There are 2 moments within the pandemic that I remember best. The first one was on the last day of in-person school that we had in March of 2020. It was 4th period, and my English teacher gave what I thought at the time was an alarmist rant about this new ‘Coronavirus’ that was spreading in Italy and New York. He said that we were going to face a pandemic, that our healthcare system was not ready for this, and that this could last for a very long time. The second moment came much later on November 9, when I got the New York Times email notification with the headline “Pfizer said early data showed its vaccine was over 90 percent effective in preventing Covid-19, pushing the company to a lead in the vaccine race.”
This was when I knew that in the foreseeable future, I was going to be able to hug my grandparents again, see my friends, go back to in-person school, and, to my relief, stop seeing posts about sourdough bread on social media.
In the next couple of weeks, news broke from other pharmaceutical companies like Moderna that the vaccines were safe and extremely effective, and eventually these vaccines got approved by the FDA (Food and Drug Administration). For many, this was a source of hope and for others, a source of skepticism. This meant a huge mobilization effort was underway for Federal, State, and Local governments across the country. But most importantly, this meant that the end of the pandemic was on its way.
When it all Started
On December 31, the World Health Organization found a statement by the health commission in Wuhan, China about cases of “viral pneumonia” that we now know was the SARS-CoV-2 or Coronavirus. In many aspects of the beginning of this pandemic, China was secretive and did not cooperate with key organizations to mitigate the spread early on. However, 11 days later, scientists in China published the genetic sequence of the virus.
A virus has many parts, but there is one that is extremely important when it comes to a vaccine, and that is the spike protein. The spike protein is a harmless part of the virus that acts as a key into your cell. When somebody gets the Coronavirus, the spike protein “opens” your cells and allows the dangerous part of the virus to hijack it, and make more viruses. When developing the vaccine, researchers isolated the part of the genetic sequence that codes for the spike protein and replicated it. The scientist turned that into what is called mRNA, which is a blueprint for the spike protein. When that mRNA is injected into the body, the cells read that blueprint and start making the harmless Coronavirus spike protein. Although this is a harmless protein that cannot do anything without the rest of the virus attached to it, the body still recognizes the spike protein as a threat, and they attack it. Once the threat is neutralized, your body will create antibodies. These antibodies are what give you immunity and they function as a way for your body to remember a certain type of invader. Now that your body has those antibodies in place after receiving the vaccine, if you were to be exposed to the Coronavirus, it would recognize the spike protein and neutralize the threat.
Why do we feel symptoms after receiving the vaccine?
After receiving the vaccine, it is common to feel symptoms like pain and swelling at the injection sight or a fever and fatigue for a day or two. It’s easy to say that the vaccine is doing harm to your body after feeling these effects, but understanding the science behind the symptoms is crucial considering the reason that the symptoms are worse than those of an Influenza or HPV vaccine is because the vaccines work really, really well.
When someone gets a cold or the flu, it is very common to have a fever, muscle soreness, and general fatigue. That happens due to the fact that either the flu virus or some sort of other tiny biological invader has entered the body. When your body recognizes this, it starts working relentlessly to neutralize the threat. If you have a severe case of the flu, you are going to be sick longer because your body has to work harder to produce more antibodies and other proteins, cells, etc. This is a lot of work for your body, so naturally, you are going to feel fatigued and a bit sore. Most viruses don’t do well in higher temperatures, so your body might turn up the heat a bit, hence the reason you often get a fever when you’re sick.
When you receive the Coronavirus vaccine, this same process occurs because the immune system sees the spike protein produced by your cells as a foreign threat that does not belong in the body. It then increases blood flow to the injection site, turns up the temperature, and works really hard producing antibodies to combat the invader. With certain vaccines, you don’t feel these symptoms as significantly.That is because they are less effective. The reason we see a 95% efficacy rate with the two mRNA vaccines by Pfizer and Moderna is because they are extremely good at triggering a strong immune response. That strong immune response is going to make your body create multitudes of Coronavirus Spike Protein antibodies, making you feel fatigued, but also protecting you from the Coronavirus more effectively and for a longer period of time.
How the Vaccines go from development to FDA approval
A vaccine is pointless if it is not effective and safe for humans to take, so there is a lengthy and in-depth process where scientists conduct trials and analyses to make sure both are true.
The first step of the process is development. This is where scientists and doctors from different pharmaceutical companies and organizations work to create a vaccine that they think will be effective and safe. With the Coronavirus vaccine effort, the duration of this step was much shorter due to the new vaccine methods that do not require scientists to handle live viruses. Instead, the scientists were working with mRNA and DNA (the instructions that were aforementioned). Once the vaccine is developed the next step is to test it.
