COVID-19

2023

FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults (June 2023) [PDF - 143 KB]

FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines (April 2023) [PDF - 182 KB]

FDA authorizes GOHIBIC (vilobelimab) injection for the treatment of COVID-19 [PDF - 59 KB]

Updated Bivalent COVID-19 Vaccines EUA For Booster Dose in Children Down To 6 months [PDF - 216 KB]

EUA Changes to Paxlovid® and Lagevrio™ Removing Positive COVID-19 Test Requirements [PDF - 196 KB]

Clinical Research Linking Paxlovid® to Lower Long COVID-19 Risk [PDF - 195 KB]

FDA announces Evusheld is not currently authorized for emergency use in the U.S. [PDF - 184 KB]

FDA and CDC Identify Preliminary Safety Signal in Pfizer COVID-19 Vaccine in Person 65 Years and Older [PDF - 254 KB]

2022

FDA Authorizes Kineret® (anakinra) injection for the treatment of COVID-19 in certain hospitalized patients [PDF - 279 KB]

FDA Authorizes Updated Bivalent COVID 19 Vaccines For Children Down To 6 Months (Dec 2022) [PDF - 183 KB]

FDA Announces Bebtelovimab Not Authorized in Any US Region (Dec 2022) [PDF - 178 KB]

EUA for Novavax COVID-19 Vaccine Booster in Select Patients (Oct 2022) [PDF - 273 KB]

FDA Authorizes Bivalent COVID-19 Boosters in Younger Age Groups (Oct 2022) [PDF - 263 KB]

FDA Approves Bivalent COVID-19 Vaccines as Booster (Sept 2022) [PDF - 272 KB]

Novavax COVID-19 vaccine EUA expansion to include ages 12 through 17 years (Aug 2022) [PDF - 378 KB]

FDA issues EUA for Novavax COVID-19 vaccine (July 2022) [PDF - 266 KB]

FDA authorizes revisions to Evusheld dosing (July 2022) [PDF - 57 KB]

FDA Authorizes Pharmacists To Prescribe Paxlovid (July 2022) [PDF - 189 KB]

CDC recommends Moderna Vaccine in Children Ages 6 Years through 17 Years (June 2022) [PDF - 197 KB]

FDA Authorizes Moderna and Pfizer COVID-19 Vaccines Down to Children Aged 6 Months (June 2022) [PDF - 236 KB]

Paxlovid & COVID-19 Rebound (May 2022) [PDF - 116 KB]

FDA Exapnds Pfizer BioNTech Vaccine Booster Dose to Children 5 through 11 Years (May 2022) [PDF - 137 KB]

FDA limits Use of Janssen COVID-19 Vaccine (May 2022) [PDF - 407 KB]

FDA expands approval of Remdesevir (VEKLURY) for pediatric patients down to 28 days of age (April 2022) [PDF - 387 KB]

Drug Safety Alert: Paxlovid Renal Dose Packs Availability (Apr 2022) [PDF - 121 KB]

Distribution of Sotrovimab Paused to all US States and Territories (Apr 2022) [PDF - 279 KB]

FDA Authorizes Second Booster Dose for Older and Immunocompromised Individuals (Mar 2022) [PDF - 203 KB]

Distribution of Sotrovimab Paused to Certain States (Mar 2022) [PDF - 385 KB]

NPTC Meeting COVID-19 Update (Feb 2022) [PDF - 222 KB]

Eight week mRNA Vaccine intervals (Feb 2022) [PDF - 117 KB]

Revised Interim Clinical Considerations (Feb 2022) [PDF - 121 KB]

EUA for monoclonal antibody, bebtelovimab (Feb 2022) [PDF - 277 KB]

FDA approves (Spikevax) Moderna COVID-19 vaccine (Feb 2022) [PDF - 342 KB]

FDA Limits Use of Bamlanivimab/Etesevimab and REGEN-COV (Jan 2022) [PDF - 461 KB]

FDA Expands Use of Remdesivir for Outpatients With Mild-to-Moderate COVID-19 (Jan 2022) [PDF - 621 KB]

Moderna COVID-19 Booster Interval Shortened To Five Months (Jan 2022) [PDF - 98 KB]

FDA expands use of Pfizer-BioNtech COVID-19 vaccine EUA (Jan 2022) [PDF - 287 KB]

2021

HHS Pause in Distribution of MABs & Omicron Variant (Dec 2021) [PDF - 295 KB]

EUA for oral antiviral molnupiravir (Dec 2021) [PDF - 277 KB]

EUA for oral nirmatrelvir-ritonavir [Paxlovid®] (Dec 2021) [PDF - 275 KB]

Drug Safety Alert_Janssen COVID-19 Vaccine EUA Update: Increased risk of TTS (Dec 2021) [PDF - 201 KB]

Pfizer-BioNTech COVID-19 Vaccine (expanded EUA) Booster Dose in 16 and 17 Year Olds (Dec 2021) [PDF - 327 KB]

