COVID-19 Vaccine AstraZeneca submitted for CMA with EMA

The European Medicines Agency today said it has received an application for conditional marketing authorization (CMA) for a COVID-19 vaccine developed by AstraZeneca (LSE: AZN) and Oxford University.

The vaccine was approved for emergency supply on December 30 by the UK Medicines and Healthcare products Regulatory Agency (MHRA), and in a number of countries since then. However, late on December 30, the EMA made clear that, despite conditional approval from the UK regulator, it is still awaiting additional data before it could announce its decision.

The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca (previously dubbed AZD1222), will proceed under an accelerated timeline. An opinion on the marketing authorization could be issued by January 29 during the meeting of EMA’s scientific committee for human medicines (CHMP), provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required to complete the assessment is promptly submitted.