All articles tagged with #emergency use authorization
The FDA approved updated Covid booster vaccines but revoked emergency use authorizations, limiting access mainly to higher-risk groups and making it more difficult for children under 5 to receive vaccines, especially affecting healthy young children. The move aligns with new policies and clinical trial requirements, amidst ongoing debates about vaccine safety and policy conflicts.
The U.S. Department of Health and Human Services has authorized emergency use of animal drugs to combat the threat of screwworm infestations, which are approaching the U.S. border from Mexico and pose a risk to livestock and wildlife, with potential economic impacts on the cattle industry, especially in Texas.
The FDA issued emergency use authorizations for two rapid tests to detect influenza A/B and COVID-19, granted authorization for an AI-based software to identify sepsis risk, and published a draft guidance for new dietary ingredient notifications for dietary supplements. Additionally, an import alert was issued for a Chinese medical device company not meeting quality system requirements, and the FDA highlighted postmarket surveillance and risk assessment programs for adverse drug reactions and medication errors.
The World Health Organization (WHO) has granted emergency-use authorization to Novavax's updated COVID-19 vaccine for individuals aged 12 and older. The vaccine, which targets a descendant of the XBB lineage of the coronavirus, was previously authorized in the U.S. The emergency use listing will facilitate the import and administration of the vaccine by member states. Novavax's original COVID-19 shot was authorized in the U.S. in July 2022, later than the mRNA vaccines developed by Pfizer and Moderna. The updated Novavax shot utilizes a protein-based technology.
Novavax's protein-based COVID-19 vaccine, Adjuvanted (2023-2024 Formula), has received Emergency Use Authorization (EUA) from the FDA and has been recommended by the CDC for individuals aged 12 and older. This authorization makes Novavax's vaccine the only protein-based non-mRNA COVID vaccine option in the U.S. Doses will be available at thousands of locations across the country in the coming days. The vaccine has shown immune responses against multiple variants and has reported common side effects such as headache and fatigue. Novavax is working with global regulatory authorities for further authorizations.
The FDA has granted emergency use authorization for Gohibic (vilobelimab) injection for the treatment of COVID-19 in hospitalized adults who have received invasive mechanical ventilation or extracorporeal membrane oxygenation. The treatment targets a part of the immune system that is thought to play a role in the inflammation that leads to COVID-19 disease progression. Clinical trials showed that patients treated with Gohibic had a lower risk of death by day 28 and day 60 of treatment compared to placebo.