A recent study from England examined the Pfizer BioNTech BNT162b2 COVID-19 vaccine's safety and effectiveness in children and adolescents. The results of this study raise an important question:

Is the limited, short-term protection against COVID-19 worth the potential risk of adverse reactions?

First, let’s discuss the study itself, then we can get into what this information means for us as parents, health advocates and healthcare providers.

Study Background and Objectives

As part of England’s efforts to curb COVID-19 spread, the vaccination program was extended to include children aged 5-15. This study assessed how well the Pfizer-BioNTech vaccine reduced severe COVID-19 cases and evaluated the risks of myocarditis and pericarditis, which are rare heart conditions.

Methodology

Researchers used data from the OpenSAFELY-TPP database, which includes extensive health records from English primary care practices. By comparing vaccinated and unvaccinated children and adolescents, the study aimed to mimic a randomized trial. Over 500,000 participants were analyzed, with matched controls ensuring comparability across groups.

Key Findings

Effectiveness of the Vaccine

Among adolescents (12-15 years), vaccination with BNT162b2 reduced the incidence of COVID-19-related emergency visits by approximately 40% and hospitalizations by 42%. Specifically, emergency visits decreased from 2.54 per 10,000 in unvaccinated adolescents to 1.91 per 10,000 in vaccinated adolescents over a 20-week period. Hospitalizations similarly declined, with vaccinated adolescents experiencing 3.09 hospitalizations per 10,000 compared to 4.23 per 10,000 in their unvaccinated counterparts.

For younger children (5-11 years), COVID-19-related emergency visits and hospitalizations were rare across both groups, making it challenging to draw definitive conclusions on vaccine effectiveness. However, there was a slight reduction in emergency visits in vaccinated children, suggesting some level of benefit in preventing severe cases in this age group.

Myocarditis and pericarditis were seen only in vaccinated groups, with myocarditis affecting adolescents at rates of 27 per million after the first dose and 10 per million after the second. Among children aged 5-11, three cases of non-severe pericarditis were reported, with no myocarditis observed.

Strengths

The study's key strength lies in its use of a comprehensive, large-scale dataset from the OpenSAFELY-TPP database, which covers a substantial portion of primary care records across England. This extensive data source allowed for an analysis of both vaccinated and unvaccinated groups, enhancing the reliability of the results. Furthermore, by employing a matched control design, the study effectively reduced the impact of confounding factors, offering a clearer view of vaccine effectiveness and associated risks. This design approach enhances confidence in the findings, providing a solid foundation for understanding vaccine outcomes in children and adolescents.

Limitations

While the study provides valuable insights, there are notable limitations. The BNT162b2 booster was developed to target an earlier strain of the SARS-CoV-2 virus, which is no longer the prevalent variant. As the virus evolves, the effectiveness of this booster against new variants may differ, potentially diminishing its relevance in the current landscape. This means the data on vaccine efficacy and adverse events may not apply to newer strains, highlighting the need for updated research.

The study's short duration is another limitation. With only 20 weeks of follow-up, it doesn’t provide insights into the long-term safety of this new medical treatment. This is particularly important because mRNA technology is still relatively new, and earlier versions were never FDA-approved for regular, non-emergency use in children under 12 (as of the publication of this article).

Additionally, potential reporting biases could influence the findings, as heightened awareness of myocarditis and pericarditis might have led to increased documentation of these events in vaccinated individuals. The study also excluded clinically vulnerable children, limiting the applicability of results to that group.

Study Conclusion and Implications

This study sheds light on the vaccine's ability to reduce severe COVID-19 outcomes while also posing a risk of myocarditis and pericarditis, observed only in vaccinated children. These insights are crucial for vaccine policy, safety monitoring, and parental decision-making.

However, looking at other data which show that those with comorbidities like asthma, diabetes, obesity, and other chronic issues make up nearly 90% or more of all of the reported deaths in children. Additionally, when you consider the lack of access to healthcare and the pervasiveness of the chronic disease epidemic here in the USA, you have to wonder how much of that remaining 10-15% of children also had an undiagnosed or subclinical chronic disease.

A Call to Reassess Booster Recommendations

Given the rapid decline in vaccine efficacy and the potential risk of heart-related side effects, it may be time to rethink booster recommendations for children. Since children — especially healthy kids — have a very low risk of severe COVID-19 outcomes, the benefits of frequent boosting are limited, especially when weighed against possible compounding adverse effects from each booster. A more customized approach, where boosters are reserved for those with severe underlying health conditions, would, in my view, strike a better balance between protection and minimizing unnecessary risks.

Hormone Health & Long-Term Safety

After vaccination, 30,000 women in the UK reported menstrual changes according to one study. Another study done in Turkey states that over half of the women reported concerning menstrual cycle changes including heavy bleeding, and delayed menses. These, in addition to countless anecdotal reports, and other studies online shine a light on the potential impacts on reproductive health. If adults are experiencing these side effects, imagine the impact it could have on prepubescent children. It’s also worth noting that the full list of ingredients for any of these treatments is unreleased to the public, so we really don’t know what all is being injected.

Conclusion

In conclusion, this study and many others mentioned suggest a need for more customized booster recommendations based on individual risk assessments rather than a blanket strategy. Doctors should be able to operate freely without government or corporate interference based on clinical evidence. Parents should be given full informed consent about the risks and benefits of any medical procedure and be supported to make a free and uncoerced choices for their children.

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