The Biden administration plans to end the national emergency that was called for the monkeypox virus outbreak as cases appear to be under control; bisexual and gay men will more easily be able to donate blood under new guidelines set to be released by the FDA; the FDA has paused the emergency use authorization for the monoclonal antibody treatment bebtelovimab.
The public health emergency declared by the Biden administration for the monkeypox outbreak will likely end with a 60-day notice to be released later this week, Politico reports. Should the 60-day notice be released, the public health emergency would be on track to expire by January 31, 2023. The decision, which is still not set in stone, would come as cases of monkeypox are hitting new lows, easing the impact associated with the disease. The CDC is recording only a handful of cases per day, which is less than the 400 average daily cases recorded at the peak of the outbreak.
New guidelines from the FDA could make donating blood easier for bisexual and gay men in monogamous relationships, which would almost entirely lift bans on these men that were first put in place in the 1980s amid the HIV/AIDS epidemic, according to The Wall Street Journal. The new guidelines would allow bisexual and gay men to donate blood without having to abstain from sex for a year prior to donation, which are the current guidelines enacted in 2015. The abstinence period was shortened to 3 months during the pandemic due to blood shortages.
Bebtelovimab, the last remaining monoclonal antibody treatment for COVID-19, will no longer be authorized by the FDA due to its ineffectiveness against the most dominant subvariants of Omicron that are spreading in the United States, The Hill reports. The manufacturer of the treatment, Eli Lilly, has paused the distribution of bebtelovimab, and the Administration for Strategic Preparedness and Response will also be pausing the fulfillment of pending requests for the drug. The FDA recommends that appropriate treatments and drugs including authorized antivirals be used in the place of monoclonal antibodies while also recommending the use of convalescent plasma for patients with compromised immune systems.
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