Pfizer has recently gained FDA approval to begin offering their vaccination to children between the ages of 5 and 11 years old.
If you have children between these age ranges, or know someone who does, this will be worth the time invested reading it.
As I had previously mentioned, I am not anti-vaccination, as my wife and I have been immunized with the Pfizer product.
However, the risk of contracting Covid, and/or becoming seriously ill from it, is far different for children as compared to adults. The risk is also dramatically different between children with comorbidities as compared to those without pre-existing non-covid illnesses. (I will illustrate this later.)
But first let us look at the research data, Pfizer has chosen to release, forming the basis for the recent vaccine approval.
The data that Pfizer has provided shows that their study group consisted of around 2,268 children between the ages of 5 and 11 years old. 1,517 children got the shot and 751 did not, getting a placebo injection instead.
The “shot” dosage was about one third the dose given to older children or adults. The study was double blinded, meaning that no one (other than those reviewing the data) knew who got what. The researchers analyzed the results after a median follow-up time of two months beyond the second injection.
A summary of the main findings from this study, published in The New England Journal of Medicine https://www.nejm.org/doi/full/10.1056/NEJMoa2116298, are:
Three of the children getting the shot (out of 1,517) contracted Covid as compared to sixteen (out of 751) of those given the placebo.
No child in either group developed severe Covid or Multi-System Inflammatory Syndrome.
Minimal adverse effects (like those previously reported for adults) occurred in a small percentage of both groups.
The researchers concluded that, based on their data, the vaccine was 90.7% effective.
Only 20% of the children studied had a comorbid condition (12% obese and 6% asthma.) with the data not indicating the Covid positive status of these as compared to others. (I will illustrate the importance of this later)
Granted, the above results seem promising, but the researchers took it a step too far by making other statements not supported by their data.
For example, they said:
“Direct benefits of preventing SARS-CoV-2 infection in children include protection against severe disease, hospitalizations, and severe or long-term complications, such as MIS-C.” MY NOTE: It is important to recognize that this study did NOT identify any severe disease, long term complications, or hospitalizations in ANY test subject (either vaccinated or not). Because of this, they cannot state that their vaccine would be effective in doing so.
“Indirect benefits include the likelihood of reduced transmission in the home and in school settings, including transmission affecting vulnerable persons, and safer in-person learning.” MY NOTE: This research paper did NOT evaluate transmissibility, how or if in-person learning would be safer, or if a vaccinated child would increase or decrease the risk of transmission when near vulnerable persons. As such, these statements are unsubstantiated.
“Without effective Covid-19 vaccines for this age group, children could potentially become ongoing reservoirs of infection and sources of newly emerging variants.” MY NOTE: Being redundant, the study did NOT assess this.
Bear in mind, I am NOT saying that such statements are NOT plausible. But they are NOT supported by the data included in the study.
The problem with this occurs when the press reports on such statements as being factual when they are only unsubstantiated opinions of the author(s).
As with most any scientific study, this one had limitations and the authors addressed them. However, despite the importance of knowing about the limitations of any research study, it is rare to see them mentioned by the popular press.
The authors indicated the following:
“Limitations of the study include the lack of longer-term follow-up to assess the duration of immune responses, efficacy, and safety. However, longer-term follow-up from this study, which will continue for 2 years, should provide clarification.” NOTE: The average follow-up period for this study was just 2-2 ½ months. What happens if, within those next 2 years, additional or more severe adverse effects arise? What happens if this delayed bad reaction occurred in your child? Would you feel consoled knowing that “you did your part for society” or would you feel betrayed by the “science” of using such a small window within which to observe for such negative reactions?
The authors also stated, “This study was also not powered to detect potential rare side effects of BNT162b2 in 5-to-11-year-olds. However, the safety of BNT162b2 observed in the study combined with widespread use of BNT162b2 in older populations should provide reassurance.” NOTE: Older and younger populations differ in many ways and “safety” in an older population cannot be construed to convey similar safety in a younger population. It is also important to point out that a younger population would have to deal with any severe or lasting side effects much longer than those who are older.
The final limitation, mentioned in this paper states, “that concomitant administration of BNT162b2 with other vaccines was not assessed, and cell-mediated responses to immunization are not yet available. In other words, this study did NOT answer questions about the potential interactions between the Covid vaccine and others (such as the Flu, etc.) that may be given concurrently or within close temporal proximity of each other.
Other limitations, NOT mentioned in this study, but warranting consideration are:
There were NO deaths or severe cases of Covid in either group. As such, the benefit of the vaccine in preventing deaths or severe cases in children cannot be determined from the data in this study. In fact, based upon one of the most recent CDC reports, (https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-2-3/03-COVID-Jefferson-508.pdf) the number of Covid cases (in 5-11 year old children) reported between March 2020 and Oct. 2021 was 1.9 million, of which 94 died.
