COVID-19 Vaccine Risks

Along with all aspects of life, there are risks related to viruses and the vaccines that are designed to protect us from those viruses. For a majority of the population, many studies strongly suggest that the benefits of vaccine far outweighs the risks of vaccine.

In the case where the risk of a virus is only slightly greater, equal-to, or lower than the risk of a vaccine for a given sub-population group, use of vaccines should be carefully evaluated. For example, with very young children who are at very low risk for a serious COVID-19 case, vaccination may not be of enough benefit to outweigh the risks. The initial December 2020 EUA’s for Pfizer and Moderna vaccines only addressed use in adults. With the very frail elderly, there is increased likelihood of adverse events associated with a strong immune response to a full-strength vaccine and very-near-term booster such as the 21 / 28 day Pfizer / Moderna boost schedules. Many reports of significant immune response side-effects including fever, myalgia, headache, chills, etc. appear to be far more prevalent with dose 2, while many report only injection site side-effects for dose 1.

Certain vaccines (e.g., adult tetanus and diphtheria toxoids [Td], pediatric diphtheria and tetanus toxoids [DT], tetanus toxoid) produce increased rates of local or systemic reactions in certain recipients when administered more frequently than recommended. Interestingly, IgM (and IgG) unbound antibody immune responses are generally peaking around the 15 to 30 day period past dose 1 vaccination. Small numbers of anecdotal cases of death 2-3 weeks past dose 1 and immediately following dose 2 do seem to fit a plausible pattern of occurring during the peak immune response period suggesting that additional research of this phenomena and deferral of dose 2 and dose reduction may be prudent.

The generally high efficacy of the mRNA vaccines and significant numbers of adverse events may suggest that the dosages are not yet optimized and may be slightly high for some adults and children. Admittedly, the mRNA purification process leaves some undesirable mRNA elements within the resulting product which could lead to very rare odd protein synthesis and unexpected immune response. While the vaccines have proven very favorable for reducing the impact of COVID-19 on many who are not in low-risk categories, improved research could lower the risk of the vaccine to those who are at very low risk of severe COVID-19. A September 2021 study stated: “Post-vaccination CAE rate was highest in young boys aged 12-15 following dose two. For boys 12-17 without medical comorbidities, the likelihood of post vaccination dose two CAE is 162.2 and 94.0/million respectively. This incidence exceeds their expected 120-day COVID-19 hospitalization rate at both moderate (August 21, 2021 rates) and high COVID-19 hospitalization incidence. Further research into the severity and long-term sequelae of post-vaccination CAE is warranted.“.

Since there are reasonable perceptions that mRNA vaccines have insufficient long-term safety data, and there are known concerns about mRNA manufacturing purification processes, and all vaccines have demonstrated adverse events and death in very healthy people at low-risk of severe COVID-19, optimal (lower) dosing options and boost timing, specific to physiology / risk / “weight” categories should be developed and available as options to the low-COVID-risk population to encourage vaccine acceptance and maximize safety ~Primum non nocere. While it is not possible nor pragmatic to expect elimination of all vaccine risks, it likely that optimizations of dose and schedule could make the vaccine vs COVID risk enticing to the entire population, even those who have recovered from natural infection.

In November 2021, Moderna said their Covid vaccine has fewer breakthrough cases than Pfizer’s, but higher myocarditis rates in young men, further illustrating that there is a tradeoff between dose/efficacy and adverse events such that current vaccine dosage may not provide a suitable benefit/risk ratio for the entire population. Further, a senior NIH expert is pushing back on growing vaccine mandates: “I think the way we are using the vaccines is wrong,” he told Fauci. Matthew Memoli, a 16-year veteran at the NIH, who has reportedly applied for vaccine exemptions, favors vaccinations in vulnerable populations, but not the entire population. Excessive boosting also adds risk.

In mid-2021 there has been more discussion of intra-dermal vaccination in place of the currently prescribed intra-muscular vaccination method because the intra-dermal approach can achieve similar efficacy with only 1/4 the dose. Since the dosage is lower, it would be possible to vaccinate 4x more people in areas of the world with low access to vaccine. Additionally, a potential risk of the intra-muscular approach is that, if the administration misses muscle and it effectively becomes a intra-dermal delivery, the dosage could result in an effective dose 4x higher which could put the individual being vaccinated at higher risk of adverse events due to excessive immune response which can result in clotting and other issues. This may also help explain some of the severe and terminal events surrounding dose 2 adverse events where IgM and general immune response is peaking. Thailand is exploring a lower dose intra-dermal approach.

Vaccine dose/schedule optimization opportunity exists for the very low risk population. For people in average health who have not already recovered well/rapidly from natural infection, the vaccine is likely much lower than the risk of COVID; although the the full strength vaccine does carry some risk. Using care to reduce exposure levels can also reduce the risk of severe COVID. For a majority of the population, many studies strongly suggest that the benefits of vaccine far outweighs the risks of vaccine. This is particularly true when considering that “from 1999 –2000 through 2017 –2018, US obesity prevalence increased from 30.5% to 42.4%. During the same time, the prevalence of severe obesity increased from 4.7% to 9.2%“. While vaccines are helpful, some additional ways to reduce risk of developing severe COVID includes healthy amounts of exercise and reducing exposure potential.

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COVID-19 Vaccine Risks

About 2 to 3 Weeks After Dose 1 Adverse Events And Side Effects

Dose 2 Adverse Events And Side Effects

September 17, 2021 FDA Advisory Committee meeting on 3rd booster doses: