• December 22, 2021: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 - FDA issued an EUA (PDF, 359 KB)  for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. 

• December 22, 2021: MCMi email - Are you eligible for a booster? | Strengthening coronavirus models with systems biology and machine learning

• December 21, 2021: FDA and HHS ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab, which are currently authorized for emergency use only when administered together. This announcement provides a cumulative listing of all batches authorized for shelf-life extension, including batches previously authorized for shelf-life extension for bamlanivimab on August 20, 2021 and for etesevimab on October 22, 2021. As a result of this extension, unopened vials of bamlanivimab and etesevimab, injection, 700 mg/20 mL, should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and may be stored for an additional 6 months from the labeled date of expiry (See Table 1 and Table 2 here). FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of bamlanivimab and etesevimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 773 KB) and the Letter of Authorization (PDF, 488 KB) for Emergency Use Authorization (EUA) 094 for bamlanivimab and etesevimab, administered together.

• December 21, 2021: In a new project funded by the FDA Medical Countermeasures Initiative (MCMi), Australia’s national science agency CSIRO (Commonwealth Scientific and Industrial Research Organisation) and its global partners will use systems biology and machine learning approaches to enhance the understanding of nonclinical model responses to SARS-CoV-2. This project aims to develop the underpinning regulatory science needed to help the FDA evaluate nonclinical model data for assessing potential vaccines and therapeutics for COVID-19, including the impact of omicron, and future SARS-CoV-2 variants of concern.

• December 17, 2021: Possible False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit Following a COVID-19 Vaccine - Letter to Clinical Laboratory Staff and Health Care Providers - FDA issued a letter to clinical laboratory staff and health care providers about false reactivity, or "false-positive", Rapid Plasma Reagin (RPR; non-treponemal) test results when using the Bio-Rad Laboratories BioPlex 2200 Syphilis Total & RPR kit in some people who received a COVID-19 vaccine.

• December 16, 2021: FDA approved a manufacturing change for Comirnaty (COVID-19 Vaccine, mRNA) to include a formulation that uses a different buffer. Buffers help maintain a vaccine’s pH (a measure of how acidic or alkaline a solution is) and stability. This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers. This formulation of Comirnaty does not need to be diluted before use, thus, vaccination providers can more readily prepare and deliver appropriate doses. The new formulation contains Tris buffer, a commonly used buffer in other FDA-approved vaccines and biologics. The FDA previously authorized this vaccine formulation for the Pfizer-BioNTech COVID-19 Vaccine in October. The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.

• December 16, 2021: FDA reissued the EUA (PDF, 493 KB) for the authorized Pfizer-BioNTech COVID-19 Vaccine, including an update on expiration dating.

• December 15, 2021: MCMi email - FDA authorizes new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals | COVID-19 vaccine updates

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