Bivalent Boosters - Yes or No?

On September 1st, 2022, Health Canada authorized the bivalent booster for ages 18 and up for the Moderna Spikevax Covid-19 vaccine. This new vaccine targets both the original SARS-CoV-2 virus in 2019 and the Omicron (BA.1) variant. Apparently, according to Health Canada, through their independent and thorough analysis of the evidence, it provides strong protection with a high safety profile. (1)

I beg to differ.

The new bivalent boosters offered by Moderna and Pfizer (bivalent booster has not been approved yet in Canada) are based on clinical trials on mice. Yes, 8 mice to be exact. (2) No way in hell would any credible person in the position of authorizing a vaccine offered to society approve of one based on clinical trials on mice. Firstly, trials start with animal testing, mice in this matter, because they share genetic traits similar to that of humans. (3) Scientists then trial their treatments on mice and only after careful consideration of the results based on the efficacy and safety, can it be moved further to human trials. There is a reason why this careful step is taken because although mice might share genetic similarities, two-thirds of all genes are expressed differently. (4)

In 1993 a drug named fialuridine was used to treat patients with Hepatitis B that showed promising results in mice and several other animals; however, when it was brought to human trials, several people developed liver failure and five died because the drug was actually toxic to humans. (5) This isn’t surprising as most drugs do not pass animal or human trials. Stroke research is noticeable where there is difficulty in developing a standardized animal testing protocol. In fact, stroke medication affects animals differently from each other and of humans. This is also true for drug developments in other preventable or chronic health diseases such as: Alzhemier’s disease, traumatic brain injury, cancer, and more. According to the FDA in 2004, 92% of drugs that passed animal tests failed in human trials and in 2015, that has been estimated to be at least 96%. (6)

Developing a new drug and having it go through the proper channels is vital to the safety of everyone, such as the Food and Drug Administration (FDA) approval process. However, this process is costly and can amount to hundreds of thousands of dollars. (7) Which brings into question why did Health Canada and the FDA approve this vaccine after only passing the animal trial? Could there be an incentive for the pharmaceutical companies to save money? Or is it that most FDA advisors end up working for pharmaceuticals and this is a big nudge in the right direction for them?* This is speculatory, so maybe we will just stick to the facts.

This is surprising since it is well known that Omicron is significantly less severe than its predecessor but more highly transmissible, increasing the odds of reinfection in those unvaccinated and those that are mega boosted. In a study by Denmark that reviewed over 188,980 Covid-19 infections, 20.5% of the cases were of the omicron variant. In relation to the delta variant, it was determined that there is a 36% likelier chance of hospitalization. (8) Evidence of this can be supported by an investigation into an outbreak in Norway where 117 attendees aged 30-50 with 96% vaccination rate had an attack rate of 74%. The authors of the study noted that Omicron is highly transmissible even if vaccinated. (9). In support, secondary attack rates for the delta variant was assessed in a longitudinal study determining 38% and 25% for unvaccinated and vaccinated respectively. (10) In accordance, Public Health of Ontario (PHO) also agrees with the analyses as per their own findings (11) - however, they state that omicron infections can be severe, and they point out one group, the unvaccinated. Which is only true under certain circumstances such as: does the unvaccinated person have underlying health conditions? What is his/her age? Do they have natural immunity? Something PHO leaves out - how interesting.

Although the covid-19 vaccines have been determined efficacious in preventing severe illness in those who are categorized as older than 65 and those with underlying health conditions, this isn’t equivalent for healthy children, adolescents, and adults. This is indicated in all data collected on Covid-19 and is well known that those who are healthy do not end up hospitalized for severe illness. Which then begs the question - why would we need a bivalent booster now? Should we not only offer it to those that are most vulnerable? While that may be the logical thing to do, Health Canada decided that it was appropriate to offer the bivalent vaccine to anyone 18 years of age and older.

Thinking about getting boosted with the bivalent vaccine must take into consideration the benefits and risks - is the reward greater than the consequences?

