SINGAPORE — The Health Sciences Authority (HSA) has granted interim authorisation of the usage of Pfizer's Paxlovid, the first oral tablet approved in Singapore for COVID-19 treatment.
Paxlovid can be used for the treatment of mild to moderate COVID-19 in adult patients who are at high risk of progression to severe disease, to reduce the risk of hospitalisation and death, HSA said in a media release on Thursday (3 February).
It is to be taken twice daily for five days, and the treatment should be initiated as soon as possible after a diagnosis has been made, within five days of the onset of COVID-19 symptoms.
The Ministry of Health has directed that Paxlovid will be prescribed and prioritised to those at higher risk of severe COVID illness.
Reduces risk of hospitalisation by as much as 88.9 per cent
Paxlovid is a combination of two medicines: nirmatrelvir (the antiviral medicine) and ritonavir (to maintain the blood level of nirmatrelvir for antiviral efficacy).
HSA's review of the available clinical data found that it reduced the risk of COVID-related hospitalisation or death by 88.9 per cent when treatment was given within three days of onset of symptoms, and 87.8 per cent when given within five days.
In a placebo-controlled study which recruited more than 2,000 adult participants with mild to moderate COVID-19 and who had at least one risk factor for progression to severe COVID-19, eight out of 1,039 patients who received Paxlovid were eventually hospitalised. This is compared to 66 out of 1,046 patients who received placebo. There was no death in the Paxlovid group, compared to 12 deaths in the placebo group.
The efficacy analysis included patients infected with the Delta variant, and in vitro data has shown that Paxlovid is active against the prevailing variants of concern, including the Delta and Omicron variants.
The safety data also showed that Paxlovid is well‐tolerated, with few reports of adverse side-effects. The side-effects reported were mild to moderate, such as altered sense of taste, diarrhoea, vomiting, hypertension, muscle pain and chills.
Based on the available clinical evidence, HSA said the benefits of Paxlovid outweigh the risks, and there is a favourable benefit-risk profile for the treatment of mild to moderate COVID-19 in adults who are at high risk of progression to severe COVID-19.
Monitoring the use of Paxlovid
As a condition for interim authorisation by HSA under the Pandemic Special Access Route, Pfizer is required to collect the relevant safety data and monitor the use of Paxlovid, and continue submitting updated data from ongoing clinical studies to ensure the continued safety and efficacy of the medicine.
HSA will review the data submitted by Pfizer to ensure that the benefits of Paxlovid continue to outweigh the known risks. The interim authorisation may also be terminated if new data suggests that the benefits no longer outweigh the risks.
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