The United States has approved Pfizer's Covid-19 tablet for at-home treatment.
The first pill against Covid-19, a Pfizer medicine that Americans will be able to take at home to prevent the virus's worst consequences, was approved by US health regulators on Wednesday.
The long-awaited achievement comes as the number of illnesses, hospitalizations, and deaths in the United States continue to rise, and health experts warn that a wave of new infections caused by the omicron strain might overwhelm hospitals.
Paxlovid is a speedier and less expensive means to treat early Covid-19 infections, albeit initial supplies will be scarce. All of the previously approved anti-disease medications require an IV or injection.
Merck's antiviral tablet is also likely to receive FDA approval soon. However, because of its low side effects and greater effectiveness, including a nearly 90 percent reduction in hospitalizations and fatalities among patients most likely to develop severe disease, Pfizer's medicine is almost guaranteed to be the favored alternative.
"It has a good efficacy, little adverse effects, and it's an oral medication." "It checks all the boxes," Mayo Clinic's Dr. Gregory Poland stated. "In a high-risk population, you're looking at a 90 percent lower risk of hospitalization and mortality – that's incredible."
Pfizer's medication has been approved by the Food and Drug Administration for adults and children aged 12 and up who have a positive Covid-19 test and early symptoms and are at the highest risk of hospitalization. This covers the elderly as well as those suffering from obesity or heart disease. The medicine is only available to children who weigh at least 88 pounds (40 kilograms).
Both Pfizer and Merck's pills are predicted to be successful against omicron because they don't target the spike protein, which contains the majority of the variant's dangerous mutations.
The US government has agreed to buy Paxlovid in sufficient quantities to treat ten million patients. According to Pfizer, it is on track to deliver 80 million courses worldwide next year, thanks to contracts with the United Kingdom, Australia, and other countries.
Vaccination remains the best approach to defend against Covid-19, according to health experts. However, with about 40 million individuals in the United States remaining unvaccinated, effective medications will be vital in thwarting current and future outbreaks.
More than 140,000 new infections are reported daily in the United States, and federal officials fear that the omicron form could increase the number of cases. Federal officials verified earlier this week that Omicron has already spread across the country to become the prevalent strain.
Experts warn that Paxlovid's initial impact may be limited in light of this.
Covid-19 has been treated with biotech-engineered antibody medicines for more than a year. However, they are costly, difficult to make and require an injection or infusion, which is usually administered in a hospital or clinic. In addition, laboratory data indicates that the two most commonly used antibody medicines in the United States are ineffective against omicron.
Pfizer's tablet has its own set of problems.
To acquire a prescription, patients must have a positive Covid-19 test. Paxlovid is only effective if taken within five days of the onset of symptoms. With testing supplies running low, experts are concerned that patients may be unable to self-diagnose, get tested, visit a doctor, and pick up a prescription within the allotted time.
"I completely expect the effectiveness of this medicine to fall outside that window of time," said Andrew Pekosz, a virologist at Johns Hopkins University.
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 that viruses need to multiply in the human body.
The US will pay about $500 for each course of Pfizer's treatment, which consists of three pills taken twice a day for five days. Two of the pills are Paxlovid and the third is a different antiviral that helps boost levels of the main drug in the body.