Evaluating the Safety of Novavax

The answer is a resounding “no.” Data indicates that Novavax can also lead to myocarditis in younger males, occurring at a rate ten times higher than with the Pfizer vaccine. While some believed that the absence of RNA in Novavax would render it safer, the reality shows that safety cannot always be assumed; scientific studies and data collection are essential to understand vaccine effects.

The findings stem from two clinical trials conducted in the US and UK, with the US trial involving 30,000 participants—20,000 received the vaccine, while 10,000 received a placebo. The vaccine demonstrated high efficacy, about 90% in preventing COVID-19 infection. All cases of moderate to severe COVID symptoms occurred in the placebo group, marking Novavax as 100% effective against severe cases during the trial period, which took place from December 2020 to April 2021, primarily against the alpha variant. Efficacy may have diminished against subsequent variants like Delta and Omicron, prompting Novavax to explore updated formulations.

However, the troubling discovery of myocarditis cases persists. Six instances of myocarditis or pericarditis were recorded in the vaccinated group compared to one in the placebo group.

Four of the myocarditis cases appeared to be directly related to the vaccine, surfacing within days of receiving the second or third dose. One case occurred eight days post-vaccination, while another was linked to a patient with strep throat, leaving the connection to the vaccine uncertain. The sixth case emerged a month after the first dose, following a COVID infection and subsequent kidney issues, indicating that the myocarditis might have stemmed from the virus rather than the vaccine.

The occurrence of myocarditis in Novavax raises significant questions. It challenges the prevailing theories that attribute myocarditis risks to mRNA technology. With Novavax not using RNA, this factor cannot be implicated.

Moreover, the rate of myocarditis reported is higher for Novavax than for Pfizer. Collectively, the trials involved approximately 45,000 participants, revealing about four to five cases of myocarditis linked to the vaccine, suggesting a risk around 1 in 10,000. In comparison, the NIH estimates the risk for mRNA vaccines at 1 in 50,000, indicating that Novavax may pose approximately five times the risk.

Breaking down the data by age is critical. The CDC provides varied statistics for different demographics.

Young men, particularly those aged 16-17, face the highest risk of myocarditis, with estimates around 1 in 14,000. While the Novavax trial did not specify age-related odds, analysis of available data suggests that among the 2,248 participants aged 12-18, the risk for teenage boys may be approximately 1 in 1,100, indicating a 13-fold increase in danger compared to Pfizer. Similarly, estimates for young men aged 18-24 suggest about 22 times greater risk than with Pfizer. Ongoing monitoring may yield further data as Novavax rolls out.

Are Risks Understated for Pfizer and Moderna?

The absence of myocarditis cases in Pfizer and Moderna trials supports the notion of their relative safety. The rarity of such adverse effects implies they are exceptional if none were observed among 20,000 trial participants. While it is conceivable that incidents could have occurred unnoticed, national studies have consistently reported low rates of myocarditis following these vaccines.

The risk metrics vary by country, with the US estimating 1 in 14,000 for males aged 16-17, while studies in Israel report higher rates at 1 in 6,600. In contrast, an Italian study indicated lower odds at 1 in 50,000.

Comparing these figures with Novavax’s statistics, it appears that young men may want to avoid both Novavax and Moderna, favoring safer options like Pfizer, Johnson & Johnson, or AstraZeneca, while older individuals seeking robust immunity might still consider Novavax or Moderna.

Understanding Myocarditis Causes

Given that myocarditis occurs with both Novavax and mRNA vaccines, we can conclude that it is not solely a result of “gene therapy.” There are two primary theories regarding its causes.

One theory, popular among skeptics, posits that myocarditis may result from inadvertent intravenous injections. While this is unlikely due to the injection site’s anatomy, it’s not entirely impossible. Anecdotal claims, such as that of a mountain biker who reported “tasting saline” post-vaccination, raise questions, though skepticism remains regarding such testimonials.

