Moderna Seeks FDA Nod For Updated COVID-19 Vaccine To Tackle Dominant Strain: The Hill - Moderna (NASDAQ:MRNA)

In a move to combat the dominant strain of COVID-19 in the U.S., Moderna Inc. MRNA has submitted an application to the Food and Drug Administration (FDA) for the authorization of its updated vaccine, The Hill reports.

Moderna’s Updated Vaccine

The updated vaccine, which is the second update to the original vaccine authorized in late 2020, is designed to protect against the XBB.1.5 subvariant. This version does not include protection against the ancestral Wuhan strain, unlike the bivalent vaccine available last year.

FDA’s Recommendation

Last week, the FDA advised vaccine manufacturers to target the XBB.1.5 subvariant in their fall vaccines, as it accounts for approximately 40% of U.S. cases. However, this number is on the decline.

CEO’s Statement

Moderna CEO Stéphane Bancel stated that the company’s mRNA platform’s agility allowed them to update Spikevax, Moderna’s COVID-19 vaccine, to target XBB variants quickly and with clinical rigor.

Reported Side Effects

Reported side effects of the updated vaccine include injection site pain, headache, fatigue, muscle pain, and chills.

Challenges Ahead

As authorities prepare for a fall vaccine campaign, the primary challenge for health officials will be encouraging people to get the shot. Only 17% of the U.S. population received the updated bivalent shot since its availability last year. Experts are concerned that immunity against SARS-CoV-2 may not be strong enough this winter without updated immunizations.

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