According to the Adverse Events Following Immunization (AEFI) associated with Covid-19, there have been a total of 21,503 reports following a total of 34, 117, 806 vaccine doses (0.06% of all doses). One in particular of interest is myocarditis/pericarditis. This is of particular interest due to the bells being rung in Israel where the Ministry of health concluded that men aged 16 to 24 were suffering from an increased rate of myocarditis, after the Pfizer vaccine between 1 in 3000 and 1 in 6000. (12) According to the PHO, the vaccine safety surveillance data determined that there were relatively higher rates of myocarditis/pericarditis after the Moderna vaccine than the Pfizer vaccine. A total of 423 reports of myocarditis have been confirmed and men aggregate 76.6% of those reports and 70% came after the second dose.

A greater risk is put on males in this particular age group since Western University in Canada has mandated a third booster - as well as 1000 other universities in the US. In a risk/benefit analysis, the estimate of a hypothetical campus of 30,000 students would expect “1,373 to 3,234 young adults (rate of 1 in 9-22) to experience grade ≥ 3 reactogenicity disrupting daily activities or requiring medical care when vaccinated,” estimating between 1.7 to 3 and 0.7 cases of myocarditis in males and females respectively. That means there would be 3 to 4 cases of myocarditis per 1 hospitalization averted from boosting. (13)

While follow up studies on myocarditis induced by vaccine have determined the rate to be low, there is still uncertainty on how many cases went under the radar. Additionally, there is growing evidence that the rate of myocarditis is increasing and we have no indication of the safety profile of the new bivalent booster in risk of myocarditis/pericarditis. Moreover, we have no clue as to how vaccines are causing myocarditis/pericarditis - let alone the long term health effects later in the future for those afflicted. According to a recent study, they determined that the prognosis for myocarditis induced by vaccines is more favorable than myocarditis after infection (14); However, is this the right way to look at it?

The scientific empirical evidence demonstrates that the pharmaceutical and non-pharmaceutical interventions have been severely underwhelming in reducing transmission of Covid-19, in fact, doing more harm than good. Since it is inevitable that most of the population will get Covid-19 at some time and refinected many more (covid-19 harboring in animal reservoirs) it is illogical to think we can boost our way out. Now you are adding a layer of risk to those in the particular age group that has the highest risk of myocarditis/pericarditis - especially when universities mandate a third booster! This is unacceptable and irresponsible by Health Canada and the FDA. There is no indication that this bivalent booster will not increase the risk of myocarditis/pericarditis! And what if other serious adverse events were to arise from this bivalent booster? We wouldn’t have any indication because they haven’t done human trials!

It doesn’t make sense considering the omicron variant is significantly less severe and poses a remarkably low risk to people under the age of 40, especially for adults between the ages of 18-29 who are healthy - which is a large majority. Logically if there is no risk in being infected by Covid-19, only to experience symptoms similar to that of the flu, would it be rational to add a layer of risk of myocarditis/pericarditis for an unidentifiable benefit of the bivalent booster?

Answer: NO!

Furthermore, a recent study investigated the impact of immune imprinting from combinations of SARS-CoV-2 infection and vaccination histories in a London cohort of health care workers. They determined that previously infected individuals that got the primary series and a booster had a lower immune response (the health care workers showed no sign of T-cell recognition of the Omicron variant). This is true for those with two doses and infected with Alpha - showing no cross-over protection. In the health care workers that had previously had the Alpha variant proved to have higher cross-protective antibody response against the Omicron variant. To quote from the authors of the study “It also concurs with observations that mRNA vaccination carrying B.1.1.529 (Omicron) spike sequence (Omicron third-dose after ancestral sequence prime and boost) offers no protective advantage.” (15)

What can we conclude from all of this?

1. The FDA and Health Canada approved the bivalent vaccine from Pfizer and Moderna with results from clinical trials on 8 mice.
   

2. Covid-19 poses a very low risk to healthy children, adolescents, and adults and are not subject to severe illness and mortality if infected.
   

3. Vaccination does not provide additional benefits to healthy children, adolescents, and adults that are the majority of the Canadian population.
   

4. Continual vaccination does not provide any reduction in transmission.
   

5. We have no idea what continual boosting will do (only indications of immune blunting).
   

6. We are increasing the risk of individuals aged 18-24 for myocarditis/pericarditis in comparison to the zero benefits of vaccination in this age group.

So, bivalent booster, yes or no?

Absolutely fucking not.

