European Medicines Agency Initiates Rolling Review of AZD1222 While FDA Puts Trial on Hold for a Different Review

Oct 2, 2020 | AstraZeneca, AZD1222, EMA, European Medicines Agency, News, Oxford, Rolling Review, Vaccine

European Medicines Agency Initiates Rolling Review of AZD1222 While FDA Puts Trial on Hold for a Different Review

The European Medicines Agency (EMA) human medicines committee (CHMP) reports publicly the first ‘rolling review’ of a COVID-19 vaccine starting with AstraZeneca’s AZD1222 or the “Oxford” vaccine. This committee is investigating the first batch of data on the vaccine derived from laboratory (e.g. non-clinical) data. EMA declares that this cannot be a safety and efficacy review as that data is still being accumulated in clinical trials. Of course, the U.S. study is on hold due to a U.S. Food and Drug Administration (FDA) review.

What is a Rolling Review?

EMA or “the Agency” uses rolling reviews as a regulatory tool to accelerate assessments of promising medicines or vaccines during a public health emergency such as the one experienced now with the COVID-19 pandemic.

Typically, all data on an investigational product (whether drug or vaccine) is submitted at the start of the evaluation in a formal application for marketing authorization. However, in rolling reviews, the regulators can review chunks of data, such as the CHMP reviews data, as they become available from existing, ongoing clinical trials.

Positive Trigger

CHMP’s decision to commence the rolling review is based on the positive preliminary results from non-clinical and early clinical study data suggesting that this particular vaccine triggers the production of antibodies and T cells targeting SARS-CoV-2, the virus behind COVID-19.

Ongoing Phase 3 Trials

EMA reports on the ongoing Phase 3 clinical trials for this investigational vaccine, now occurring in the UK, South Africa, Brazil, and India. As TrialSite has reported, the U.S. is on an indefinite hold while the FDA scrutinizes the safety incident that occurred in the UK.

No Mention of Safety Incident or FDA Delay

In years past, EMA and FDA worked very closely and there is no reason to consider that is different today. However, it’s notable that this rolling review commenced while the U.S. Food and Drug Administration (FDA) has put a major, expensive study on hold indefinitely due to a neurological -based adverse event (thought to be transverse myelitis) associated with the study in the UK. 

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