WASHINGTON (AP) – US health regulators on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to stave off the virus’s worst effects.
The long-awaited milestone comes as US cases, hospitalizations and deaths continue to rise and health officials warn of a tsunami of new infections from the Omicron version that could overwhelm hospitals.
Paxlovid is a fast, inexpensive way to treat early COVID-19 infections, although initial supplies will be extremely limited. All drugs already authorized against the disease require an IV or injection.
An antiviral pill from Merck is also expected to win authorization soon. But Pfizer’s drug is sure to be the preferred choice because of its mild side effects and improved effectiveness, which include a nearly 90% reduction in hospitalization and death in patients most likely to develop severe disease.
“Efficacy is high, side effects are low and it is oral. It checks all the boxes,” said Dr. Gregory Poland of the Mayo Clinic. “You are 90% less likely to be hospitalized and death in a high-risk group Looking at the risk – it’s amazing.”
The Food and Drug Administration authorized Pfizer’s drug for adults and children 12 years of age and older with a positive COVID-19 test and early symptoms who face the highest risk of hospitalization. This includes older people and people with conditions such as obesity and heart disease. Children to be eligible for the drug must weigh at least 88 pounds (40 kilograms).
Pfizer’s experimental COVID-19 pills, which the drugmaker said on November 16, 2021, that it is submitting to US authorization, are setting the stage for a possible launch in the coming weeks. (Pfizer via AP)
The pills from both Pfizer and Merck are expected to be effective against Omicron because they do not target the spike protein where most types of worrying mutations reside.
Pfizer currently has 180,000 treatment courses available worldwide, with about 60,000 to 70,000 allocated to US federal health officials, hoping to quickly shipment rations to the hardest-hit parts of the country. Pfizer said the shorter supply is due to manufacturing times — currently about nine months. The company says that it can cut production time in half next year.
The US government has agreed to buy enough Paxlovid to treat 10 million people. Pfizer says it is on track to create 80 million courses globally next year under contracts with the UK, Australia and other countries.
Health experts agree that vaccination is the best way to protect against COVID-19. But with nearly 40 million American adults still unaffiliated, effective drugs will be the key to blunting current and future waves of infections.
The US is now reporting more than 140,000 new infections daily and federal officials have warned that the Omicron variant could push up the number of cases. Federal officials confirmed earlier this week that Omicron has already become a major strain across the country.
Against that background, experts warn that Paxlovid’s initial effect may be limited.
For more than a year, biotech-engineered antibody drugs have been the go-to treatment for COVID-19. But they are expensive, difficult to produce and require injection or infusion, usually given in a hospital or clinic. In addition, laboratory testing shows that the two major antibody drugs used in the US are not effective against Omicron.
Healthcare worker and new employee Amber Blunk signs up for her first COVID-19 vaccination on Friday, August 20, 2021 at Nashville General Hospital in Nashville Tenn. (AP Photo/John Partipilo)
Pfizer’s pill comes with its challenges.
Patients will need a positive COVID-19 test to receive a prescription. And Paxlovid has been shown to be effective only if given within five days of symptoms appearing. With testing supplies growing, experts worry that it may be unrealistic for patients to self-diagnose, get tested, see a physician, and get a prescription within that narrow window.
“If you go out that window of time, I sincerely expect that the effectiveness of this drug is going to decrease,” said virologist Andrew Pecoz of Johns Hopkins University.
The FDA based its decision on the results of the company’s 2,250-patient trial, which showed the pill cut hospitalizations and deaths by 89% when given to people with mild to moderate COVID-19 within three days of symptoms. Less than 1% of patients taking the drug were hospitalized and none died at the end of the 30-day study period, while 6.5 percent of hospitalized patients in the group that received the dummy pill included nine deaths.
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 the virus needs to multiply in the human body.
The US will pay about $500 for each course of treatment from Pfizer, which includes three pills taken twice a day for five days. Two pills are paxlovid and the third is a different antiviral that helps increase the levels of the main drug in the body.