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Tuesday, January 18, 2022

Pfizer oral pill gets US green light for at-home use


Trials show the oral drug is effective in preventing deaths and hospitalisations in high-risk patients.

The US Food and Agriculture Administration (FDA) approved the first oral pill against Covid-19 to prevent hospitalisation and death for high-risk patients. The move comes as coronavirus cases continue to rise around the world and the new Omicron variant spreads.

US President Joe Biden welcomed the approval of the pill on Wednesday, noting health authorities in the country will have a quarter of a million treatment courses by January.

As of now, it is unclear when the drug will be available to the rest of the world and whether it will also be rolled out in Qatar. 

The drug, Paxlovid, is especially significant in the ongoing fight against the pandemic because it is faster, cheaper, and easier to use. Previously, all authorised drugs against Covid-19 required an IV or an injection. Paxlovid, however, is administered orally. 

“It checks all the boxes,” said Dr. Gregory Poland of the US-based Mayo Clinic. “You’re looking at a 90 percent decreased risk of hospitalisation and death in a high-risk group — that’s stunning.”

According to Pfizer’s clinical trial data, the drug’s antiviral regimen is also 90 percent effective in preventing hospitalisation and death in high-risk patients. That includes older people and those with pre-existing conditions like obesity and heart disease.

The drug is also effective against the fastest spreading variant yet, Omicron. 

Pfizer’s drug is part of a family of antiviral drugs known as protease inhibitors. It works by blocking a key enzyme needed for viral multiplication in the human body. The same concept was used to revolutionise the treatment of HIV and hepatitis C. 

The FDA authorised the pill for patients who have tested positive and have a prescription from a certified physician. It also permitted the drug for emergency use in cases of mild to moderate disease for patients 12 years though they must weigh above and must weigh at least 40kgs.

Patients at high risk for progression to severe Covid-19 can also receive this treatment. 

Despite its many benefits, Paxlovid has its shortcomings. For one, it has been proven effective only when used within five days of experiencing symptoms. Due to the lack of accessible testing supplies and a narrow time frame, experts worry that it may be too late to use the pill once a positive test is confirmed. 

“If you go outside that window of time, I fully expect the effectiveness of this drug is going to fall,” said Andrew Pekosz, a Johns Hopkins University virologist.

Pfizer is not the only company involved in studying and developing medical drugs to treat coronavirus.

Merck & Co has also produced a rival pill currently under review by the FDA. Even though it is effective against variants like Omicron, it is in stark contrast to Paxlovid, with an efficiency of 30 percent. 

Pfizer has said it is ready to begin immediate delivery in the US and raised its production projections to 120 million courses of treatment.

The US government will receive 10 million courses of the pill, priced at $530 per course. 

Here in Qatar, the oral pill has yet to be rolled out, however authorities have previously followed decisions made by the FDA.

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