DHHS limits distribution of bamlanivimab in 3 stat
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Posted On: 03/15/2021 10:06:43 PM
DHHS limits distribution of bamlanivimab in 3 states
To continue our goal of timely and transparent communication regarding the allocation and distribution of monoclonal antibodies being provided by the U.S. Government (USG), ASPR has the following message to communicate to our stakeholders:
The USG is evaluating recommendations for use of bamlanivimab in regions where the SARS-CoV2 mutation L452R found in B.1.429/B.1.427 lineages (a.k.a. 20C/CAL.20C) is circulating in high numbers given concerns that the clinical activity of bamlanivimab is impacted by this variant. ASPR will limit distribution to these regions of the country by stopping direct ordering for bamlanivimab while evaluations are ongoing.
Currently, this action will only affect the states of California, Arizona, and Nevada. The other two authorized products, bamlanivimab/etesevimab and casirivimab/imdevimab, do not appear to be affected and will continue to be available for direct ordering in these states.
ASPR is working with the CDC, NIH, and FDA on any recommendations for treatment and will continue to work closely with these agencies on surveillance of this and other variants that may impact the use of the monoclonal antibodies authorized under emergency use. We will update our stakeholders with any new recommendations.
https://www.phe.gov/emergency/events/COVID19/...fault.aspx
(Note: this page is dated March 11, 2021)
We need a therapeutic which is effective against variants.
To continue our goal of timely and transparent communication regarding the allocation and distribution of monoclonal antibodies being provided by the U.S. Government (USG), ASPR has the following message to communicate to our stakeholders:
The USG is evaluating recommendations for use of bamlanivimab in regions where the SARS-CoV2 mutation L452R found in B.1.429/B.1.427 lineages (a.k.a. 20C/CAL.20C) is circulating in high numbers given concerns that the clinical activity of bamlanivimab is impacted by this variant. ASPR will limit distribution to these regions of the country by stopping direct ordering for bamlanivimab while evaluations are ongoing.
Currently, this action will only affect the states of California, Arizona, and Nevada. The other two authorized products, bamlanivimab/etesevimab and casirivimab/imdevimab, do not appear to be affected and will continue to be available for direct ordering in these states.
ASPR is working with the CDC, NIH, and FDA on any recommendations for treatment and will continue to work closely with these agencies on surveillance of this and other variants that may impact the use of the monoclonal antibodies authorized under emergency use. We will update our stakeholders with any new recommendations.
https://www.phe.gov/emergency/events/COVID19/...fault.aspx
(Note: this page is dated March 11, 2021)
We need a therapeutic which is effective against variants.
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