Itt’s getting harder to avoid COVID-19, thanks to the dominance of BA.5 in the U.S. and the growing number of other Omicron subvariants. Fortunately, Pfizer’s antiviral treatment Paxlovid can minimize illness from the disease.
But it’s not meant for everyone. Only those who are at increased risk for severe disease from COVID-19 qualify for the drug, including people over age 12 who have weakened immune systems or other health conditions that increase risk of serious effects of COVID-19—like asthma, cancer, liver disease, lung disease, heart disease, and obesity. Paxlovid has a long list of possible adverse reactions to common drugs like cholesterol-lowering statins.
Because the drug is not approved by the U.S. Food and Drug Administration, but allowed under an emergency use authorization, doctors generally can’t prescribe it outside of the authorization criteria. Yet that’s not stopping people of all ages and risk profiles from asking for Paxlovid, which went from hard-to-find to much more accessible in just a few months. According to Iqvia data, the number of prescriptions for Paxlovid has risen from just 2,500 in December 2021 to almost 1 million by June 2022.
Here’s what prescribers say about who should get Paxlovid at this point in the pandemic.
People at higher risk benefit more
Pfizer conducted studies before Paxlovid became available. They found that it reduces hospitalizations and deaths by as much as 89% in unvaccinated individuals at higher risk for poor COVID-19 outcomes. That efficacy has become less impressive as vaccination has increased: the company’s latest data show that Paxlovid is about 57% effective at achieving these outcomes in vaccinated people at lower risk of severe illness, such as those who have at least one of the risk factors that raise the risk of serious COVID-19 illness.
Other data that Pfizer released in June showed that the drug doesn’t significantly reduce the number of symptoms among people of any vaccination status who are at moderate risk of severe disease, compared to those not taking it. “That data changed how I see the medication, which was once hailed as a game changer,” says Dr. Anand Viswanathan, assistant professor of medicine at NYU Langone Health.
The drug had not been approved by the U.S. Food and Drug Administration in December 2021. Supplies were still scarce. But the Biden Administration made Paxlovid more accessible in March when it announced the Test to Treat program. People could get their test at pharmacies and then receive prescriptions on-the spot. It became popular with both doctors and patients, even though it was initially under-prescribed to keep a limited number of people at risk. FDA granted state-licensed pharmacists the ability to fill prescriptions for people over 12 years old on July 7.
Some experts think the drug is now overprescribed because of its easier access. Paxlovid, one of a handful COVID-19 antiviral therapies that the FDA has approved (others are molnupiravir pill and remdesivir intravenous therapy), is being sought by people still. “There is probably some overprescribing or prescribing in low-risk people,” says Dr. Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security and an infectious disease physician.
Despite the drug’s increased popularity, for people who are otherwise healthy and not at high risk of getting severely ill, there are limited data supporting the benefits of taking antivirals like Paxlovid. “For the average healthy person—even a 55 year old with no major medical problems—they might not benefit and just complain of the bad taste in their mouth,” which is a common side effect of Paxlovid, says Adalja. “You have to go back to the primary purpose of prescribing Paxlovid: to prevent severe disease, hospitalization, and death.”
Age is a factor in prescribing
Even for people with symptoms who don’t have other health conditions, Adalja generally doesn’t prescribe Paxlovid unless they are ages 65 or older. That’s a common yardstick that doctors are starting to use. However, there is no set of rules for age. A San Diego emergency doctor, Dr. William Durkin recently decided to not prescribe Paxlovid for an elderly patient, who was otherwise in good health and didn’t have any symptoms.
For such patients who don’t have symptoms when they test positive, doctors may write a prescription proactively and tell them to reach out if they do develop symptoms in a day or so. Paxlovid’s effectiveness is greatest if it is taken within 5 days of symptoms arising. Having the prescription in hand could help people make the most of this short time frame.
Paxlovid: The Future
If used correctly, antivirals like Paxlovid may slow down the spread of highly contagious Omicron variants. “We have been working diligently with clinicians, community organizations, and the general public to make people aware that these medications are available and how important it is to know your risk factors for severe COVID-19 disease,” says Dr. Mary Mercer, associate professor of emergency medicine at the University of California San Francisco and Zuckerberg San Francisco General Hospital and Trauma Center. This drug helps to reduce the severity of disease and keeps the virus under control.
Should a new variant appear that is even better at evading the protection afforded by vaccines, and which causes more serious disease even among the vaccinated, then “Paxlovid may find itself back in the role of game changer,” says Viswanathan.
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