Pfizer requests emergency approval for the COVID-19 treatment pill from FDA. On Tuesday, Pfizer submitted an application to the Food and Drug Administration for emergency authorization of its Covid-19 treatment pill, Paxlovid. The major corporation claims their pill will reduce hospitalization and death by 89% when administered with a common HIV drug.
If approved, this would be a significant achievement in the fight against Covid. It would allow infected people to take an oral antiviral drug at home instead of the hospital. As a result, it will alleviate the strain that many hospitals felt during the pandemic.
How It Will Work
Paxlovid blocks the activity of an enzyme the virus needs to replicate. So when used with a low dose of Ritonavir, an HIV drug, it will slow the patient’s metabolism. This allows the drug to remain active in the body at a higher concentration for a more extended period to combat the virus. Pfizer explained that the treatment is safe and added fewer adverse events reported by trial participants who took Paxlovid. If approved, Paxlovid will be administered in two 150 mg tablets along with one 100 mg tablet of Ritonavir twice daily.
“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world,” Pfizer CEO Albert Bourla said in a statement Tuesday. In addition, Bourla previously stated that Pfizer planned to submit its data to the FDA before Thanksgiving.
The Biden Administration possibly will purchase a 10 million course of the pills. Pfizer will allow generic drug manufacturers to produce the medicine through a licensing agreement with the Medicines Patent Pool. In addition, the manufacturer will supply generic pills to 95 countries, and Pfizer will waive royalty fees for low-income countries. But the World Health Organization classifies Covid as a public health emergency of international concern. If you remember, Pfizer just received final clearance for the Covid vaccine for ages 5 to 11 years old.