In late April, the White House announced that it was increasing access to Paxlovid, an antiviral pill manufactured by Pfizer, as well as other COVID-19 treatments.
As more contagious COVID-19 variants emerge and cases are on the rise in parts of the United States, interest is spiking in Paxlovid, monoclonal antibodies and other treatments.
The conversation on social media has turned specifically to Paxlovid. Some people have said the drug is “reserved for high-risk patients,” while others are discussing reported cases of relapse in COVID-19 symptoms after a course of the drug.
VERIFY explains the facts about Paxlovid and other COVID-19 treatments.
- U.S. Food and Drug Administration (FDA)
- Centers for Disease Control and Prevention (CDC)
- National Institutes of Allergy and Infectious Diseases
- U.S. Department of Health and Human Services
- Yale School of Medicine
- Study published in the New England Journal of Medicine
- Paul Sax, M.D., contributing editor for the New England Journal of Medicine’s Journal Watch
- Shira Abeles, M.D., infectious disease specialist at the University of California San Diego
Paxlovid authorized for high-risk patients: Paxlovid, an antiviral pill manufactured by Pfizer, is authorized for emergency use by the FDA for treatment of “mild to moderate coronavirus disease” in adults and patients 12 and older who are at high risk for severe COVID-19. This includes people with common conditions like asthma, diabetes, high blood pressure and depression, among others.
Potential COVID-19 relapse after Paxlovid: Federal health agencies are investigating reports of relapse in COVID-19 symptoms after a course of Paxlovid. It’s unclear right now what might be causing this, but health experts still say the pill is effective at reducing COVID-19 symptoms and rates of hospitalization.
Second antiviral pill: Molnupiravir, manufactured by Merck, is the second antiviral pill authorized for emergency use to treat COVID and it’s available to people ages 18 and older who are at high risk for severe COVID-19.
Monoclonal antibody treatment: Some people with mild to moderate COVID-19 illness may also qualify for treatment with monoclonal antibodies, which are given intravenously soon after a person develops symptoms.
What is Paxlovid?
In December 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for Pfizer’s Paxlovid, the first antiviral drug to treat COVID-19. It’s available by prescription only and should be started as soon as possible after a COVID-19 diagnosis and within five days of symptoms.
“The entire idea is to catch it [COVID] when it's early. It can kind of start off as a sniffle or…a body ache, and then progress. And it’s usually that week later where people get extremely sick and hospitalized,” said Shira Abeles, M.D., an infectious disease specialist at the University of California San Diego.
The drug is given as three tablets taken together twice daily for five days, for a total of 30 tablets. It is not authorized for use for longer than five days in a row, according to the FDA.
When applying for FDA authorization, Pfizer presented clinical trial data collected before omicron took hold in the U.S. that showed unvaccinated people who took the drug were 89% less likely to be hospitalized or die from COVID-19 compared to people in the placebo group.
A study published by the New England Journal of Medicine in March 2022 also found that the ingredients in Paxlovid are similarly effective against the omicron variant compared to other variants of concern.
How does Paxlovid work?
If you’re prescribed Paxlovid, two of the pills in your three-pill dose will be nirmatrelvir, which inhibits the SARS-CoV-2 protein from replicating, infectious disease experts at Yale Medicine explain. The other pill is ritonavir, a drug that was once used to treat HIV/AIDS, but is now used to boost levels of antiviral medications.
“As a COVID-19 treatment, ritonavir essentially shuts down nirmatrelvir’s metabolism in the liver, so that it doesn’t move out of your body as quickly, which means it can work longer — giving it a boost to help fight the infection,” according to Yale Medicine experts.
Who can take Paxlovid?
Paxlovid is authorized for the treatment of “mild to moderate coronavirus disease” in adults and patients ages 12 and older “who are at high risk for progression to severe COVID-19, including hospitalization and death,” the FDA said.
But the risk factors that qualify someone to receive Paxlovid include some common medical conditions, in addition to more serious or rare ones.
The Centers for Disease Control and Prevention (CDC) lists medical conditions on its website that make a person more likely to get very sick with COVID-19, including cancer, chronic kidney or liver disease, and heart conditions. Other more common medical conditions like moderate to severe asthma, diabetes and high blood pressure, mood disorders like depression, and being overweight or obese also make someone more likely to get very sick with the virus.
The full list is available online but may not include all conditions that put someone at higher risk of severe coronavirus illness.
Adults ages 50 and older are also more likely to be hospitalized or die from COVID-19, especially if they are unvaccinated, according to the CDC.
