EU uses ‘rolling reviews’ to speed up approval of AstraZeneca’s vaccine candidate
Real-time reviews of potential shots are under way as the FDA widens its probe into an adverse reaction
Bengaluru — The European health regulator has started reviewing data on AstraZeneca and Oxford University's potential Covid-19 vaccine as it emerges, the first of such moves aimed at speeding up any approval process in the region for a vaccine.
The European Medicines Agency (EMA) said on Thursday its human medicines committee is evaluating the first batch of non-clinical data on the vaccine from laboratory studies, and will continue to do so until sufficient data is available for a final decision.
The EMA uses “rolling reviews” to speed up evaluations of promising drugs or vaccines during a public health emergency, changing the typical process by assessing data as it is submitted, rather than waiting for all data to be made available along with a formal application.
The health-care regulator employed a similar real-time review of Gilead's remdesivir as a treatment for Covid-19 earlier in 2020, and the antiviral treatment was given conditional approval for use just months later in July.
The news of the European review also raises chances of the British vaccine becoming the first to be approved in Europe for the disease caused by the novel coronavirus which has killed more than a million people globally.
Called AZD1222 or ChAdOx1 nCoV-19, it is seen as leading the race for a successful vaccine against Covid-19. Other vaccine hopefuls in advanced stages include those from Pfizer, Moderna and Sinovac.
Thursday's news also comes just weeks after several global trials of AZD1222 were halted due to an unexplained illness in a study participant. While most studies have resumed, US trials are still on pause as the Food and Drug Administration (FDA) regulators widened their probe, Reuters reported on Wednesday.
Both Oxford and AstraZeneca welcomed the review, and the British drugmaker in a statement said it was committed to providing the EMA with all necessary data, including those on quality control.
Early-stage data in July showed the vaccine elicited immune responses in trials and produced no serious side effects, with the strongest responses seen in people who received two doses. Data on late-stage trials is 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.
AstraZeneca's large, late-stage US trial has remained on hold since September 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.
The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced Covid-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyse it, two of the sources said on Wednesday.
The administration of President Donald Trump has pledged $1.2bn to support development of the AstraZeneca vaccine and secure 300-million doses for the US. With Marisa Taylor and Dan Levine
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