The anti-vax movement is all riled up over the idea of vaccines against the virus that causes Covid-19, spreading baseless fears about their likely safety. Here’s why any vaccine, by the time it gets to you, will be very safe.
The world is awash in Covid-19 disinformation and conspiracy theories. Among the absurd and ignorant nonsense, one hears that the whole ‘plandemic’ is just a plot to force us all to get vaccinated.
In the fevered minds of the conspiracy nuts, vaccination is how ruling elites establish mind control over us and turn us into docile and obedient wage slaves.
Alternatively, vaccines are how Big Pharma makes sure we all get sick a lot, so the greedy monsters can sell us more drugs and treatments that we otherwise wouldn’t have needed.
All we need to be healthy is nature’s remedies, say the people who forget that when all we had was nature’s remedies, average life expectancy was 30.
This kind of delusional paranoia would be funny if it didn’t have such serious consequences. People die because of anti-vax beliefs, or, as the anti-vaxxers prefer to call it, ‘vaccine hesitancy’.
Watch the story of Arlyn B. Calos from the Philippines, who lost both her young children to measles because she believed anti-vax propaganda on television and Facebook:
Thanks to the incredible success of vaccination, cases of and deaths due to diseases like measles, pertussis and rubella have plummeted worldwide over the last few decades. In recent years, however, there has been an uptick in many locations, including South Africa.
Not enough children get vaccinated against serious childhood diseases, both because of the unavailability of vaccines in some poor countries and because rich people have deluded themselves into believing that a vaccine is somehow riskier than the disease itself. And the problem is getting worse.
The same could happen with Covid-19 vaccines, if and when they become available. Disinformation about vaccines in general, and Covid-19 vaccines in particular, has spread far and wide on social media. If enough people choose not to be vaccinated, we could fall short of herd immunity, which means that the virus will continue to pose a serious danger to older people, or people with conditions like high blood pressure, heart disease or diabetes.
‘Rushed’ vaccines
Among the most common claims are that the development of Covid-19 vaccines is being ‘rushed’, and that this implies cutting corners and greater safety risks.
Depending on what is meant by ‘rushed’, this could potentially be true. For the most part, governments and drug manufacturers have been accelerating their development not by short-cutting safety and efficacy testing, but simply by throwing money and manpower at the problem and removing unnecessary bureaucratic hurdles. This introduces no risks. In fact, the increased scrutiny can lead to better outcomes.
For example, AstraZeneca, working with Oxford University, is a leading contender in the race towards a Covid-19 vaccine. Its vaccine is reported to be 70% effective, will be very affordable, and can be stored in an ordinary refrigerator, which makes it a prime candidate for developing countries.
It has been conducting clinical trials involving thousands of volunteers in the United Kingdom, United States, India, Brazil and South Africa.
In September, a single patient in the UK trial developed a neurological condition after receiving the vaccine. There was no evidence that the event was caused by or related to the vaccination. Still, the company did pause its trials worldwide while it investigated.
The death of a test subject in Brazil also briefly halted the trial, until it was established that this particular subject had received a placebo, and not the vaccine. When you have thousands of people in a trial, pure chance dictates that some of them will fall ill for reasons other than the vaccine trial.
The company recently disclosed that due to a dosing error, it had stumbled upon the curious fact that giving half a dose with the initial jab, and a full dose with the follow-up, actually increased the vaccination’s effectiveness from 62% to 90%. The problem was that the half-dose-full-dose regimen was not part of the trial design, and not enough people received it to reach sound conclusions. It will now go back to trial the newly discovered dosage regimen more broadly.
Adverse events
Both the adverse event in the UK and the dosing error prompted scientists and regulators to express concern over the transparency and rigour of AstraZeneca’s trial process.
This has consequences. Both events led to a steep decline in the company’s share price, and it is possible that the entire approval process could be delayed or even derailed.
No process is perfect, but this anecdote illustrates that regulators do not take concerns over clinical trial data and the approval process lightly.
The last time that any vaccine caused serious side-effects was in 1976, when a rapidly developed vaccine against a swine flu pandemic that never materialised caused Guillan-Barré Syndrome, a rare neurological disorder, in one out of 100 000 people who received the vaccine.
Before that, some early polio vaccines in the 1950s weren’t so great. One company’s vaccine actually caused polio and had to be withdrawn very quickly. Others were contaminated with Simian Virus 40, thanks to the method by which vaccines were cultured in those days.
Science is a process of learning, however. Scientists and regulators have both learnt from these experiences, and the chance of a recurrence of similar missteps is vanishingly small. Against that, we have to weigh the advantages of being able to stop a pandemic that has so far killed 1.5 million people.
Safety testing
The process to develop a vaccine and prove that it is both safe and effective occurs in phases. At last count, there are as many as 55 vaccines in clinical trials on humans, and another 87 in preclinical testing in labs or in animals.
That means that a huge number of potential candidates compete to become the preferred vaccine around the world. Any weaknesses in any of them means they won’t make it to production and roll-out.
