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The Food and Drug Administration (FDA) authorized this Friday the emergency use in the United States of the vaccine against covid-19 from the company Moderna, after a committee of experts decided to recommend approval.
In this way, Moderna’s becomes the second vaccine approved in the United States to combat the ravages of the new coronavirus, after last week the Pfizer-BioNTech drug received the same authorization for emergency use from the US authorities.
At a meeting Thursday, the FDA’s Vaccines and Biologics Advisory Committee decided to endorse Moderna’s project after reviewing the results of phase III trials the company submitted that reported 94 percent efficacy and safety in those who received the drug.
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Scientists analyzed the results of a clinical trial with 30,400 volunteers who allowed to establish that Moderna’s vaccine is 94.1 percent effective in preventing covid-19 compared to a placebo, with slightly better performance in young adults compared to the elderly.
The FDA had already endorsed the results of the submitted clinical trials, in which no “specific safety concerns” were found.
The most common side effects associated with this vaccine, called mRNA-1273, they were fatigue (70%), headache (60%), muscle pain (60%), joint pain (45%), and chills (45%).
The rare “serious” side effects tend to occur in younger participants more than older ones. Cases of lymphadenopathy, or swelling of the lymph nodes, appeared in 1.1% of the participants who received the vaccine, compared with 0.6% of those who received the placebo.
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Moderna, a small Massachusetts-based biotech company partnered with scientists from the US National Institutes of Health to develop the vaccine. Work began in January, shortly after China shared the Sars-CoV-2 virus genome.
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His project has received more than 2.5 billion dollars from the United States government and has promised to deliver six million doses in a first phase.
As announced by President Donald Trump, anticipating the official announcement of the FDA, Moderna’s vaccine will begin to be applied as soon as possible in the United States to reinforce the vaccination campaign that began last week with that of Pfizer.
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HEALTH UNIT