The Ridgewood Blog Brings a Free Market Laissez-faire Point of View to Local, New Jersey State and National Issues.
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WASHINGTON, D.C. — The Food and Drug Administration (FDA) has approved updated COVID-19 vaccines for fall, but with the tightest restrictions yet on who should receive them.
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced the approval on Aug. 27, stating that emergency-use authorizations have ended and that updated vaccines from Pfizer, Moderna, and Novavax are now approved for people considered at high risk of severe illness.
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Ridgewood NJ, the U.S. Food and Drug Administration (FDA) has announced major changes to how annual COVID-19 boosters are approved in the U.S., signaling a shift in vaccination policy that could limit eligibility to older adults and high-risk individuals. The new guidance, published in the New England Journal of Medicine, emphasizes the need for new clinical trials before extending yearly COVID-19 vaccines to healthy Americans under age 65.
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Continue reading Moderna in dispute Over Patent Rights to the SARS-CoV-2 mRNA Vaccine
photo courtesy of Valley Hospital
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Ridgewood NJ, It’s a milestone day for Valley Hospital! Valley has administered 50,000 doses of the Moderna, Pfizer, and Johnson & Johnson COVID-19 vaccines! They will continue to open up appointments as the vaccine becomes available. You can check appointment availability here: https://www.valleyhealth.com/vaccine.
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Ridgewood NJ, new guidelines from the Centers for Disease Control and Prevention (CDC) suggest it is safe for fully vaccinated people to gather indoors with each other without masks. “If you and a friend, or you and a family member are both vaccinated, you can have dinner together” without wearing masks or without distancing, CDC Director Rochelle Walensky told reporters on Monday.
Continue reading CDC Now Says Vaccinated People can Safely Gather Indoors without Masks
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Washington DC, the White House Chief Medical Advisor Dr. Anthony Fauci said on Sunday he would take the newly approved Johnson & Johnson Covid-19 vaccine and urged Americans to take whichever shot is available when they are eligible.
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HACKENSACK NJ, Bergen County Executive Jim Tedesco announces that the County of Bergen in partnership with Bergen New Bridge Medical Center have received 1000 doses of the Moderna COVID-19 vaccine and will begin distribution to Bergen County category 1A healthcare workers on Monday, December 28.
Continue reading DISTRIBUTION OF MODERNA VACCINE TO BERGEN COUNTY HEALTHCARE WORKERS BEGINS MONDAY
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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.
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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.
the staff of the Ridgewood blog
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 independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This 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.
Continue reading Moderna’s COVID-19 Vaccine 94.5% Effective !
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CAMBRIDGE Mass. Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support late stage clinical development including the expanded Phase 3 study of the Company’s mRNA vaccine candidate (mRNA-1273) against COVID-19.
Continue reading Moderna Starts Phase 3 Trial For Its Coronavirus Vaccine
