An article by the ESV Newspaper
We are all hoping for a Covid-19 Vaccine to be released. It seems to be the only way our lives can go back to normal. Some of us have gotten so used to not leaving the house without a mask, keeping distance from others and disinfecting our hands every chance we get, that we forget what life was like before the Coronavirus. Remember going outside without having to bring a mask? Or going to actual parties or to the city? Remember hugging your friends? Everyone is hoping for these things to be normal again, and it seems a Covid-19 vaccine will be the only way.
But how are vaccines actually created? When can we finally expect a safe vaccine to be released to the public? How far along in the development process are the possible Coronavirus vaccines currently? What is “Operation Warp Speed” that everybody is talking about? What about the new Covid-19 vaccine we hear about in the news? How will the public react once or if the vaccine is made public? What if the government decides to make it mandatory? Will some people refuse and protest the vaccine that could bring normalcy back into our lives? I will answer all these questions and more in this article.
Firstly, I would like to explain the process of how a vaccine is being developed and thoroughly tested. As you probably know, a vaccine is a substance used to stimulate the production of antibodies and provide immunity against one or several diseases. We have all gone to the doctors at some point in our lives and received a vaccine, such as a Tetanus shot. The shot usually hurt for a second, and sometimes the arm tingled a bit afterwards. What we couldn’t exactly feel or see, is that these vaccines gave us immunity from illnesses and diseases, which claimed the lives of countless people prior to the development of the vaccine. Because such a vaccine is administered to millions of people every year, it must be tested thoroughly to make sure that it is safe. In fact, the development of a vaccine is a long and complex process, which often lasts 10-15 years and includes a combination of private and public involvement. This process follows a standard set of steps, in order to guarantee the safety of the population.
I will explain the process of how a vaccine is being created by the set of laws and regulations enforced in the USA, as a possible Covid-19 vaccine will most likely be developed first in the US. The development of a vaccine can be divided into three main steps, the first being called “Laboratory and Animal studies”. This stage begins with the Exploratory stage, which lasts about 2 to 4 years and entails basic laboratory research. Next, the pre-clinical stage lasts about 1 to 2 years and consists of animal testing, usually on mice and monkeys. This stage mainly helps to determine a safe dose and the best administering methods. Countless possible vaccines have failed at this point. Once these steps have been overcome, the creators of the possible new vaccine are required to submit an application for an IND (IND= Investigational New Drug) in order to proceed.
Only with the FDA’s (FDA= Food and Drug Administration) approval can they move on the second major step, called the “clinical studies with human subjects”. This step is divided into three phases as well, the first being simply called the Phase I vaccine trials. During this step, the vaccine is administered for the first time to a small group of adults, typically about 20-80 people.
Once this human clinical study is successful, the creators of the vaccine can move on to the Phase II vaccine trials. This stage involves the testing of the product on several hundreds of people. Also, for the first time, the trials of this step include a placebo group. A placebo is a substance that has no therapeutic or physical effect, it is used as a control in testing new drugs.
After this step, Phase III vaccine trials can be initiated. This step entails trials with thousands to tens of thousands of participants. Again, placebo plays an important role during this time. This stage aims to assess vaccine safety, determine possible side-effects, and test the effectiveness of the vaccine.
Only once all these phases are overcome successfully, can the developers of the vaccine reach the last major step: “Approval and Licensure”. Here, the vaccine creator must submit a Biologics License Application to the FDA. Only once this is approved, can the vaccine be mass produced and distributed to the public.
As we have seen, the development of a vaccine is a long and intricate process, which normally lasts over 10 years. So how is it possible that within less than a year, we hear about possible Covid-19 vaccines already in Phase III testing? The vaccines can be developed this quickly because of unprecedented financial investments and scientific collaboration. In addition to this, some steps in research and development are happening simultaneously, in order to speed up the process. This reduced time period does not affect the quality of the vaccines, as they still have to go through the same rigorous testing process.
Some of you may have heard about “Operation Warp Speed”. So what is it really? “Operation Warp Speed” is a partnership between the American Defence Department and the Department of Health and Human services that aims to provide coordinated financial government support to the most promising developers of Covid-19 vaccines. Therefore, it is a scheme which provides financial aid in order to speed up the development process for possible Covid-19 vaccines. Currently, 6 vaccines are a part of “Operation Warp Speed”.
