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AstraZeneca to deliver 500,000 more doses of AZD7442 to the US

AstraZeneca to deliver 500,000 more doses of AZD7442 to the US
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United Kingdom , Pascal Soriot , Department Of Defense Do , Vanderbilt University Medical Center , Human Services , Biomedical Advanced Research , Dod Joint Program Executive Office For Chemical , Development Authority , Department Of Health , Nuclear Defense , Army Contracting , Emergency Use Authorisation , Army Contracting Command , Dod Joint Program Executive Office , ஒன்றுபட்டது கிஂக்டம் , துறை ஆஃப் பாதுகாப்பு செய் , வாண்டர்பில்ட் பல்கலைக்கழகம் மருத்துவ மையம் , மனிதன் சேவைகள் , தோட் கூட்டு ப்ரோக்ர்யாம் நிர்வாகி அலுவலகம் க்கு இரசாயன , வளர்ச்சி அதிகாரம் , துறை ஆஃப் ஆரோக்கியம் , அணு பாதுகாப்பு , இராணுவம் ஒப்பந்தம் , இராணுவம் ஒப்பந்தம் கட்டளை , தோட் கூட்டு ப்ரோக்ர்யாம் நிர்வாகி அலுவலகம் ,

FDA Authorizes Lilly COVID-19 Antibody Combination for Emergency Use


FDA Authorizes Lilly COVID-19 Antibody Combination for Emergency Use
February 10, 2021
The FDA has granted Emergency Use Authorization (EUA) for a 700 mg dose of bamlanivimab (LY-CoV555) in combination with a 1400 mg dose of a second Lilly antibody candidate, etesevimab (LY-CoV016), for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. [Eli Lilly]
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The FDA last night granted Emergency Use Authorization (EUA) for a 700 mg dose of bamlanivimab (LY-CoV555)  in combination with a 1400 mg dose of a second Lilly antibody candidate, etesevimab (LY-CoV016), for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. ....

District Of Columbia , United States , Daniel Skovronsky , Vaccine Research Center , Biomedical Advanced Research , Dod Joint Program Executive Office For Chemical , Development Authority , Lilly Research Laboratories , Nuclear Defense , Army Contracting , Emergency Use Authorization , Dod Joint Program Executive Office , Operation Warp Speed , மாவட்டம் ஆஃப் கொலம்பியா , ஒன்றுபட்டது மாநிலங்களில் , தடுப்பூசி ஆராய்ச்சி மையம் , தோட் கூட்டு ப்ரோக்ர்யாம் நிர்வாகி அலுவலகம் க்கு இரசாயன , வளர்ச்சி அதிகாரம் , லில்லி ஆராய்ச்சி ஆய்வகங்கள் , அணு பாதுகாப்பு , இராணுவம் ஒப்பந்தம் , அவசரம் பயன்பாடு அங்கீகாரம் , தோட் கூட்டு ப்ரோக்ர்யாம் நிர்வாகி அலுவலகம் , செயல்பாடு போரிடு வேகம் ,

U.S. Department of Health and Human Services and Controlant Announce Agreement for 360 Monitoring of COVID-19 Vaccines


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KOPAVOGUR, Iceland and SAN FRANCISCO, Dec. 18, 2020 /PRNewswire/  Controlant, a leader in real-time supply chain monitoring and visibility for heavily regulated industries, such as pharmaceuticals and life sciences and food and beverage sectors, today announced the company is working with the U.S. Department of Health and Human Services (HHS) and other Operation Warp Speed agency partners to help ensure the availability of COVID-19 vaccines to the American public.
Controlant is providing on-site temperature monitoring of the mRNA-based Pfizer-BioNTech COVID-19 vaccine at preferred channel and designated vaccination locations in order for federal and state health officials to help ensure continuity, actionable communication, and seamless monitoring and visibility throughout the entire supply chain journey of the Pfizer vaccine. ....

United States , Gisli Herjolfsson , Jessie Vanderveen , Human Services , Biomedical Advanced Research , Us Department Of Health , Dod Joint Program Executive Office For Chemical , Development Authority , Office Of The , Nuclear Defense , Operation Warp Speed , Assistant Secretary , Dod Joint Program Executive Office , Cold Chain , ஒன்றுபட்டது மாநிலங்களில் , ஜெஸ்ஸி வந்தேருவீன் , மனிதன் சேவைகள் , எங்களுக்கு துறை ஆஃப் ஆரோக்கியம் , தோட் கூட்டு ப்ரோக்ர்யாம் நிர்வாகி அலுவலகம் க்கு இரசாயன , வளர்ச்சி அதிகாரம் , அலுவலகம் ஆஃப் தி , அணு பாதுகாப்பு , செயல்பாடு போரிடு வேகம் , உதவியாளர் செயலாளர் , தோட் கூட்டு ப்ரோக்ர்யாம் நிர்வாகி அலுவலகம் , குளிர் சங்கிலி ,

Special Storage and Adverse Reactions for First COVID-19 Vaccine Approved by the FDA


Limitations and Safety Concerns of the Pfizer Vaccine 
The FDA s Advisory Committee on Immunization Practices (ACIP) panelists met Dec. 11 and recommended approval of the vaccine for those age 16 and older. The panel said clinicians need more guidance on whether to use the vaccine on pregnant or breastfeeding women, the immunocompromised, those who have a history of allergies and those under age 16. 
The FDA-issued healthcare provider information sheet on the vaccine said there is not enough data to recommend vaccinating those women or the immunocompromised, and also advises against giving the vaccine to individuals who have a history of serious allergic reaction to any component of the vaccine. ....

United States , Alex Azar , Janssen Johnson , National Institute Of Allergy , Dod Joint Program Executive Office For Chemical , Pfizer Inc , Nuclear Defense , Biologics Advisory Committee , National Institutes Of Health , Biomedical Advanced Research , Human Services , Us Department Of Health , Drug Administration , Advisory Committee On Immunization Practices , Development Authority , Office Of The , Products Advisory Committee , Army Contracting , Related Biologics Advisory Committee , Operation Warp Speed , Multiple Dose Vials , Safety Concerns , Pfizer Vaccine , Immunization Practices , May See , Assistant Secretary ,

FDA Clears First COVID-19 Vaccine Under an Emergency Use Authorization


Storage and Handling and the Pfizer mRNA COVID-19 Vaccine
The vaccine uses messenger RNA, which is extremely fragile and requires very cold storage temperatures and can be damaged by light. This is the is the first ever messenger RNA vaccine to gain FDA clearance. 
Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials are shipped in thermal containers with dry ice. Once received, hospitals need to remove the vial cartons immediately from the thermal container and store in an ultra-low temperature freezer between -112ºF to -76ºF (-80ºC to -60ºC). Vials must be kept frozen and have minimized exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. ....

United States , Alex Azar , Janssen Johnson , National Institute Of Allergy , Dod Joint Program Executive Office For Chemical , Pfizer Inc , Nuclear Defense , Biologics Advisory Committee , National Institutes Of Health , Biomedical Advanced Research , Human Services , Us Department Of Health , Drug Administration , Advisory Committee On Immunization Practices , Development Authority , Office Of The , Products Advisory Committee , Army Contracting , Related Biologics Advisory Committee , Operation Warp Speed , Multiple Dose Vials , Safety Concerns , Pfizer Vaccine , Immunization Practices , May See , Assistant Secretary ,