Category: Coronavirus

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Vaccine Makers are Working to Determine how well the Current Vaccine Formulations hold up Against Omicron

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the staff of the Ridgewood blog
Ridgewood NJ, the emergence of the Omicron SARS-CoV-2 variant in southern Africa has vaccine manufacturers discussing vaccine effectiveness and the possibility of updating vaccines to make them variant-specific. Omicron has around 50 mutations, and more than 30 of the mutations are located on the viral spike protein that is responsible for entry into host cells. The SARS-CoV-2 spike protein also is one of the primary antibody targets for the immune system. According to some analysis, most of the antibody target sites on Omicron’s spike protein are mutated, and several of those differences could indicate that Omicron is capable of escaping current vaccine formulations. A subset of Omicron’s spike mutations have been previously reported in the Beta and Delta variants, but 26 spike mutations are believed to be unique. Scientists are anticipating a decrease in antibody neutralization of the virus, and doctors in South Africa are reporting reinfections in patients who have already recovered from COVID-19.

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Two New Court Rulings Halt Vaccine Mandate for Federal Contractors and Health Workers

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the staff of the Ridgewood blog

Ridgewood NJ, a pair of rulings by separate federal judges  on Tuesday temporarily halted parts of the Biden administration’s mandatory COVID-19 vaccine policy for federal contractors, health workers.

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Former NY Governor Andrew Cuomo’s Impeachment Investigation Confirms Nursing Home COVID Death Coverup

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the staff of the Ridgewood blog

Ridgewood NJ, while the media has mostly focused on his sexual misconduct of former governor Andrew Cuomo, not to be missed in Monday’s investigative report from Davis, Polk, & Wardell is confirmation of Andrew Cuomo’s involvement in the nursing home deaths coverup.

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18% of Healthcare Workers in the US have Quit

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the staff of the Ridgewood blog

Ridgewood NJ, due to the protracted nature of the COVID-19 pandemic, many US healthcare workers are facing extreme burnout and leaving their posts in droves. About 18% of healthcare workers in the US have quit since the beginning of the pandemic and another 12% have been laid off. The stressors of the current emergency have nearly doubled the risk of burnout among physicians, with up to 75% reporting symptoms of exhaustion, depression, sleep disorders, or post-traumatic stress disorder (PTSD). Healthcare workers also are reporting higher rates of “moral injury,” prolonged moral trauma caused by factors including staffing shortages, a lack of equipment necessary to treat patients, decreasing wages, or feelings of helplessness.

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The Occupational Safety and Health Administration suspends enforcement of COVID-19 vaccine mandate for businesses

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the staff of the Ridgewood blog

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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Pfizer Requests Emergency Authorization for its Oral Antiviral Oral COVID-19 Treatment

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the staff of the Ridgewood blog

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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Concerns Mount Over Moderna SARS-CoV-2 Vaccine Use for Individuals Under the Age of 30

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the staff of the Ridgewood blog

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.

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“Vaccine Mandate” Put on Hold Following a Ruling by a 3-judge panel of the 5th US Circuit Court of Appeals

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the staff of the Ridgewood blog
Washington DC, the United States’ “vaccine mandate”* was put on hold following a ruling by a 3-judge panel of the 5th US Circuit Court of Appeals. The panel concluded that the mandate, an Emergency Temporary Standard (ETS) issued by the Occupational Safety and Health Administration (OSHA) that generally applies to companies and organizations with 100 or more employees, is “staggeringly overbroad” and does not sufficiently account for variations in working conditions and environments. The panel concluded that the policy should be suspended until the case can be argued in court. Lawyers from the Biden Administration appealed the initial panel ruling, arguing that a delay in implementing the mandate could result in many unnecessary deaths, but the judges upheld the initial decision. In its ruling, the panel described the policy as “fatally flawed” and indicated that lawsuits aiming to overturn it “are likely to succeed on their merits,” which suggests that the White House could face an uphill battle to institute the mandate in January.

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Moderna in dispute Over Patent Rights to the SARS-CoV-2 mRNA Vaccine

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the staff of the Ridgewood blog
Ridgewood NJ, Moderna and the US National Institutes of Health (NIH) are currently in a dispute over which entity should receive patent rights to the SARS-CoV-2 mRNA vaccine the company and the agency developed in partnership. The collaboration to develop the vaccine was widely hailed as a shining example of successful interaction between public and private entities for the benefit of the global population. However, Moderna’s patent paperwork noticeably does not include the government scientists involved in the vaccine development process as co-inventors. Moderna’s stance on this dispute is that they “reached the good-faith determination that these individuals did not co-invent” the vaccine. The NIH and consumer advocacy group Public Citizen disagree with this assessment, believing that federal scientists were core to the invention of the vaccine and should be included on the patent. The NIH and Moderna currently are engaged in talks to resolve the dispute, but if left unresolved, the issue could be taken into the court system for resolution.

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FDA has issued a recall for batches of Ellume’s at-home COVID-19 test kits

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the staff of the Ridgewood blog

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.

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Regeneron Pharmaceuticals REGEN-COV reduced the risk of developing COVID-19 by 81.5%

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the staff of the Ridgewood blog

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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Pfizer Antiviral Pill to Treat COVID-19 Reduced the Risk of COVID-19-related Hospitalization or Death

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the staff of the Ridgewood blog
Ridgewood NJ, Pfizer announced last week that its investigational antiviral pill to treat COVID-19 reduced the risk of COVID-19-related hospitalization or death from any cause by 89% when compared to a placebo among patients treated within 3 days of symptom onset. The planned interim results come from a Phase 2/3 clinical trial examining the pill—which is called Paxlovid and is taken in combination with an older antiviral named ritonavir—among COVID-19 patients recovering at home who are at high risk of developing severe disease. The company said it plans to submit the data to the US FDA as soon as possible to request emergency use authorization (EUA) for the antiviral. This is the second oral pill that has shown positive results in clinical trials for treating people with COVID-19 at home and could help alleviate the strain of the pandemic on hospitals. The other antiviral, molnupiravir, being developed by Merck and Ridgeback Biotherapeutics, reduced the risk of hospitalization and death by about half, and UK regulators granted conditional authorization to the pill last week. Clinical trial data for both drugs have not yet been peer-reviewed or published in a journal.

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COVID 19 Infection Long Term Negative Health Effects Associated with Persistent Anosmia, Loss of Smell

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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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Federal Court Temporarily Blocks OSHA COVID Vaccine Mandate

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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.

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U.K.’s Medicines and Healthcare Products Regulatory Agency Authorizes Molnupiravir for the Treatment of Mild-to-Moderate COVID-19 in Adults 

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Applications Remain Under Review by Other Regulatory Authorities, Including U.S. Food and Drug Administration and the European Medicines Agency

the staff of the Ridgewood blog

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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