This means that the study would need to include at least 20,200 (1.9 million cases divided by 94 deaths) children within these ages to have even expected one death in a non-immunized group of children. Obviously, determining the likelihood of immunization preventing a death would take a larger number.
Only 20% of the Pfizer study group had comorbidities (mostly asthma or obesity) and, as such, was not representative of the type of children who contract covid or develop a severe illness from it.
The CDC study, referenced above, found that 68% of the hospitalized children in their study had a comorbidity, primarily asthma, other lung disorders, or obesity.
Multiple studies have found the same thing. For example, The International Journal of Infectious Diseases (International Journal of Infectious Diseases 103 (2021) 246–256) found severe disease in only .2% of children WITHOUT comorbidities as compared to 5.1% of those WITH comorbidities.
In other words, those WITH comorbidities had about a 25 (YES THAT’S TWENTY FIVE) times greater risk of severe Covid as compared to those without.
As one final example, and I could give more, a study in the British Medical Journal showed that 42% of 651 children, under age 19, admitted to various regional hospitals with a diagnosis of Covid had underlying medical comorbidities. Six of those died, all of whom had a comorbidity (asthma, diabetes, obesity) No deaths occurred in children without a comorbidity. (BMJ. 2020; 370: m3249)
The last part of this article will offer theoretical scenarios to help assess the risk that Covid presents to children between age 5 and 11.
The data from the most recent CDC presentation, previously discussed, will be used. Once again, here’s the link: (https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-2-3/03-COVID-Jefferson-508.pdf)
Between March 2020 and Oct 2021, 1.9 children between the ages 5 and 11 had contracted Covid.
Of that 1.9 million, 94 deaths were recorded.
This means that the risk of death is .0049%, or 1 death for every 20,212 children afflicted with Covid.
BUT…..Remember that only 32% of those deaths (30 children) occurred in children without an identifiable comorbidity.
So, the risk of HEALTHY CHILD, without comorbid conditions, contracting Covid-19 then dying from it is just .00157%.
In other words, one out of every 63,333 healthy children, who contract Covid, would be expected to die from it. It’s also important to remember that NOT every child will contract Covid.
There are about 28 million children, between the ages 5 and 11, currently living in the United States. (Annie E Casey Foundation-Kids Count Data Center)
For a moment, assume that they are ALL UNVACCINATED and that they WILL ALL contract Covid.
The CDC statistics, presented above, suggest that 1372 deaths would occur. (.000049 of ALL who contract Covid)
Of those deaths, 933 (or 68%) would have occurred in children WITH comorbidities
439 of those deaths (32%) would have occurred in children WITHOUT comorbidities.
Now look at a theoretical scenario where ALL CHILDREN are vaccinated in comparison to the one given above where NO ONE was vaccinated.
Based upon Pfizer’s data (discussed above) 3 out of every 1,517 vaccinated children (.00198, or .198%) will contract Covid.
Remember, there are 28 million children between the ages 5 and 11.
28 million divided by 1,517 = 55,372
3 (the number of Covid cases per 1517) x 55372 (28 million divided by 1517) = 166,116
So, the number of Covid cases expected if all children between age 5 and 11 were vaccinated is 166,116
Based upon the CDC data (illustrated above) one Covid-related death occurs for every 20,212 children affected which would amount to (166,116 divided by 20,212) 8.2 Covid-related deaths out of a fully vaccinated population of 28 million children between the ages of 5-11.
So, there you have it.
Extrapolating Pfizer’s data suggests that there would be far fewer deaths in a fully vaccinated population of children between ages 5-11 as compared to that same population being completely unvaccinated.
However, despite Pfizer’s encouraging numbers, several things remain undetermined.
What is the potential for delayed onset, longer term side effects? Delayed onset adverse effects are known to occur with other medications, and it is likely that they will also eventually occur with the Covid vaccine.
Since children have a low risk of severe disease; (especially those without comorbid conditions) would contracting covid, and developing natural immunity, be better in the long-term as compared to the artificial immunity resultant from the vaccine?
Would natural immunity, secondary to an infection, provide better protection against Covid variants than would a vaccination?
Would it be better to prioritize immunizations for those known to have the greatest risk (comorbidities) as compared to suggesting mass inoculation?
Could receiving repeat Covid vaccines (boosters, etc) hamper the immune systems natural response to the virus rendering an individual less able to fight it off on their own?
In summary, the data provided by Pfizer suggests that their vaccine is successful in preventing the development of Covid 19. But, how well it prevents Covid 19 in the most susceptible individuals (those with comorbidities) remains unclear as does the potential for delayed adverse effects in those receiving it.
Also unclear is if the benefits of immunization are worth ANY (even if small) potential risks, especially for healthy children contracting Covid, considering that their risk of death from it is just .00157%
Thanks for reading. Comments always welcome.
rdf-10