Vaccines are whack: 11 in final trial, no approval in sight

Caitlyn Dieckmann

cdieckma@uccs.edu 

As of Oct. 2, according to the World Health Organization (WHO), 142 COVID-19 vaccines are in the pre-clinical phase, 35 vaccines have moved to phase one trials, 19 are in phase two trials, 11 are in the final trial phase (phase three) and none have been approved. The race to develop a vaccine could not be more evident. But which one will break the tape at the finish line?  

     Before we jump the gun, let us look at some more facts to see what makes this vaccine race so special.  

     Vaccines are not an easy feat — in other words, vaccines are whack. In fact, there are several hurdles to jump over before they can be approved for distribution. Once enough is understood about a particular virus, then the real science can begin.  

     The triathlon of clinical trials is just around the corner. Pre-clinical trials allow vaccines to be tested on animals to determine the safety of the vaccine for humans. But as easy as it is to get through pre-clinicals, many vaccines drop out before the real clinical trials.  

     Within this next step are three separate phases. Each phase tests more people, starting at a few dozen and leading to several thousand inoculated individuals if the vaccine is lucky to make it to phase three. In this case, 11 COVID-19 vaccines are currently being tested on several thousand individuals per vaccine.  

A person receiving a vaccine.
Stock photo courtesy of PixaBay.com

     Of course, none of these vaccines mean anything at all without approval. According to the U.S. Food and Drug Administration (FDA), “if successful, the completion of all three phases of clinical development can be followed by the submission of a Biologics License Application (BLA),” from which the data collected throughout the trials is viewed by several committees under the FDA before approval.  

     Approval is one issue, production is another. If a vaccine becomes available, it is not always accessible. In the U.S.’ case, our manufacturing capacity is low compared to the large amounts of doses needed to inoculate every citizen. So, don’t get too excited when a vaccine sees the finish line. It’s really a few miles away, and it’s all on an incline to reach you. 

     Supposing a vaccine makes it through the long trek, it is unfortunately not foolproof. Essentially, any vaccine you receive is not 100 percent effective, according to the WHO. The risk of getting the flu after vaccination, for example, is only reduced by 40-60 percent, as provided by the Centers for Disease Control and Prevention (CDC).  

     This does not mean we should not get vaccinated. Vaccines are lifesaving and important, and if you need proof, visit the CDC or WHO websites, which are filled with endless statistics on different diseases and viruses and the large number of lives protected by simple, safe vaccines.  

     Usually, this process of vaccine development takes a long time. Time is sometimes (most-of-the-time, if you ask the right people) highly dependent on funding. Can the richest and best-funded companies produce vaccines faster? I don’t know, do the research yourselves and then let me know. Or ask Bill Gates and see what he says. Your call. It is safe to say, however, that money is vital if a vaccine is to even make it to the first human trial, let alone get through all three. 

     Back to the current race on hand. Out of the 11 vaccines currently in phase three, which ones are the best? This question is more significant when answered by the person reading this article. Which vaccine do you think is best? 

     In my opinion, it is BioNTech/Pfizer’s vaccine. This, as well as the Moderna vaccine, are two of the leading vaccines in the race. However, it’s anyone’s guess as to which one completes phase three fastest, and with the most efficacy.  

     Pfizer and BioNTech recently moved to enlarge their study in the phase three trials from 30,000 individuals to 44,000 individuals, according to Stat News. However, this slows its process through the final phase.  

     With leaders throughout American institutions constantly promising the approval of a vaccine before the end of the year, I feel as if my hopes are being stimulated nonstop. If neither of the two vaccines I mentioned above are approved by then, I guess I wouldn’t be surprised, due to broken promises becoming a staple from the people we elect to lead us.