Moderna Takes Next Big Step on Vaccine

Company asks US, EU regulators for approval after results come back 94.1% effective
By Newser Editors and Wire Services
Posted Nov 30, 2020 6:55 AM CST
Moderna Seeking Emergency Approval for Vaccine
In this Monday, May 18, 2020, file photo, a sign marks an entrance to a Moderna, Inc., building, in Cambridge, Mass. Moderna Inc. says it will ask US and European regulators to allow emergency use of its COVID-19 vaccine as new study results confirm the shots offer strong protection.   (AP Photo/Bill Sikes, File)

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—ramping up the race to begin limited vaccinations as the coronavirus rampage worsens. Multiple vaccine candidates must succeed for the world to stamp out the pandemic, which has been on the upswing in the US and Europe. Moderna is just behind Pfizer and its German partner BioNTech in seeking to begin vaccinations in the US in December. Across the Atlantic, British regulators also are assessing the Pfizer shot and another from AstraZeneca. Moderna created its shots with the National Institutes of Health and already had a hint they were working, but said it got 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 US study, 185 were trial participants who received the placebo and 11 who got the real vaccine. The only people who got severely ill—30 participants, including one who died—had received dummy shots, said Dr. Tal Zaks, the company's chief medical officer. When he learned the results, “I allowed myself to cry for the first time,” Zaks told the AP. “We have already, just in the trial, have already saved lives. Just imagine the impact then multiplied to the people who can get this vaccine.” The European Medicines Agency, Europe’s version of FDA, has signaled it also is open to faster, emergency clearance. If the FDA allows emergency use, Moderna expects to have 20 million doses ready for the US by year’s end. Recipients will need two doses, so that’s enough for 10 million people.

(More coronavirus stories.)

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