BREAKING NEWS: FDA seeks probe into communications between its staff and Biogen after controversial approval of Alzheimer’s drug FDA commissioner Janet Woodcock has asked for a probe into her staff’s communications with Biogen Biogen’s Aduhelm received FDA approval for Alzhiemer’s disease in early June despite limited data that it worked in clinical trials By Mansur Shaheen … Read more
Covid antibody tests CANNOT prove you are immune to the virus from prior infection OR vaccination, FDA warns The FDA warned Wednesday that relying on antibodies for protection from COVID-19 may leave people vulnerable A vaccine is still needed to confirm immunity from the effects of the virus Positive antibody tests also won’t work as … Read more
U.S. regulators gave Pfizer’s COVID-19 vaccine emergency use authorization for children ages 12 to 15, making it the first shot available to kids younger than 16, the Food and Drug Administration (FDA) announced Monday. The shot was authorized for people ages 16 and up in December, and Pfizer has been in trials for teens since … Read more
FDA expected to authorize Pfizer’s Covid vaccine for teens ages 12-15 by next WEEK Food and Drug Administration is preparing to authorize Pfizer’s Covid vaccine for people ages 12-5, officials told the New York Times Authorization is expected to come as early as late this week, or early next week The Pfizer vaccine was authorized … Read more
FDA orders US plant to STOP making J&J’s Covid vaccine as it investigates ingredient mix-up that ruined 15 MILLION doses of the shot The FDA asked Emergent BioSolutions manufacturing plant in Baltimore to halt production of J&J’s vaccine on April 16 It comes after the plant accidentally used an ingredient intended for the AstraZeneca vaccine – … Read more
Covid vaccine blood clot fears have struck a second jab as the US today stopped using the Johnson & Johnson shot which the UK may approve within days. The Food and Drug Administration (FDA) has called for use of the jab to be suspended after six young women developed blood clots after receiving it. British … Read more
US regulators suspend use of Johnson & Johnson’s Covid vaccine over blood clot fears – with UK set to approve the single-dose jab ‘within days’ and start supply of 30million in summer UK expects deliveries in the second half of 2021, with approval likely this week Johnson & Johnson’s jab is the only one-dose vaccine … Read more
FDA and CDC call for Johnson & Johnson COVID vaccine to be PAUSED after six women out of nearly seven million people developed rare blood clots The FDA and CDC have called for Johnson & Johnson’s single-dose vaccine to be stopped in the U.S Seven million people in the U.S. have recieved the Johnson & … Read more
FDA and CDC call for Johnson & Johnson COVID vaccine to be PAUSED after six women out of nearly seven million people developed rare blood clots Seven million people in the U.S. have recieved the Johnson & Johnson vaccine By Dailymail.com Reporter Published: 11:59 BST, 13 April 2021 | Updated: 12:15 BST, 13 April 2021 … Read more
Regeneron Pharmaceuticals plans to ask the U.S. Food and Drug Administration (FDA) to allow its COVID-19 monoclonal antibody cocktail to be used as a preventative treatment. It comes after data from a Phase III clinical trial, run together with the National Institutes of Health, found the drug reduced the risk of asymptomatic coronavirus patients developing symptoms … Read more