Vaccination has received significant media attention with concerns raised about links to autism and other dangerous side effects. Scientists, physicians, parents and the media have been battling with evidence and statistics, but so far no side has been able to convince the other.
In this article you will find some of the knowledge you need to form your own opinion about vaccination. We will revisit the arguments for and against its use, explain its mechanics and take a step back to look at what all this is really about. We also seek advice from an expert based here in Qatar. Modern science is not about blind trust, but about examining sources of knowledge and arriving at your own conclusions: this is our duty as responsible members of society and loving parents.
Bias or Science?
A major problem in examining the pros and cons of vaccination lies in the question of who you can trust to provide reliable information. A meta-analysis published in the British Medical Journal in 2009 found that “Publication in prestigious journals is associated with partial or total industry funding, and this association is not explained by study quality or size.” They found that higher quality studies were less likely to favor effectiveness of vaccines, and Government funded studies were also less likely to have conclusions favoring the practice of vaccination.
Despite regulated efforts to remove bias, it is inherent in any profit making organization, and vaccination is a hugely profitable business — the global vaccination market has dramatically increased in value from $5 billion in 2000 to over $40 billion in 2015.
Vaccination has been around for a much longer time than people realize: the basic mechanics have been used in China since the 10th century to prevent smallpox infections. Our immune system is an amazing biological process: able to heal our body from many diseases, given enough time to develop an antidote. However, if the threat is rapid, faster than our body can respond, we get sick or even die.
Vaccines prevent serious life-threatening diseases by exposing the patient to a small dose of the pathogen, or virus, that the body can safely handle. Sometimes this is a dead, un-infective form of the pathogen, sometimes it is modified to make it less infectious, and sometimes it is the live form of the disease we are trying to prevent.
In reacting to the vaccination, the immune system develops a ‘blue print’ for how to deal with the disease, and remembers it for later use. Some of these ‘memories’, recorded as specific antibodies, can last a long time, while others ‘fade’ and need to be renewed at regular intervals with boosters.
Ingredients and Testing
The main concern raised about vaccines relates to their ingredients, which include formaldehyde, mercury and aluminum, substances that are known to be dangerous, even deadly, for the human body. However, vaccines contain very minute amounts of these substances, to make the pathogen ineffective, to preserve the vaccine or to increase the body’s immune response.
While scientists and doctors claim that these ingredients are safe since the dose is so low, some parents and experts are expressing concerns and simply do not think the risk is one worth taking. However, before release onto the market, vaccines are tested in clinical trials by pharmaceutical companies. During this time healthy adults and children are given the vaccine and monitored to look for side-effects, technically known as Adverse Events.
Pharmacovigilence (Drug Safety)
After clinical trials, when vaccines are released into the market and added to vaccination schedules, the number of patients who receive the vaccine goes up dramatically. From just a few thousand in clinical trials to a few million, in what can be a very short period of time. During this period, the vaccine manufacturers continue to monitor reactions to the vaccine, the Adverse Events, and always see a much wider range of symptoms than during trials due to the numbers of patients exposed combined with environmental, health and genetic variations.
Adverse Event reporting is known to have serious shortfalls: in a systemic review published in the Journal of Drug Safety, conducted by Berkeley University, they found the average under-reporting was 94 percent. That means for every incident of, for example, seizure, thought to be as a result of the vaccine there were possibly another 19 children who experienced the same symptom and, for one reason or another, this simply was not officially recorded and reported through the correct channels.
When Adverse Events are reported, pharmaceutical companies collect and analyze the data and try to determine if there is a link between the vaccine and the event. If they do establish a possible link, they then work out the frequency, or likelihood, of the symptom occurring, and add this information to the Datasheet about the product. This information is then made publicly available and provided to doctors with the vaccines.
Although rare, some of these Adverse Events are life threatening or even deadly. In addition, it is sometimes difficult for the pharmaceutical companies to work out just how often they are occurring, partly due to the under-reporting but also because post-marketing surveillance often relies on sales data to estimate how many children have received the vaccine.
