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vaccine

Moderna’s first bivalent COVID-19 vaccine booster candidate shows promise

May 19, 2022 By Brian Buntz

Moderna’s (NYSE:MRNA) bivalent booster COVID-19 vaccine candidate, mRNA-1273.211, bested its first-generation mRNA-1273 vaccine in a Phase 2/3 study. The study compared the neutralizing antibody levels generated from both vaccine boosters. The mRNA-1273.211 vaccine booster candidate offered superior performance against all variants of concern, including omicron. Get the full story from our sister site, Drug Discovery […]

Filed Under: Clinical Trials, Featured, Pharmaceutical Tagged With: COVID-19 vaccine candidate, Moderna, mRNA-1273, mRNA-1273.211, vaccine

FDA hits pause on reviewing Moderna COVID-19 vaccine for adolescents

October 18, 2021 By Brian Buntz

The FDA has decided to postpone deciding whether to extend emergency use authorization of Moderna’s (NSDQ:MRNA) COVID-19 vaccine. Some regulators have concluded that the risk of myocarditis is higher in recipients of the Moderna vaccine than the Pfizer-BioNTech vaccine. Japan recently authorized men 30 and under who received an initial dose of the Moderna vaccine […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: coronavirus, COVID-19, FDA, Moderna, vaccine

Report: Two vaccine leaders set to step down from FDA

August 31, 2021 By Sean Whooley

Two senior vaccine leaders within the FDA are reportedly relinquishing their positions within the administration. According to a report from Endpoints News, which cites a letter released internally to FDA staff first reported on by BioCentury, Marion Gruber and Phil Krause will depart in the coming months due to frustrations over the delegation of certain decisions within some governing […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: coronavirus, COVID-19, FDA, Personnel Moves, vaccine

Norway investigating deaths of 23 individuals who received COVID-19 vaccine

January 15, 2021 By Brian Buntz

In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). To date, it has analyzed data from 13 of those individuals. The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly […]

Filed Under: Featured, Pharmaceutical Tagged With: CDC, Clinical Trials, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, Norway, U.S. Centers for Disease Control and Prevention (CDC), vaccine

BREAKING: FDA grants emergency use authorization to Moderna COVID-19 vaccine

December 21, 2020 By Brian Buntz

FDA has decided to permit emergency use of Moderna’s (NSDQ:MRNA) mRNA-1273 COVID-19 vaccine. A week ago, FDA granted the same designation for the vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).  The U.S. government will collaborate with the company to distribute the vaccine. Although the EUA permits the vaccine to be used in individuals 18 and older, medical workers […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: coronavirus, COVID-19, FDA, Moderna, SARS-CoV-2, vaccine

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