The Ridgewood Blog Brings a Free Market Laissez-faire Point of View to Local, New Jersey State and National Issues.
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New Brunswick NJ, Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
Continue reading Johnson & Johnson single-shot COVID-19 vaccine Gets the Green Light from FDA
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CAMBRIDGE, Mass. Moderna, Inc., (Nasdaq:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for the Company’s COVID-19 vaccine candidate, mRNA-1273. 20 VRBPAC members recommended for EUA, 0 members voted against, and 1 abstained.
Clinical Contributors to this Story Ihor Sawczuk, M.D. contributes to topics such as Medical Research, Urology.
Hackensack NJ, The United States has begun to roll out COVID-19 vaccines in an effort to help stop the pandemic. Millions of people will line up across the country to get the vaccine, expected to be approved by the U.S. government.
For many, we’ve never really thought about the approval process that every vaccine, including the COVID-19 vaccine, must go through before getting approved for public use. It’s an extensive and rigorous process to ensure it’s safe before it can be distributed to the community.
Continue reading Hackensack Meridian Health : Behind the COVID-19 Vaccine Approval Process
the staff of the Ridgewood compiled from the CDC website
Ridgewood NJ, In the United States, there is not yet an authorized or approved vaccine to prevent coronavirus disease 2019 (COVID-19). The federal government, through Operation Warp Speedexternal , has been working since the pandemic started to make one or more COVID-19 vaccines available as soon as possible. Although CDC does not have a role in developing COVID-19 vaccines, CDC has been working closely with health departments and partners to develop vaccination plans for when a vaccine is available.
With the possibility of one or more COVID-19 vaccines becoming available before the end of the year, here are things you need to know about where those plans currently stand.
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CAMBRIDGE Mass , Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1%. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB). The Company also announced that today, Moderna plans to request an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA). The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
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INDIANAPOLIS IN, The U.S. Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The authorization allows for the distribution and emergency use of bamlanivimab, which is administered via a single intravenous infusion.
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Ridgewood NJ, according to Johns Hopkins Center for Health Security ,Pharmaceutical manufacturer Eli Lilly submitted an EUA request to the FDA for its monoclonal antibody cocktail as a COVID-19 treatment after clinical trials for the drugs met the target clinical endpoints. Results from a Phase 2 clinical trial indicate that a combination of two of Eli Lilly’s monoclonal antibodies reduced viral load in COVID-19 patients mitigated symptoms and resulted in fewer hospitalizations and emergency department visits. The study included 268 total participants with mild-to-moderate COVID-19 symptoms, 112 of whom received the treatment and 156 who received a placebo. Additionally, a press release issued by the company indicates that no serious adverse events were reported. The company stated that it aims to make 100,000 doses of a single antibody available by the end of October and 1 million by the end of 2020. For the combination therapy, the company hopes to produce 50,000 doses by the end of 2020, and it is collaborating with various external partners to ensure availability for lower-income countries.
