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Moderna Seeks FDA Approval For 2nd COVID Booster For Adults

Moderna Seeks FDA Approval For 2nd COVID Booster For Adults

U.S. health officials, including top infectious disease expert Dr. Anthony Fauci, have raised the prospect of a fourth COVID vaccine, especially for older people and to prepare for the possibility of another surge in cases. Data from the U.S. Centers for Disease Control and Prevention (CDC) data has shown that vaccine efficacy wanes over time and a third shot helps restore it.

Now, Moderna Inc is seeking emergency use authorization from U.S. health regulators, asking on Thursday for approval for a second COVID-19 booster shot as a surge in cases in some parts of the world fuels fears of another wave of the pandemic. The U.S. biotechnology company said its request covered all adults over the age of 18 so that the appropriate use of an additional booster dose of its vaccine, including for those at higher risk of COVID-19 due to age or comorbidities, could be determined by the  (CDC) and health care providers.

While COVID cases are falling in the United States and much of the world, infections are rising in China. In the UK and Europe, there has been a reversal in the downward trend of COVID cases as economies have opened up and the BA.2 variant of Omicron circulates.

Moderna’s request is significantly broader than Pfizer’s application that was filed earlier this week with U.S. regulators for a second booster shot for people aged 65 and older. Without specifically commenting on the effectiveness of a fourth shot, Moderna said its submission was partly based on data recently published in the United States and Israel following the emergence of the Omicron variant. Both Pfizer and Moderna are betting additional booster doses will be needed as new virus variants emerge.

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