Everything to know about Pfizer's Paxlovid pill
Korea this week gave emergency-use approval of U.S. drugmaker Pfizer’s oral treatment for Covid-19, Paxlovid, the first antiviral pill approved in the country to treat symptoms of the coronavirus which may become available domestically as early as next month.
Paxlovid is a combination of Pfizer’s investigational antiviral Nirmatrelvir tablets and a low dose of ritonavir, an antiretroviral medication traditionally used to treat H.I.V.
The treatment disrupts the replication of the Covid-19 virus in the body by binding to an enzyme crucial to the coronavirus’ function and reproduction.
The oral antiviral treatment is considered a game changer because it doesn’t need to be administered with an injection and can be consumed at home, according to the prescription.
Korea’s Ministry of Food and Drug Safety announced Monday that Paxlovid was granted emergency authorization and said that the Pfizer treatments could arrive in the country as early as mid-January. The government announced that day it sealed deals with Pfizer and Merck Sharp & Dohme to purchase enough Covid-19 pills to treat 604,000 people. The contract with Pfizer is for 362,000 people.
The Korea Disease Control and Prevention Agency requested the ministry for emergency approval on Dec. 20, and it was granted after just five days a review of the safety and efficacy of Paxlovid conducted by a government-civilian panel of experts. It came a week after the U.S. Food and Drug Administration (FDA) granted its emergency use authorization of Paxlovid.
The Paxlovid pills can be consumed by patients 12 years of age and older, weighing at least 40 kilograms (88 pounds), who tested positive for Covid-19 and are at high risk for progression to severe symptoms. Experts advise that the treatment be taken as soon as symptoms appear.
The treatment is comprised of two pink Nirmatrelvir tablets and one white ritonavir pill, to be consumed every 12 hours, or twice a day, for five days after the onset of symptoms.
It can be stored at room temperature at between 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit).
According to the Drug Safety Ministry, side effects include diarrhea, high blood pressure, muscle aches and an altered sense of taste, but most of the symptoms were mild and had little impact on safety.
The treatment is not recommended for patients with severe liver or kidney disease.
The U.S. FDA also warned the treatment could cause severe or life-threatening side effects if used in conjunction with some widely used medications, including statins, blood thinners and some antidepressants.
Pregnant women are expected to be able to take the treatment if the benefits outweigh the risks, but it is not recommended for breast-feeding mothers.
The Korean Drug Safety Ministry did not disclose the specific cost of the contract with Pfizer.
The U.S. government deal costs about $530, or 630,000 won, per patient.
However, Koreans will not have to pay for the Covid-19 antiviral treatment, as the cost will be borne by the government, according to the Infectious Disease Control and Prevention Act.
Coronavirus patients in Korea who are critically ill are currently treated through injections of Remdesivir, an antiviral medication developed by U.S. biopharmaceutical company Gilead Sciences. Rekirona, Korean pharmaceutical company Celltrion’s antibody treatment for Covid-19 patients, is also administered through intravenous injection.
Minister of Food and Drug Safety Kim Gang-lip said in a briefing Monday, “Paxlovid, which was approved for emergency use, will be the first oral Covid-19 treatment introduced in the country. Along with the injectable treatments currently in use in the medical sector, it will be possible to diversify the types of treatment options for selection according to the patient's situation.”
Pfizer said its antiviral Covid-19 pill showed around 88 percent efficacy in preventing hospitalizations or deaths in high-risk patients. Its recent lab data suggests the drug is effective against the Omicron variant.
BY SARAH KIM [email@example.com]