UK: AstraZeneca resumes trial of Covid-19 vaccine

Grant Boone
September 13, 2020

This week, China National Biotec Group (CNBG), a state-run vaccine company, said early data from its Phase Three trials showed that its two leading immunisations were effective in preventing volunteers contracting Covid-19 - the first time a claim of efficacy has been made.

AstraZeneca also says it can not disclose further medical information because it is the study sponsor, but added in its statement, "All trial investigators and participants will be updated with the relevant information, and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards".

A large, United Kingdom-based Phase 2/3 study testing a Covid-19 vaccine being developed by AstraZeneca has been restarted, according to a statement from the company.

Although Oxford would not disclose information about the patient's illness due to participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed severe neurological symptoms that prompted the pause.

"All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards".

In an email to NPR Saturday, an AstraZeneca spokesperson said "the company will continue to work with health authorities across the world, including the FDA, and be guided as to when other clinical trials can resume".

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The pause came only days after the announcement from the University of Oxford that trials were being expanded, led by AstraZeneca.

AstraZeneca's vaccine candidate is one of nine around the world now in late-stage Phase 3 human trials. Testing resumed after the July pause following a safety review.

Pauses in drug trials are commonplace and the temporary hold led to a sharp fall in AstraZeneca's share price following the announcement Tuesday. The company didn't immediately respond to a question on when the trials would resume in the US, which officially began late last month, or elsewhere.

During the study, participants who received the vaccine had detectable neutralising antibodies, which have been suggested by researchers as important for protection, and these responses were strongest after a booster dose, with 100 per cent of participants' blood having neutralising activity against the coronavirus.

While temporary halts are common in vaccine trials, the interruption to the closely watched Astra-Oxford study had raised concerns about the viability of one of the fastest-moving experimental shots seeking protection from the pandemic.

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