Nepal | October 22, 2020

EU regulator launches real-time review of AstraZeneca’s COVID-19 vaccine

Reuters
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BRUSSELS: The European health regulator said on Thursday it had started a rolling review of the experimental COVID-19 vaccine from AstraZeneca and Oxford University, in a move aimed at speeding up any future approval process.

The European Medicines Agency (EMA) said its human medicines committee had started evaluating the first batch of data on the vaccine, and will continue till sufficient data is available and a formal application is submitted.

The news raises the chances of the vaccine being the first to be approved in the region, and comes just weeks after several global trials of the vaccine were halted due to an unexplained illness in a study participant.

US trials are still under review, with regulators widening their probe, Reuters reported on Wednesday.

“This (EMA’s review) 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 watchdog said.

Early-stage data in July showed the vaccine elicited immune responses in clinical trials and produced no serious side effects, with the strongest response seen in people who received two doses. Data on late-stage trials are expected soon.

The EMA would make final recommendations, once the review is completed, to the European Commission, which has the ultimate say over approvals. The commission typically follows EMA endorsements.

The EMA began a similar real-time review of Gilead’s Veklury as a treatment for COVID-19 earlier this year, and the antiviral treatment was given conditional approval for use just months later in July.


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