The World Health Organization (WHO) on Thursday approved Pfizer’s Paxlovid oral antiviral treatment for COVID patients with milder symptoms of the disease. In its authorizing statement, the WHO mentioned that the pill is “strongly recommended” for patients infected with COVID-19 at risk of hospitalization. The green light comes after the U.S. Food and Drug Administration (FDA) signed Paxlovid’s Emergency Use Authorization (EUA) for 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 physician Patrizia Cavazzoni said the oral treatment will bolster the fight against the global pandemic. “This authorization provides a new tool to fight 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 of progression to COVID-19. harsh,” she said. in a press release in December 2021.
Here’s everything you need to know about Pfizer’s Paxlovid
The leading drug maker, Pfizer’s Paxlovid, is a combination of two antiviral pills (nirnatrelvir and ritonavir tablets). It is recommended for high-risk adults and high-risk pediatric patients from 12 years of age. The “breakthrough therapy,” according to Pfizer CEO Albert Burla, has the ability to dramatically reduce hospitalizations and deaths. 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% (in five days after 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 18 years of age. and more with confirmed COVID-19 who are at increased risk of progressing to severe illness,” Pfizer said in its report. The data demonstrated an 89% reduction in the risk of COVID-related hospitalization or death. -19 from any cause in adults treated with PAXLOVID, compared to placebo, within three days of symptom onset (primary endpoint) No deaths occurred in the group of treatment compared to nine deaths in the placebo group on day 28. Similar results were seen in people treated within five days of symptom onset (secondary endpoint), with an 88% reduction in risk and no death observed in the Treatment Group.
Paxlovid treatment reduces hospitalizations by 85% in COVID patients
The current WHO recommendation is based on new data from two randomized controlled trials involving 3078 patients. The data revealed that consumption of Paxlovid reduced hospitalizations by 85% among COVID patients, 10% of whom belonged to the high-risk group. This means that 84 fewer people were likely to be hospitalized for every 1,000 people infected.
The top health body has now asked Pfizer to make sure its pricing and deals are more transparent for a global license with the Medicine Patent Pool so generic makers can start production to make oral antiviral treatment easily available at inexpensive rates. The WHO has also recommended Paxlovid over Merck’s Molnupiravir pill, monoclonal antibodies and Remdesivir.