COVID-19: Pfizer's oral treatment Paxlovid gets 'strong recommendation' from WHO

The World Health Organisation (WHO) approved Pfizer's anti-viral oral treatment Paxlovid on Thursday for COVID patients with milder symptoms of the disease. In its authorisation statement, WHO mentioned that the pill is "strongly recommended" for patients with COVID-19 infections at-risk of hospitalisation. The nod comes after US Food and Drug Administration (FDA) signed emergency use authorisation (EUA) of Paxlovid in both high-risk adults and mild-to-moderate adult and pediatric patients.

Calling it a major "step forward" in the treatment of COVID-19, US FDA MD Patrizia Cavazzoni had said that the oral treatment will bolster the fight against the global pandemic. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19," she had said in a statement on December 2021.

Here's all one needs to know about Pfizer's Paxlovid

The leading drug manufacturer, Pfizer's Paxlovid is a combination of two anti-viral pills (nirnatrelvir and ritonavir tablets). It is advised for both high-risk adults and high-risk pediatric patients from 12 years and above. The "breakthrough therapy," according to Pfizer CEO Albert Burla, has the capability to significantly reduce hospitalisations and dead. EUA based on clinical data from the EPIC-HR study, also showed that PAXLOVID reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo, according to the company's findings.

"The FDA based its decision on clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial, which enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness," Pfizer had said in its report. The data demonstrated an 89% reduction in the risk of COVID-19-related hospitalization or death from any cause in adults treated with PAXLOVID, compared to placebo, within three days of symptom onset (primary endpoint). No deaths occurred in the treatment group compared to nine deaths in the placebo group by Day 28. Similar results were seen in those treated within five days of symptom onset (secondary endpoint), with an 88% reduction in risk and no deaths observed in the treatment group.

Paxlovid treatment reduces 85% hospitalisation among COVID patients

WHO's current recommendation is based on new data from two randomised controlled trials on 3,078 patients. The data revealed that Paxlovid consumption reduced 85% hospitalisation among COVID patients,10% of which is from the high-risk group. That means 84 fewer people were likely to be hospitalised among 1000 infected.

The apex healthcare body has now asked Pfizer to ensure its pricing and deals are more transparent for a global licence with the Medicine Patent Pool so that generic manufacturers can begin production to make the oral anti-viral treatment readily available at inexpensive rates. WHO also recommended Paxlovid over its rival Merck's Molnupiravir pill, monoclonal antibodies, and Remdesivir.

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