New and Updated Resources: Lagevrio Information Sheet, Digital Toolkit, and CDC Webpages
ASPR has added a new Lagevrio Information Sheet and updated their Digital Toolkit with Test to Treat social media content.
CDC has also updated the Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19 for Healthcare Professionals. This update highlights Age being the strongest risk factor for severe COVID-19 outcomes.
New: Make My Test Count
NIH has implemented a new initiative called Make My Test Count that helps public health teams determine how fast the SARS CoV 2 virus is spreading or where surges are happening.
Individuals can easily and quickly notify NIH of their COVID 19 test results in one click. The data from Make My Test Count can help public health teams monitor the COVID 19 environment while keeping your personal test results private and anonymous.
Reminder: Bebtelovimab Not Authorized for Emergency Use in U.S.
On November 30, 2022, U.S. Food and Drug Administration announced bebtelovimab not currently authorized for emergency use in U.S.; it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1., according to data included in the Health Care Provider Fact Sheet.
Given the likelihood that infection is be caused by a non-susceptible variant, and consistent with the terms and conditions of the Letter of Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time.
The U.S. Government recommends all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the United States. Retained product must be appropriately held in under proper storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization.
There are several treatments authorized or approved which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1.
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Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg).
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Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are hospitalized or not hospitalized.
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Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults, and for whom Paxlovid and Veklury are not accessible or clinically appropriate.
See updated guidelines here: NIH COVID 19 Treatment Guidelines and CDC Interim Clinical Considerations for COVID-19 Treatment in Outpatients.
NEW: Shelf-Life Extensions
Additional Shelf-Life Extension for Evusheld
On December 5, 2022, FDA authorized an additional extension to the shelf life from 18 months to 30 months for specific lots of Evusheld (tixagevimab co packaged with cilgavimab).
- As a result of this extension, some batches may be stored for longer than the labeled date of expiry, and unopened vials of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab ), must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Visit ASPR’s website to learn more and review the table with co-pack lot numbers, labeled co-pack expiration dates, and the extended co-pack expiration dates.
Update: No additional shelf-life extension is possible for etesevimab
- Refer to online resources to determine true expiration date for etesevimab and bamlanivimab vials.
- Product can be returned for destruction as a bam/ete patient course using expired ete with matching bam vial of earliest expiration date (patient course = 2 vials ete, 1 vial bam).
For up to date information on expiration dates, please visit: Important Updates | HHS/ASPR and Expiration Dating Extension | FDA.
ALL COVID-19 therapeutics have received extensions for some or all lots. Please check with the manufacturer before removing any products from the proper storage conditions.
Maintain all monoclonal antibodies under proper refrigerated temperatures, even if they are not currently authorized for use. It is possible that monoclonal antibodies will be authorized again in the future for use against new strains of SARS-COV2.
NOTE: ASPR continues to work with product manufacturers to maximize shelf-life. We will provide any updates for upcoming expiration dates as soon as we receive.
Evusheld Fact Sheet Update
The Evusheld Fact Sheet has been updated to reflect In-vitro neutralizing data for several Omicron subvariants.
- Evusheld is unlikely to be active against BF.7, BA.2.75.2, BQ.1 and BQ.1.1.
- Evusheld does retain neutralization activity against BJ.1.
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Refer to section 5.3 in the EVUSHELD Fact Sheet for further information on Risk for COVID-19 Due to SARS-CoV-2 Viral Variants Not Neutralized by EVUSHELD.
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FDA continues to recommend EVUSHELD as an appropriate option for pre-exposure prophylaxis to prevent COVID-19.
- Breakthrough infections are possible. Advise patients to have a treatment plan in place and to seek timely medical attention if symptoms occur.
Refer to FDA releases important information about risk of COVID-19 due to certain variants not neutralized by EVUSHELD.
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