By Admin 
Covid Vaccine Black Box Warning: America’s FDA is soon preparing to impose its most serious warning, black box warning, on the Covid vaccine. This is the same warning which is placed on medicines in bold letters at the top and it clearly means that the medicine contains a serious danger or a fatal risk, which should be considered very seriously before use. According to CNN’s report, this step within the FDA is coming at a time when the Trump administration is again raising questions about the safety of the vaccine. Many outside experts are surprised by this decision because according to them, there is no scientific need for such a warning regarding the Covid vaccine.
What is a black box warning?
Black box warnings are usually placed when a drug can cause death, stroke, serious heart damage, or other side effects that can even leave a person disabled. For example, there are warnings about addiction, overdose and death on opioid medicines or the possibility of birth defects is written on some medicines for pregnant women. The role of Dr. Vinay Prasad, who has been raising questions about the policy and safety of the vaccine for a long time, is being said to be the role of Dr. Vinay Prasad in putting forward this warning within the FDA. However, this plan is not yet in the final stage and may also change.
What do the companies say?
On the other hand, both Moderna and Pfizer companies are repeatedly reiterating that the safety of their vaccine has been proven by the data of millions of doses across the world and no new serious risk has emerged in children and pregnant women. Scientific data also says that the Covid vaccine saved the lives of about 2 crore people across the world in just the first year. The latest CDC report also said that the vaccine has significantly reduced the risk of going to the hospital in children aged 9 months to 17 years.
In the initial phase of the vaccine, the rare problem of myocarditis i.e. heart inflammation was seen in some youth, but CDC has clearly said that most people recover completely and now this rate has become much lower than before.
This is why the discussion started
Despite this, some officials in the FDA believe that this risk should be written more openly on the vaccine label and this is why the discussion of black box warnings has started. This would mean that it would be clearly written on the vaccine pack that rare but serious heart-related risks exist. However, several former FDA commissioners have strongly objected to this move, saying that spreading fear without showing solid data on such a major decision would be harmful to public health. The current situation is that the FDA is conducting an internal review on this issue, but if a black box warning is issued then it will mean the same message will be sent across the world, this drug has serious risks, so it should be used with utmost caution.
What do experts say?
Dr. Aaron Kesselheim, who runs the Regulation, Therapeutics and Law Program at Harvard University, told CNN that “These types of warnings are either initiated by the drug company or imposed by the FDA itself. But usually the FDA first tells the public that it is investigating a question related to the safety of a drug or vaccine. Sometimes the FDA also convenes an advisory committee consisting of independent outside experts, so that they can openly review the safety-related data and Can give suggestions to the agency.
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Disclaimer: This information is based on research studies and expert opinion. Do not consider this as a substitute for medical advice. Before adopting any new activity or exercise, please consult your doctor or relevant specialist.
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