Is the antiviral drug Paxlovid a dud?

Of all the antiviral drugs for Covid-19, Pfizer’s Paxlovid has been the most successful. Not for its safety and efficacy, but for its ability to earn the company billions in profits despite being largely ineffective for most people.

In November 2021, before any data had emerged, the Biden Administration committed to purchasing 10 million treatment courses of Paxlovid worth $5.3 billion, pending authorisation by the US drug regulator.

One month later, Paxlovid was granted emergency use authorisation (EUA) by the FDA for use in adult and paediatric populations, 12 years or older.

The authorisation was based on early trial data showing the drug could reduce hospitalisations or death (89% relative risk reduction, 6% absolute risk reduction) in high-risk patients who were unvaccinated and had no prior exposure to Covid-19.

But the problem was, most Americans by that time (Dec 2021) had already been vaccinated against Covid-19 or had prior exposure to the virus, making the trial results irrelevant to the majority of people.

Pfizer had to prove its drug could benefit a broader market.

The manufacturer commenced the EPIC-SR trial, investigating the use of Paxlovid in unvaccinated people and vaccinated people with at least one risk factor for Covid-19 [clinicaltrials.gov].