wide range of exploratory discussions relating to COVID-19 research, with a variety of partners,” a spokeswoman said, asked about the possibility of challenge trials.

Any trials conducted in the United Kingdom would have to be approved by the Medicines and Healthcare products Regulatory Agency (MHRA), the healthcare regulator which looks into safety and protocol.

The MHRA did not respond to Reuters’ requests for comment, but 1Day Sooner, which lobbies for challenge trials to accelerate vaccine development, welcomed the report.

“1Day Sooner congratulates the British government on their plans to conduct challenge trials to test vaccines,” it said in a statement, confirming it would petition the government to house the trial participants.

The industry has seen discussions in recent months about potentially having to inject healthy volunteers with the novel coronavirus if drugmakers struggled to find enough patients for final trials.

The FT report did not name the vaccines that would be assessed in the project. British drugmaker AstraZeneca, and French firm Sanofi both told Reuters that their vaccine candidates were not involved in the programme.

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