The safety of age de-escalation trials and why you should get your children vaccinated

It is a very sensitive issue and polarising, but it really shouldn't be. The data speaks for itself.

Over the last month, a number of you asked me to write a children’s covid-19 vaccine specific article. And after having spent the last 3 weeks reading through the clinical trial data and safety profile, I now feel comfortable enough to write this article. So here goes.

New Zealand is in the process of rolling out countrywide childhood vaccine drives and this is a good thing for the country. If you have children who are concerned, I have deliberately tried to write this article so as to make sense to a lower age bracket, so by all means, get them to read this. And for you parents out there, I wrote this for you too. I completely understand the concern and even anxiety you may have around this issue, but let me assure you, you do not need to worry, this vaccine is completely safe for children to take.

Why?

When the immune system is developing in a child, it is one the most protective safety barriers that evolution has conjured up. The organ responsible for creating naive T-cells, the thymus, is the largest it will ever be during an individual’s life. The reason why children get on average twice as many cold and and flu infections is because their immune system is still figuring out what is foreign and what is self in terms of cells that it encounters. That’s why traditionally a child will have 4-5 colds in any given year while the adult average is 2-3. A child’s immune preparedness is quite an incredible checks and balance system. Provided a child has been exposed to a variety of pathogens, by the time a child is between 6-7 years old, it is capable of the most robust immune response of any human in any age. 

The lymphatic and blood circulatory systems are abuzz with a wide variety of immune cells ready to fight off any foreign invader. The body at this age is akin to a fortress filled with soldiers just waiting for someone to invade. It is one common misconception that children are given a lower dose because of their smaller size, but the reasoning is actually a lot more comforting - the reason kids get a lower dose is because their immune systems are THAT MUCH MORE ACTIVE and don’t require a larger dose than us adults. As opposed the years of our life going up, our immune system actually decreases in power the older we get, which can be seen in the thymus getting smaller and smaller as each year progresses (thymic atrophy.)  

Covid-19 vaccine

As such, a child is the most capable of staging an immune response to the covid-19 vaccine, of any age. Their systems are way better equipped than people in any other age category. It is not children that need to worry, it is the elderly and immunocompromised (people who have problems with their immune system) that will often struggle with vaccines, and for obvious reasons. It is for these people that we get vaccinated after all, to protect them by lowering our chances of having a contagious infection (one that we can pass on to others.) 

Take a moment and read that sentence again. We get vaccinated for others. As opposed to old people and those who have immune system complications, a child’s immune system is replete with the capability to deal with the information that the vaccine provides in a much more safe and effective manner. It is also why children have a much lower rate of showing side effects than humans of other ages. 

Age de-escalation trials

This is the reason that clinical trials are mandated by the FDA to be run following age de-escalation protocols. What this means is that new medications are tried out in the oldest age cohorts first and then are progressively tried in younger and younger ages. So that the youngest age category 6 months to 2 years old is always the last to receive any new medication.

The rigorous covid-19 vaccine trials have been no different and that is why we are only now just gaining access to vaccines that have been tested rigorously in the 6 month to 2 year old and the 2 to 5 year old category. The Pfizer vaccine trial encountered run in those two age categories made a mistake and got the dosage wrong for the category 2 year old to 5 year old and that is why they had to recently run an adjunct trial to increase the dose in this age range as they tried the same dose as the 6 month to 2 year olds and it turned out to not be as affective, so what they did was that they ran an add on trial that added one more booster dose to this age. Technically, Pfizer could have started the trial from scratch but taking prescience (timeliness) and cost into account, as well as following the absolutely strict FDA mandated trial protocols, they opted to run the trial as an add on so as to get the vaccine to market as quickly as possible. 

Let’s not forget we are in a pandemic here and timing is of the essence.

It’s the hardest decision ever, but it shouldn’t be

Not being a parent myself, I can only try to empathise with those who have young children. A friend recently told me in a very emotional message about how much her children mean to her and I think many parents can relate to this, she said if the decision came to give her own life to protect her child, she wouldn’t hesitate even for a minute. Barack Obama once famously remarked, having his two daughters was akin to:

“Seeing my own heart walking around in front of me.”

So considering this, I can only say to you that when it comes to vaccinating your children, you do not need to feel this concern, well, you can still feel it, but your overall emotional state should be one of happiness and pride because you are giving your child the best possible opportunity for a healthy and safe life. That much is certain. I had another friend ask me whether or not she would be damaging her child’s immune system in the long run because of side effects that could be happening down the line. Here I can only reiterate that with vaccines long term side effects are near impossible because the active ingredient is passed from the system within 10 days, so that within two weeks your child’s body will be like nothing has happened, except for the fact that its immune cells will be primed to fight covid for the rest of their life. 

Another friend wrote to me about the concern that the spike protein will be expressed for life and that this could potentially cause an autoimmune reaction in her child’s life later on. Again, the spike protein is only produced for the duration of the presence of the mRNA in the cells, which is about two weeks. mRNA has a very short life span and is broken down very quickly after the spike protein has been produced and it NEVER enters the nucleus, which means that a life long expression of this protein is impossible.

