The Food and Drug Administration (FDA) on Tuesday granted emergency use authorization (EUA) to an updated version of Novavax’s COVID-19 vaccine based on safety data from previous versions. The Oct. 3 EUA allows people aged 12 and above to receive a dose of the new Novavax vaccine, regardless of their prior vaccination history, according to […]
U.S. drug regulators on Sept. 11 cleared new COVID-19 vaccines to try to counter the poor effectiveness the current slate provide. The U.S. Food and Drug Administration (FDA) cleared shots from Moderna and Pfizer that will be available to Americans as young as 6 months of age later this month. “Vaccination remains critical to public […]
U.S. Food and Drug Administration (FDA) advisers made a unanimous recommendation that updated COVID-19 shots, which are to be launched for a vaccination campaign this fall, are to target one of the dominant variants. The shots are to be aimed at the XBB coronavirus variants, which are reportedly the current most dominant variants, according to […]
A higher than expected number of heart inflammation cases have occurred in people who received Novavax’s COVID-19 vaccine, researchers reported in a new study. Sixty-one cases of myocarditis, pericarditis, or both following a Novavax vaccination were reported in the World Health Organization’s vaccine safety database through Aug. 23, 2022, Spanish researchers found. Using pre-pandemic rates of […]
The Centers for Disease Control and Prevention (CDC) on Monday signed off on the use of Novavax Inc.’s COVID-19 vaccine for adolescents aged 12 through 17. The recommendation follows the Food and Drug Administration’s (FDA) authorization for the vaccine for the age group last week. The protein-based vaccine received emergency use authorization in July for […]
The U.S. Centers for Disease Control and Prevention (CDC) on Tuesday endorsed Novavax’s more conventional COVID-19 vaccine for use as a primary shot for eligible Americans aged 18 and older. The CDC’s independent advisory committee voted unanimously to recommend the vaccine for adults after reviewing safety and effectiveness data at a public meeting on Tuesday. Signing […]
The Food and Drug Administration (FDA) on Wednesday issued an emergency use authorization for Novavax’s protein-based COVID-19 vaccine. “Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” FDA Commissioner Robert Califf said in a statement. The […]
A U.S. Food and Drug Administration (FDA) vaccine advisory panel voted on Tuesday to recommend the emergency use of Novavax’s COVID-19 vaccine. The advisory voted 21–0 with one abstention, after seven hours of discussion, agreeing that the benefits of a two-dose Novavax vaccine outweighed its risk for use in adults aged 18 and older. Dr. […]
Staff with the U.S. Food and Drug Administration (FDA) on Friday flagged the risk of heart inflammation following the administration of the Novavax COVID-19 vaccine, although they concluded the shot reduces the risk of mild-to-severe COVID-19. In the company’s nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of myocarditis, […]
Novavax announced Monday it has formally submitted a request to the U.S Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for its two-dose vaccine, NVX-CoV2373, for people 18 years and older. If granted, NVX-CoV2373 would become the fourth COVID-19 vaccine to be made available in the United States. Currently available COVID-19 vaccines are […]
Indonesian health officials have approved the COVID-19 vaccine produced by U.S.-based biotechnology company Novavax Inc., marking the Asian nation the first country worldwide to authorize the new shot. “The first authorization of Novavax’s COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia,” said Stanley Erck, Novavax’s chief […]
Prime Minister Boris Johnson announces plans to produce a new COVID-19 vaccine in the UK. The pandemic has brought an unprecedented backlog of cases in the Crown Court. An independent watchdog says London police acted appropriately at the vigil for Sarah Everard.
