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  • Moderna requests emergency authorization from FDA for mRNA – 1273

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Moderna requests emergency authorization from FDA for mRNA – 1273
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Moderna requests emergency authorization from FDA for mRNA – 1273

bioxone December 1, 2020December 1, 2020

Prama Ghosh, Amity University Kolkata

The Cambridge, Massachusetts – based Biotech Company, Moderna asked for emergency authorization from the U.S. Food and Drug Administration to use its COVID – 19 vaccines, mRNA – 1273, after receiving confirmation about its safety and efficacy on Monday. According to a new study, the shots offer a strong protection and will be helpful in providing limited vaccination in the times of coronavirus.

According to the clinical trial consisting of 196 people with COVID – 19, 185 of them had received the dummy shots and only 11 received the active vaccine, bringing the effectiveness rate of the vaccine above 94%. 30 participants, all in the placebo group who suffered severely from the disease, suggest that the vaccine can be used to treat both mild and serious forms of the disease. A single death from the placebo group has been recorded. The report was confirmed by Dr. Tal Zaks, the Cambridge, and Massachusetts chief medical officer. Only temporary side effects like flu were recorded.

Moderna will be the second company to ask for authorization after Pfizer and its German partner BioNTech from the federal government. The British Biotech company expects a discussion on mRNA – 1273 from the FDA’s advisory committee on December 17, a week after discussing Pfizer’s vaccine. The authorization is expected to come a few days after each meeting.

Dr. Peter Hotez, a paediatrician and co – director of the Texas Children’s Hospital Center for Vaccine development and Moderna’s president, Dr. Stephen Hoge, were impressed with the efficacy of the vaccine and emphasized on the success of developing the vaccine in such a short period of time. Around 80 million doses will be provided for U.S. next year.

Also read: Lapatinib, Doramapimod with Remdesivir teamed against COVID-19

Reference: 1) https://www.thehindu.com/sci-tech/health/moderna-asking-us-european-regulators-to-ok-its-virus-shots/article33213883.ece

2) https://www.usatoday.com/story/news/health/2020/11/30/moderna-emergency-fda-authorization-covid-19-vaccine-pfizer/6376336002/

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-Shristi Sharma, Team bioXone Eli Lilly Job – Life Science Publishing Specialist Recruitment. Life Science eCTD publishing specialist Job Opening. Interested and eligible applicants can check out all of the details on the same  below: Name of the Post: eCTD publishing specialist Req ID: R-6271 Location: Bengaluru, Karnataka, India Purpose: The Central Regulatory Registration (CRR) […]

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