US Politics
FDA plans to put a ‘black box’ warning on COVID vaccines: report
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The FDA will reportedly add a “black box” warning to Covid-19 vaccines as the Trump administration steps up its attack on public trust in vaccines, sources say.
Black boxes are the FDA’s most serious warning sign and are usually placed on medications that come with a risk of life-threatening or disabling reactions.
Two people familiar with the controversial plans told CNN that the news has shocked experts outside the FDA.
According to the sources, the plan is being overseen by the FDA’s chief medical and scientific officer, Dr Vinay Prasad, and has not yet been finalized.
It is also unclear whether the warning, which is often applied to opioids and Accutane medications, will be included on all COVID-19 jabs or just mRNA vaccines.
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Currently, three COVID-19 vaccines are available: Pfizer, Moderna, and Novavax. Both Pfizer and Moderna are mRNA vaccines.
Andrew Nixon, a spokesperson for the US Department of Health and Human Services, told CNN that any claim not officially made by the FDA is “pure speculation.”
Also, earlier this year, Moderna issued a statement about its Spikevax COVID-19 vaccine, reassuring the public about its safety.
In the statement, the pharmaceutical company said that its jab was “rigorously monitored by Moderna, the U.S. FDA, and regulators in more than 90 countries.”
The company also revealed that one million doses of the vaccine had been distributed globally and that it has not “reported any new or undisclosed safety concerns in children or in pregnant women.”
Most side effects of COVID-19 vaccines are limited to arm tenderness from the injection, fatigue, and a mild headache. Light flu-like symptoms are uncommon, according to the Mayo Clinic.
There have been some instances of allergic reactions and heart inflammation caused by the vaccine, but these are exceedingly rare.
However, this is far from the first assault on public trust in vaccines by the Trump administration. Much of the president and RFK Jr’s Make America Healthy Again movement has centered around vaccine skepticism and outrageous claims about the effects of shots.
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The president claimed in September that children are being given “massive vaccines like you’d give to a horse,” bizarrely raising concerns about how a “little baby” can be “injected with that much fluid.”
He has also suggested that scientists distribute vaccines for mumps, measles, and rubella separately rather than in a combined MMR vaccine.
However, he was quickly trolled online for his scientific musings, with many users pointing out that he previously suggested injecting bleach as a method for curing COVID-19.
Medical experts firmly shut down his suggestion, claiming that it could endanger lives.
Robert F Kennedy Jr’s federal vaccine advisory committee voted to end the recommendation that newborns receive a Hepatitis B injection to protect them from the liver infection. The shots are widely considered to be a substantial public health success, preventing thousands of newborns from dying.
The Independent has contacted the FDA and Moderna for further comment.