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The Biden White House said today that, at a cost of more than $5 billion, it has secured 10 million treatment courses of Pfizer’s COVID-19 oral antiviral drug, contingent on emergency use authorization or approval from the U.S. Food and Drug Administration.
The move is intended to reduce hospitalizations and help curb the pandemic, which is still ongoing after almost two years.
The investigational drug, Paxlovid, is being developed to treat non-hospitalized, symptomatic adults diagnosed with COVID-19 who are at increased risk of progressing to severe illness that could lead to hospitalization or death.
The company recently announced the results of a phase 2/3 clinical trial, which found that a treatment course of one dose every 12 hours for five days reduced the rate of hospitalization or death due to COVID-19 by nearly 90% in patients treated within three days of symptom onset. Similar results were found when treated within five days of symptom onset.
WHAT’S THE IMPACT
Paxlovid is a protease inhibitor designed to block an enzyme the SARS-CoV-2 virus needs to replicate in human cells. Protease inhibitors are a class of drugs that prevent viruses from replicating within cells in the human body, which renders them unable to multiply and spread within the body.
In laboratory studies, Paxlovid blocked not only SARS-CoV-2 replication but also other coronaviruses. If the drug is found to be effective in treating COVID-19 infections, future clinical trials could test the drug’s efficacy against other coronaviruses.
Ritonavir, an antiviral that is often used in conjunction with other medications, is expected to help Paxlovid remain in the human body for longer periods of time to allow the drug to maintain higher concentrations to help combat the virus, and previously has been used in combination with other antivirals for that reason.
Through the purchase agreement, the U.S. government will receive 10 million treatment courses for $5.295 billion, with the first courses delivered by the end of 2021, pending EUA.
The Biomedical Advanced Research and Development Authority, part of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, collaborated with the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command on the agreement.
THE LARGER TREND
The contract with Pfizer is the latest in the administration’s antiviral efforts to reduce hospitalizations and get a better handle on the pandemic.
HHS announced in June it was investing $3 billion from the American Rescue Plan to accelerate the discovery, development and manufacturing of antiviral medicines as part of a “whole-of-government” strategy to develop the next generation of COVID-19 treatments.
HHS and DOD also collaborated on an agreement with Merck in June for an antiviral drug to treat non-hospitalized patients who are at high risk for severe illness. Merck said the drug, molnupiravir, reduces the risk of hospitalization and death among people with mild-to-moderate cases of the coronavirus.
At the interim analysis, molnupiravir reduced the risk of hospitalization or death by about 50%, according to Merck; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients.
Having a new tool to combat the pandemic could be critical, given that in the U.S. vaccine hesitancy continues to be a major concern. Though the vaccines have shown to be highly effective at preventing severe illness or hospitalization from COVID-19, Sermo’s Real Time Barometer showed in May that more than 72% of physicians surveyed said that patients continue to voice concerns over vaccine side effects.
Still others have reported ongoing misinformation discouraging people from getting vaccines. And close to 30% of physicians reported encountering patients who have skipped their second dose due to unpleasant side effects from the first dose, or concerns over side effects.
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