The FDA Just Authorized the First COVID-19 Pill, a Pfizer Drug That Can Be Taken At Home
The first anti-COVID-19 pill was approved by U.S. regulators Wednesday. It is a Pfizer medication that Americans can take at home. This will help to prevent the most severe effects.
As U.S. hospitalizations, deaths and cases are increasing rapidly, officials at the health department warn that there could be a flood of new infections due to the omicron variation.
Paxlovid (a cheaper and faster way to get rid of early COVID-19 infected) is available, although initial stock will be limited. Each of the drugs previously approved for the treatment of this disease need to be administered intravenously or by injection.
Merck is also expected to approve an antiviral drug. But Pfizer’s drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness, including a nearly 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.
“The efficacy is high, the side effects are low and it’s oral. It checks all the boxes,” said Dr. Gregory Poland of the Mayo Clinic. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group — that’s stunning.”
The Food and Drug Administration authorized Pfizer’s drug for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risks of hospitalization. These include older adults and people with diseases such as obesity or heart disease. The drug is only available to children who weigh less than 88 pounds and 40 kilograms.
The pills from both Pfizer and Merck are expected to be effective against omicron because they don’t target the spike protein where most of the variant’s worrisome mutations reside.
Pfizer currently offers 180,000 courses of treatment worldwide. Around 60,000 to 75,000 are available to the U.S. Federal officials will likely ration the early deliveries to those most in need. Pfizer said the small supply is due to the manufacturing time — currently about nine months. Pfizer claims it could reduce production by half next year.
U.S. government agreed to buy enough Paxlovid for 10 million patients. Pfizer says it’s on track to produce 80 million courses globally next year, under contracts with the U.K., Australia and other nations.
According to experts, vaccination is the best method of protecting against COVID-19. However, with nearly 40 million adults in America still not vaccinated effective medications will be crucial for reversing any future outbreaks.
U.S. officials are now reporting over 140,000 new infections per day and warn that the Omicron variant could cause case numbers to skyrocket. Omicron, which has already spread across the country and become the dominant strain was confirmed by federal officials earlier in the week.
Against that backdrop, experts warn that Paxlovid’s initial impact could be limited.
The most effective treatment for COVID-19 has been biotech-engineered anti-body drugs. However, they can be expensive and difficult to manufacture. They also require injections or infusions, which are usually administered at hospitals or clinics. Also, laboratory testing suggests the two leading antibody drugs used in the U.S. aren’t effective against omicron.
Pfizer’s pill comes with its own challenges.
For a prescription to be issued, patients must have a positive COVID-19 testing. Paxlovid can only be administered to patients within 5 days of symptoms arising. Experts fear that patients may not be able to get the testing they need, so it is difficult for them to do a self-diagnosis, have their symptoms checked, then see a doctor and receive a prescription.
“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.
FDA relied on data from the company that revealed 89% reduction in hospitalizations for COVID-19 patients with moderate-to-severe symptoms. The FDA found that less than 1 percent of patients who took the drug ended up in hospital, and there was no death. In contrast, 6.5% of those hospitalized were given a placebo pill.
Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body.
The U.S. will pay about $500 for each course of Pfizer’s treatment, which consists of three pills taken twice a day for five days. Paxlovid is two of the three pills, and an additional antiviral helps to boost the level of the main drug.
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