U.S. health regulators approved the first pill to help alleviate COVID-19 symptoms on Wednesday. The drug, manufactured by Pfizer, treats early COVID-19 infections.
This development comes as the number of cases, hospitalizations, and deaths rise in the U.S. Health officials are also concerned the Omicron variant may cause a surge in new infections that could overwhelm hospitals. In north Texas that has not been the case, hospitalizations have not increased with the rise in new cases.
All previously authorized drugs for use against the virus require either an injection or an IV. The pill, called Paxlovid, is a less expensive and less invasive method for treating COVID.
For over a year, intravenous antibody drugs have been used to treat COVID. These treatments are difficult to produce, expensive, and require an injection or infusion, usually administered at a clinic or hospital. Lab testing also suggests that the two leading antibody drugs in the US aren’t effective against Omicron.
Another antiviral pill manufactured by Merck is also expected to be authorized soon. However, the pill from Pfizer has reportedly been shown to have milder side effects and greater effectiveness. Pfizer’s drug claims an almost 90% reduction in hospitalizations and deaths among high-risk patients.
“The efficacy is high, the side effects are low, and it’s oral. It checks all the boxes,” Dr. Gregory Poland of the Mayo Clinic commented to Dallas Morning News. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group — that’s stunning.”
Both the Merck and Pfizer pills are expected to “effectively treat” the Omicron variant, as they don’t target the protein where Omicron’s makeup diverges from that of other COVID strains.
The FDA has authorized the use of Pfizer’s pill for adults and children twelve years and older who have tested positive for COVID-19, show early symptoms of the virus, and are at high risk for hospitalization, such as older people or people with conditions like heart disease or obesity.
The Pfizer drug does present its own challenges, however. Patients are required to present a positive COVID test to get a prescription for Paxlovid, and the drug has proven effective only if administered within five days of the first appearance of symptoms.
Given the high demand and low stock of testing supplies, experts are concerned it may be difficult for patients to self-diagnose, get a test, go to the doctor to get a prescription, and pick up that medication within such a short amount of time.
“If you go outside that window of time, I fully expect the effectiveness of this drug is going to fall,” said Johns Hopkins University virologist Andrew Pekosz.
The FDA approved the drug based on results from a 2,250-patient trial that showed an 89% decrease in hospitalization and deaths when participants took the Pfizer pill within three days of the onset of their symptoms.
By the end of the study’s thirty-day trials, less than 1% of participants taking the Pfizer drug had been hospitalized, and none had died. In comparison, 6.5% of the study participants given the placebo drug were hospitalized, and nine died.
The Pfizer pill is part of a family of antiviral drugs called protease inhibitors, initially utilized in treating HIV and hepatitis C, which block one of the enzymes in viruses that allow them to multiply within the body.
Pfizer has so far manufactured 180,000 treatment courses for global use, 60,000 to 70,000 of which are allocated to the U.S. The U.S. government is expected to ration the initial supply of the drug to regions of the country with the greatest density of COVID cases, as the early shipment is limited.
Pfizer stated the small supply is due to the length of the manufacturing time, which currently takes about nine months. However, the company says it can decrease production time next year by half.
The U.S. government has contracted with Pfizer to purchase enough Paxlovid to treat 10 million people. The company says it will manufacture 80 million courses of the drug for use globally next year under contracts with countries such as the UK and Australia.
Health experts maintain that the best method of protection against COVID-19 is vaccination, despite decreasing effectiveness rates as more information surfaces. As approximately forty million adults in America remain unvaccinated, medications that prove effective against the virus will be a tool to decrease hospitalization and mortality rates.