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AstraZeneca to bring non-US vaccine data before FDA for emergency approval

If and when AstraZeneca reaches the first statistically reliable efficacy and safety results from those trials, based on more than 25,000 volunteers in total, it would present them to the US Food and

Topics
Coronavirus | AstraZeneca

Reuters 

Coronavirus, vaccine, covid, drugs, clinical trials
Some experts have argued that, once a successful vaccine is widely available or soon expected, the runners-up in the vaccine race may find it difficult to recruit volunteers

will start discussing emergency approval of its experimental Covid-19 vaccine with US regulators once it has good trial data from Britain, South Africa and Brazil, as it has no indication the watchdog would favour US data.

If and when reaches the first statistically reliable efficacy and safety results from those trials, based on more than 25,000 volunteers in total, it would present them to the US Food and Drug Administration (FDA) even though any read-out from an ongoing US trial will be months later.

"If you hit those thresholds we are going to have a conversation with them," executive team member Mene Pangalos told Reuters.

"What the FDA has signalled is what their expectations of data are for an approval," he said, adding the company had not spoken to the US watchdog about where the data should some from.The future of the US trial would not be called into question by any successful non-US trial result, Pangalos stressed.

Some experts have argued that, once a successful vaccine is widely available or soon expected, the runners-up in the vaccine race may find it difficult to recruit volunteers willing to risk being randomly assigned to a control group on placebo.

Pangalos said a vaccine would not be available for everyone immediately following approval. "That is not how it happens. It will take months to vaccinate people (widely)," he said.

"By the time the (UK) study reads out, we submit regulatory documents, and assuming we get an approval and the vaccine starts to be distributed across the US, I think there will be more than enough time to get the study almost fully recruited."

"Being on a vaccine study is probably going to be a good way ... to get access to the vaccine," he said, adding that only one in three US trial participants will be on placebo.

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First Published: Thu, November 05 2020. 20:53 IST
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