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HHS quickens pace of Johnson & Johnson COVID-19 vaccine candidate
The Department of Health and Human Services said it will speed the development and manufacturing of vaccines to prevent COVID-19, starting a candidate from Johnson & Johnson subsidiary Janssen Research & Development.
Agencies partner with private sector to speed COVID-19 vaccine, treatments
The Department of Health and Human Services will partner with more than a dozen biopharmaceutical companies and the European Medicines Agency to prioritize vaccine and drug candidates, streamline clinical trials and coordinate regulatory processes to respond to the pandemic, the National Institutes of Health announced.
FDA issues vaccine development guidance, authorizes new molecular-based COVID-19 test
The Food and Drug Administration issued guidance for the development of a SARS-CoV-2 vaccine, outlining key considerations to satisfy requirements for chemistry, manufacturing and control, nonclinical and clinical data.
HHS backs AstraZeneca COVID-19 vaccine candidate, could be ready by October
A collaboration between the Department of Health and Human Services and AstraZeneca is projected to make available 300 million doses of a COVID-19 vaccine, the first of which could be available as early as October, HHS said.
Pair of COVID-19 vaccine candidates move on to next trial phases
A COVID-19 trial vaccine developed by the University of Oxford and AstraZeneca produced neutralizing antibody responses in patients with SARS-CoV-2, according to a study published July 20 in The Lancet.
National Academies to convene July 24 meeting on COVID-19 vaccine’s equitable allocation
The National Academies of Sciences, Engineering, and Medicine and the National Academy of Medicine July 24 will host its inaugural committee meeting on the equitable allocation of a COVID-19 vaccine.
Moderna to produce 100M doses of its vaccine candidate for U.S.
The departments of Health and Human Services and Defense will pay Moderna Inc. about $1.5 billion to produce and deliver 100 million doses of its COVID-19 vaccine candidate to vaccinate Americans if authorized by the Food and Drug Administration, the agencies announced.
AHA urges unified guidelines to lead COVID-19 vaccine allocation process
The AHA urged the National Academies of Sciences, Engineering and Medicine to adopt a unified set of guidelines to account for the variables associated with all issues of the eventual allocation of COVID-19 vaccine allocation.
FDA partners with European agency for coronavirus vaccine development
FDA said it is partnering with the European Medicines Agency (EMA) on regulatory strategies to facilitate the development of COVID-19 vaccines.
NIH: Experimental COVID-19 vaccine safe, generates immune response
The first human study evaluating an mRNA COVID-19 vaccine made by Moderna Inc. produced neutralizing antibodies in healthy adults, who generally tolerated the vaccine well, the National Institutes of Health reports.