Europe starts accelerated review of AstraZeneca vaccine

LONDON • European regulators have started an accelerated review of a Covid-19 vaccine front runner from the University of Oxford and AstraZeneca in a sign the shot could be the first to seek approval in the region.

The European Medicines Agency (EMA) announced the start of the so-called "rolling review", an assessment typically used in health emergencies to allow regulators to see clinical trial data while the development is ongoing to speed up approvals.

The move is a key step forward for the Oxford-AstraZeneca shot after trials were halted last month due to concerns about a participant in the British study who became ill.

The partners, along with companies such as Pfizer and Moderna, are sprinting ahead with experimental shots as governments look for a way out of the global crisis.

The EMA said it is starting the review based on preliminary results and that it does not mean "that a conclusion can be reached yet on the vaccine's safety and effectiveness".

A spokesman for AstraZeneca said the company welcomed the development and will be providing the EMA with access to the vaccine data as it becomes available.

While the British regulator cleared the Oxford-AstraZeneca trial to restart less than a week after it was paused and studies in South Africa, Brazil and India have resumed, the United States authorities have yet to give the go-ahead.

EMA head of vaccines Marco Cavaleri said in July the agency would start rolling reviews of potential candidates after the summer.

Dr Cavaleri said at the time the first approval of a vaccine could come by the end of the year.

In a normal environment, drugmakers submit trial data to the regulator for a review that can take many months.

Once that is complete, an opinion is given on whether the product should be authorised for use, which must be signed off by the European Commission (EC).

In emergencies like a pandemic, a rolling review avoids delays so that an EMA recommendation and approval from the EC can be sought as quickly as possible.

The agency started such an evaluation of remdesivir to treat Covid-19 in April, while trials were ongoing, and the drug was given conditional approval three months later.

Meanwhile, early clinical trials of a second Russian coronavirus vaccine have proved successful, its developer said yesterday, after the country boasted of approving the world's first vaccine.

Russia's Vektor - a top-secret state virology research centre in Siberia - said early-stage trials were successful for its own experimental vaccine, named EpiVacCorona.

Russian Health Minister Mikhail Murashko told President Vladimir Putin this week that Vektor's vaccine could be approved by the ministry in three weeks.

BLOOMBERG, AGENCE FRANCE-PRESSE