It might be of interest of you to know that certain immunocompromised children have had the covid vaccine tested on them and have faired very well. This includes children with acute leukaemia and certain auto-immune disorders. If your child is otherwise healthy, you do not need to be concerned for their safety. You are doing them a favour and everyone that comes into contact with them. That’s the way your brain should be processing this.  

Pregnant women and the vaccine: Get it!

On top of the information on children getting vaccinated, I also read the trial data in pregnant women and the results have been extremely reassuring. The covid-19 vaccine is completely safe and effective in pregnant women and the way you need to be viewing this is that you are doing you and your unborn baby a huge favour in being vaccinated. The data in unvaccinated pregnant women who have contracted covid-19 is on the other hand, very sobering and quite alarming. 

Again, the best thing you can do as an expectant mother is to get vaccinated. The data speaks for itself. Over 88% of pregnant women admitted to hospital with covid-19 were unvaccinated and furthermore in one study, of the 230 pregnant women admitted to the intensive care unit of hospitals, only 1.4% were vaccinated. So yes, it does not guarantee that you won’t get sick, but it gives you a way better chance at staying out of hospital when you get vaccinated.

Trial data in terms of side effects

In a randomised placebo-controlled trial that was held in the US and 3 European countries, over 2000 children, the results were very reassuring. The kids were split into receiving the Pfizer covid-19 vaccine and a placebo. In terms of adverse events reported, both groups faired the same at around 10%. This is a pretty standard response in a group that large and comprised of that age. The best news was that in terms of severe side effects, both groups reported less than <0.1%. 

The biggest difference in terms of side effects reported between the two groups was that the vaccine group reported swelling under the arm pit at a higher rate (where the lymph nodes sit and most of the immune cells are hard at work multiplying and dealing with spike protein that has been expressed to them) - this was totally to be expected and is a sign that both the vaccine and the immune system of the children worked as they were supposed to.   

The greatest part after knowing the vaccine worked, was that in none of the thousands of children tested in these 5 countries were there any reports of anaphylaxis (a common side effect to some vaccines,) nor any of myocarditis, pericarditis, or any hypersensitivity that could have been expected. Also, most importantly, there were no reported deaths in either group. The trial results were extremely positive and should really comfort you as a parent.

One question that you may have is when to get your child vaccinated, especially considering the dose difference between 11 and 12 year olds (administered adult doses) - the best answer to this is to just go and get your child vaccinated as soon as possible. Do not worry about any age related vaccine dose differences. Timing is critical here.

I hope this article has been of some benefit and comfort to you, I know these are difficult and trying times for everyone let alone those parents among us. Big kudos to you and keep your head up and stay safe. Please post any questions you may have below or email me at chrisvonroy@gmail.com.   

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REFERENCES

Ensuring Vaccine Safety for Children
https://covid19.nih.gov/news-and-stories/ensuring-vaccine-safety-children 

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults 
https://clinicaltrials.gov/ct2/show/NCT04816643

SARS-CoV-2 infection and COVID-19 vaccination rates in pregnant women in Scotland
https://www.nature.com/articles/s41591-021-01666-2 

Covid-19 Vaccination in Children
https://mvec.mcri.edu.au/references/covid-19-vaccination-in-children/ 

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age
https://www.nejm.org/doi/full/10.1056/NEJMoa2116298

Pfizer plans to test a third dose of its COVID vaccine on infants and young children
https://www.npr.org/sections/coronavirus-live-updates/2021/12/17/1065200225/pfizer-third-dose-covid-vaccine-infants-young-children 

COVID-19: Vaccine clinical trials and testing
https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-clinical-trials-and-testing 

Spike Protein Behaviour
https://www.science.org/content/blog-post/spike-protein-behavior 

Duration of Spike Protein Presence
https://directorsblog.nih.gov/tag/spike-protein/ 

Women and children last? Shaking up exclusion criteria for vaccine trials
https://www.nature.com/articles/s41591-020-01199-0

What Stops the Body from Continuing to Produce the COVID-19 Spike Protein after Getting an mRNA Vaccine? (VIDEO)
https://www.chop.edu/centers-programs/vaccine-education-center/video/what-stops-body-continuing-produce-covid-19-spike-protein-after-getting-mrna-vaccine  

A Study to Evaluate the Safety and Immunogenicity of a 2-dose Regimen COVID-19 Vaccine in Children and Adolescents Aged 6-17 Years
https://clinicaltrials.gov/ct2/show/NCT05169008

Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings (PACIFIC)
https://clinicaltrials.gov/ct2/show/NCT04969601

Covid-19 vaccination in pregnancy
https://www.midwife.org.nz/women/covid-vaccination-in-pregnancy/

Investigating COVID-19 Vaccine Immunity in Children in the Melbourne Infant Study of BCG for Allergy and Infection Reduction (COSI BAIR)
https://clinicaltrials.gov/ct2/show/NCT05168709 

COVID-19 Vaccine Confidence Among Pregnant Women and Mothers (VCCOVID) 
https://clinicaltrials.gov/ct2/show/NCT04694664

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