Typically before the vaccine is injected into a human, there is a phase called pre-clinical trials where the vaccine is injected into a non-human living thing in order to make sure that it is safe for humans. Once the developers feel that the vaccine is harmless to humans they start conducting clinical trials.
There are 3 stages of clinical trials, and each one plays a crucial role in determining whether the vaccine is safe and effective for humans. When developing the Coronavirus vaccine, due to the urgency of the matter, the researchers were able to overlap some parts of the trial to reduce time.
In the first phase trials, vaccine companies will recruit a small number of volunteers and give them the vaccine. After they have received it, they will be monitored closely for the following days, weeks and months to come, in order to see if any reactions or adverse events occur. The purpose of this first stage is to make sure that the vaccine is safe. That’s why only a small group of volunteers is used. For example, for the Vaccine developed by Moderna, they had a group of 120 volunteers. The volunteers were then split up into 13 different subgroups. In each of these subgroups, a different dose of vaccine (Ex. 50mcg or 100mcg) was administered to a different age group. By conducting a trial this way, the companies are able to make sure that certain quantities of the vaccine are not dangerous to certain age groups. In order to ensure transparency, the data from these trials are public and trusted medical institutions, like the New England Journal of Medicine, analyzed the results.
Once the stage 1 trials have been conducted, and the pharmaceutical companies have determined that the vaccines cause no serious long or short term problems, they move on to stage 2. In stage 2, they bring in a second group of volunteers that is slightly larger. These volunteers are placed in what is called a double blind study. This means that a doctor will give a patient an injection, but both the subject and the people analyzing the subjects are unaware which type of injections were given. This prevents bias in both the behavior of the subjects and analysis of the scientists. For instance, in the Moderna trials, this injection was one of 3 things. It was either a 50mcg dose of the vaccine, a 100mcg dose of the vaccine or a harmless injection that had no effect on the subject. The harmless injection, also known as a ‘placebo’ functions as a baseline for the researchers to compare the actual treatments to. The next step is to then monitor the subject as they receive the dose, and for a certain period of time after that to double check the safety of the vaccine. However, the most important step of this phase is to monitor the amount of antibodies produced, because this gives the researchers a good idea of how effective the vaccine is going to be.
Last but not least, there is the phase 3 trial that takes place after scientists have determined that the vaccine is safe and most likely effective. In this trial, the pharmaceutical companies gather a large group of people. For example, Moderna had north of 28,000. The reason that a group this large is necessary is due to the fact that the vaccine is tested on a wide variety of people. With this amount of people, they are able to get an extremely good estimate on the effectiveness of the vaccine to prevent serious infection as well as test the safety. They take a very similar approach to this phase as they do in phase 2 by conducting a double blind study. Half of the participants receive a harmless injection and the other half receive the real vaccine. Once both groups have received both doses, the scientists are able to look for any dangerous reactions and count the amount of infections that pop up in both groups. In the phase 3 clinical trial conducted by Moderna, 14,073 subjects received the placebo and there were 185 reported cases of Coronavirus in that group. Compare that to the 14,134 subjects who received the actual vaccine, where there were 11 reported cases of Coronavirus in the group. Among all of the subjects who received the actual vaccine in the phase 3 trials, there were no cases of any disease or disorder that was caused by the vaccine.
In both the clinical trials for the Moderna and Pfizer vaccine, no deaths were reported. To this day, there still have not been any vaccine-related deaths. More importantly, there were no deaths or hospitalizations reported from Covid-19 in clinical trials.
The companies have conducted their trials and they have determined that their vaccine is indeed safe. Their next step will be to submit a BLA (Biological License Application) into the FDA. The FDA will then assemble a team of Chemists, Physicians, Biologists, Statisticians and many other professionals from different sectors and organizations. They’ll take input and look into data from many different companies, organizations, and nonprofits to analyze every aspect of the vaccine itself, as well as manufacturing, rollout and effectiveness. If the FDA deems the vaccine safe and effective, they will approve it to be distributed. But their work does not end there. The FDA continues to monitor the distribution effort in order to ensure that there are no safety issues and that the manufacturing and distribution of the vaccine is completely safe.
Creating a vaccine in record time, in response to a one in a century pandemic with the lives of millions at risk, is no small thing. But with the tried and tested procedure of clinical trials and with the oversight of the meticulous United States Food and Drug Administration, the process can balance the need for a speedy journey from the lab into our arms, with the most important aspect of all being safety. In the end, the tireless efforts of countless doctors, scientists, volunteers, and governments, are bringing us near the end of the pandemic.