• January 26, 2022: MCMi email - FDA takes actions to expand use of treatment for outpatients with mild-to-moderate COVID-19 | At-home diagnostic test updates

• January 24, 2022: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant - As we have throughout the COVID-19 pandemic, FDA has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind. Ensuring that healthcare providers on the frontlines have the best tools available to treat patients is a top priority for the agency. In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.  

• January 21, 2022: FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19 - FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization.

• January 19, 2022: UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel - FDA updated the device shortage list to include all blood specimen collection tubes (product codes GIM and JKA) to the testing supplies and equipment – specimen collection category on the device shortage list. The list previously included sodium citrate (light blue top) tubes only. The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time. The FDA will continue to update the list as the COVID-19 public health emergency evolves. To mitigate ongoing shortages, FDA is providing blood specimen collection tube conservation strategies. Also see: Blood Specimen Collection Tube Shortage: Frequently Asked Questions

• January 19, 2022: MCMi email - Video FAQs about COVID-19 vaccines | Apply by Jan. 21 for regulatory science funding

• January 13, 2022: FDA 2021 Year in Review (PDF, 5.9 MB) - This year-end report highlights key FDA actions in 2021 to protect and improve public health, including a COVID-19 vaccine approval and authorizations of COVID-19 tests and treatments. 

• January 12, 2022: MCMi email - COVID-19 response updates: tests, vaccines, events, and more

• January 11, 2022: FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (PDF, 1.5 MB) and the Fact Sheet for Recipients and Caregivers (PDF, 776 KB). These revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia (ITP), a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 Vaccine.

• January 11, 2022: Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication - FDA is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States. The LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx. The FDA believes that these tests were distributed for use in laboratories or for at-home testing.

• January 7, 2022: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months - FDA amended the EUA for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older. 

• January 5, 2022: MCMi email - Boosters are now authorized for people 12 years of age and older

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