Pfizer CEO Albert Bourla on Tuesday hailed his company’s antiviral pill Paxlovid as a “game changer” after final trial data showed it reduced risk of hospitalization among high-risk groups by nearly 90%.
An antiviral pill that prevents serious illness, to be taken soon after people develop symptoms, has long been understood as a path to easing the pandemic. Alas, the National Institutes of Health and Biden Administration were slow to invest in oral treatments, which is one reason the pills have taken longer to develop than have vaccines and monoclonal antibodies.
Vaccines are enormously beneficial, but many people won’t get vaccinated. And as we’ve discovered, vaccine protection against infection wanes with time and against some COVID variants. This leaves older people and those with certain health conditions at higher risk for severe illness.
Monoclonal antibodies have been helpful, but they’re also susceptible to mutations. German researchers said Tuesday that Eli Lilly and Regeneron monoclonals lost most of their effectiveness in lab tests against COVID’s Omicron variant. Monoclonals have also been rationed because they’re difficult to produce. Administered by infusion, they occupy scarce healthcare staff when needed to treat hospitalized patients during COVID surges.
Enter Paxlovid, which was found to reduce hospitalization or death by 88% in high-risk groups when taken within five days of symptom onset. The antiviral inhibits the machinery the virus uses to replicate so it’s less likely to be dodged by new variants. Pfizer says the drug blocked Omicron in lab tests.
Once the FDA approves Paxlovid, Americans who test positive for COVID could request that their doctor prescribe Paxlovid like Tamiflu when they get the flu. About 1,300 Americans a day are currently dying of COVID, so making Paxlovid widely available could save tens of thousands of lives this winter.
The Biden Administration last month ordered 10 million courses at a cost of $5.3 billion. While the pills are relatively inexpensive to produce, their cost of $530 per treatment rewards Pfizer’s innovation and is a pittance given their apparent effectiveness. Pfizer has signed a voluntary licensing agreement with the United Nations-backed nonprofit Medicines Patent Pool for distribution around the world.
Pfizer has submitted data for emergency use authorization, and the FDA has every reason to approve it as quickly as possible. Individuals who received the drug showed no worse side effects than those who got the placebo, so there don’t appear to be safety concerns.
As manufacturing and supply ramp up, the government may recommend that Paxlovid be prescribed only for those at higher COVID risk. But Pfizer’s preliminary trial data showed that younger, healthy people who got the pill experienced a 70% decline in hospitalization. They would benefit from broader authorization.
Pfizer’s study also showed a 10-fold reduction in viral load, which suggests it could substantially reduce transmission. Once Paxlovid becomes widely available, government travel restrictions and mandates will be even more unnecessary. Perhaps even President Biden will then thank Pfizer.