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Applications for authorization in the US and Europe will come after the results confirm an estimated high efficacy of 94.1%.
US company Moderna said on Monday it will ask US and European regulators to allow emergency use of its COVID-19 vaccine as new study results confirm shots offer strong protection, accelerating the rush to start vaccinations. limited as the coronavirus pandemic worsens.
“Moderna plans today to apply for EUA (Emergency Use Authorization) from the US FDA (Food and Drug Administration),” Moderna said in a statement, adding that it would also “apply for a conditional marketing authorization with the European Medicines Agency (EMA). “
More vaccine candidates must succeed for the world to eliminate the pandemic, which has been on the rise in the United States and Europe.
US hospitals have been pushed to their limits as the nation saw more than 160,000 new cases per day and more than 1,400 deaths per day.
Since it first appeared nearly a year ago in China, the virus has killed more than 1.4 million people around the world.
Moderna is right behind Pfizer and its German partner BioNTech as they attempt to start vaccinations in the United States in December.
Across the Atlantic, British regulators are also considering Pfizer and another AstraZeneca coup.
Moderna created his shots with the U.S. National Institutes of Health and already had a suggestion that they were working, but said he got the final results needed over the weekend which suggest the vaccine is over 94% effective. .
Of the 196 COVID-19 cases so far in its massive US study, 185 were study participants who received the placebo and 11 who received the real vaccine.
The only people who became seriously ill – 30 participants, including one who died – had received sham injections, said Dr. Tal Zaks, chief medical officer of the Cambridge, Massachusetts firm.
When he learned the results, “I allowed myself to cry for the first time,” Zaks told The Associated Press.
“We have already, only in the process, we have already saved lives. Just imagine that the impact has multiplied by the people who can get this vaccine. “
Moderna said the effectiveness of the shots and a good safety record so far – with only temporary flu-like side effects – mean they meet the requirements set by the U.S. Food and Drug Administration for emergency use prior to completion. testing in the final phase.
The European Medicines Agency, the European version of the FDA, has signaled that it is also open to a quicker emergency authorization.
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