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Washington DC, the Occupational Safety and Health Administration (OSHA) is suspending enforcement of the Biden administration’s COVID-19 vaccine mandate for large private businesses after a federal appeals court upheld a stay on it last week.
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Ridgewood NJ, Pfizer requested emergency authorization for its antiviral oral COVID-19 treatment on Tuesday after a study found the pills dramatically reduced the risk of hospitalization.
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Ridgewood NJ, France and Germany joined Finland, Norway, and Sweden in recommending that the Moderna SARS-CoV-2 vaccine not be used for individuals under the age of 30 due to increased risk of myocarditis in that age group. Denmark has similarly recommended against offering the vaccine to individuals under the age of 18. French authorities recently emphasized, however, that vaccine effectiveness was slightly higher for the Moderna vaccine than for the Pfizer-BioNTech vaccine, and the Moderna product should be preferentially utilized for individuals aged 30 years or older. The European Medicines Agency (EMA) has authorized the Moderna vaccine for use in individuals aged 12 years and older.
Continue reading Moderna in dispute Over Patent Rights to the SARS-CoV-2 mRNA Vaccine
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Ridgewood NJ, The FDA has issued a recall for additional batches of Australia-based company Ellume’s at-home COVID-19 test kits for potentially false-positive results. This recall is for the same issue that was previously reported in early October and classified as a Class I recall, the most serious recall designation that may result in “serious adverse health consequences or death.” Product batches with a manufacture date between February 24 and August 11, 2021, and distribution dates between April 13 and August 26, 2021, are included in the recall, which includes more than 2.2 million of the 3.5 million tests shipped to the US; Ellume’s previous estimate of faulty tests was 427,000. Those who attempt to use the affected tests will be notified through the app of the recall status, and replacement tests can be requested online. Thus far, the FDA has received reports of 35 false positives from the tests.
Continue reading FDA has issued a recall for batches of Ellume’s at-home COVID-19 test kits
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Ridgewood NJ, Regeneron Pharmaceuticals on November 8 announced positive results from a Phase 3 clinical trial of its combination monoclonal antibody REGEN-COV for SARS-CoV-2 prevention. The trial—jointly run with the US National Institute of Allergy and Infectious Diseases (NIAID)—enrolled SARS-CoV-2-negative individuals who lived in the same household as someone who tested positive for SARS-CoV-2 within the prior 4 days. Participants received either one 1,200mg dose of REGEN-COV, administered via 4 subcutaneous injections, or a placebo.
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Ridgewood NJ, a major health concern of Americans is whether COVID 19 infection can lead to long term negative health effects. The Journal of the American Medical Association published large, elegantly designed French study that analyzed the association between purported long COVID symptoms and “self-reported” COVID versus serologically confirmed COVID. The results: “A serology test result positive for SARS-COV-2 was positively associated only with persistent anosmia,” that is a loss of smell.
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Ridgewood NJ, The United States Court of Appeals for the Fifth Circuit temporarily halted the Biden administration’s rule requiring employers with over 100 workers to mandate COVID-19 vaccinations or implement weekly testing.
Continue reading Federal Court Temporarily Blocks OSHA COVID Vaccine Mandate
Applications Remain Under Review by Other Regulatory Authorities, Including U.S. Food and Drug Administration and the European Medicines Agency
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KENILWORTH NJ, Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom (U.K.) for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. In the U.K., LAGEVRIO® (lah-GEV-ree-oh) is the planned trademark for molnupiravir; the trademark for molnupiravir in other countries has not been approved. Merck announced its application with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of molnupiravir is under review and recently announced the European Medicines Agency has initiated a rolling review of the company’s Marketing Authorization Application. Merck is actively working to submit applications to other regulatory agencies around the world.
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Ridgewood NJ, nearly half of voters believe Dr. Anthony Fauci lied about U.S. funding for “gain-of-function” research, and a plurality think the government’s top COVID-19 expert should be forced to resign.
Continue reading Plurality of Voters Want Dr. Anthony Fauci to Resign
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Newark NJ, A dual New York and Florida resident today admitted his role in a scheme to fraudulently obtain federal Paycheck Protection Program (PPP) loans totaling over $6.8 million, Acting U.S. Attorney Rachael A. Honig and Assistant Attorney General Kenneth A. Polite Jr. of the Justice Department’s Criminal Division announced today.
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Ridgewood NJ, More than 18 months into the COVID-19 pandemic, the U.S. government’s leading expect on the virus has lost credibility and a plurality of Americans now have a negative opinion of Dr. Anthony Fauci.
Continue reading Most Americans Think Dr. Fauci Has ‘Lost Credibility’
Pfizer Scientists Agree on Natural Immunity’s Protection
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Trenton NJ, as evidence continues to mount that recovered COVID-19 patients are as protected against the virus as those who are vaccinated, Senator Joe Pennacchio today said it is time for the Murphy Administration to face facts and acknowledge the reality of natural immunity.
