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A highly contagious coronavirus variant first identified in Britain has been detected in Colorado, according to Gov. Jared Polis. The first U.S. case of the variant was found in a man in his 20s with no travel history, Polis said. That individual is in isolation in Elbert County, located southeast of Denver.
Novavax announced Monday it is beginning to enroll volunteers for a Phase III clinical trial of its experimental COVID-19 vaccine in the United States and Mexico. The randomized, placebo-controlled study will include up to 30,000 participants at about 115 sites in the two countries.
As the first COVID-19 vaccines roll out, an increasing number of Americans are saying they want to get vaccinated. While many had expressed concern over the past year about the fast pace of development, potential political ploys, and other theories, the shift from a hypothetical vaccine to real ones has seen a shift in attitudes as well.
MAJ Joseph Remesz-Guerrette, PharmD, U.S. Army, has had plenty of experience in the storage and handling of pharmaceuticals over his decade or so in pharmacy. When he joined Operation Warp Speed (OWS) as a medical planner, that know-how was a tremendous asset. “I didn't have to be brought up to speed on how to properly handle these vaccines,” he said. That has been a crucial part of a massive undertaking.
On Friday, FDA granted an emergency use authorization (EUA) to a second COVID-19 vaccine—Moderna’s mRNA COVID-19 vaccine, which is indicated for individuals ages 18 years and older.
In a study published in the New England Journal of Medicine on December 11, a worldwide group of researchers showed that adding baricitinib, an orally administered, selective inhibitor of Janus kinase 1 and 2, to remdesivir can reduce recovery time and accelerate improvement in clinical status among patients with COVID-19. FDA issued an emergency use authorization for the dual treatment on November 19.
Former U.S. Representative and California Attorney General Xavier Becerra—President-elect Joe Biden’s pick for U.S. Department of Health and Human Services (HHS)—is a friend to pharmacy, said California Pharmacists Association (CPhA) CEO Susan Bonilla. “CPhA has had a good working relationship with the California Department of Justice, of which he was the Attorney General,” she said. “More broadly, because he very publicly supported health care access and affordability when he was serving in Congress, I believe that he will prove to be a strong ally for pharmacists.”
FDA issued an emergency use authorization (EUA) on Friday, December 11, for the Pfizer/BioNTech COVID-19 vaccine, which is indicated for those ages 16 years and older. CDC’s Advisory Committee on Immunization Practices (ACIP) gave the vaccine its official recommendation on Saturday, December 12, and finalized its endorsement to prioritize COVID-19 vaccination for health care workers—including pharmacists—and residents of long-term-care facilities with the limited supply that will be available initially.
FDA's vaccine advisory panel on Thursday voted 17-4 to recommend regulatory emergency authorization of Pfizer and BioNTech's COVID-19 vaccine, which the agency is expected to push forward within a matter of days.
The Vaccines and Related Biological Products Advisory Committee is likely to recommend today that FDA approve a COVID-19 vaccine developed by Pfizer and BioNTech.