This is irresponsible of Health Canada and it is bad public health policy. If we do not stand on a solid foundation of good science and only pushing political agendas, what are we really doing? What are we here for?

As JBP says - Tell the truth, or at least don't lie.

1. Health Canada. Health Canada authorizes first bivalent COVID-19 booster for adults 18 years or older. Published September 1, 2022. Accessed September 22, 2022. https://www.canada.ca/en/health-canada/news/2022/09/health-canada-authorizes-first-bivalent-covid-19-booster-for-adults-18-years-and-older.html
   

2. Gutentag A. Drug Companies Test New Booster On Eight Mice and Zero Humans, FDA Approves It Anyway. Tablet Magazine. Published September 18, 2022. Accessed September 22, 2022.
   

3. Bryda EC. The Mighty Mouse: the impact of rodents on advances in biomedical research. The Journal of the Missouri State Medical Association. 2013;110(3):207-2011. PMID: 23829104. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3987984/
   

4. NIH. Why Mouse Matters. Updated July 23, 2010. Accessed September 22, 2022. https://www.genome.gov/10001345/importance-of-mouse-genome
   

5. Thompson L. The Cure That Killed. Discover Magazine. Published May 1, 1994. Accessed September 22, 2022. https://www.discovermagazine.com/health/the-cure-that-killed
   

6. Akhtar A. The flaws and human harms of animal experimentation. Cambridge Quarterly of Healthcare Ethics. 2015;24(4):407-419. doi: 10.1017/S0963180115000079 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4594046/
   

7. Scarborough R. Of mice and men: why animal trials results don’t always translate to humans. The Conversation. Published August 29, 2017. Accessed September 22, 2022. https://theconversation.com/of-mice-and-men-why-animal-trial-results-dont-always-translate-to-humans-73354
   

8. Begar P, Wohlfahrt J, Bhatt S, et al. Risk of hospitalisation associated with infection with SARS-CoV-2 omicron variant versus delta variant in Denmark: an observational cohort study. The Lancet Infectious Diseases. 2022;22(7):967-976. DOI:https://doi.org/10.1016/S1473-3099(22)00154-2
   

9. Brandal LT, Macdonald E, Veneti L, et al. Outbreak caused by the SARS-CoV-2 Omicron variant in Norway, November to December 2021. Euro Surveillance. 2021;26(50):2101147. Doi: 10.2807/1560-7917.ES.2021.26.50.2101147.
   

10. Singanayagam A, Hakki S, Dunning J, et al. Community transmission and viral load kinetics of the SARS-CoV-2 Delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study. The Lancet Infectious Diseases. 2022;22(2):183-195. Doi: https://doi.org/10.1016/S1473-3099(21)00648-4
    

11. Public Health of Ontario. Omicron Disease Severity - What We Know So Far. Published March 2022. Accessed September 22, 2022. https://www.publichealthontario.ca/-/media/Documents/nCoV/COVID-WWKSF/2022/03/wwksf-omicron-disease-severity.pdf?sc_lang=en
    

12. Vogel G, Couzin-Frankel J. Israel reports link between rare cases of heart inflammation and COVID-19 vaccination in young men. Science. Published June 1, 2021.
    

13. Bardosh, Kevin and Krug, Allison and Jamrozik, Euzebiusz and Lemmens, Trudo and Keshavjee, Salmaan and Prasad, Vinay and Makary, Martin A. and Baral, Stefan and Høeg, Tracy Beth, COVID-19 Vaccine Boosters for Young Adults: A Risk-Benefit Assessment and Five Ethical Arguments against Mandates at Universities (August 31, 2022). Available at SSRN: https://ssrn.com/abstract=4206070 or http://dx.doi.org/10.2139/ssrn.4206070
    

14. Kracalik I, Oster ME, Broder KR, et al. Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study. The Lancet Child & Adolescent Health. 2022;1-11. DOI:https://doi.org/10.1016/S2352-4642(22)00244-9
    

15. Reynolds CJ, Pade C, Gibbons JM, et al. Immune boosting by B.1.1.529 (Omicron) depends on previous SARS-CoV-2 exposure. Science. 2022;227(6603):1-14. DOI: 10.1126/science.abq1841 https://www.science.org/doi/10.1126/science.abq1841?utm_source=substack&utm_medium=email