The FDA may be about to add its strongest safety warning to the Covid vaccines.
The experimental jabs were rolled out during the so called ‘covid pandemic’ and have for the past five years been used on human guinea pigs.
The Food and Drug Administration is preparing to add what’s known as a “black box” warning to Covid vaccines by the end of the year.
Black boxes are the FDA’s most serious warning sign and is not used lightly. It appears at the top of a medicine’s prescribing information and is designed to warn about risks such as death or serious injuries that should be weighed against a product’s benefits.
The plan to install the warnings is reportedly being orchestrated by Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research.
CNN reports: The record-speed development of Covid-19 vaccines during the pandemic, under the project dubbed Operation Warp Speed, was a crowning achievement of President Donald Trump’s first term, one that several Republican lawmakers have recently said should be awarded the Nobel Peace Prize. But Trump installed as his Health and Human Services Secretary Robert F. Kennedy Jr., a vaccine skeptic who has faced criticism from public health experts and lawmakers for his efforts to impose his personal views despite the science.
Administration targets vaccines
Kennedy and his allies have long questioned the safety and effectiveness of the Covid-19 vaccines, which were studied in placebo-controlled trials in about 75,000 people and given to millions of people in the US and around the world during the pandemic.
Prasad has been a controversial figure, both in his role at the FDA and previously, as a podcaster and professor in the Department of Epidemiology and Biostatistics at the University of California at San Francisco. A critic of the government’s response to the Covid-19 pandemic and vaccine policy, he was named CBER director under FDA Commissioner Dr. Marty Makary in May before resigning in July under pressure from the White House and right-wing activist Laura Loomer. Prasad then returned to the job weeks later.
In late November, Prasad sent a memo to staff within CBER, the division at the FDA that oversees vaccines, claiming that staff in the agency’s Office of Biostatistics and Pharmacovigilance had “found that at least 10 children have died after and because of receiving Covid-19 vaccination.” He did not provide additional information but promised “swift action” in response.
“The FDA takes very seriously any death that is attributed to a regulated medical product,” Nixon, of HHS, said Thursday.
Prasad focused on myocarditis, or heart inflammation, a very rare side effect after administration of the mRNA vaccines. It was detected with early use of those shots, when the first and second doses were recommended to be spaced as closely as three weeks apart, and was predominantly seen in boys and young men.