The Moderna vaccine is already being rolled out in the U.S.

Photo: Meg Mclaughlin/Zuma Press

The European Union’s main drug regulator on Wednesday cleared Moderna Inc.’s Covid-19 vaccine for use, offering the region a second shot to fight the coronavirus at a time when it is already struggling to distribute the doses it has.

The decision, which is expected to be formalized by the European Commission within 24 hours, comes more than two weeks after Moderna’s shot received emergency-use authorization in the U.S. and Canada, a timeline that shows how the EU’s regulators have struggled to assess vaccines as quickly as their Western counterparts.

The agency said the vaccine should be administered in two doses, the second 28 days after the first, as intended by the manufacturer. The recommendation comes after public-health institutions elsewhere have explored the possibility of delaying second doses so that more people can receive their first.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, executive director of the European Medicines Agency. “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.”

Immunizations using Moderna’s Covid-19 vaccine started in December. WSJ’s Betsy McKay reports on how injections will be distributed among high-priority groups. Photo: Paul Sancya/AFP/Getty Images (Originally Published Dec. 21, 2020)

Since Dec. 27, the EU has been offering its first authorized vaccine, developed by BioNTech SE and Pfizer Inc., to nursing-home residents and health-care workers. But the rollout has been slowed by logistical bottlenecks, wasted doses, the challenges of bringing temperature-sensitive vaccines to distant facilities, and reluctance by even some hospital staff to receive a novel vaccine against a disease many of them have already contracted.

“When the first doses came, we realized we are not vaccinating fast enough,” said Nikolas Dietis, assistant professor of pharmacology at the University of Cyprus. “Will it make a difference if Moderna vaccine doses now come also? Having more vaccines, if we don’t change our processes, it won’t make it faster.”

The EU has preordered 160 million doses of the two-shot vaccine, which does offer some hope for a faster vaccine rollout. Moderna’s vaccine doesn’t require storage at temperatures as low as the Pfizer-BioNTech shot and doesn’t need to be mixed with sodium chloride before an injection, a small step that only takes a few moments but adds up to a considerable delay when multiplied by hundreds of millions of injections.

The decision comes as a potentially more contagious variant of the coronavirus, first detected in the U.K., has been spreading in Europe—in France, Germany, Sweden and elsewhere—raising fears that the virus is infecting people faster than the EU can vaccinate them.

“We’re going to have people scrambling around saying, ‘how are we going to give those vaccines,’” said Deenan Pillay, a professor of virology at University College London. “All the ways around, it’s looking like a disaster.”

Corrections & Amplifications
The EU has preordered 160 million doses of the Moderna vaccine. An earlier version of this article incorrectly said it had preordered 160 doses. The EMA’s decision came more than two weeks after Moderna’s vaccine received emergency-use authorization in the U.S. and Canada. An earlier version of this article incorrectly said it had been authorized in the U.S. and U.K. (Corrected on Jan. 6)

Write to Drew Hinshaw at [email protected]

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This post first appeared on wsj.com

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