Moderna Seeks FDA Authorization for Enhanced COVID Vaccine

Moderna has formally submitted its application for FDA authorization of its updated COVID-19 vaccine, designed to target the current dominant strain in the U.S. This latest version, the second update to the original vaccine, will provide protection specifically against the XBB.1.5 subvariant, rather than the ancestral Wuhan strain.

Following the FDA’s guidance to vaccine manufacturers, which identified XBB.1.5 as the primary target for this fall’s vaccines, Moderna has swiftly adapted its mRNA platform to develop Spikevax, its updated COVID-19 vaccine.

Moderna CEO Stéphane Bancel expressed confidence in the company’s ability to adapt quickly and effectively, saying, “The agility of our mRNA platform has enabled us to update Spikevax, Moderna’s COVID-19 vaccine, to target XBB variants with speed and clinical rigor.”

In terms of side effects, Moderna notes that injection site pain, headache, fatigue, muscle pain, and chills have been reported. However, the vaccine has proven to be safe and effective.

As health officials prepare for the fall vaccine campaign, similar to annual flu vaccinations, the challenge lies in persuading individuals to get vaccinated. Currently, only 17 percent of the U.S. population has received the updated bivalent shot, which provides protection against the ancestral strain as well as the BA.4 and BA.5 omicron subvariants.

Experts are concerned that immunity against SARS-CoV-2 may not be strong enough to withstand the winter without updated immunizations, highlighting the importance of widespread vaccination.

Image source: The Hill

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