Oxford COVID vaccine nearing approval? European rolling review expected soon

By Rahul Vaimal, Associate Editor
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COVID Vaccine
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European authorities are reportedly considering to expedite the entire vaccine approval process by conducting an accelerated review of the Oxford-AstraZeneca COVID-19 vaccine candidate. 

European agency for evaluation and supervision of medicinal products, European Medicines Agency (EMA) is expected to conduct a “rolling review” as early as this week which could make the Oxford COVID-19 vaccine the first to request for general vaccination approval in the region. Similar assessments, which provide regulators access to trial data during an ongoing vaccine development process will expedite the approval process of drugs and vaccines which are required to be cleared as soon as possible.

The decision provides much stimulus to the Oxford-AstraZeneca vaccine trials and approval process which was abruptly stopped last month as one of the volunteers who received the vaccine dosage was found to be ill.

The duo was provided clearance to resume the trial in the UK within a week as regional regulators reviewed the situation and found the incident as a one-off occurrence and posed no serious risk in general.

Trials in South Africa, Brazil and India have since resumed with the US authorities still holding out for further clarification on the incident.

Drug and vaccine candidates which are part of a rolling review mostly end up receiving final approvals within a matter of days after the review period ends. EMA’s rolling review of remdesivir to treat COVID-19 in April resulted in a conditional approval three months later.

While refusing to comment on the review, EMA shared that it “has always stated that it will communicate the start of a rolling review for COVID-19 treatments or vaccines” and it has not made such an announcement for a vaccine.