The FDA says “health care providers should consider the benefit-risk for an individual patient” when prescribing Paxlovid.
Paxlovid has not been used to treat pregnant or breastfeeding people, but the benefit of taking the drug may be greater than the risk from treatment for a mother and unborn baby, according to the FDA.
Does Paxlovid have side effects?
Common side effects of Paxlovid include an altered sense of taste, diarrhea, high blood pressure or muscle aches.
Are people relapsing after taking Paxlovid?
In a blog post for the New England Journal of Medicine’s Journal Watch, contributing editor Paul Sax, M.D., documented a case where his patient with HIV relapsed, meaning her COVID-19 symptoms returned, after taking Paxlovid. The patient had “more nasal congestion, cough and fatigue – not as bad as when the illness started, but unmistakably a relapse,” Sax wrote.
The patient’s at-home COVID-19 test was also positive again after her symptoms returned, meaning it’s safe to assume she was still contagious, Sax added.
The National Institutes of Allergy and Infectious Diseases (NIAID) confirmed there are “anecdotal reports” of cases where the amount of virus in a person increased after finishing a course of treatment with Paxlovid. NIAID said the reports are “being evaluated by the FDA and that agency will share additional recommendations on this topic, if appropriate.”
A spokesperson for Pfizer said the company believes the viral rebound “is unlikely to be related to treatment with Paxlovid, and we remain very confident in its clinical effectiveness at preventing severe outcomes from COVID-19 in high-risk patients.”
What is Molnupiravir?
Molnupiravir, manufactured by Merck, is the second antiviral pill authorized by the FDA for emergency use. It should be started as soon as possible after COVID-19 diagnosis and within five days of symptoms.
The drug is given as four capsules taken every 12 hours for five days, for a total of 40 capsules. It is not authorized for use for longer than five consecutive days.
An interim analysis in 2021 found that Molnupiravir reduced the risk of hospitalization and death by about 50%, according to Merck.
How does Molnupiravir work?
When Monulpiravir enters a person’s bloodstream, it blocks the ability of the virus that causes COVID-19 to replicate, Albert Shaw, M.D., Ph.D., a Yale Medicine infectious diseases specialist, explained.
Who can take Molnupiravir?
The drug is authorized for adults 18 and older “who are at high risk for progression to severe COVID-19, including hospitalization or death.” Its use should also be limited to situations in which other COVID-19 treatments such as Paxlovid "are not accessible or clinically appropriate,” according to the FDA.
The drug is not authorized for people under the age of 18, and it isn’t recommended for pregnant people because it could cause fetal harm.
Does Molnupiravir have any side effects?
Health experts say possible side effects of the drug include diarrhea, nausea and dizziness. Some allergic reactions have also been reported.
What is monoclonal antibody treatment?
In February 2022, the FDA authorized a monoclonal antibody treatment called bebtelovimab. The treatment, made by Eli Lilly, is given intravenously soon after a person develops symptoms.
This treatment should also be used when others approved or authorized by the FDA “are not accessible or clinically appropriate.”
The U.S. Department of Health and Human Services (HHS) said in February that two other monoclonal antibody treatments – another made by Lily and one made by Regeneron – are “highly unlikely” to work against omicron. Early data suggest that bebtelovimab works against the omicron variant and omicron subvariant BA.2, according to HHS.
Who can receive monoclonal antibodies?
Bebtelovimab can be used to treat adults and children over the age of 12 who are not in the hospital, have mild to moderate COVID-19 symptoms, and who are at risk for severe COVID-19 or hospitalization, like Paxlovid.
Is there a preventative medication for COVID-19?
Some people ages 12 and older might be eligible for a preventative medication for COVID-19 called Evusheld, which has received emergency use authorization from the FDA.
Those who might qualify include moderately or severely immunocompromised people who might not have an adequate immune response to the COVID-19 vaccination or have had a history of allergic reactions to vaccines.
According to the CDC, the preventative medication contains two different antibodies that can help prevent COVID-19 and must be given before you’re exposed to COVID-19.
What should you do if you’re not at high risk of severe disease and test positive?
If you have COVID-19 and your doctor has told you to recover at home, you should get plenty of rest, stay well-hydrated, and take acetaminophen, ibuprofen or naproxen to reduce aches and pains.
Despite concerns earlier in the pandemic, it is safe to take ibuprofen and naproxen when you have COVID-19 and the CDC recommends the medications. Additionally, the World Health Organization (WHO) says there is no evidence ibuprofen has any negative effects for people with the virus.