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Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...
In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...
Vaccine maker Moderna announced today that the US Food and Drug Administration (FDA) has granted full approval of its ...
Yet only small percentages of patients with new diagnoses sought follow-up care, started or completed treatment, or attained ...
The full approval of Spikevax covers children aged six months through 11 years who are at increased risk for severe COVID-19, transitioning the vaccine from emergency use to full licensure.
Moderna, Inc. (MRNA) on Thursday announced that the U.S. Food and Drug Administration (FDA) has fully approved its COVID-19 ...
The company also recently received FDA approval for its new Covid-19 vaccine mNEXSPIKE. To mitigate the price decline and loss of revenue, the company has shifted to focus on cost efficiencies, as ...
Those limits match the terms FDA recently approved for Novavax’s shot, Nuvaxovid and Moderna’s mNexspike. Novavax’s vaccine is the only protein-based coronavirus vaccine available in the U.S.
The government’s top vaccine official, working under Health Secretary Robert F. Kennedy Jr., restricted the approval of two COVID-19 vaccines, disregarding recommendations from government scientists.
He cited similar safety concerns in a May 30 document, entitled “override memo,” regarding wide recommended use of Moderna’s latest version of its mRNA vaccine, mNexspike.
The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use of two Covid-19 vaccines, newly released documents show.
The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots.