US EditionMakary denies plans for COVID-19 black box warning
FDA leaders reviewed safety data and found no evidence warranting the strongest warning on COVID-19 vaccines despite ongoing safety monitoring and disputed claims.
- On Monday, FDA Commissioner Marty Makary announced the U.S. Food and Drug Administration will not add `black box` warnings to coronavirus vaccines, which flag death or life-threatening risks.
- Following last week's leaked CBER memo, Vinay Prasad prompted an internal FDA review after claiming `at least 10 children` died post COVID-19 vaccination, with reports the FDA intended boxed warnings.
- CDC data show vaccines are about 76% effective for children ages 9 months to 4 years and 56% for children ages 5 to 17 in the 2024-25 season.
- A dozen former FDA commissioners and public‑health experts demanded transparency and data, expressing concern over sweeping FDA vaccine safety claims and calls for released data linking vaccines to pediatric deaths.
- On Tuesday, Children's Health Defense filed a petition amid a measles resurgence, with 1,912 cases as of December 9, raising concerns over vaccine confidence and government messaging.
14 Articles
14 Articles
FDA Commissioner Makary: No Plans to Put “Black Box” Warning on Covid Vaccines
The FDA has no plans to add a “black box” warning to Covid-19 vaccines, FDA Commissioner Dr. Marty Makary told Bloomberg on Monday. ... The post FDA Commissioner Makary: No Plans to Put “Black Box” Warning on Covid Vaccines appeared first on The New American.
America First Report
FDA Is NOT Adding ‘Black Box’ Warning to Covid-19 Jabs
(The Epoch Times)—The Food and Drug Administration is not adding “black box” warnings to COVID-19 vaccines, even though an agency center recommended it, FDA commissioner Dr. Marty Makary said on Dec. 15 “When it comes to the ‘black box’ warning, we have no plans to put that on the COVID vaccine,” Makary said during an appearance on Bloomberg Television. Black box warnings are the highest safety-related warnings that FDA officials can place on pr…
FDA Not Adding ‘Black Box’ Warning to COVID-19 Vaccines: Commissioner
The Food and Drug Administration is not adding “black box” warnings to COVID-19 vaccines, even though an agency center recommended it, FDA commissioner Dr. Marty Makary said on Dec. 15 “When it comes to the ‘black box’ warning, we have no plans to put that on the COVID vaccine,” Makary said during an appearance on Bloomberg Television. Black box warnings are the highest safety-related warnings that FDA officials can place on products. Scenarios …
FDA Has No Plans to Put Black Box Warning on Covid Vaccines, Commissioner Says
FDA Commissioner Dr. Marty Makary says the agency has no plans to put a black box warning on Covid-19 vaccines. He says a recommendation was made, but it won't be adopted since the vaccines have changed since they first came out. He speaks on "Bloomberg The Close." (Source: Bloomberg)
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