• April 29, 2022: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines - FDA announced plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of EUA requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.

• April 27, 2022: MCMi email - FDA approves first COVID-19 treatment for young children 

• April 26, 2022: On April 26, 2022, FDA granted an extension (PDF, 179 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps) from 9 months to 12 months when stored between -90°C to -60°C.

• April 25, 2022: FDA Approves First COVID-19 Treatment for Young Children - FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. 
  This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the EUA for Veklury that previously covered this pediatric population. Before now, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with COVID-19. 

• April 14, 2022: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples - FDA issued an EUA (PDF, 448 KB) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage. The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes. Also see the new web page: In Vitro Diagnostics EUAs - Other Diagnostic Tests for SARS-CoV-2

• April 13, 2022: Statement Regarding Shelf-Life Extension of Bamlanivimab and Etesevimab (from HHS/ASPR and FDA) - Evaluation of future extension of shelf-life for bamlanivimab and etesevimab is ongoing and an update regarding shelf-life extension for bamlanivimab and/or etesevimab is planned for early May 2022. Therefore, in the interim, all bamlanivimab and etesevimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. More info: Expiration Dating Extension: COVID-19 Therapeutics

• April 13, 2022: FDA granted an extension (PDF, 374 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine for the two presentations of the Tris/Sucrose formulation (supplied in multiple dose vials with orange caps and labels with an orange border and in multiple dose vials with gray caps and labels with a gray border). The frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF) for up to 12 months from the date of manufacture. 

• April 13, 2022: MCMi email - FDA authorizes more OTC at-home COVID-19 tests | Shelf life extension for a COVID-19 vaccine

• April 7, 2022: FDA authorized an extension (PDF,  136 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. Learn more: Expiration Dating Extensions - COVID-19 Vaccines

• April 6, 2022: MCMi email - EUA updates and FAQs | Watch live today: VRBPAC meeting

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