European Medicines Agency Official Warns that Continuous COVID-19 Vaccine Boosters Could Threaten Human Health

Posted originally on TrialSite New by Staff on January 12, 20220 Comments

Europe’s regulatory body known as the European Medicines Agency (EMA) held a press briefing on Tuesday, January 11 for updates on the COVID-19 pandemic. Marco Cavaleri, the EMA head of biological health threats and vaccine strategy, raised significant concerns about the present mass vaccination program implemented across the European continent. Acknowledging the highly contagious nature of the Omicron variant, the regulatory official expressed that the level of severity appears milder than the Delta variant yet emphasized the importance of further data collection for a true understanding of the unfolding Omicron epidemiological impact. Cavaleri explained that based on recent studies, vaccine effectiveness against symptomatic disease becomes significantly reduced, waning over time, and this means more fully vaccinated people in Europe become susceptible to breakthrough infections caused by either Delta or Omicron. However, the EMA official noted that with a booster, vaccine effectiveness shoots back up. Significant risks to human health manifest, however, based on the premise of a public health response driven by continuous COVID-19 vaccination booster jabs. Cavaleri cautions that repeated booster jabs may adversely impact the human immune system. The regulator’s comments effectively challenge the current paradigm of the COVID-19 response. Is it time now to transition to an endemic-based COVID-19 response regimen?

Health agencies in Israel have initiated a fourth COVID-19 booster for higher risk demographic cohorts (e.g. over the age of 60), and Turkey, as well as Holland, are contemplating a fifth booster jab. What are the implications for such a public health strategy? This could potentially be dangerous, negatively impacting the immune system, suggests EMA’s Cavaleri. 

A pharmacologist by training, Cavaleri spent several years in pharma research and development (R&D) with a specialization in antibacterial and antifungal programs spanning preclinical to clinical development. By 2005 he joined EMA as a Scientific Administrator, progressively advancing in the regulatory organization. 

Cavaleri’s message implies the need for an urgent dialogue on the present mass vaccination program. While TrialSite has continuously challenged the underlying premise that vaccines can eradicate a consciously evolving pathogen such as a coronavirus, greater concern centers on mounting risks associated with continuous COVID-19 boosters. Cavaleri shares the same concern during this press conference, emphasizing the need now to transition from pandemic to endemic stage of the COVID-19 pandemic.Subscribe to the Trialsitenews “COVID-19” ChannelNo spam – we promise

Danger of Over-Vaccination

Openly critiquing what in the United States is considered gospel by health officials, Cavaleri went on the record about the potential harm of ongoing COVID-19 boosters declaring they “can be done once, or maybe twice, but it’s not something that we can think should be repeated constantly.”

Pandemic to Endemic?

Openly questioning the current public health trajectory in Europe, the official continued, “We need to think about how we can transition from the current pandemic setting to a more endemic setting.”

Cavaleri’s message should be seriously embraced, as COVID-19 booster shots administered every four to six months may very well threaten the human immune system leading to dangerous vulnerability, thereby possibly exacerbating the current health crisis, and creating what could become a dire situation.

TrialSite’s founder Daniel O’Connor shared, “thus far clinical trials haven’t been designed, funded, and conducted to evaluate the impact of ongoing booster programs on human safety. How do we know what the impact of multiple boosts could be on our health in the short, intermediate, and long term?” 

O’Connor further emphasized that “this kind of ongoing, unfolding response with powerful novel technology without the appropriate data to better understand the health implications seems haphazard, even reckless.” The TrialSite founder suggested that the ongoing public health response to COVID-19 itself “seems to be one big, ongoing real-world research initiative.”

A growing number of medical and health experts introduce the need to soon transition to an endemic-centric response model (e.g., treat COVID-19 as a bad seasonal flu). However, many other experts such as the University of Illinois, Chicago infectious disease chief Dr. Richard Novak was quoted yesterday stating that we are still quite a way off from such a transition. Speaking with Chicago-area media Novak said, “No, we probably won’t be carrying vaccine cards forever, but eventually we will have a virus that is endemic and will cause mild illness and become sporadic.” According to Novak’s interview with ABC7, the milestone marking pandemic to endemic stage may be a few more years away, “depending on future variants.”

However, EMA’s Cavaleri indicates at least in Europe, the various national health agencies ought to start a dialogue, perhaps exploring how to integrate the COVID-19 vaccine into a seasonal influenza vaccine regimen.


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