January 22, 2021

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Moderna will request authorization from the FDA today for its vaccine against Covid-19 | Present


The firm Moderna Inc. said it will ask US and European regulators today to allow emergency use of its Covid-19 vaccine, as the results of a new study confirm that the injections offer strong protection.

Multiple vaccine candidates must succeed for the world to fight the pandemic, which has been on the rise in the United States and Europe. The United States has seen more than 160,000 new cases a day and more than 1,400 deaths a day. Since it first appeared nearly a year ago in China, the virus has killed more than 1.4 million people worldwide.

Moderna is behind Pfizer and its German partner BioNTech in seeking to start vaccination in the United States in December. Across the Atlantic, British regulators are also evaluating the Pfizer vaccine and another from AstraZeneca.

Moderna created her vaccines with the US National Institutes of Health and already had a clue that they were working, but she said she got the final necessary results over the weekend that suggest the vaccine is more than 94% effective.

Of 196 cases of Covid-19 so far in their large US study, 185 were trial participants who received the placebo and 11 who received the actual vaccine. The only people who became seriously ill – 30 participants, including one who died – had received dummy injections, said Dr. Tal Zaks, the company’s chief medical officer in Cambridge, Massachusetts.

When he learned of the results, “I allowed myself to cry for the first time,” Zaks told The Associated Press. “In the studio alone, we have already saved lives. Imagine that the impact then multiplies in the people who can receive this vaccine. “

Moderna said the vaccines’ effectiveness and a good safety record so far, with only temporary flu-like side effects, means they meet the requirements set by the U.S. Food and Drug Administration (FDA) for emergency use before final stage testing is completed. The European Medicines Agency, the European version of the FDA, has noted that it is also open to faster emergency authorization.



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