Singapore has approved the use of Covid-19 oral tablet, Pfizer’s Paxlovid. The drug is prescribed as a treatment for adult patients at risk of severe complications from the virus. But what exactly is the Paxlovid pill and does it really reduce the risk of infection?
In a press release by the Health Sciences Authority (HSA) on Thursday (3 February), it was stated that the interim authorisation for the oral medicine was granted under the Pandemic Special Access Route (PSAR).
The authority also said, “This is the first oral tablet approved in Singapore 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.”
What is Paxlovid: Everything You Need to Know
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Found to reduce the risk of Covid-19 related hospitalisation or death by 88.9%
According to the HSA’s review of the available clinical data based on rolling submissions of the results from an ongoing Phase II/III study, the Paxlovid pill was found to be able to reduce the risk of Covid related hospitalisation or death by 88.9 per cent when treatment was given within three days of the onset of symptoms. It was also found to reduce the risk by 87.8 per cent when given within five days of the onset of symptoms.
HSA said the efficacy analysis included patients infected with the Delta variant. Vitro data has shown that Paxlovid is “active” against the prevailing variants of concern, such as the Delta and Omicron variants.
The randomised, placebo-controlled study
There were more than 2,000 people aged 18 to 88 years old who participated in the randomised, placebo-controlled study. HSA said all participants had mild to moderate Covid-19. They also had one or more risk factors for progression to severe Covid-19.
Paxlovid was given to 1,039 participants while the rest of the 1,046 received placebos. Results showed that 0.8 per cent of patients who were given Paxlovid were hospitalised as compared to 6.3 per cent of those who got the placebo. No deaths were also recorded in the Paxlovid group while there were 12 deaths in the placebo group.
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The Paxlovid pill may interact with other medications
HSA added how the safety data showed that Paxlovid is “well-tolerated”. It said the incidences of adverse events that were reported in the clinical study were “generally low”. The common adverse events reported were mild to moderate, such as the following:
- Altered sense of taste
- Diarrhoea
- Vomiting
- Hypertension
- Muscle pain
- Chills
Paxlovid may interact with various medications, such as those for irregular heart rate, migraine, cholesterol, and more. It could also increase the amount of these medications in the blood that could lead to “serious adverse events”.
Some medicines, like those for epileptic seizures, could reduce the levels of the Paxlovid pill, resulting in a loss of anti-viral efficacy. HSA then advised, “The potential for drug interactions should be carefully considered by the prescribing doctor prior to treatment initiation.”
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To be taken twice a day for five days
HSA said the Paxlovid pill should be taken twice a day for five days. The authority added how “treatment should be initiated as soon as possible after a diagnosis has been made, within 5 days of the onset of COVID-19 symptoms”.
The pill will also be prescribed to those at higher risk of severe Covid illness, as directed by the Ministry of Health (MOH).
First batches are expected within this month
Responding to queries from CNA, MOH has confirmed that an agreement had been signed with Pfizer’s Singapore arm to purchase the drug. The ministry is working with Pfizer to deliver the first batches within this month of February.
“Based on the available clinical evidence, 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,” said HSA.
Pfizer will have to collect relevant safety data and monitor the use of the pill as a requirement of interim authorisation. HSA will also require Pfizer to continue submitting updated data from ongoing clinical studies. This is to ensure the continued safety and efficacy of Paxlovid, such as its efficacy against prevailing variants.
Interim authorisation of vaccines, medicines and medical devices under the PSAR can be terminated by HSA at any time. For instance, if new data suggest that their benefits no longer outweigh the risks.
Source: HSA website, CNA
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