US firm Moderna said it would ask US 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 as the coronavirus pandemic worsens.
“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).”
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.
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 US National Institutes of Health and 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 percent 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 Cambridge, Massachusetts, company’s chief medical officer.
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.”
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 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 also is open to faster, emergency clearance.
SOURCE : NEWS AGENCIES