As the second wave of infections is significantly rising globally after strict regulations were relaxed during the end of spring and summer, Covid19 has been impacting our lives again daily and causing remarkable stress in each one of us.
FACT: Covid19 cases reached nearly to 40.000.000 and caused death of 1,111,998 people globally. – https://covid19.who.int)- 20-10-2020
Fictional presumptions/conspiracy theories have been wiped out of the discussion as experts previously warned. Some common ones:
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” The warm weather and climate will destroy COVID19 disease”
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“It will disappear all of a sudden”
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“The virus will become weaker and weaker and soon won’t affect us anymore”
So what do we do? What is our way out from this pandemic?
There is only one clear way out from this pandemic, namely the same way we have been tackling other infectious diseases (rabies, smallpox, Influenza) for centuries with the same method. Through vaccination! And most likely not by “Allowing controlled natural infections and creating a herd immunity”.
Luckily scientists did not rely on presumptions and waited. Vaccine developments started on rocket speed as a historical challenge is to over win. Currently, eleven companies have reached the last phase of clinical trials. Moderna/NIH, BioNtech/Pfizer/Fosun Pharma‘s vaccines for Covid19 are both based on mRNA technology and AstraZeneca/Oxford‘s vaccine for COVID19 is based on vector technology. AstraZeneca/Oxford‘s clinical trials for a vaccine for Covid19 are set to “on hold” for an investigation by FDA( Food and Drug Administration), however not anymore by EMA (see below).
The European and US authorities are still skeptical about the Russian and Chinese clinical trial data from their vaccines for Covid19 which as well creates certain political tension between different countries.
What about the fast-tracked development?
As pharma companies are trying to achieve a safe and efficient vaccine within a year, which would have taken under normal circumstances a few years, the fast-track procedure has immediately triggered skepticism towards vaccines in many people and leading to questions like:
Is the vaccine safe? And/ Or is it sufficiently efficient? Are we sure that we are not ignoring some steps in the clinical trials to speed up the approval procedures?
Dr. Paul Offit (MD-Member of FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) mentions regularly in his podcasts that there is nothing wrong with being vaccine skeptical as he is one as well for each vaccine and would much welcome transparent data from clinical trials before any clear decision could be made. (https://www.paul-offit.com/link-to-podcasts).
However, it should not be reaching a level where all kinds of conspiracy theories are implemented and shared which aim to manipulate public opinion with, basically, incorrect information.
He is expressing also the language that has been used around the vaccine like “race for the vaccine” is confusing and destructing people and should be avoided in communication with the public.
FDA, CDC (Centres for Disease Control and prevention), and EMA (European Medicine Agency) are crystal clear about the safety and efficiency of the vaccine. Despite the public, economic and political pressure, they will take their time to control each data separately, monitor independently, and investigate each case.
“We simply cannot afford to make mistakes and recall a vaccine. The guidelines are very clear and are followed step by step by each company”.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.htmlhttps://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/covid-19-vaccines-key-facts
Implementing safety guidelines in clinical trials
Recently, there were also three very clear examples about implementing strict safety regulations during the clinical trials for the companies AstraZeneca/Oxford (1), Johnson Johnson (2), Inovio (3)
The clinical trials for those vaccine candidates are placed “on hold” due to a problem occurring during clinical trials. They are now being investigated by the authorities. The current state (20/10/2020) for all three clinical trials is “on hold “and “under investigation” by the FDA. FACT
As Stephen Hahn (M.D., FDA Commissioner, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research) would express deliberately, despite all the pressure, in case authorities would detect any major or minor irregularity/incident during the trials, they will pause the trials and investigate.
“We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”
How do we guarantee safety with a shortened development period?
There is also a very logical and understandable question that follows immediately after this declaration: How come that a vaccine development would take 4-6 years under normal circumstances and we can develop a vaccine for COVID19 within a year?
The European Commission had a very clear statement on 17/06/2020, how we can achieve a safe, efficient sufficient dose of vaccine within a very limited time:
“A vaccine against COVID-19 is needed more urgently than this. In the current crisis, teams around the world are working with the ambition of delivering a successful vaccine within a timeframe of 12 – 18 months. Besides, once a successful COVID-19 vaccine is available, hundreds of millions, or even billions, of doses will need to be produced to cover global needs, without compromising the production of other essential vaccines.”
Delivering such an undertaking within such a compressed timeframe requires running clinical trials in parallel with investing in production capacity and securing raw materials so that production can start as soon as those trials are concluded, or even earlier. The need to deliver quickly, the high upfront costs, and the high failure rate make investing in a COVID-19 vaccine a high-risk decision for vaccine developers.