Now, lets get to what we really want to know: When will we have access to a Covid-19 vaccine? It is estimated that a vaccine will be ready in early to mid- 2021, as there are several potential vaccines in development, some of which have already advanced to phase III trials. One vaccine in particular has been in the news more than others: the one produced by Pfizer and BioNTech. Pfizer is an American multinational pharmaceutical corporation, while BioNTech is a German company. These two firms announced initial results that suggest that the vaccine they created is more than 90% effective.
However, it is important to keep in mind that these news are preliminary, as not much is known about the vaccine or its effectiveness yet. In response to the news that the vaccine is allegedly more than 90% effective, the question arises: How good is this result? It is actually a promising figure, as the FDA set a bar of at least 50% effectiveness for vaccine producers who wish to submit their vaccine for emergency authorisation. The vaccine produced by Pfizer and BioNTech greatly exceeds this value. For reference, influenza vaccines are only 40-60% effective. On the other hand, two doses of the measles vaccine leads to an effectiveness of 97%.
Many people have raised concerns regarding the safety of this new vaccine. Pfizer and BioNTech reported that there are no serious safety concerns or side effects that have been reported by the test subjects. Nevertheless, it is always a possibility that some side effects may occur with more time elapsing, which only happens very rarely.
Many of you may be thinking right now: Great, a new Coronavirus vaccine sounds promising, but when will I finally be able to get it and when will life return to normal? Well, if everything goes according to plan and there are no delays, the first people could receive a dose of the vaccine before the end of the year. However, since the vaccine is currently being developed in the US, it may take longer for Europeans to receive it. In addition to this, Prizer and BioNTech can’t provide billions of doses of the vaccine so soon, it can only be produced at a certain rate. Because of this, there will be a limited number of doses available, which will have to be distributed to the public.
Now the difficult question will arise, who receives these doses? People who are most vulnerable to the virus are likely to have priority, so people who are older adults or those with health issues and risk factors. Next, health care workers such as doctors and nurses would receive the vaccine. The third group will then be people in important societal positions, for example teachers, firemen and members of the police force. Only after all these people, will the general public receive doses of the vaccine, so a slightly longer wait can be anticipated.
It is important to remember that all these questions and solutions are theoretical, as the vaccine produced by Pfizer and BioNTech is still within trial phase. Other Covid-19 vaccines are also promising, as 10 other vaccines are already in late-stage trials as well.
Another important question that should be addressed is whether the government will make possible future Covid-19 vaccines mandatory. At this point in time, it is unknown whether certain countries will make the vaccine mandatory, however it is unlikely. This is an ethically challenging question, because many people may not want the vaccine. The moral question will arise of whether it is acceptable to force the vaccination upon individuals who don’t want it.
On the other hand, if hypothetically only half the population gets the vaccine, the other half will remain at great risk of catching the virus. Therefore, it is likely that governments will not make it mandatory, but instead heavily encourage it. Other measures could be taken as well, for example it is possible that some employers may not accept a person coming to work without the Coronavirus vaccine.
A study on this matter has been conducted in the USA, with interesting results. In May 2020, 72% of Americans would have gotten the vaccine, had it been available at the time. This figure decreased to only 51% by September 2020. A similar phenomenon could be observed with the refusal of many to wear masks in America. Millions of people didn’t wear a mask during this pandemic, a behaviour which could translate to refusing a vaccine.
Personally, I observed this concept myself. About 2 months ago, I went to the city and noticed a booth. I went and asked what it advertised. I was surprised when the lady at the stand said that she was collecting signatures against the possibility that the government could make the Covid-19 vaccine mandatory. Keep in mind, this was 2 months ago, when there was less talk about vaccines. Judging from this and several studies, it is inevitable that a certain section of the population will disagree with the possibility of a mandatory vaccine. Subsequently, it is very possible that protests will be staged. However, these are all future scenarios that may or may not occur.
To conclude, many of the scenarios mentioned in this article are hypothetical, the future may look very different from what we expect. As you can see, there is so much information out there regarding this matter, but I hope I could convey some of it to you. Let us await the future and hope for the best.
Sources:
https://www.nytimes.com/live/2020/pfizer-covid-19-vaccine
https://www.fda.gov/media/142749/download
https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html
https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1903
