UK regulators use "rolling review" to speed Pfizer, AstraZeneca vaccines

Oct. 30, 2020

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is undertaking a rolling review process of Pfizer/BioNtech and AstraZeneca/Oxford experimental COVID-19 vaccines, in order to expedite the review process, says Bloomberg sources.

Rolling reviews enable regulators to see clinical data in real time and discuss ongoing trials and manufacturing processes with drugmakers so that approvals can be granted more quickly. In the U.S., drugs given FDA Fast Track designation become eligible for rolling review, allowing drugmakers to submit completed sections of BLA or NDA for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

The European Medicines Agency (EMA) announced its own rolling reviews of both the Pfizer/BioNtech and AstraZeneca/Oxford candidates in early October. With the Brexit transition, the U.K. is still subject to the approval process of the EMA until the end of December 2020. However, if there is a  "compelling case" to move more quickly than the EMA, the UK government has said it would look at granting a temporary authorization for an unlicensed vaccine.