January 20, 2022

COVID-19 antiviral tablet will get FDA authorization: Here is the small print

Pfizer’s Paxlovid is the primary oral COVID-19 therapy to get FDA authorization to be used within the US. The well being company introduced its choice right this moment, noting that it is just out there for sure sufferers. Although Paxlovid received’t shield you from creating COVID-19, taking it early sufficient might forestall the an infection from changing into extreme.

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What’s Paxlovid?

Paxlovid medicine box


Paxlovid is a tablet that sufferers take by mouth, including a brand new choice to the rising — however nonetheless slim — arsenal of medication developed to deal with COVID-19. Pfizer printed particulars on its drug in early November, revealing a notable lower in hospitalization and dying danger amongst sufferers who got Paxlovid quickly after testing optimistic.

The brand new oral antiviral medicine is what’s referred to as a SARS-CoV-2-3CL protease inhibitor, in accordance with the pharmaceutical firm. The drug works by blocking an enzyme the virus wants so as to replicate; the inhibitor is dosed alongside ritonavir, an antiretroviral medicine, which works to gradual the breakdown of the proteases inhibitor.

By combining the 2 medicine, Pfizer notes, the inhibitor can stay energetic within the affected person’s physique for an extended time period — and at larger concentrations — so as to decelerate how briskly the virus replicates. This, in flip, may help guarantee one’s sickness doesn’t progress to a extra extreme stage, although its efficacy relies on taking the drug inside the first few days of testing optimistic.

Eligible sufferers

Pfizer Paxlovid in bottle

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The FDA’s Paxlovid authorization solely covers sure sufferers, the company defined right this moment. The antiviral drug could be given to children ages 12 and older who weigh no less than 88lbs, in addition to adults, in the event that they’ve examined optimistic for COVID-19 and nonetheless solely have gentle to reasonable signs. These sufferers, the FDA notes, should be thought of high-risk for extreme illness outcomes to get the drug.

The drug is supposed to be administered inside the first 5 days of signs and is taken twice a day over the course of 5 days. These contaminated with COVID-19 can solely get the drug as a prescription, with the largest enchantment being its simplicity: somebody might be able to take this drug at house quickly after testing optimistic, probably avoiding hospitalization altogether.

The FDA stresses that Paxlovid isn’t an alternative to preventative measures, particularly getting the first sequence of COVID-19 vaccines and, when eligible, the booster shot. The EUA was granted amid the fast unfold of omicron, the newest SARS-CoV-2 variant of concern first recognized in South Africa.

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