Moderna to Request Emergency Approval of Its Covid-19 Vaccine

Moderna Inc. said it would ask US and European regulators Monday to allow emergency use of its COVID-19 vaccine as new study results confirm the shots offer strong protection against the virus.

If authorization is granted, the first shots could be given as early as December 21. Moderna expects to have 20 million doses ready for the US by the end of the year.

Multiple vaccine candidates must succeed for the world to stamp out the pandemic, which has been on the upswing in the US and Europe. US hospitals have been stretched to the limit as the nation has seen more than 160,000 new cases per day and more than 1,400 daily deaths. Since first emerging nearly a year ago in China, the virus has killed more than 1.4 million people worldwide.

“We believe these data are robust and should be clearly sufficient to enable the emergency use authorization in the U.S. and we hope global marketing authorizations as well and other jurisdictions,” said Dr. Tal Zaks, the company’s chief medical officer in Cambridge, Massachusetts.

Moderna is just behind Pfizer and its German partner BioNTech in seeking to begin vaccinations in the U.S. in December. British regulators also are assessing the Pfizer shot and another from AstraZeneca.

Moderna, which created its vaccine with the U.S. National Institutes of Health, already had a hint they were working but said it got the final needed results over the weekend that suggest the vaccine is more than 94% effective. Of 196 COVID-19 cases so far in its huge U.S. study, 11 were trial participants who received the real vaccine instead of a placebo. The only people who got severely ill — 30 participants, including one who died — had received dummy shots.

Moderna said the shots’ effectiveness and a good safety record so far — with only temporary, flu-like side effects — mean they meet requirements set by the FDA for emergency use before the final-stage testing is complete. The European Medicines Agency, Europe’s version of FDA, has signaled it also is open to faster “conditional” clearance.

The FDA has pledged that before it decides to roll out any COVID-19 vaccines, its scientific advisers will publicly debate whether there’s enough evidence behind each candidate.

On December 10, Pfizer and BioNTech will present data suggesting their vaccine candidate is 95% effective. Moderna said its turn is expected exactly a week later, on December 17.

If the FDA allows emergency use, Moderna expects to have 20 million doses ready for the US by year’s end.

Rita Osakwe/Agency Reports

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