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Moderna files with FDA for emergency use of second Covid-19 booster shot

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Moderna late on Thursday sought emergency use authorization from US health regulators for a second Covid-19 booster shot, as a surge in cases in some parts of the world fueled fears of another wave of the pandemic.

The US 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 Centers for Disease Control and Prevention (CDC) and healthcare providers.

Moderna’s request is significantly broader than Pfizer and its German partner BioNTech’s application that was filed earlier this week with US regulators for a second booster shot for people aged 65 and older.

Moderna, without specifically commenting on the effectiveness of a fourth shot, said its submission was partly based on data recently published in the United States and Israel following the emergence of the Omicron variant. ...

 

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