This is not only a European challenge; it is also a global one. All regions of the world are affected. The spread of the virus has shown that no region is safe until the virus is under control everywhere. In addition to it being in their clear self-interest to do so, high-income countries have a responsibility to accelerate the development and production of a safe and effective vaccine and make it accessible for all the regions of the world. The EU recognizes this task as its responsibility”
https://ec.europa.eu/info/sites/info/files/communication-eu-strategy-vaccines-covid19_en.pdf
To summarize, we will have to start with the production and manufacturing of the vaccine in parallel and fund it before the clinical trials end with the risk that the production of the vaccine may not be authorized to be used. This would save a tremendous amount of time which is not the case in a non-prioritized vaccine development where the results of the clinical trials are waited to be able to start with investments/production and manufacturing.
Conspiracy theories in COVID19
Although authorities are assuring the public about the safety and efficiency of the vaccine, there still is a significant anti-vaccine campaign ongoing – fuelled by conspiracy theories.
How come people are believing in this nonsense? What is behind/feeding those conspiracy theories? According to scientists Jan-Willem van Prooijen and Mark van Vugt, it is a part of our evolved human functioning and psychological mechanisms. (PMID: 30231213) In their article, they underline two theories explaining what makes us believe in those conspiracy theories:
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Conspiracy beliefs are a by-product of different psychological mechanisms (e.g., pattern recognition, agency detection, threat management, alliance detection) that are prone to cognitive bias and have evolved for different aims (e.g. personal safety, learning, efficiency etc.)
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Conspiracy beliefs are part of a psychological mechanism specifically aimed at detecting dangerous coalitions that have evolved as in the evolutionary past, believing in conspiracy theories uniquely helped ancestral humans to navigate their social world better and anticipate and overcome imminent dangers in their environment.
Their review compared a by-product explanation with an adaptive explanation, concluding that those conspiracy theories are widespread because, in the evolutionary history of our species, it was beneficial to hold these beliefs. “Whether it is still adaptive for humans in the modern world to be overly susceptible to conspiracy theories remains to be seen” the researchers conclude.
In line with this finding, it is suggested that believing in conspiracy theories is a defense mechanism that we have created after having lived through certain experiences. The historical facts in vaccine development may have contributed to this phenomenon, for example:
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The Cutter incident In 1955, for example, insufficiently inactivated batches of polio vaccine caused an outbreak of polio due to the presence of wild-type poliovirus strains in which 40,000 children developed mild polio, 200 were permanently paralyzed and 10 died. FACT
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Aggravated or atypical disease following vaccination and exposure to wild-type viruses caused by measles and respiratory syncytial virus FACT
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In 1976, there was a small increased risk of GBS after swine flu vaccination, which was a special flu vaccine for a potential pandemic strain of flu virus. The National Academy of Medicine, formerly known as the Institute of Medicine, conducted a scientific review of this issue in 2003 and found that people who received the 1976 swine flu vaccine had an increased risk for developing GBS. FACT
https://www.nature.com/articles/nbt0910-910
Counter-strategy against conspiracy theories
What should be our counter-strategy against conspiracy theories as it is very important to have a global vaccination program where the majority of the population is vaccinated?
Jan-Willem van Prooijen and Mark van Vugt have summarized some suggestions to tackle conspiracy theories in their publication, supported by other empirical findings:
“An alternative way of functionally responding to a suspected conspiracy is to actively confront it. For instance, one might peacefully try to reason with the suspected conspiracy, or one might form a countercoalition and commit a pre-emptive strike. These approach-oriented responses can effectively decrease the dangers associated with the conspiracy under some circumstances, such as when one can quickly mobilize a countercoalition that is at least as strong as the suspected conspiracy. In some of these activities, approach-oriented reactions may be relatively peaceful. For instance, conspiracy theories increase protest intentions to change the status quo (Imhoff & Bruder, 2014). Likewise, conspiracy theories predict motivations to uncover and expose the suspected conspiracy, as suggested by increased support for democratic principles (Swami et al., 2011) and a call for greater transparency (Clarke, 2002).”
Transparancy is paramount
Having greater transparency about the outcome, status, and data about each step of clinical trials and a good communication strategy would be a good start.
Each one of us who could enjoy an academic education is also individually responsible to spread the right information and convince people to get vaccinated when it is approved by the authorities. Because every human being counts, this is the only way we can overcome this horrible pandemic.
Blog by Orkun Ozhelvaci
