Cambridge: Moderna Inc. said it would ask U.S. and European regulators on 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 even as the coronavirus rampage worsens.
"We believe these data are robust and should be 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 Cambridge, Massachusetts, company's chief medical officer.
Read:| Moderna says its COVID-19 vaccine is nearly 95% effective
Multiple vaccine candidates must succeed for the world to stamp out the pandemic, and Moderna 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 vaccine 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. 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. And the only people who got severely ill — 30 participants, including one who died — had received dummy shots.
When he learned the results, "I allowed myself to cry for the first time," Zaks told The Associated Press. "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 signalled it also is open to faster, emergency clearance.
AP
Read:| Moderna expecting to announce results of COVID-19 vaccine by month-end
