EU Considers Emergency Approval Process to Speed Distribution of COVID-19 Vaccines

To speed the rollout of COVID-19 vaccine doses, the European Commission (EC) is considering an emergency approval mechanism in lieu of its more time-consuming and stringent conditional marketing authorization process.

The European Medicines Agency (EMA) also announced yesterday, in what could be the first EU-wide emergency approval for a vaccine, that it would hold an “extraordinary meeting” on March 11 to offer its recommendation on Johnson & Johnson’s single-shot vaccine. However, J&J’s vaccine is just being considered for a conditional marketing authorization, according to the EMA’s website.

Despite its large vaccine supply contracts ― a staggering potential arsenal of 2.6 billion doses ― the 27-member bloc has struggled with receiving doses on an agreed upon schedule, following delivery delays from vaccine developers such as Pfizer and AstraZeneca.

EC President Ursula von der Leyen tweeted yesterday that the commission held a “discussion on a potential EU emergency authorization” during its latest COVID-19 response meeting.

If implemented, such a mechanism would give the EU a regulatory tool previously reserved for individual members ― and a tool the EC has not always recommended that member states should exercise. As an example, in late January, Hungary raised the hackles of the EC when it struck out on its own to approve Russia’s Sputnik V vaccine for emergency use (DID, Jan. 22), a vaccine that has yet to receive authorization in the EU.

The EU has granted conditional marketing authorizations to three COVID-19 vaccines, developed by Pfizer/BioNTech, Moderna and AstraZeneca/Oxford University, and has recently forged additional supply contracts with Pfizer and Moderna to get shots into the arms of its 446 million citizens quicker (DID, Feb. 18).

In addition, the EMA is currently conducting rolling reviews for CureVac’s and Novavax’s COVID-19 vaccines, which are both in late-stage trials and could benefit from the new emergency approval strategy.

But a new mechanism allowing for faster approval of vaccines may not be enough to quell the frustration of some EU member states. In fact, Austria and Denmark, dismayed by the slow vaccine rollout across the continent, have partnered with Israel to develop the next generation of vaccines able to combat viral variants ― with Austrian Chancellor Sebastian Kurz announcing the pact yesterday on Twitter. ― Jason Scott