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March 23, 2024
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in specific adults and adolescents aged 12 years and older, weighing at least 40 kilograms (approximately 88 pounds).
Pemgarda is authorized for individuals who meet the following criteria:
- Non-Infection and No Known Recent Exposure: Those who are not currently infected with the SARS-CoV-2 virus and have not had a known recent exposure to an individual infected with SARS-CoV-2.
- Moderate-to-Severe Immune Compromise: Individuals with moderate-to-severe immune compromise due to a medical condition or taking immunosuppressive medications or treatments. These individuals are unlikely to mount an adequate immune response to COVID-19 vaccination.
The emergency use authorization comes amidst ongoing efforts to mitigate the spread of COVID-19 and protect vulnerable populations, particularly those with compromised immune systems who may be at higher risk of severe illness from the virus.
Pemgarda, a novel therapeutic agent, represents a significant advancement in COVID-19 prevention strategies, offering an additional layer of protection for individuals who may not achieve sufficient immunity through vaccination alone.
This authorization underscores the FDA’s commitment to expediting access to potentially life-saving treatments amid the evolving landscape of the pandemic. It follows a thorough review of available data on Pemgarda’s safety and efficacy in preventing COVID-19 in the specified population.
Healthcare providers and individuals meeting the specified criteria are encouraged to consult with medical professionals to determine the appropriateness of Pemgarda for COVID-19 prevention.
The FDA’s emergency use authorization for Pemgarda marks a critical milestone in the ongoing battle against COVID-19, providing hope for enhanced protection for those most vulnerable to the virus.
As the pandemic continues to pose challenges worldwide, the authorization of Pemgarda represents a significant step forward in the global effort to combat COVID-19 and safeguard public health.
The FDA’s emergency use authorization of Pemgarda offers new hope in the fight against COVID-19, particularly for individuals with compromised immune systems who may benefit from additional preventive measures.
