China approves Pfizer’s Covid-19 pill Paxlovid for emergency use
- Oral pill to be given to adults with mild to moderate Covid-19 with co-morbidities, and high risk of progression to severe disease, drug regulator says
- Pfizer will be required to continue with research work and submit the results of follow-up studies for a general approval
Such patients would include the elderly, and those with chronic kidney issues, cardiovascular or chronic lung disease, diabetes, and other high-risk factors for Covid-19, it said.
“On February 11, the National Medical Products Administration conducted an emergency authorisation review of Paxlovid in accordance with the special drug approval process and an approval with conditions was granted for the import registration of Pfizer’s Covid-19 treatment,” it said in a statement on Saturday morning.
Pfizer will be required to continue with research work and submit the results of follow-up studies for a general approval.
Other pathways mentioned by Zhong included a less severe strain that limited the Covid-19 case fatality rate to less than 0.1 per cent, keeping the virus’ reproduction number within the range of 1.0 to 1.5, and establishing herd immunity with a high vaccination rate.
As of Monday, 1.22 billion people, or 87.1 per cent of China’s population, had been fully inoculated against Covid-19, including 459.8 million administered a booster shot.
However, the emergence of the highly transmissible new Omicron variant has rendered herd immunity a distant, almost unattainable goal – given the frequent reinfections.
Clinical trials showed Pfizer’s antiviral pill could reduce the risk of hospitalisation and death by 88 per cent when given to unvaccinated people at high risk of severe Covid-19 within five days of the onset of symptoms, according to results announced by the company in December. Last month, lab studies showed the pills were still effective against the Omicron variant.
Paxlovid was approved by the US Food and Drug Administration on December 22, for coronavirus patients aged 12 and above who were vulnerable to becoming severely ill.
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The Chinese approval also marks the availability of the first small-molecular antivirals in China.
Several Chinese firms have been authorised by the UN-backed Medicines Patent Pool (MPP) to produce the raw ingredients and finished product of a generic version of Merck’s oral antiviral medicine molnupiravir, but those would only be supplied to low-income countries and not be sold in China.