A study on mice injected intravenously with large quantities of the Pfizer vaccine indicated cardiac damage, suggesting a potential mechanism whereby some vaccine components could enter the bloodstream and affect the heart. The lipid nanoparticles in the vaccine are hypothesized to concentrate within heart muscle cells, potentially leading to damage either directly or via immune response.

Conversely, Novavax employs nanoparticles that, while different in composition from Pfizer’s lipid nanoparticles, still present a similar size. The absence of RNA in Novavax suggests that the spike protein itself or the nanoparticles could be potential culprits for heart cell damage.

Determining the precise mechanism remains elusive, but the alternative theory posits that myocarditis may arise as an autoimmune response triggered by exposure to the COVID spike protein. Studies indicate that antibodies produced in response to the spike protein can mistakenly target similar proteins in the heart muscle, leading to inflammation.

This autoimmune theory accounts for the observed age and gender discrepancies in myocarditis cases. Men, especially younger ones, face a greater risk from both vaccines and natural infections. The heightened risk may be related to hormonal factors, as testosterone is known to influence immune responses.

If this theory holds, it implies that simply aspirating the needle before injection would not mitigate risks, as the immune response triggered by the spike protein is systemic.

In summary, stronger vaccines may elicit better protective responses against COVID-19 but also carry increased risks of myocarditis. Current data suggest that Novavax is among the strongest, followed by Moderna, with Pfizer trailing. Younger men should consider opting for less potent vaccines, while others may prioritize stronger protection.

Implications for Younger Children

For children under 12, the Pfizer vaccine shows a minimal incidence of myocarditis, with risks estimated at 1 in 250,000 for boys aged 5-11 and 1 in 500,000 for girls.

This discrepancy may relate to differences in children's hormonal and immune responses. Notably, the Pfizer vaccine for kids utilizes a reduced dosage, which could be beneficial in mitigating risks for young males. Conversely, Novavax's ongoing trials for children under 12 may utilize the same dosage as for adults, which raises concerns.

Other Potential Side Effects

Aside from myocarditis, Novavax may induce other rare side effects. During trials, nine strokes were observed in the vaccinated cohort compared to two in the placebo group, suggesting a higher incidence rate.

With these small numbers, random variations could skew results, but given existing data on other vaccines, the possibility of a link remains plausible. If the additional strokes were vaccine-related, the risk might approximate 1 in 4,000, notably higher than the 1 in 50,000 risk associated with Pfizer.

Additionally, Novavax appears to correlate with clotting issues, with seven instances reported among recipients compared to just one in the placebo group, suggesting a similar risk profile. Other rare side effects, including atrial fibrillation and Guillain-Barré Syndrome, were also noted, though the overall risk remains low.

In terms of mortality rates, the trial did not indicate any fatalities directly attributable to the vaccine, with deaths in the trial group largely due to unrelated causes.

To summarize, the primary risks associated with Novavax include: 1. A 1 in 1,000 chance of myocarditis for young men. 2. A 1 in 4,000 chance of stroke for older individuals.

When compared to COVID-19 itself, the stroke risk from the virus is about 1 in 2,200, indicating that the vaccine may be safer than infection. While Novavax presents a higher side effect profile than other vaccines, it remains a safer alternative to contracting COVID-19.

The Experience of Vaccine-Hesitant Individuals

Despite endorsements from vaccine skeptics, such as Malone and Kirsch, the uptake of Novavax has been minimal.

Even with a million doses available, many people remain unvaccinated, citing various reasons for their hesitance. Some express a desire to wait for Novavax, while others suspect a conspiracy to suppress its distribution.

For many, resistance to vaccines stems from a political identity rather than safety concerns, leading them to dismiss the Pfizer vaccine as “gene therapy” while downplaying the dangers of COVID-19. This has resulted in a disproportionate impact on Republicans, who have experienced higher mortality rates from the virus.

While some express fears regarding Novavax’s production process involving moth cells, such concerns appear unfounded. The vaccine's development draws parallels to historical vaccine practices, which have faced similar fears without basis in fact.

In conclusion, while Novavax has yet to become widely accepted, ongoing monitoring of its safety profile will provide clearer insights into its real-world impacts.