However, sales data is a very unreliable predictor of patient exposure when you consider:
– Different dosing regimens (some vaccines are given from 1 to 5 times)
– Shelf-life (of up to 3 years) and losses due to incorrect storage
So if a vaccine producer sells 10,000,000 vaccine doses in a year it COULD have been given to 10,000,000 different children, but, it COULD also have been given to approximately 2,000,000 (assuming 35 percent is still in storage or was disposed of, and an average regimen of 3 doses). So between not knowing how many doses have been used up; how many have been given to different patients; combined with mammoth 94 percent underreporting — how do we know how often side effects actually occur?
While most side effects are mild, such as swelling at the site of the injection, the rarer side effects are very troubling and potentially more serious than the disease the vaccination prevents. Herein lies the problem: infrequent, even “extremely rare” in a statistical sense can still translate into a huge amount of affected human beings when a drug is applied to an entire population. If a vaccine can lead to deadly seizures for one in ten million cases, vaccinating all of India, for example, could result in 125 deaths.
However the Adverse Events need to be considered in context of the diseases being prevented. The Centre for Disease Control in the US estimates that the vaccination program has prevented a total of 21 million hospitalizations and 732,000 deaths in 20 years.
Balance that out with figures from the US Vaccine Injury Compensation Program, which has paid out $3.18 billion to over 16,000 patients in 8 years. The program was established to compensate for vaccine injuries, using a special court process instead of typical proceedings — effectively making pharmaceutical companies ‘immune’ to legal proceedings regarding vaccination injuries.
Yet another factor to consider is determining if a side effect was really the result of the vaccine, or whether it was just diagnosed in the same time period. It could be a temporal (same time), rather than causal (direct reason) relationship — if you ate a banana then stubbed your toe you might blame the banana for your pain, but really they are unrelated from a causal perspective.
So it is clear that while side effects are very rare and serious side effects extremely rare, there are risks involved in getting vaccinations but also serious risks in avoiding them.
Health & Life spoke with Dr. Mohd. Ahmed M. Sh. Janahi, Chairman, Department of Pediatrics, Hamad Medical Corporation, to help us understand the impact of the debate and the situation here in Qatar.
The Doctor’s Opinion and Evidence
Dr Janahi told us that in his 15 years as a pediatrician he has not encountered any serious vaccine reaction cases being administered to his department. He strongly believes that if the side effects were present he would have been aware of sick children coming into his ward. The lack of vaccine related problems in his extensive experience is evidence enough for him to trust their safety and strongly advise their use. He also told us that the hospital is currently treating an unvaccinated child with a critical illness, which could have been prevented with vaccination — the real impact of vaccines is evident in his work every day.
The Doctor acknowledged there is a significant problem with under-reporting despite well-documented procedures, but proudly shared with us the news that in just a few months they will implement an electronic reporting system. Replacing the old ‘paper’ system with an online system will greatly improve compliance and make it much easier for clinicians to gather and accurately report any problems. This will provide a much clearer perspective on the actual risks involved with these very rare reactions.
He reassured us that there is no clear evidence linking autism, or other neurodevelopmental disorders, with vaccination, and felt the benefits hugely outweighed the risks. For example Qatar has been certified Polio free since 1991 when just a single case was accidentally imported from Oman.
He acknowledged that the sheer size and monetary value of the pharmaceutical industry means they do have influence — specifically he found it hard to obtain research that is not conducted by the industry itself. However, he is also actively working to ensure this influence is not allowed to bias Qatar’s own vaccination policies, for example resisting the introduction of the Human Papilloma Virus (HPV) vaccine for teenage girls, as it is not necessary in a non-promiscuous society.
On the subject of flu vaccination, the Doctor told us that he himself had received the vaccine — health care workers are advised to receive the shot to prevent patient exposure. While the effectiveness of the vaccine is not as well defined as typical immunizations, due to the variety in flu strains, he believes there is sufficient efficacy to warrant the recommendation.
The Decision Is in Your Hands
Many decisions in life are difficult, and weighing up the pros and cons with huge amounts of data and numbers in their millions is very tricky. However, many times we simply do not know the risks, for example even taking a short journey in the car has significant risks attached. Parents need to ask questions and do their own research if they have concerns — and also trust their instincts.
If you are concerned that your child has experienced a reaction to a vaccination, or any other medicine, it is very important that you inform your clinician. With thorough testing and improved reporting vaccines will undoubtedly continue to save lives and still provoke controversy.References