FDA Advisory Committee Has Progression of a New Covid-19
vaccine at its assembly on Wednesday. According to the panel, vaccine brands design updated vaccines to target the JN. 1 variant of SARS-CoV-2. Ideally, those updated vaccines should be available in the fall.
The FDA’s Advisory Committee on Vaccines and Related Biological Products evaluated the effectiveness of existing vaccines and discussed the need for a new vaccine formulation. Representatives from Moderna, Pfizer-BioNtech and Novavax presented information on the coverage offered by existing vaccines against emerging variants and the prospects. benefits of vaccines that target these new strains in particular.
Following submissions and a public comment period, the panel voted unanimously to propose that the 2024-2025 Covid-19 vaccine be a monovalent vaccine against the SARS-CoV-2 JN. 1 variant.
To better understand today’s recommendation, it is helpful to review the history of existing Covid-19 vaccines. In December 2020, the FDA granted emergency use authorization for mRNA-based vaccines produced by Moderna and Pfizer-BioNTech. Both corporations have designed their vaccines to target the ancestral or original strain of SARS-CoV-2. The FDA granted EUA to the Novavax vaccine in July 2022. Unlike the Moderna and Pfizer-BioNTech vaccines, this vaccine used a protein-based platform.
In the fall of 2022, Moderna and Pfizer-BioNTech began providing bivalent vaccines targeting the ancestral virus and the BA. 4/BA. 5 bureaucracy of the Omicron variant. A year later, the FDA legalized that the three brands for vaccines evolved to fight the XBB. 1. 5 subvariant of Omicron. With the committee’s most recent recommendation, all 3 brands will now begin introducing JN. 1-specific vaccines.
An updated vaccine would potentially solve two problems. First, we know that immunity against Covid-19 wanes over time. Second, we know that the virus continues to evolve and that new variants show some degree of immune escape. A representative from Moderna presented the committee with compelling knowledge on any of those points. Its specific XBB. 1. 5 vaccine offers strong coverage against the XBB. 1. 5 virus, but this coverage decreases over time. This vaccine offers some coverage against variants that have been circulating lately such as JN. . 1 and KP. 2, however, the grades are reduced. And this coverage also decreases over time. Therefore, a new vaccine would likely improve immunity against all variants and help our immune formula attack new viruses more effectively.
Researchers first learned about the JN. 1 variant in the United States in August 2023 and its prevalence has increased, but other variants predominate today. The CDC estimates that KP. 2 and KP. 3 account for more than 40% of infections in the United States. Only about 8% of existing infections are caused by JN. 1. So why expand an express vaccine to JN. 1? Dr. Archana Chaterjee, dean of the Chicago Medical School, commented at the meeting: “The immunogenicity prospects for a JN. 1 vaccine to cover those variants appear to be quite good. Dr. Alan Berger of the NIH agrees. agree, stating that existing knowledge “really suggests that JN. 1 is the right vaccine upgrade to do right now. “
But a JN. 1-based vaccine is not actually a panacea. Chaterjee went on to comment, “What we’re presenting today probably isn’t what will circulate in a few weeks or months. The virus will continue to evolve. Unless researchers expand the so-called variant-proof vaccine, we will continue to detect up. Today’s advice from the FDA panel won’t actually be the last.
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