By: Elijah Pinkert
With COVID vaccines being distributed across the USA, many people have raised concerns over their safety. The EU has delayed the distribution of a COVID vaccine over possible safety concerns, and many are refusing the vaccine over fears that the vaccine may not be safe. While extensive investigation and testing has confirmed all the vaccines to be safe, with any serious side effects being incredibly rare, drug safety has been and remains to be a hotly debated topic between civilians and experts alike.
Drugs require extensive testing to be approved for humans. Most drugs are tested first in vitro, which is soon followed with animal testing. Human testing often takes at least a year or more to begin, in which every age group is tested for possible side effects. By this point, most treatments are still only administered in special or emergency cases until they are fully understood and are confirmed to be safe. In the USA, drugs must be approved by the FDA before they can be legally sold.
This system has been in effect for a long time, yet it has had its failures. One particularly widespread disaster caused by relaxed testing was the Thalidomide crisis, where Thalidomide, a drug commonly used to treat morning sickness, was discovered to cause birth defects. The drug was commonly used across Europe, and was about to make its way into the USA before FDA reviewer and pharmacologist Frances Oldham Kelsey blocked its approval, citing the lack of testing or evidence of the drug’s effects, leading to the drug’s side effects being discovered.
Since the crisis, procedure for drug testing has tightened significantly. However, the COVID-19 pandemic brought loosened requirements to speed up the time of vaccine development. While there have been no instances of any of the vaccines proving unsafe, many still expressed concern over the practice. However, with the state of the pandemic, many more believe that the risk was worth the reward. No matter what happens, however, the FDA will continue to test incoming drugs, and the pharmaceutical industry will continue producing necessary medication that has proven itself as beneficial.