10.02.20

EMA Starts Rolling Review of AstraZeneca’s COVID-19 Vaccine Candidate AZD1222

Source: FirstWord

The European Medicines Agency said Thursday that its Committee for Medicinal Products for Human Use (CHMP) has initiated a rolling review of AstraZeneca and the University of Oxford’s COVID-19 vaccine candidate AZD1222. The agency explained that the start of the rolling review, the first for a vaccine against SARS-CoV-2, means that the CHMP has begun evaluating the first batch of data on AZD1222 from laboratory studies.

According to the EMA, the decision to start the real-time review process is based on preliminary data from non-clinical and early clinical studies suggesting that AZD1222 induces the production of antibodies and T-cells that target SARS-CoV-2. Phase 1/2 results published in The Lancet in July found that while no serious adverse events were linked to AZD1222, the vaccine was associated with common side effects such as injection-site pain, feverishness and chills.

‘Usual standards’ apply

The EMA stated that it intends to complete its evaluation “according to its usual standards for quality, safety and effectiveness,” adding that while the overall timeline is not yet known, “the process should be shorter than a regular evaluation due to the time gained during the rolling review.”

Meanwhile, Phase III testing of AZD1222 is currently ongoing, having resumed recently in the UK and some other countries after a brief pause early last month that was triggered when a study participant in the UK fell ill with what is believed to be transverse myelitis. The US trial remains on hold, with a report this week suggesting regulators there are seeking more information about the adverse event that prompted the study to be suspended in the first place.

More data in weeks, months ahead

The EMA anticipates data from the large-scale trials will become available over the coming weeks and months, and that these results “will provide information on how effective the vaccine is…and will be assessed in later rolling review cycles.” It added that the assessment will continue until enough evidence has been gathered to support a formal marketing authorisation application. AstraZeneca CEO Pascal Soriot has suggested that the vaccine could be ready by the end of the year despite the recent trial suspension.

The rolling review process was previously used by the EMA in assessing Gilead Sciences’ antiviral Veklury (remdesivir), which obtained conditional EU approval in July for COVID-19 patients aged 12 and older with pneumonia requiring supplemental oxygen.

Related Content