European regulators are set to start an accelerated review of a Covid-19 vaccine front-runner from the University of Oxford and AstraZeneca Plc.
According to a person with knowledge of the situation, in a sign, the shot could be the first to seek approval in the region.
The European Medicines Agency (EMA) is expected to announce the “rolling review” as soon as this week, according to the person.
The move would be a key step forward for the Oxford-AstraZeneca shot after trials were halted earlier this month due to concerns about a participant in the U.K. study who became ill. The partners, along with companies such as Pfizer Inc. and Moderna Inc., are sprinting ahead with experimental shots as governments look for a way out of the global crisis.
The death toll from the disease exceeded 1 million this week, while the infection rate has rapidly picked up again in Europe.
While the British regulator cleared the Oxford-Astra trial to restart less than a week after it was paused and studies in South Africa, Brazil, and India have resumed, U.S. authorities have yet to give the go-ahead.
Marco Cavaleri, the EMA's head of vaccines, said in July that the agency would start rolling reviews of potential candidates after the summer. Moreover, he also 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’s complete, an opinion is given on whether the product should be authorized for use, which must be signed off by the European Commission.
However, in emergencies like a pandemic, a rolling review avoids delays so that an EMA recommendation and approval from the European Commission 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.
AstraZeneca declined to comment. A spokesperson for the EMA declined to comment on the review.
“EMA has always stated that it will communicate the start of a rolling review for Covid-19 treatments or vaccines,” it said in a statement. “We have not made such an announcement for a vaccine.”