Commission hopes for COVID-19 vaccine market authorisation in November

However, there is confusion over the timeline of the vaccines' first deliveries. [Shutterstock/UDOM PINYO]

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.

EU agency not worried about COVID-19 mutations

The SARS-CoV-2 mutates but these mutations do not change significantly the main features of the virus, the EU agency for infectious diseases control has said.

Commission ‘confused’ over delivery

However, there is confusion over the timeline of the vaccines’ first deliveries.

EU Commission chief Ursula von der Leyen said at the beginning of the pandemic that a vaccine could be ready by autumn, a statement that was described as too ambitious by EMA, which said in May that a vaccine could be ready in a year’s time in an “optimistic” scenario.

On 18 August, the Commission refuted claims by Greece’s health minister that a first batch of COVID-19 vaccines is expected in December saying there is no timeline as there is no vaccine yet.

Asked by EURACTIV, EU spokesperson Vivian Loonela said: “We are in a situation where we cannot tell the exact date of delivery. We are working to have the vaccine ready as fast as possible as well as safe as possible.”

Xavier De Cuyper, director general of Belgium’s Medicines Agency (FAMHP), said on Wednesday that Belgium could expect the first batch of vaccines against COVID-19 by spring.

“Based on all the information I have, I dare to say that in March 2021 we could have a vaccine against COVID-19 in Belgium. It’s a realistic deadline,” De Cuyper told Het Laatste Nieuws.

According to De Cuyper, a manufacturer will never be able to supply vaccines for all of Europe at the same time, which would make a distribution key necessary, based on the population of each member state.

“A first European delivery will undoubtedly involve 50 million doses. Belgium will receive around 1.2 million”, he told the newspaper.

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