Get the Facts on Paxlovid: A Promising Pill to Treat COVID-19
On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer’s Paxlovid, making it the first oral treatment for mild-to-moderate coronavirus disease (COVID-19) in at-risk patients.
This authorization is a potential gamechanger for treating COVID-19 and its variants. As stated in the FDA press release, “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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER).
This is very exciting news, but there is a lot to know about this new drug. Below is a factsheet with all you need to know.
How Does an EUA Differ from FDA Approval?
As reported by Norton Healthcare, the differences between FDA EUA versus full FDA approval for a treatment mainly relates to the quantity of data from studies. Both processes by the FDA rely on data regarding a treatment’s safety and effectiveness and require a conclusion that potential benefits outweigh any potential risks. If the FDA concludes that a product’s “known and potential benefits outweigh the known and potential risks,” an EUA can be granted. FDA approval requires the same conclusion but has more data backing the conclusion.
Paxlovid is an investigational drug because it is still being studied. As stated in the FDA Factsheet, there is limited information about the safety and effectiveness of using Paxlovid to treat people with mild-to-moderate COVID-19.
Is Paxlovid a Vaccine?
No, Paxlovid is a treatment for those who test positive for COVID-19 and have mild to moderate symptoms.
Paxlovid is not a substitute for vaccination. Therefore, the FDA urges the public to get vaccinated and receive a booster if eligible.
Who Is Eligible for Paxlovid?
Paxlovid is for people who test positive for COVID-19 and are considered at high risk for severe complications of the virus. Patients must be at least 12 years old and weigh at least 40 kg (88 lbs.)
How Does Paxlovid Work?
Paxlovid is a protease inhibitor designed to prevent the coronavirus from multiplying. The design of this medication prevents the development of drug resistance as well.
Does Paxlovid Work?
According to Healio, the clinical studies demonstrated a reduction in the risk for COVID-19-related hospitalization and death of 89 percent among patients who received the antiviral within three days of experiencing symptoms and 88 percent among participants who received it within five days, Pfizer said.
When Should Paxlovid Be Given to Patients?
Paxlovid is available by prescription only and should be taken as soon as possible after a patient is diagnosed with COVID-19 and within five days of symptom onset, the FDA said.
How Is Paxlovid Administered?
It is an oral medication taken twice a day for five days.
What Are the Side Effects of Paxlovid?
Possible side effects of Paxlovid include altered or impaired sense of taste, diarrhea, increased blood pressure, and muscle aches.
Nirmatrelvir and ritonavir, which comprise Paxlovid, interact with other medicines, leading to severe or life-threatening adverse reactions. Therefore, patients should tell their health care providers all the medication they are taking when deciding whether to take Paxlovid.
Patients should talk with their health care provider if they have a history of liver or kidney problems or HIV infection.
Limited clinical data are available for Paxlovid. Therefore, serious and unexpected adverse events that have not been previously reported with Paxlovid use may occur.
Are There Drug Interactions for Paxlovid?
As reported by Prevention, Paxlovid has many drug interactions. “Paxlovid will have a slew of drug-drug interactions including cardiac medications, certain antibiotics, certain anti-epileptic drugs, and certain statins,” says infectious disease expert, Dr. Adalja, M.D.
How Much Does Paxlovid Cost?
Paxlovid costs 530 dollars per treatment course, according to Reuters. However, the U.S. government will cover the cost, making it free to the public.
How Many Pills Are Being Ordered?
The federal government purchased a total of 10 million courses of Paxlovid in December 2021 and doubled the purchase for 2022.
How Will Paxlovid Be Distributed?
The U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response will oversee the fair and equitable allocation of Paxlovid to state and territorial health departments, and select Health Resources and Services Administration funded health clinics.
Research and materials for this article were compiled, written, and distributed on behalf of the National Public Health Information Coalition. The views and opinions expressed in this blog are those of the various authors and do not necessarily reflect the official policy or position of the National Public Health Information Coalition or its members.
References: