Two weeks after European regulators endorsed Pfizer and BioNTech’s COVID-19 vaccine, a second shot is getting ready for a broad rollout in the region. Moderna scored regulatory support for its vaccine, enabling health officials to expand their vaccination push amid fresh lockdowns and increases in cases.
The European Medicines Agency recommended a conditional marketing authorization for Moderna’s vaccine, and the European Commission signed off. The shot “provides us with another tool to overcome the current emergency,” EMA’s executive director Emer Cooke said in a statement.
Europe has secured 160 million doses of the vaccine, and the first deliveries are set to begin next week.
Under the conditional authorization, Moderna is required to keep sending data from its pivotal trial, which is still underway, for two years. Researchers aim to learn how long the vaccine's protection lasts, plus how well it prevents severe COVID-19 and more.
Europe's backing for the vaccine comes at an important time during the pandemic. After harsh lockdowns and outbreaks last spring, many countries have seen cases spike again, CNN reports. Germany, Italy and Greece are among the countries that have implemented new lockdowns or extended lockdowns in response to surges in cases. And England is continuing to battle a new variant; the country this week entered a national lockdown set to last six weeks or more.
Wednesday’s EMA recommendation followed an endorsement for Pfizer and BioNTech’s COVID-19 vaccine—also an mRNA shot—back in December. But while officials in the U.K. have started rolling out the AstraZeneca/Oxford vaccine, too, the European Medicines Agency recently said it needs more data to sign off on that program, RFI reports.
The agency in a statement said more data was needed "related to quality, safety and efficacy of the vaccine...to support the rigor required for a conditional marketing authorization,” according to the news service.
With the first COVID-19 vaccine authorizations in the books in countries around the world, 15 million COVID-19 vaccines have been given so far worldwide, Bloomberg reports.
Meanwhile, in the U.S., federal researchers and Moderna itself are looking into whether doses can be cut in half to stretch supply, without compromising efficacy, the New York Times reported Tuesday. The report came after FDA commissioner Stephen Hahn said it was “premature” to change dosing based on available data.