Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

Washington, D.C…. Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments […]

Governor Newsom Launches “Vaccinate All 58” Campaign Based on Safety and Equity as First Vaccines Arrive to California

Governor Newsom Launches “Vaccinate All 58” Campaign Based on Safety and Equity as First Vaccines Arrive to California

Los Angeles, CA… As the first doses of the Pfizer vaccine arrive in California, Governor Gavin Newsom today launched “Vaccinate All 58”, California’s campaign for a safe, fair and equitable vaccine for all 58 counties in the state. The Governor joined Kaiser Permanente Los Angeles Medical Center, one of the first locations in the state […]

Governor Cuomo Announces First Dose of COVID-19 Vaccine Administered in U.S.

Governor Cuomo Announces First Dose of COVID-19 Vaccine Administered in U.S.

Albany, NY… Governor Cuomo: “We trust science here in New York. The federal government approved the vaccine. We then had a separate panel that also approved the vaccine and we’ve been following the science all along. I hope this gives you, and the healthcare workers who are battling this every day, a sense of security […]

FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses

FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses

Washington D.C…. Today, the U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. This is the first IGA in an animal that the FDA has approved for both human food consumption and […]

U.S. CDC Committee of Independent Health Experts Recommends Vaccination with Pfizer and Biontech COVID-19 Vaccine for Persons Ages 16 Years and Older

U.S. CDC Committee of Independent Health Experts Recommends Vaccination with Pfizer and Biontech COVID-19 Vaccine for Persons Ages 16 Years and Older

New York & Mainz, Germany… Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted today to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older under the Emergency Use Authorization (EUA) issued […]

Pfizer and Biontech to Submit Emergency Use Authorization Request Yesterday to the U.S. FDA for COVID-19 Vaccine

Pfizer and Biontech to Submit Emergency Use Authorization Request Yesterday to the U.S. FDA for COVID-19 Vaccine

New York & Mainz, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by […]

FDA Authorizes Drug Combination for Treatment of COVID-19

FDA Authorizes Drug Combination for Treatment of COVID-19

Washington, DC…The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical […]

Covid Update from Vice President Pence and Members of the Coronavirus Task Force

Covid Update from Vice President Pence and Members of the Coronavirus Task Force

Washington, DC…Well, good afternoon. We just completed our second meeting this week with members of the White House Coronavirus Task Force. And we’ve continued — we’ve continued to be on the same mission we’ve been on throughout the course of this year, and that is to save American lives and to work every day toward […]

COVID-19 Vaccine Candidate Found to be More than 90% Effective in Preventing COVID-19

COVID-19 Vaccine Candidate Found to be More than 90% Effective in Preventing COVID-19

New York, NY & Mainz, DE– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee […]