What you need to know
- Paxlovid received full FDA approval as a treatment for mild to moderate COVID-19 in high-risk adults.
- The FDA confirmed there are no major safety concerns around Paxlovid, but the drug can react negatively with other medications.
- Paxlovid is expected to remain free for everyone for at least the next few months.
The COVID-19 emergency may have ended, but people who are unvaccinated, older in age, or immunocompromised continue to be vulnerable to the virus. Luckily, we have treatments like Paxlovid to reduce the risk of hospitalization or death. On May 25, the FDA granted full approval to the COVID-19 antiviral pill. Below, we cover what this means and how you can access Paxlovid.
Why is it important that Paxlovid received full FDA approval?
Paxlovid has been available for people ages 12 and older under an emergency use authorization (EUA) since December 2021. Now, the antiviral pill is fully approved by the FDA to treat mild to moderate COVID-19 in high-risk adults. This decision indicates that there is extensive data showing that Paxlovid is safe and effective, as the standards for full approval are stricter than those for an EUA.
Paxlovid’s full approval also gives doctors more freedom in how they use the drug. For example, they will eventually be able to prescribe Paxlovid for “off-label” use, such as by prescribing it for long COVID symptoms or by prescribing a longer course to prevent a rebound infection.
For kids ages 12 and older, Paxlovid remains available as a COVID-19 treatment under an EUA.
What do we know about Paxlovid’s safety and efficacy?
Paxlovid is very effective in lowering the risk of hospitalization or death from COVID-19. One trial found that the drug reduced the risk by 86 percent in unvaccinated adults who had no prior infection. The FDA also confirmed that there are no major safety concerns around Paxlovid. However, the drug can react negatively with other medications, mainly immunosuppressants. If you are on any medications, consult the National Institutes of Health’s guidance on Paxlovid’s drug interactions with your health care provider.
How can I access Paxlovid?
The easiest way to access Paxlovid is to contact your health care provider as soon as you test positive for COVID-19. The drug needs to be taken no later than five days after symptom onset for it to be effective, so timeliness is key. If you don’t have a health care provider, use this locator to find a test-to-treat site near you.
Is Paxlovid free?
Yes. Right now, there are still millions of Paxlovid doses available at pharmacies and health care providers nationwide. These doses will remain free for everyone and are expected to last for at least the next few months. Once this supply runs out, the cost of Paxlovid will fall on health insurers and patients. To ensure that people without insurance aren’t left behind, the U.S. plans to help cover Paxlovid’s costs through a “bridge access program” with pharmacies, though the details on this are still unclear.
It’s important to note that, even though Paxlovid itself is free, you may face out-of-pocket fees when you go in for a health care consultation to receive a prescription, especially if you are uninsured. To lower costs, people with health insurance should seek in-network care when possible. For people without insurance, some test-to-treat sites are federally qualified health centers that can provide free or low-cost COVID-19 care and prescribe you with Paxlovid.