• March 10, 2022: On March 4, 2022, FDA authorized an extension (PDF, 33 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 9 months. The vaccine was previously authorized to be stored for up to 6 months. This shelf life extension applies to all batches that have been released to the U.S. market, and that have been held in accordance with the manufacturer’s storage conditions. Vaccines that are authorized under an EUA do not have fixed expiration dates, and their expiration dates may be extended based on data submitted by the manufacturers. Health care providers administering the vaccine should check the company’s website (https://vaxcheck.jnj) to obtain the most up-to-date expiration dates for specific lots of the Janssen COVID-19 vaccine. 

• March 9, 2022: MCMi email - More video FAQs on COVID-19 vaccines | Regulatory science update: 3D tissue chips

• March 2, 2022: MCMi email - COVID-19 testing updates | Revisions to COVID-19 therapeutic EUAs

• March 1, 2022: NASA, the National Institutes of Health (NIH), the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), and FDA announced the award of eight contracts in a multi-agency collaboration to extend longevity of complex in vitro (human) models, such as 3D tissue chips and microphysiological systems, to at least six months. Currently, such chips are viable for about one month, limiting researchers’ ability to track longer-term effects of treatments on tissues using these systems. Results from longer studies could be used to better understand disease models, supporting development of and clinical trial design for a variety of medical countermeasures. 

• March 1, 2022: FDA issued safety communications for 3 COVID-19 tests that people should not use:

  • Do Not Use Certain Celltrion DiaTrust COVID-19 Tests

  • Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests

  • Do Not Use Certain ACON Flowflex COVID-19 Tests

• February 25, 2022: FDA updates Sotrovimab EUA - FDA is continually monitoring how authorized and approved treatments for COVID-19 are affected by changing variants—currently Omicron and the Omicron subvariants.  On February 23, 2022, FDA revised the emergency use authorization for sotrovimab to clarify that sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a variant that is not susceptible to this treatment. However, sotrovimab is currently authorized in all U.S. regions until further notice by FDA. For other limitations and conditions, refer to the EUA (PDF, 375 KB).

• February 24, 2022: FDA authorizes revisions to Evusheld dosing - FDA has revised the EUA (PDF, 899 KB) for Evusheld (tixagevimab co-packaged with cilgavimab) to change the initial dose for the authorized use as pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric patients. Based on the most recent information and data available, Evusheld may be less active against certain omicron subvariants. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose.

• February 24, 2022: HHS news release: HHS Secretary Becerra Highlights Progress Made in Strengthening U.S. Medical Supply Chain and Industrial Base - Health and Human Services Secretary Xavier Becerra issued a new report highlighting the progress that has been made over the past year to strengthen the U.S. public health and medical supply chain and industrial base. The report highlights the U.S. government’s accomplishments in addressing public health and medical supply chain challenges since the beginning of the COVID-19 pandemic, describes how HHS is implementing the recommendations and goals in the National Strategy for a Resilient Public Health Supply Chain, and outlines additional actions the U.S. government can take to build on its progress. Also see the updated FDA page: Executive Order 14017 on America’s Supply Chains

• February 23, 2022: MCMi email - New resource on at-home OTC COVID-19 tests | MCMi job alert: Interdisciplinary scientist

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