Latest FDA, CDC, HHS, NIH Guidance & Guidelines

2022

Apr. 5, 2022: FDA - Monoclonal Sotrovimab no longer authorized to treat COVID-19 in any U.S. region

Mar. 31, 2022: NIH begins clinical trial evaluating 2nd COVID-19 booster shots in adults

Mar. 29, 2022: FDA Authorizes 2nd Booster of COVID-19 Vaccines for Older and Immunocompromised Individuals

Mar. 25, 2022: FDA updates Sotrovimab emergency use authorization

Mar. 8, 2022: HHS: WH Launches Nationwide Test-to-Treat Initiative (‘On the Spot’ Access to Lifesaving COVID Treatments)

Feb. 24, 2022: FDA Authorizes revisions to Evusheld dosing

Feb. 10, 2022: HHS Announces Purchase of 600K doses of New Monoclonal Antibody That Works Against Omicron

Jan. 24, 2022: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant

Jan. 21, 2022: FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19

Jan. 19, 2022: NIH on Therapies for High-Risk, Nonhospitalized Patients With Mild to Moderate COVID-19

Jan. 5, 2022: NIH on Tixagevimab Plus Evusheld for Pre-Exposure Prophylaxis for SARS-CoV-2 Infection

Jan. 3, 2022: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine (for 12 and older)

2021

Dec. 31, 2021: ASPR - Updated guidelines regarding allocation of bamlanivimab/etesevimab and REGEN-COV therapeutics

Dec. 27, 2021: CDC Updates and Shortens Recommended Isolation and Quarantine Period for General Population

Dec. 23, 2021: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults

Dec. 23, 2021: NIH on Patient Prioritization for Outpatient Anti-SARS-CoV-2 Therapies

Dec. 22, 2021: FDA Authorizes First Oral Antiviral for Treatment of COVID-19

Dec. 16, 2021: NIH - Anti-SARS-CoV-2 Monoclonal Antibodies

Dec. 9, 2021: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds

Dec. 8, 2021: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19

Dec. 3, 2021: FDA Expands use of Monoclonals for Treatment / Prevention of C19 to Pediatric Patients + Newborns

Nov. 19, 2021: FDA Expands Eligibility for COVID-19 Vaccine Boosters

Nov. 2, 2021: CDC Recommends Pediatric COVID-19 Vaccine for Children 5 to 11 Years

Sept. 13, 2021: HHS Announces State / Territory Distribution for Monoclonal Antibody Therapeutics

May 26, 2021: FDA expands rules for Monoclonal Antibody treatment