Europe on course for Christmas coronavirus vaccine approval

EU citizens may be in for an extra special Christmas gift — their first coronavirus vaccine approval. 

The European Medicines Agency announced on Tuesday that the committee that’s expected to recommend a conditional marketing authorization for the BioNTech/Pfizer vaccine will meet on December 21 — which means official authorization could come a few days later. 

That meeting is eight days earlier than the previously floated December 29 date, the latest day this year that the EMA said it would meet to decide on the authorization recommendation. Commission President Ursula von der Leyen welcomed the news Tuesday, tweeting that it was “likely that the first Europeans will be vaccinated before end 2020.”

Still, this approval will still come several weeks after the U.K.’s green light, and more than a week after the U.S. granted approval. 

Indeed, the U.S. regulator on Tuesday also cleared the path for the Moderna vaccine to receive authorization later this week — making the EU look increasingly behind. 

The EMA delivered its news in a statement that noted the agency had received additional data from the drugmakers late Monday. Pending the outcome of the evaluation of this new data, it said, the recommendation could be made at the December 21 meeting. 

However, it will act only “once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks,” the EMA added.

Following any EMA recommendation, the Commission still needs to grant the marketing authorization, but the EMA said that this would be fast tracked and available “within days.” 

Political pressure

The news of a possible Christmas approval comes in the wake of increasing pressure from European leaders.

On Tuesday morning, Italian Health Minister Roberto Speranzo said he hoped the EMA, in compliance with all safety procedures, will be able to approve the BioNTech/Pfizer vaccine “earlier than expected and that vaccinations can also begin in the countries of the European Union as soon as possible.”

Even German Health Minister Jens Spahn — who previously cautioned that the idea was “not that we be first” but that the EU “have safe and effective vaccines in the pandemic” — entered the fray on Monday night, when he said the goal was to have the vaccine approved by Christmas and for vaccinations to start this year.

On Tuesday morning, Spahn welcomed reports in German media that authorization could come on December 23.  

German media have also increasingly focused on the fact that the vaccine was developed by a German company but that several other countries were already vaccinating their citizens, including the U.K. and the U.S.

A bureaucratic process

The U.K., the first Western country to approve the vaccine, used an EU mechanism that allows member countries to temporarily approve a drug during an emergency. While EU countries would be able to approve the vaccine under the same regulations, they wouldn’t be able to receive doses of the jab as these have been negotiated at EU level. Under Brexit transition provisions, the U.K. still follows some EMA rules but chose not to be part of the EU vaccine-purchase plan. 

While the EMA has worked at a speed never seen before, it has remained slower than other regulators. Much of the difference in the EU approval process is the bureaucratic nature of an authorization that involves all 27 member states. 

“The consequence is that the workload is shared, that the decision making is shared,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine and former independent expert member of the EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC). “When you do that, then it means you are going to be a bit slower when there’s an emergency.” 

It’s also about getting vaccine skeptics on board. With high rates of vaccine skepticism in the bloc, the EMA has used every opportunity to stress the careful nature of the authorization.

It underscored again Tuesday that the authorization “ensures that COVID-19 vaccines meet the same high EU standards as for all vaccines and medicines,” and that it will let the entire EU begin rolling out a vaccine at the same time. 

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.