Tixagevimab and Cilgavimab (Evusheld) EUA (Dec 2021) [PDF - 286 KB]

Bamlanivimab-Etesevimab EUA expanded for COVID Treatment and Post-Exposure Prophylaxis in Pediatrics and Newborns (Dec 2021) [PDF - 412 KB]

FDA Expands Eligibility for COVID-19 Vaccine Boosters (Nov 2021) [PDF - 298 KB]

Pfizer-BioNTech COVID-19 Vaccine expanded for children aged 5-11 years (Nov 2021) [PDF - 289 KB]

Moderna and Janssen Vaccine Boosters & Mix and Match (Oct 2021) [PDF - 656 KB]

Pfizer-BioNTech Vaccine Booster (Sept 2021) [PDF - 689 KB]

EUA Update: Resumption of Bamlanivumab-Etesevimab Use (Sept 2021) [PDF - 197 KB]

Third Dose for Immune Compromised (August 2021) [PDF - 706 KB]

Updates to REGEN-COV EUA (August 2021) [PDF - 756 KB]

FDA Surveillance of 4 Adverse Events of Interest & Pfizer/BioNTech Vaccine (July 2021) [PDF - 126 KB]

Guillain-Barré Syndrome & Janssen/Johnson and Johnson COVID-19 Vaccine (July 2021) [PDF - 230 KB]

Tocilizumab EUA (July 2021) [PDF - 738 KB]

Casirivimab and Imdevimab (REGEN-COV) EUA Update (June 2021) [PDF - 728 KB]

Bamlanivumab-Etesevimab Distribution Paused (June 2021) [PDF - 294 KB]

FDA warning: mRNA COVID-19 vaccines & myo- and pericarditis (June 2021) [PDF - 146 KB]

Sotrovimab EUA (June 2021) [PDF - 757 KB]

05-2021 COVID Vaccine and myo_pericarditis (June 2021) [PDF - 106 KB]

Suspected COVID-19 P.1 Variant Resistance to bamlanivimab/etesevimab (May 2021) [PDF - 159 KB]

Amended EUA: Pfizer-BioNTech COVID-19 Vaccine_Use in Adolescents Aged 12-15 years (May 2021) [PDF - 244 KB]

COVID-19 Clinical Update - NPTC Meeting (April 2021) [PDF - 199 KB]

Drug Safety Alert_Johnson & Johnson/Janssen Vaccine Update (April 2021) [PDF - 105 KB]

Revocation of Bamlanivimab monotherapy EUA (April 2021) [PDF - 526 KB]

Johnson & Johnson/Janssen COVID-19 Vaccine (April 2021) [PDF - 143 KB]

Janssen COVID-19 Vaccine EUA (Mar 2021) [PDF - 543 KB]

Bamlanivimab and Etesevimab EUA (Feb 2021) [PDF - 748 KB]

NPTC COVID-19 Emerging Treatments & Vaccine Update (Jan 2021) [PDF - 188 KB]

COVID-19 Vaccine Safety Alert: Anaphylaxis (Jan 2021) [PDF - 356 KB]

2020

Moderna COVID-19 Vaccine EUA (Dec 2020) [PDF - 151 KB]

Pfizer-BioNTech-COVID-19-Vaccine EUA (Dec 2020) [PDF - 276 KB]

CDC "v-safe" Vaccination Health Checker [PDF - 137 KB]

Baricitinib + Remdesivir EUA (Nov 2020) [PDF - 295 KB]

Casirivimab and Imdevimab EUA (Nov 2020) [PDF - 789 KB]

Bamlanivimab EUA (Nov 2020) [PDF - 638 KB]

COVID-19 Vaccines Overview (Nov 2020) [PDF - 145 KB]

Routine Vaccination During COVID-19 (Nov 2020) [PDF - 196 KB]

FDA Approval: Remdesivir (Oct 2020) [PDF - 644 KB]

Reporting Adverse Vaccine Events handout (October 2020)

COVID-19 Convalescent Plasma (August 2020)

Remdesivir (Veklury) EUA Update (August 2020)

COVID-19 Impact and Therapies (July 2020)

Dexamethasone for COVID-19 (July 2020)

Revocation of Hydroxychloroquine EUA for COVID-19 (June 2020)

Remdesivir Transfer Guidance (June 2020)

Remdesivir Treatment Priorotization Strategy (June 2020)

Remdesivir (GS-5734) (May 2020)

FDA Drug Safety Communication: Hydroxychloroquine and Heart Rhythm ADEs (April 2020)

Hydroxychloroquine for COVID-19 (March 2020) [PDF - 172 KB]

Unknown Risks with Unapproved COVID-19 Treatments (March 2020)

Vaccinations and COVID-19 (March 2020) [PDF - 101 KB]

Nebulizers and COVID-19 (March 2020) [PDF - 346 KB]

CDC Health Safety Alert: Non-pharmaceutical Chloroquine (March 2020)