EU regulator green-lights Moderna coronavirus vaccine

The EU added a second vaccine to its armory Wednesday, as the European Medicines Agency recommended using Moderna’s coronavirus vaccine in people over the age of 18.

The Commission should rubber-stamp the vaccine within hours. 

In a clinical trial of around 28,000 people, the two-dose mRNA vaccine was 94.1 percent effective in preventing COVID-19 cases, and almost 91 percent effective in preventing severe cases. 

The drugmakers are on the hook to provide more information throughout the next two years, including how long immunity lasts and whether the jab prevents the transmission of the virus. But the EMA decision means that the vaccine is safe, effective and ready to use.

The Commission has already secured 160 million doses of the vaccine, and deliveries will start next week. 

“This vaccine provides us with another tool to overcome the current emergency,” EMA Executive Director Emer Cooke wrote in a press release. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by the WHO.”

The green light comes as the EU is facing increasing flak for its slow deployment of coronavirus vaccines compared to some other countries. The U.S. and U.K. have already rolled out two vaccines and vaccinated more than 5 million and 1 million people, respectively. Meanwhile, Russia has vaccinated 1 million, and Israel has covered more than 12 percent of its population. 

Like the BioNTech/Pfizer vaccine, approval of the Moderna vaccine won’t instantly save EU’s slow vaccination campaigns. The jabs’ rollout will take time as drugmakers rush to ramp up manufacturing and countries struggle to use them in great numbers.

But no single vaccine is a magic bullet out of the pandemic: Countries will need to maintain other measures social distancing and masks for the foreseeable future — and more quickly use the vaccines they have.

Still, some politicians in Germany have blamed the Commission for not purchasing enough doses of the first approved vaccines from BioNTech/Pfizer. The Commission is reportedly purchasing up to 50 million more, with Bloomberg reporting it could purchase another 300 million doses, although an EU diplomat close to the negotiations said it will be closer to 100 million.

Part of the EU’s sluggishness comes from the EU’s approval process, which opts for a conditional marketing authorization from the EMA, rather an emergency approval like the U.S. and U.K. The CMA process is more bureaucratic but offers a more robust review, liability protection and obligations for drugmakers. 

But EU countries have been slow to actually use the first millions of doses of the BioNTech/Pfizer vaccines when they arrived. The Netherlands will only begin this week; France had only vaccinated hundreds as of January 1; and Germany — the country that has vaccinated more people than any other in the EU —  still only used a quarter of the doses it has available. 

The Moderna vaccine will help some of these issues, as it doesn’t need to be stored on dry ice, which could make the rollouts easier. (It has to be kept at minus 20 degrees Celsius and can be stored in a standard refrigerator for 30 days.) However, the American company has limited production capacity in Europe, at least initially. The doses are made by Lonza in Switzerland, while ROVI in Spain does the fill finish. 

Moderna recently increased its projections for doses globally, saying it could produce between 500-600 million doses for 2021, but the company has not said how much would be allocated to the EU.

Regardless, the second vaccine helps bring the EU “closer to our goal of having a portfolio of safe and effective #COVID19 vaccines,” Health Commissioner Stella Kyriakides tweeted Wednesday. 

This story has been updated.