Biden Declares 'COVID-19 Pandemic Over' as Biopharma Reacts (Updated)

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Pres. Joe Biden declared the COVID-19 pandemic over but recognized there is still an ongoing problem with viral infections. 

"If you notice, no one's wearing masks,” Biden said in a transcript of the speech. Everybody seems to be in pretty good shape. And so I think [COVID] is changing,"

Despite the president’s declaration, biopharma companies across the globe continue to work on new vaccines to address variants of the SARS-Cov-2 virus and antivirals for treatment of the infected.

The announcement had a ripple effect on the stock market. Share prices for vaccine makers such as Moderna, Pfizer and Novavax slid after the president’s interview aired. European vaccine makers saw stock slides as well.

  • Miami-based Veru, Inc. announced the FDA set a Nov. 9th meeting for the Pulmonary-Allergy Drugs Advisory Committee to assess its Emergency Use Authorization request for the experimental treatment, sabizabulin.
    • Veru developed sabizabulin for use with hospitalized COVID-19 patients who are at high risk for acute respiratory distress syndrome.
    • Veru is seeking EUA based on data from a Phase III trial conducted in 204 hospitalized patients with moderate to severe COVID-19 at high risk for ARDS and death. Data showed treatment with sabizabulin once-per-day resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared to placebo, according to the company.
    • In addition to the FDA, sabizabulin is under review for potential use in the European Union, Australia and the U.K.
    • Sam Fisch, executive director of investor relations and corporate communications at Veru, told BioSpace the company will continue to operate in urgency because the number of daily COVID deaths in the United States remains unacceptably high.

      “Although Biden has declared that the pandemic has ended, Biden has also remarked that we still have more work to do on COVID-19 so a public health emergency still exists for the endemic phase of COVID-19. New therapeutics, like sabizabulin, that greatly reduce deaths in hospitalized patients with moderate to severe COVID-19 infection are still greatly needed,” he said.

  • China’s Clover Biopharmaceuticals secured a European Union Good Manufacturing Practice certificate to support potential commercial manufacturing of its vaccine candidate, SCB-2019. A successful inspection of the CDMO site indicated the facility met the regulatory agency’s standards, thus securing the certificate.
  • Revive Therapeutics filed an amended protocol to the FDA for its Phase III trial assessing bucillamine in mild to moderate COVID-19 patients. Bucillamine is an oral drug with anti-inflammatory and antiviral properties.
    • The amended protocol addresses a new primary endpoint, the time to resolution from COVID-19 infection via a polymerase chain reaction test. Secondary endpoints include evaluating time to clinical improvement and comparing frequency of hospitalization or death and disease course in patients with mild-moderate COVID-19.

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