COVID-19: Vaccines and Therapeutics
As COVID-19 vaccine development continues to progress, leading U.S. medical, nursing and health organizations today affirmed their commitment to ensuring COVID-19 vaccines are evaluated and ultimately authorized through a rigorous scientific and regulatory process.
Following analysis of additional primary efficacy data for its mRNA-1273 COVID-19 vaccine candidate, Moderna Inc. said it will apply for emergency use authorization from the Food and Drug Administration.
The Centers for Medicare & Medicaid Services released updated guidance for states and territories on Medicaid, Children’s Health Insurance Program and Basic Health Program coverage and reimbursement for COVID-19 vaccinations.
The Centers for Disease Control and Prevention released recommendations for the ethical allocation of COVID-19 vaccines, once available to the public.
The Food and Drug Administration authorized administering the monoclonal antibodies casirivimab and imdevimab together to certain COVID-19 outpatients at risk for severe disease.
Drug maker AstraZeneca said it will seek an emergency use authorization for its AZD1222 vaccine candidate for SARS-CoV-2 following positive high-level results from an interim analysis of ongoing clinical trials.
The Food and Drug Administration authorized the emergency use of baricitinib in combination with remdesivir to treat suspected or laboratory confirmed COVID-19 in certain hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation.
Pfizer Inc. announced it will request emergency use authorization from the Food and Drug Administration for its BNT162b2 mRNA vaccine candidate against SARS-CoV-2.
The principals behind the federal Operation Warp Speed initiative expressed optimism that the Food and Drug Administration could soon authorize two safe and highly effective COVID-19 vaccines.
This snapshot provides an overview of three treatments including Veklury (remdesivir), Eli Lilly’s bamlanivimab, and Regeneron’s antibody cocktail.