Pfizer Submits COVID-19 Pill Application for Emergency Approval

Pfizer Paxlovid COVID-19 pill. | Image from The Conversation

On November 16, Pfizer submitted an application to the FDA for emergency approval of its COVID-19 treatment pill. The company spokesperson claims that it reduces hospitalization and death by 89% when taken with a common HIV drug.  

Pfizer claims it could help revolutionize the fight against COVID-19 by letting people at high risk take the oral drug instead of going to the hospital. This would help alleviate some of the stress that hospital systems have been facing during the pandemic.    

According to Pfizer, in a clinical trial of people 18 years of age and older with a high risk of developing COVID-19, the pill reduced the hospitalization and death rate by 89% when taken within three days of the initial symptoms. The pill is known as Paxlovid and blocks the activity of an enzyme that the COVID-19 virus needs to replicate.    

The pill is used in combination with a low-dose HIV drug called Ritonavir, which slows the patient’s metabolism, allowing the drug to remain active in the patient’s system for the period it needs to combat the virus. Pfizer is planning to administer Paxlovid in two 150 mg tablets if approved. Alongside these tablets, patients will also take a 100 mg tablet of Ritonavir twice a day.    

“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients,” said Pfizer CEO Albert Bourla in a statement on Tuesday. “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.”     

This week, the Biden administration is expected to announce a multibillion-dollar deal with Pfizer to purchase 10 million courses of Pfizer’s pill. Pfizer also announced on Tuesday that they would allow generic drug manufacturers to produce the medication through a licensing agreement with Medicines Patent Pool, a public health group backed by the U.N.   

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