Moderna requests vaccine authorization in US and Europe on Monday US news

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U.S. company Moderna 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 vaccines offer strong protection – intensifying the race to start limited vaccinations as the coronavirus pandemic worsens.
“Moderna plans today to apply for EUA (Emergency Use Authorization) to the US FDA (Food and Drug Administration),” Moderna said in a statement, adding that she “would also apply for conditional marketing authorization from the European Medicines Agency (EMA). ”

Multiple vaccine candidates must be successful for the world to eradicate the pandemic, which is on the rise in the United States and Europe.

US hospitals have been stretched to the limit as the country has seen more than 160,000 new cases per day and more than 1,400 deaths daily.

Since it emerged almost a year ago in China, the virus has killed more than 1.4 million people worldwide.

Moderna is right behind Pfizer and its German partner BioNTech in an attempt to start vaccinations in the United States in December.

Across the Atlantic, British regulators are also assessing the shot from Pfizer and another from AstraZeneca.

Moderna created his snaps with the US National Institutes of Health and already had a clue that they were working, but said he got the necessary end results over the weekend that suggest the vaccine is working. more than 94%.

Of 196 cases of COVID-19 so far in its massive US study, 185 were trial participants who received the placebo and 11 who received the real vaccine.

The only seriously ill people – 30 participants, including one who died – had received dummy injections, said Dr Tal Zaks, medical director of the Cambridge, Massachusetts-based company.

When he heard of the results, “I allowed myself to cry for the first time,” Zaks told The Associated Press.

“We have already, just during the trial, saved lives. Just imagine the impact multiplied by the people who can get this vaccine. ”

Moderna said the effectiveness of the injections and a good safety record so far – with only temporary, flu-like side effects – mean they meet requirements set by the state Food and Drug Administration. – United for emergency use before the end of final stage testing.

The European Medicines Agency, the European version of the FDA, has said it is also open to faster emergency clearance.



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