1st Oct 2020 14:34
(Alliance News) - AstraZeneca PLC's Covid-19 vaccine candidate will be the object of a "rolling review" in a bid to speed up the assessment process, a European health regulator said on Thursday.
The AZD1222 programme is being developed the drugmaker alongside Oxford University.
"The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data). This does not mean that a conclusion can be reached yet on the vaccine's safety and effectiveness, as much of the evidence is still to be submitted to the committee," the EMA said.
"A rolling review is one of the regulatory tools that the agency uses to speed up the assessment of a promising medicine or vaccine during a public health emergency. Normally, all data on a medicine's effectiveness, safety and quality and all required documents must be submitted at the start of the evaluation in a formal application for marketing authorisation. In the case of a rolling review, the CHMP reviews data as they become available."
Back in September, trials of the vaccine paused after a UK volunteer developed an unexplained illness. Trials have since resumed.
In July, Astra posted encouraging interim results from a trial of the vaccine. The much-anticipated findings showed that a single dose of AZD1222 resulted in a four-fold increase in antibodies fighting SARS-CoV-2, the virus strain which causes Covid-19.
Astra shares were up 0.9% at 8,531.00 pence each in London on Thursday afternoon.
By Eric Cunha; [email protected]
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