Pharmaceutical Company Submits Application for Updated Covid-19 Vaccine Authorization
The pharmaceutical company has recently submitted an application for authorization to the Food and Drug Administration (FDA) in the United States for their latest version of the Covid-19 vaccine. This updated vaccine specifically targets the sublineage XBB.1.5 of SARS-CoV-2, known as mRNA-1273.815.
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According to the biotechnology company, the CEO, Stéphane Bancel, emphasized the company’s agile capacity to quickly update the vaccine using their messenger RNA platform. This allows them to effectively address the XBB variants of the virus.
Bancel stated that they have been working diligently for months to ensure a sufficient supply of doses ready to be shipped in time for the autumn vaccination season in the northern hemisphere.
Preliminary clinical results from Moderna indicate that the mRNA-1273.815 vaccine is effective in generating an immune response against the current XBB variants of concern.
The company has consistently demonstrated its ability to reduce hospitalizations and severe cases of Covid-19 over the past three years.
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The authorization request is based on the recommendations of the FDA, which advises updating Covid-19 vaccines to a monovalent composition XBB.1.5, as explained by the laboratory.
This recommendation aligns with those of other regulatory bodies and public health agencies worldwide, which have also advised a monovalent XBB composition.
During a recent meeting of the Vaccine and Related Biologicals Advisory Committee (VRBPAC), Moderna was the only company to present preliminary clinical data comparing monovalent and bivalent vaccines. The data demonstrated a robust immune response in humans against multiple sublineages descended from XBB, such as XBB.1.5, XBB.1.16, and XBB.2.3.2.
It should be noted that common adverse effects of Moderna’s updated Covid-19 vaccine include pain at the injection site, as well as systemic reactions like headache, fatigue, myalgia, and chills.
Moderna is currently in the process of submitting additional applications to regulatory bodies around the world and is prepared to supply updated Covid-19 vaccines in time for the fall vaccination season.