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The US Food and Drug Administration (FDA) issued a positive assessment on Tuesday about the American laboratory Moderna’s vaccine against covid-19 before an expert meeting to assess your emergency approval.
If approved by the FDA’s vaccine panel, it could become the second coronavirus vaccine to be approved in the US.
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The FDA was optimistic about the vaccine, stating that it did not show “specific safety concerns” that “prevent the issuance” of an emergency use authorization.
The US agency determined that clinical trial results and safety data are “consistent with the recommendations required by the Guide in the Authorization of Use Emergency for Vaccines to prevent covid-19 “.
Moderna indicated that in clinical trials has been shown to be 94.1 percent effective in preventing disease and 100 percent when it comes to avoiding serious cases.
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“The FDA has determined that the manufacturer has provided adequate information to ensure the quality and consistency of the vaccine for product authorization,” the document added.
An independent advisory committee will meet this Thursday to evaluate the new vaccine, a meeting in which its approval is awaited and that would give the green light to begin its supply in the US in the next few days.
This Monday, the first injections of the vaccine developed by Pfizer and BioNTech in the United States began, which Moderna would be the second serum available to combat covid-19 in the country.
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The Centers for Disease Control and Prevention (CDC) recommended vaccinating first for healthcare workers and those who work or live in facilities dedicated to long-term medical care, such as nursing homes or centers for the people. with disabilities.
The hopeful news of the inoculation of the first vaccines comes amid one of the deadliest streaks since the pandemic began, as the US surpassed 300,000 confirmed deaths from covid-19 on Monday.
About the vaccine
Like Pfizer’s vaccine, Moderna’s is based on new messenger RNA technology, but its advantage is that it is reportedly it does not need ultra-cold storage, which would facilitate its distribution. In fact, Moderna expects it to be stable at standard refrigerator temperatures of 2 to 8 degrees Celsius for 30 days and can be stored at -20 degrees Celsius for 6 months.
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The United States Government supported Moderna’s project through the National Institutes of Health with an initial $ 1 billion and in August $ 1.5 billion were added in exchange for 100 million doses, if the vaccine shows that it is safe and effective . Moderna is known to have made similar agreements with other countries.
HEALTH UNIT
* With information from AFP and EFE
