Pfizer Withdraws EUA Application for COVID Shot in India After Regulator Asks for Independent Safety Study
Pfizer, Inc. has withdrawn its emergency use authorization (EUA) application for its experimental BNT162b2 (also known as “Comirnaty”) messenger RNA (mRNA) COVID-19 biologic (developed in collaboration with Germany’s BioNTech) in India.1 Pfizer was the first pharmaceutical company to apply for an EUA to distribute a COVID biologic in India in 2021. However, India’s regulatory agency […]
Pfizer, BioNTech Seek COVID Biologic Emergency Use Authorization for Infants as Young as Six Months Old
Pfizer and BioNTech have requested emergency use authorization (EUA) for doctors to administer two doses of their mRNA COVID-19 biologic to infants as young as six months old. A statement from Pfizer states that the “rolling submission” application was submitted on Feb. 1, 2022 at the request of the U.S. Food and Drug Administration (FDA) […]
Treatment Protocols for COVID-19: An Overview
Two years into the global pandemic of the novel coronavirus SARS-CoV-2, there is scant guidance from government agencies, universities, or professional medical organizations to help individuals recover from the SARS-CoV-2 infection that causes COVID-19 without the need for hospitalization. The U.S. Centers for Disease Control and Prevention (CDC), which recommends monoclonal antibodies for high-risk individuals […]
Some Physicians Warn Against Warp Speed COVID Vaccinations for Children
On Oct. 29, 2021 the U.S Food and Drug Administration (FDA) approved the use of Pfizer/BioNTech COVID-19 vaccine by five- to 11-year-old children under federal Emergency Use Authorization (EUA) guidelines. As California became the first state to announce that COVID vaccine will be required for children to attend school, districts in several other states plan […]
Merck and Pfizer Seek Approval for COVID-19 Antiviral Drugs
Merck and Pfizer have submitted Emergency Use Authorization (EUA) applications to the U.S. Food and Drug Administration (FDA) to authorize distribution of what would be the first antiviral drug specifically designed to treat COVID-19 disease.1 Merck/Ridgeback Biotherapeutics are seeking EUA approval for Molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral drug originally developed to treat influenza.2 Pfizer […]
FDA, CDC Green Light Pfizer’s Experimental COVID Biologic for Children 5 to 11 Years Old
One Oct 29, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the experimental messenger RNA (mRNA) Pfizer/BioNTech COVID-19 biologic BNT162b2 for children five to 11 years old. The FDA’s decision, which is based on a clinical trial earlier this year involving 2,268 kindergartners and elementary school-aged kids and an […]