“If that’s the case, you’re going to see the empowerment of local enterprises, giving mandates that could be colleges, universities, places of business, a whole variety and I strongly support that. The time has come. … We’ve got to go the extra step to get people vaccinated.” Said Fauci in regards to the FDA approval of the COIVD-19 Vaccine.
Before any vaccine can be used in the United States, it must first be approved by the FDA. The FDA grants approval after it has confirmed that vaccine developers have followed a process consisting of multiples stages that in turn has generated enough information for the FDA to assess the safety and effectiveness of a vaccine. According to Johns Hopkins, this approval generally takes around 5-10 years. However, as Johns Hopkins points out, vaccines can be accelerated in the case of a pandemic.
But, just how quickly can each stage of vaccine development be accelerated? How many exceptions can really be made? In general, how far did the FDA take this “extra step” for vaccine approval?
The first stage of a vaccine development is labeled the “preclinical trial” in which scientists work to create a plan for a vaccine based upon the way in which the infectious organism causes the disease in question. This stage occurs in the lab, and once the scientific findings prove to have “practical applications,” the research continues as the vaccine begins to be tested on animals. This part of the development phase is important as it works to eliminate vaccines that do not produce an immune response, or that are toxic.
If the vaccine proves to be promising in this “preclinical trial” stage, the vaccine candidate will move on to the “clinical development” stage. This stage consists of 3 subphases and marks the beginning of human testing.
In Phase 1, around 10-100 volunteers of whom have yet to be exposed to the disease that is in study and who are also otherwise healthy are administered the vaccine. In this phase, scientists work to gather information regarding short term safety and adverse reactions, and to gain somewhat of an understanding of the efficacy of the vaccine in producing an immune response. Accelerated Phase 1 trails have the ability to be completed in two to three months, which allows for two doses of a vaccine administered three to four weeks apart.
Phase 2 of the clinical development stage continues to survey the safety and immune responses of a vaccine but adds more people into the studies as they work to test various doses on hundreds of people, all of whom have varying health statuses and from different demographic groups. Furthermore, in this stage, control groups are often introduced and people who are receiving the vaccine are compared to this control group. Accelerated Phase 2 trials are able to be completed in three to four months.
Phase 3 of the Clinical development stage is when the vaccine is widely administered to thousands of people which allows researchers to gain more information regarding effectiveness and additional safety data. One important factor of this stage is the presence of a control group, which is necessary to test the efficacy of the vaccine: the number of cases in the vaccinated group is compared to the number of cases in the control group, which provides information on whether or not the vaccine reduces the possibility of disease. Accelerated Phase 3 Trials may take around six to nine months in order to test early assessment of safety and efficacy.
At a minimum, even with acceleration, it takes 11 months to conduct the proper research that the FDA requires for approval. Pfizer filed for vaccine licensing on May 7, 2021, and on August 23, the FDA granted full approval to the COVID-19 Vaccine which was developed by Pfizer/BioNTech, for use of individuals 16 years of age or older. The data that Pfizer submitted to the FDA was only six months’ worth of testing and research. This is five months short of the necessary amount of time that researchers need to collect the data required by the FDA for vaccine approval.
Not only did the FDA disproportionately accelerate the approval process of the Pfizer/BioNTech Vaccine, but they also made grave exceptions regarding the presence of a control group in the “clinical development” stage of the approval process. In the second week of December of 2020, the control group, which is so vital to the third stage of the process was unblinded; the vaccine was offered to the control group and 93% opted to get the vaccine rather than remain in the control for the remainder of the trial. In other words, researchers have no ability to discern if the vaccine under study is safe or effective, and they will also be unable to properly observe the long-term effects of the vaccine.
Now, the purpose of this blog is not to dissuade anyone from getting the vaccine, rather it is to provide individuals with the proper information needed to make a decision about getting the vaccine amongst this massive campaign “to get people vaccinated”. Despite mainstream media and popular news outlets alike creating a narrative around the safety of the Covid-19 Vaccine now that it is “FDA approved”, the reality of it all is that there is still not enough information regarding its efficacy or safety. Doing one’s own research when it comes to individual health decisions, in specific when it comes to the receiving the vaccine, is of the utmost importance in today’s highly polarized climate.