On Wednesday, the Food and Treatment Administration (FDA) stated that it has approved Pfizer’s antiviral pills to treat COVID-19 for emergency use, allowing the drug to be used in individuals as young as 12 who are at “high risk of progression to severe COVID-19.”
The effective drug option arrives at a time when doctors are confronting a widespread shortage of monoclonal antibodies to treat high-risk patients of the disease, with most formulations ineffective against the Omicron variant. Early evidence suggests that Pfizer’s Paxlovid pills are beneficial against Omicron instances. According to the drugmaker, it works by preventing the virus from multiplying itself.
“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” the FDA’s Dr. Patrizia Cavazzoni said in a statement.
Paxlovid was initially approved for emergency use by Pfizer in November. In clinical studies, it was demonstrated to reduce the likelihood of hospitalization or mortality by 88 percent in persons at high risk of severe COVID-19 compared to a placebo.
Paxlovid therapy should begin within a few days of the onset of symptoms. The treatment consists of three tablets given twice a day, in the morning and evening, for five days, for a total of 30 pills. Two of the tablets include nirmatrelvir, a Pfizer antiviral meant to target SARS-CoV-2, and one contains ritonavir, a treatment also used for HIV.
The FDA stated Wednesday that it was continuing to investigate Paxlovid’s safety and efficacy and that it should not be taken with certain other medications or by persons with untreated HIV-1 infection.
The medicine’s most often reported adverse effect in studies was the loss of taste, which occurred in 6% of recipients compared to fewer than 1% of placebo recipients. Diarrhea, elevated blood pressure, and muscular pains were also reported in a slightly higher proportion of Paxlovid patients. The optimistic outcomes reported in Pfizer’s experiment were among those who started taking medicine within days of being diagnosed early in the course of their condition.
“Paxlovid is available by prescription only and should be initiated as soon as possible after the diagnosis of COVID-19 and within five days of symptom onset,” the FDA said.
According to Pfizer, the company is ready to start delivering Paxlovid in the United States immediately, with plans to give up to 10 million courses of the medication through next year. However, only thousands of doses of the medicine are scheduled to be available this month.
“This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital system,” Pfizer’s CEO Albert Bourla said in a press release.
Sources: FDA, Pfizer