The FDA Should Immediately Approve Pfizer's Anti-COVID-19 Pill Paxlovid
The omicron COVID-19 variant is likely to sweep through the country in the next month or so.
Preliminary data indicate that the new omicron COVID-19 variant is apparently highly contagious, doubling infections every two days or so. In addition, early U.S. data find that the virus variant can cause breakthrough infections in people who have received two and even a third booster dose of current 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. One big caution with respect to concluding that these data suggest that the omicron variant may be less dangerous is that a significant proportion of South Africans have been vaccinated or had already been infected with earlier versions of the coronavirus which may have blunted the symptoms caused by omicron variant infections. In other words, we don't know whether people who have not yet been infected or inoculated are at more serious risk of hospitalization and death from omicron variant infections.
Considering how fast the omicron variant is spreading through various European countries, it looks likely that the U.S. will experience a winter surge of COVID-19 infections. Vaccinations, especially booster shots, remain an effective first line of defense against the new variant. However, the bureaucrats at the Food and Drug Administration (FDA) have been dilatory about approving a second line of defense in the form of a new antiviral pill developed by Pfizer.
The drugmaker is reporting today that clinical trials find that its Paxlovid pill "reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo; no deaths compared to placebo in non-hospitalized, high-risk adults 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.
"Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic," said Pfizer CEO Albert Bourla in a statement.
The pill proved so effective in clinical trials that the company stopped enrolling participants in its study in early November 2021 because it would have been unethical to give new participants a placebo. The company has been all along sharing with the FDA its data as part of an ongoing rolling submission for emergency use authorization (EUA) of the treatment. Four weeks ago, the Biden administration announced that it had already purchased 10 million treatment courses of the Pfizer antiviral COVID-19 pill.
It is beyond stupid that the agency has apparently not yet scheduled a meeting of its advisory committee to review Pfizer's EUA application. It's not like some 1,200 Americans aren't still dying daily from COVID-19 infections and that another highly contagious variant looks likely to cause millions of breakthrough infections as the winter comes on.
