Anna KovacevichGHTC
Anna Kovacevich is a senior program assistant at GHTC who supports GHTC's communications and member engagement activities.
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On Wednesday, the US Food and Drug Administration (FDA) authorized Novavax’s COVID-19 vaccine for individuals 18 and over, making it the fourth COVID-19 shot recommended by the agency for use in the United States. The Novavax vaccine is also the first authorized protein-based COVID-19 shot, which works by delivering a protein present on the virus’s service, along with a chemical adjuvant that spurs the immune system to recognize it. The new authorization is for a series of two shots, separated by three weeks; it does not cover use of the Novavax vaccine as a booster shot, which the agency will need to evaluate separately. The vaccine must still be recommended by the Centers for Disease Control and Prevention (CDC) before becoming widely available; the United States has acquired 3.2 million doses of the vaccine to be shipped to states once authorized by the CDC director.
The National Institutes of Health has launched a clinical trial of an mRNA vaccine candidate to prevent Nipah virus infection, a zoonotic disease with no currently authorized vaccine or treatment. The phase 1 clinical trial will test an mRNA-based vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate its safety, tolerability, and ability to generate an immune response in 40 healthy adults. NIAID’s Pandemic Preparedness Plan, published earlier this year, established a framework to study viruses of pandemic potential, like Nipah, and prioritize research on prototype pathogens. The newly launched study is the first clinical trial to use the prototype pathogen approach since the plan’s publication.
In a new report, the World Health Organization outlines the pipeline of bacterial vaccine candidates and emphasizes the urgent need to step up investment and research into vaccines that can help combat antimicrobial resistance (AMR). The analysis is the first to provide detailed analysis of the pipeline of vaccines with potential to address drug resistance from priority pathogens, identifying 61 vaccine candidates in various stages of clinical development and 94 candidates in preclinical development. While highlighting existing vaccines and the promising candidates in late-stage development, the report also notes a critical need to accelerate trials of vaccines to address AMR and makes a case for bolstered investment that can lead to increased global health equity.