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Merck says its New COVID Antiviral Pill Reduces the Risk of Hospitalization

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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 molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.

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FDA Issues Emergency Use Authorization for Johnson & Johnson Sigle Dose COVID Vaccine

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the staff of the Ridgewood blog

Washington DC, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

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Johnson & Johnson Requests Emergency Use Authorization from FDA for One Dose COVID Vaccine

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the staff of the Ridgewood blog

New Brunswick NJ,  Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The Company expects to have product available to ship immediately following authorization.

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What Ingredients are Really in the COVID Vaccines

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Clinical Contributors to this Story Juan C. Ravell, M.D. Hackensack Meridian Health

Hackensack NJ, The Pfizer-BioNTech and Moderna COVID-19 vaccines were given Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in mid-December 2020. Prior to authorization by the FDA, these vaccines underwent the same rigorous safety and effectiveness standards as all other vaccines. Quickly, vaccine distribution began, starting with health care professionals on the frontlines of patient care.

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