Friday 16 / May / 2025
US pharmaceutical firm Moderna said it would file requests for emergency authorization of its Covid-19 vaccine with US and European regulators on Monday, after new study results found that the shots had an efficacy rate estimated at 94.1%.
"Moderna plans today to request EUA (Emergency Use Authorization) from the US FDA (Food and Drug Administration)," Moderna said in a statement, adding it would also "apply for a conditional marketing authorization with the European Medicines Agency (EMA)."
The announcement could prove another step forward in the race to begin limited vaccinations, as infection rates around the world continue to rise.
Moderna says it has already initiated so-called rolling review processes with the EMA, as well as regulatory authorities in Canada, Switzerland, Britain, Israel and Singapore, aimed at speeding up authorization. Earlier interim results said it was 94.5% effective against the virus. The company says the vaccine trials have so far raised no serious safety concerns.
With its application, Moderna will become the first pharmaceutical company to apply for authorization of its vaccine in the EU. Last week, European Commission President Ursula von der Leyen announced that the EU had concluded a contract for up to 160 million doses of the Moderna vaccine.
The contract foresees an initial delivery of 80 million vaccine doses, with the option of 80 million additional doses at a later date.
Moderna says its vaccine could be delivered to the EU as early as December, if it receives approval.
Could be delivered to EU by December
Meanwhile, Moderna said the shots' effectiveness and good safety record so far — with only temporary, flu-like side effects — mean they meet requirements set by the US Food and Drug Administration for emergency use before the final-stage testing is complete. The European Medicines Agency, Europe's version of FDA, has signaled it is also open to faster, emergency clearance.
Multiple vaccine candidates must succeed in order to distribute vaccines across the world.
The company is just behind Pfizer and its German partner BioNTech in seeking to begin vaccinations in the U.S. in December. Across the Atlantic, British regulators also are assessing the Pfizer shot and another from AstraZeneca.
Vaccines made by three Chinese companies and a Russian candidate also are being tested in countries around the world.
