The FDA’s Conundrum

After a year long wait, the world finally seems to have an answer for Covid 19. This unprecedented disease caught everyone by surprise, hence for a good deal of time no one had a clue about what to do. However, the vaccination for this deadly virus is now finally available to the general public. Countries around the world are going on aggressive vaccination drives to ensure the bigger chunk of their population is immunized. While more and more people are getting their vaccine shot, it must be noted that this vaccine is still largely available for adults or kids above a certain age (age scales varying from country to country). The relevant authorities are mulling over whether they should expand it to every age group or more research needs to be done in order to find out if the vaccine is safe enough for kids. The conundrum of US’s Food and Drug Administration is pretty much the same at the moment. The agency is constantly engaging in talks with their advisors over the topic of how safe it is to roll out the vaccine for the kids below the age of 12. At the moment, FDA seems to be on the fence, as some advisors have pointed out that the kids are at relatively lower risk of contracting Covid, therefore they can wait it out.

Nevertheless, there are also advisors who believe it’s important to have authorization on hand, in case there is another wave in the forthcoming months. FDA has also pointed out that regardless of the risk level, Covid 19 can and has already killed many children below the age of 12. For now, the agency has provided the companies with direction to conduct clinical trials. These companies have also been informed about what kind of data the FDA would like to see, if they are to extend authorization or full approval to roll out the vaccine for kids who are still below the aforementioned mark. One major factor that can delay the introduction of vaccination to these kids is the concerning information of potential heart inflammation issue observed in the children who were given the Covid vaccine. FDA is currently facing a fork in the road, and it remains to be seen which route they choose to walk.

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