COVID-19
While Vaxart can proceed with its study, fellow COVID-19 vaccine developers GeoVax and Novavax continue to be hamstrung by various regulatory roadblocks.
The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its investigational COVID-19 vaccine.
Such a change would put the U.S. more in line with guidance in other countries and with the World Health Organization, which recommends one dose for children and adolescents only if they have comorbidities.
The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1, but the agency’s principal deputy commissioner intervened.
A group of medical experts expressed concern about growing “disinformation” and “misinformation,” calling for adherence to recommended vaccine schedules.
As we reflect on five years of COVID-19, it’s clear that the impacts are still unfolding. The life sciences—and we as individuals—will never be the same again.
As sales of its COVID vaccine plummet, Novavax is looking ahead toward other novel vaccines, brought to market with the help of the company’s pharma partners—something it opted not to do as the pandemic swept the globe in 2020.
Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent requirements for antibody activity boxed out its potential use as a post-exposure treatment.
Just a few months after Vir Biotechnology lost an emergency authorization for its COVID-19 antibody, Marianne de Backer stepped in as CEO to answer a critical question: What’s next?
Former president and CEO of CytoDyn Nader Pourhassan along with Kazem Kazempour, former CEO of the CRO running CytoDyn’s trials, are awaiting sentencing but could face up to 20 years in prison for each count of securities and wire fraud and insider trading.
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