Commission hopes for approval to sell COVID-19 vaccine in November

The European Commission hopes for the first COVID-19 vaccine to have market authorisation in November, an EU official said yesterday (3 September). However, a timeline for its distribution is still unknown.

The condition for the vaccine to be marketed is that it be deemed “safe and efficacious”, the official added.

The EU Commission is negotiating advance purchases of COVID-19 vaccines with several drug manufacturers on behalf of the 27 EU states and has previously said that EU governments cannot buy vaccines through parallel procurement schemes.

The EU executive has made a €336 million downpayment to British firm AstraZeneca to secure at least 300 million doses of its potential COVID-19 vaccine, a spokesman said on Thursday (27 August).

If AstraZeneca’s vaccine phase III clinical trial is successful, then EU officials hope for its market authorisation as early as in November.

The price of the candidate vaccines is still unknown. EU officials say the executive is in negotiations with several drugmakers and therefore at this stage such information cannot be revealed.

An EU source pointed out that under European rules the liability for the safety of a vaccine lies solely with the manufacturer unless “hidden side-effects”, undetected by the European Medicines’ Agency (EMA), appear.

Once a vaccine is available, Piotr Kramarz, deputy Chief Scientist at the European Centre for Disease Prevention and Control (ECDC), recently told EURACTIV that the EU was preparing a system to monitor its effectiveness and safety across Europe.

“We are working with the European Medicines’ Agency to prepare a monitoring system, when the vaccines come to monitor how they are used and how effective and safe they will be in real life,” he said.

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