The FDA Should Immediately Approve Pfizer’s Anti-COVID-19 Pill Paxlovid

The new COVID-19 variant of the omicron is highly contagious. It can cause doubled infections in as little as two days. The virus variant may also cause breakthrough infections in those who have had two doses or more of COVID-19 vaccines. The good news from a new South African study is that while two shots of the Pfizer/BioNTech vaccine provide 33 percent protection against infection from the omicron variant, the inoculation offers 70 percent protection against being hospitalized from it.

In addition, most infections were described as mild and symptoms—nasal congestion, a dry cough, and body aches—resolved in about three days. While these data may suggest the omicron version may not be as dangerous, there is one thing to note. A large number of South Africans had been vaccinated. They may also have been exposed to earlier coronavirus versions. These may have reduced the severity of omicron-variant infections. This means that we do not know if those who aren’t yet infected or have been inoculated with the omicron virus may be at greater risk for hospitalizations and even death due to omicron varietal infections.

It is possible that there will be a surge in COVID-19-related infections during winter, given the rapid spread of the omicron version through different European countries. The first line defense against this new variant is vaccinations, particularly booster shots. The Food and Drug Administration (FDA), however, has been slow to approve a second line defense that was developed by Pfizer.

Today, the drugmaker reported that Paxlovid pills have shown a reduced risk of death or hospitalization by 89% and 88% respectively (within three days) of symptoms onset. There were no deaths in placebo-treated patients with COVID-19. Paxlovid is a combination of the ritonavir protease HIV inhibitor and a new protease inhibitor that targets a specific enzyme that the coronavirus, including the omicron variant, needs to replicate and grow.

Albert Bourla, CEO of Pfizer, stated that “emerging variants, such as Omicron have increased the need for access to treatment options for people who contract the virus.”

In clinical trials, the pill was so successful that company decided to stop enrolling new participants in their study. In an ongoing rolling submission of emergency use authorization (EUA), of the treatment, the FDA has had access to data from the company since the beginning. The Biden administration reported that 10 million Pfizer antiviral COVID-19 pills had been purchased.

It is beyond stupid that the agency has apparently not yet scheduled a meeting of its advisory committee to review Pfizer’s EUA application. There are still 1,200 Americans dying each day from COVID-19, and another contagious variant is likely to infect millions more.