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The preventive effect of the phase 3 test is 94.1%, similar to the result of the preliminary analysis … “Change the direction of the pandemic”
The American pharmaceutical company Modena has initiated procedures for the urgent use of a new vaccine against coronavirus infection (Corona 19) in the United States and Europe.
According to Reuters and CNBC Broadcasting on the 30th (local time), Modena revealed that the final analysis of its own phase 3 clinical trial of the vaccine showed a 94.1% preventive effect.
Moderna is applying for the emergency use of its vaccine to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The result of a 94.1% vaccine effect is almost the same as the preliminary analysis of the phase 3 clinical trial announced on day 16 by Modena and the prevention rate of 94.5%.
A total of 196 confirmed cases of corona19 occurred in a phase 3 clinical trial involving 30,000 participants, of which 185 were in the group that administered placebo (a fake drug), and only 11 were confirmed in the group that received the vaccine of Modena.
In particular, the 30 seriously ill patients participated in the clinical trial that administered placebo, the company said. This means that none of the modders or vaccinators were seriously ill.
“This analysis specifically confirmed the ability of our vaccine to prevent severe disease COVID-19,” said Steve Vancel Modena, CEO, “Our vaccine changed the direction of the pandemic (a global infectious disease pandemic) and” We believe it will be a powerful new tool to help prevent death. “
Moderna said her vaccines were consistently effective regardless of age, race or gender, and that no serious side effects occurred. Common side effects such as fatigue, muscle pain, headache, and injection site pain were noted but were not serious.
This is the second time that Modena has applied to the FDA for approval of the emergency use of the corona vaccine after Pfizer-Bioentech. Both the Modena and Pfizer vaccines were developed using a new technology called “messenger ribonucleic acid” (mRNA, messenger RNA).
If the FDA approves urgent use, vaccination will begin in the US in a few weeks, primarily for medical personnel, high-risk groups, and workers in essential industries. The FDA will hold an advisory committee meeting on Dec. 17 to review Modena’s vaccines, Modena said.
Earlier, the US Secretary of Health and Human Services, Alix Aza, said the FDA would carry out the approval process for the Pfizer and Modena vaccines as quickly as possible.
Moderna said 20 million doses of the vaccine could be produced in the United States this year and that it will begin distribution as soon as it is approved.
He also added that Moderna plans to begin a vaccine trial for teens ages 11 to 17 within the year.
But, like other vaccines, CNBC notes that it is not yet clear how long immunity lasts for modders and vaccines, and how often revaccination is required if necessary.
Yunhap news
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