European regulators are set to begin an expedited review of a pioneering Covid-19 vaccine from the University of Oxford and AstraZeneca Plc, according to a person with knowledge of the situation, in a sign that the vaccine could be the first to seek approval. in the region.
The European Medicines Agency is expected to announce the “continuous review” as soon as this week, according to the person, who did not want to be identified because the decision is still private. These assessments are used in emergencies to allow regulators to view trial data while development is underway to expedite approvals of urgently needed drugs and vaccines.
The move would be a key step for the Oxford-AstraZeneca injection after trials were halted earlier this month due to concerns about a UK study participant falling ill. The partners, along with companies like Pfizer Inc. and Moderna Inc., are forging ahead with experimental shots as governments seek a way out of the global crisis.
The death toll from the disease surpassed one million this week, while the infection rate has recovered rapidly in Europe.
While the British regulator authorized the resumption of the Oxford-Astra test less than a week after it was halted and studies were resumed in South Africa, Brazil and India, US authorities have yet to give the go-ahead.
On Wednesday night, Reuters reported that the US Food and Drug Administration had expanded its investigation of the incident that led to the suspension of the trial, citing people familiar with the matter.
EMA Vaccine Director Marco Cavaleri said in July that the agency would begin conducting ongoing reviews of potential candidates after the summer. The focus means that a final approval could be granted within days after the review period ends. Cavaleri said at the time that the first approval of a vaccine could come by the end of the year.
In a normal environment, drug manufacturers submit test data to the regulator for a review that can take several months. Once it is complete, an opinion is given on whether the product should be authorized for use, which must be approved by the European Commission.
In emergencies such as a pandemic, ongoing review avoids delays so that a recommendation from the EMA and approval from the European Commission can be sought as soon as possible. The agency began such an evaluation of remdesivir to treat Covid-19 in April, while trials were ongoing and the drug received conditional approval three months later.
AstraZeneca declined to comment. An EMA spokesperson declined to comment on the review.
“The EMA has always stated that it will communicate the start of an ongoing review for Covid-19 treatments or vaccines,” it said in a statement. “We have not made such an announcement for a vaccine.”
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