The United States on Wednesday authorised Pfizer's antiviral COVID-19 pill for at-risk people aged 12 and above, making it the first oral treatment and which can be taken at home, providing a potentially important tool in the fight against the fast-spreading Omicron variant.
"Paxlovid's approval is a major milestone that marks another step towards making COVID-19 a much more manageable infection," said Amesh Adalja, a senior scholar at the Johns Hopkins Institute for Health Security. The Food and Drug Administration's decision to issue emergency authorisation for the treatment comes as the US combats a surge in COVID-19 cases driven by the Omicron variant, with President Joe Biden announcing plans for more federal vaccination and testing sites.
The Omicron variant, first identified in southern Africa and Hong Kong in November, has spread across the world and now constitutes over 70 per cent of new coronavirus cases in the United States, according to data from the US Centers for Disease Control and Prevention. Prior infection and vaccines have been shown in studies to only partly prevent infection from the variant, though a booster shot does increase protection.
While the clinical trials did not include patients under the age of 18, Pfizer said, the authorised adult dosing regimen is expected to result in comparable blood concentration levels of the drug in paediatric patients 12 and older weighing at least 40kg .
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