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Emergency Use Authorization

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COVID-19: FDA Announces New At-Home Test Recall COVID-19: FDA Announces New At-Home Test Recall
Covid-19: FDA Announces New At-Home Test Recall Federal health officials are cautioning Americans not to use a specific COVID-19 at-home testing kit that has not been approved or authorized by medical authorities. The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), are advising against the use of the LuSys Laboratories COVID-19 Antigen Test because they have not been cleared for use. In total, nearly 165,000 at-home kits are subject to the recall, according to the FDA. Officials said that the LuSys Laboratories COVID-19 Antigen Test uses a nasal swab, or a saliva (spit) sample intended to de…

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by Zak Failla
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COVID-19: Moderna Vaccine Gets Full Approval From FDA COVID-19: Moderna Vaccine Gets Full Approval From FDA
Covid-19: Moderna Vaccine Gets Full Approval From FDA Federal officials have granted full approval to Moderna’s COVID-19 vaccine following its authorization last year for emergency use. On Monday, Jan. 31, the Food and Drug Administration (FDA) announced that Moderna’s vaccine has been granted its full approval, joining the Pfizer shot which was authorized months ago. The move comes after tens of millions of doses of the Moderna vaccine have already been administered across the country. It also represents Moderna’s first FDA-approved product in the US. Officials said the FDA reviewed months of additional follow-up data submitted by Moderna to…

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by Zak Failla
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COVID-19: FDA Expands Pfizer Booster Eligibility Among Adolescents As Omicron Cases Skyrocket COVID-19: FDA Expands Pfizer Booster Eligibility Among Adolescents As Omicron Cases Skyrocket
Covid-19: FDA Expands Pfizer Booster Eligibility Among Adolescents As Omicron Cases Skyrocket As the Omicron COVID-19 variant rages across the country, federal health officials have expanded the eligibility for booster shots in younger Americans. The Food and Drug Administration (FDA) announced on Monday, Jan. 3 that it is expanding the eligibility for Pfizer and BioNTech booster shots to American between the ages of 12 and 15 years old as children return to school amid a surge of new COVID-19 infections. FDA vaccine chief Dr. Peter Marks said in a statement the agency made its decision because a booster “may help provide better protection against both the delt…

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by Zak Failla
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COVID-19: FDA Authorizes Second Antiviral Pill COVID-19: FDA Authorizes Second Antiviral Pill
Covid-19: FDA Authorizes Second Antiviral Pill For the second time in as many days, the Food and Drug Administration (FDA) has authorized the use of an antiviral pill to treat mild and moderate COVID-19 cases. On Thursday, Dec. 23, the FDA approved the use of Merck’s molnupiravir pill for emergency use authorization, a day after officials authorized the use of Pfizer’s COVID-19 treatment pill. Earlier story - COVID-19: FDA OKs First Authorized Home Treatment For Virus Merck’s pill has been cleared for use by adults 18 and older who have tested positive for COVID-19 and are at the greatest risk of being hospitalized or dying from t…

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by Zak Failla
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COVID-19: FDA Expands Booster Vaccine Eligibility To Include Ages 16 & 17 COVID-19: FDA Expands Booster Vaccine Eligibility To Include Ages 16 & 17
Covid-19: FDA Expands Booster Vaccine Eligibility To Include Ages 16 & 17 The United States Food and Drug Administration (FDA) has expanded eligibility for Pfizer's COVID-19 booster vaccines to include 16- and 17-year-olds. The FDA said in an announcement on Thursday, Dec. 9, that it has amended the emergency use authorization of the booster vaccine to include those aged 16 and older at least six months after they've completed their primary vaccination. “Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,”…

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by Nicole Valinote
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COVID-19: Pfizer Asks FDA To Approve Vaccine For Children Ages 5 To 11 COVID-19: Pfizer Asks FDA To Approve Vaccine For Children Ages 5 To 11
Covid-19: Pfizer Asks FDA To Approve Vaccine For Children Ages 5 To 11 Pfizer has officially asked the US Food and Drug Administration (FDA) for emergency use authorization for its COVID-19 vaccine to be administered to children between the ages of 5 and 11. With parents and politicians alike agreeing that keeping children learning in the classroom after a lost year in 2020, Pfizer is pushing to allow its vaccine to be administered among younger Americans. Pfizer tweeted this week that the company had submitted their formal request for Emergency Use Authorization of the vaccine to the FDA. "With new cases in children in the U.S. continuing to be at a high lev…

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by Zak Failla
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COVID-19: Here's When Vaccine Rollout May Start For Kids Ages 5 To 11 COVID-19: Here's When Vaccine Rollout May Start For Kids Ages 5 To 11
Covid-19: Here's When Vaccine Rollout May Start For Kids Ages 5 To 11 The Pfizer COVID-19 vaccine could be available to children ages 5 and older late in the fall or early this winter, according to a company board member. Former Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb told CNBC that he believes the company's COVID vaccine will be approved for emergency use for children ages 5 to 11 sometime this fall or winter. Gottlieb told the news outlet that the application will likely be submitted to the FDA in October.  He said the FDA will likely take four-to-six weeks to review the application, so the emergency use authorization c…

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by Nicole Valinote