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November 9, 2021

Scott Gottlieb: 'We're close to the end of the pandemic'

Daily Briefing

    Former FDA Commissioner Scott Gottlieb on Sunday said he believed the coronavirus pandemic is "close" to an end in the United States—largely due to the development of antiviral Covid-19 treatments.

    7 reasons why Merck's antiviral Covid-19 pill is a bigger deal than you think 

      'We're close to the end of the pandemic'

      In an interview with CBS' "Face the Nation" on Sunday, Gottlieb said he believed the surge of Covid-19 cases caused by the delta variant will be the last wave of the pandemic.

      In particular, Gottlieb highlighted two recent developments that he believes will prevent another surge in cases. First, Covid-19 vaccines are now available to children as young as five years old. Second, Gottlieb said we will have "[a] widely available or orally accessible drug that could treat coronavirus at home to prevent people from being hospitalized or dying," noting that there are "two of those potential pills, one from Pfizer and one from Merck, and there will be more behind that."

      "I think that we're close to the end of the pandemic phase of this virus, and we're going to enter a more endemic phase and as things improve, cases may pick up. ... But that doesn't mean we're entering into another wave of infection," Gottlieb added.

      Why antiviral Covid-19 treatments may be a 'game-changer'

      Currently, two separate antiviral drugs from Merck and Pfizer have shown strong evidence of efficacy against Covid-19, Axios reports.

      In October, Merck and Ridgeback Biotherapeutics released data from a clinical trial showing their antiviral Covid-19 drug, molnupiravir, reduced the risk of hospitalization or death by roughly 50% in participants with mild-to-moderate Covid-19.

      Based on this data, health regulators in the United Kingdom last week authorized molnupiravir for use in Covid-19 patients, becoming the first country to do so. Merck has also applied to FDA for emergency use authorization of molnupiravir. FDA's expert advisory committee is scheduled to review the drug on Nov. 30—which, depending on the committee's decision, could potentially clear the way for authorization by the end of the year.

      Separately, Pfizer last week announced its experimental Covid-19 treatment, Paxlovid, reduced hospitalizations and deaths from Covid-19 by 89% in a clinical trial when given within three days of symptom onset. Paxlovid is a protease inhibitor that blocks a key enzyme the coronavirus needs to replicate. It is intended to be taken alongside ritonavir, a drug used in combination treatments for HIV infection.

      According to Advisory Board's Pamela Divack, antiviral Covid-19 treatments may be a "game-changer" when it comes to accessibility. Currently, authorized treatments for Covid-19, such as monoclonal antibody therapies, face significant barriers to access and use. Patients must go to a hospital or infusion center to receive the IV-based treatment, and they must do so within a narrow time window after diagnosis.

      Nahid Bhadelia, founding director of the Center for Emerging Infectious Diseases Policy & Research at Boston University, called oral antiviral drugs "incredibly important" in helping improve access to Covid-19 treatments.

      "With an oral antiviral, patients have more time and greater access to a treatment that will keep them out of the hospital," Bhadelia said. "But the promise of oral antivirals will only be recognized if they're available at your local pharmacy, and you can afford it, and you can get the test that tells you that you're positive for Covid, so you can actually take advantage of this drug. So, the promise is there, but the rest of the pieces need to come together."

      According to the Washington Post, some countries, including the United Kingdom and the United States, have already signed deals to purchase the antiviral treatments. In the U.K., the country's Antivirals Taskforce announced it would purchase 480,000 courses of Merck's molnupiravir and 250,000 courses of Pfizer's Plaxovid. The Biden administration has also already agreed to buy 1.7 billion courses of Merck's drug for $1.2 billion in anticipation of its authorization.

      And last month, Merck announced it granted a royalty-free license of molnupiravir to the Medicines Patent Pool, a United Nations-backed nonprofit that works to make medical treatment and technologies accessible worldwide. Under this license, companies in 105 low- and middle-income nations, primarily in Asia and Africa, will be allowed to produce the drug after it is granted regulatory approval. (Vakil, The Hill, 11/7; Axios, 11/7; Raphael, Washington Post, 11/8)

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