The process starts with preclinical tests on cell tissue, and then proceeds to trials in animals that are believed to be good analogues for the human body.
The first phase of safety trials in humans involves a small number of test subjects. The purpose of phase one safety trials is to establish that the vaccine works, what the correct dosage should be, and whether the vaccine is safe enough to continue with wider trials.
In phase two, the trials are expanded to hundreds of volunteers, and test subjects are separated into different categories, such as the young, the elderly and people with pre-existing conditions. This way, scientists can get a broader view of how different people respond to the vaccine.
In phase three trials, the testing is expanded to many thousands of people. This phase includes placebo controls, to confirm that those who receive a vaccine fall ill less often than those who do not. Any serious or unexpected adverse events are recorded and painstakingly analysed to see whether it was related to the trial, and if so, what that means for the overall safety of the vaccine. Because so many people participate at this level, even relatively rare side-effects can be detected and studied.
When a drug successfully passes a phase three trial, it is ready to be approved for market. However, the testing does not end there. There is a fourth phase, in which longer-term follow-ups are conducted and those who received the placebo during phase three are given the actual vaccine. This expands and deepens the safety data that is available.
Approval is not a blank cheque, either. It is possible to receive emergency-use approval, under which a vaccine may be used in patients who are severely at risk from the disease. This approval can be withdrawn at any point, if new adverse data comes to light. That is what happened with hydroxychloroquine, for example, which was given emergency-use approval until new data showed that its effectiveness was limited and its side-effects worse than anticipated.
China and Russia have both approved locally developed vaccines for limited use, despite those vaccines not having cleared phase three clinical trials. This is the kind of rush that might give one pause. Not only does this mean that patients cannot be sure of the safety of the vaccine, but if a serious side-effect does crop up in the remainder of the trials, public confidence in the vaccine will be dented.
mRNA vaccine
There is also some concern over the fact that two of the leading vaccine contenders are based on new technology involving messenger RNA (mRNA). Established pharmaceutical giant Pfizer, working with biotech firm BioNTech, and biotech upstart Moderna working independently, have both produced highly effective vaccines that are sailing through their phase three clinical trials and towards approval.
The key to their success was that mRNA technology was ready and waiting for an event just like this coronavirus pandemic.
The story of how mRNA vaccines came to be is an inspirational story of 25 years of persistent work by Katalin Karikó, a scientist who got ignored and demoted for her belief in the technique, and her collaborator, Drew Weissman. The New York Times also has a great article about how Pfizer/BioNTech and Moderna won the race for the vaccine.
If there is any justice, there will be a Nobel Prize in it for Karikó and Weissman. The story of these vaccines would also make a great movie script.
However, the spectre of genetic engineering makes many people fearful because they don’t understand it. They worry that mRNA vaccines will ‘genetically modify’ humans by altering our DNA.
This is simply not true. Messenger RNA codes for certain proteins, in this case, the coronavirus spike protein, enabling the body to create antibodies that bind to this spike. It creates no DNA, modifies no DNA, and does nothing other than make the protein required to bind to the virus.
The beauty of mRNA technology is that all you need is the gene sequence for the antigen for which you’re coding, and your vaccine is complete. It took Moderna two days to design their Covid-19 vaccine once they had received its genetic sequence.
Moreover, because you’re targeting very specific proteins, there is far less risk of unwanted side-effects, even in people who might otherwise be at risk due to auto-immune diseases.
This is science at work, relentlessly innovating and improving the tools we have to fight disease. The development of mRNA vaccines is a reason for optimism and relief, not worry.
Reasons for confidence
By the time you or I get to be vaccinated, we can be sure that whatever vaccines are available in South Africa will have been tested on thousands, and probably millions, of people around the globe.
We will know that only the best vaccines will have made it through the rigorous trial process to win approval for widespread use. We will know that only the best vaccines will have made it through the tough competition among dozens of private companies, all hoping to get their product accepted by the market.
We will know what the frequency and severity of adverse events are, and that they will be extremely low.
When you listen to people who issue grave warnings about the supposed dangers of vaccines, listen out for the dead giveaway: anecdotal evidence. It’s always someone who knows someone whose child got this or that after being vaccinated. These stories always lack sound scientific evidence of causality that suggests the problem is real, or good statistical evidence that suggests the problem is widespread.
When you hear them tell how reckless and greedy pharmaceutical companies are, and how they are in cahoots with corrupt governments, listen out for tell-tale signs of paranoid conspiracy thinking. Imagine the scale of organised deceit that would be required to make these conspiracies work without anybody spilling the beans.
Ponder why anyone would want to foist half-baked vaccines upon the world, when the future profits of these very companies is dependent on public faith in their products.
And then dismiss these fears, born of ignorance as they are. Any vaccine, by the time it gets to you, will be exceptionally safe. It would be wise to take it, if you can.
[Picture: Gerd Altmann from Pixabay]
The views of the writer are not necessarily the views of the Daily Friend or the IRR
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