By John Q. Hosedrinker 
The FDA’s leading vaccine regulator has announced stricter approval processes, citing a review that linked Covid vaccines to the deaths of at least ten children, primarily due to myocarditis. This shift involves re-evaluating existing vaccination policies, potentially limiting simultaneous vaccinations, and demanding more robust safety data. Experts suggest these changes could significantly slow the vaccine approval pipeline and may even discourage innovation in vaccine research. Critics, including former FDA officials and independent scientists, question the lack of detailed evidence supporting these claims and the potential politicization of the agency’s approach, emphasizing the importance of thorough investigation and peer review.
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Experts say strict new FDA protocol for vaccine approval is ‘dangerous and irresponsible’, a sentiment that has sparked considerable debate and concern. The core of the issue seems to be a perceived shift towards overly stringent requirements, potentially hindering the development and availability of crucial vaccines. The concern here is not about wanting vaccines to be unsafe; rather, the worry is that the focus on such strict protocols could inadvertently make the process less effective and even lead to more harm. It’s a delicate balance, and many feel the scales are tipping in the wrong direction.
This new approach has been described as a move away from established scientific norms. A particularly telling point is the demand for complete agreement with the new approach, even to the point of requesting resignations from dissenting staff. This seems less like a genuine invitation to debate and more like a dictatorial edict, which further fuels the skepticism. The fundamental principles of scientific rigor, such as peer review and the need for evidence to be published before being considered valid, are seemingly being overlooked in favor of unproven allegations and anecdotal claims.
The underlying concern seems to be that an “overabundance of caution” is actually causing more harm than good. In other words, by creating increasingly difficult hurdles for vaccine approval, the process may inadvertently delay or even prevent the release of life-saving vaccines. Some express the belief that the current administration is willing to risk millions of lives under the guise of “doing nothing is better than trying something.” This is especially jarring considering the criticism of the FDA being overly lax with approvals for other potentially harmful products like certain cosmetics. The argument is, how can the standards be “strict” for vaccines, while other potentially dangerous products seem to get a free pass?
It’s also pointed out that this approach feels like a politicized attack on science, rather than a genuine attempt to enhance safety. One of the significant issues mentioned is the propagation of unverified claims, specifically regarding the supposed deaths of children due to COVID vaccinations. Such allegations, made without peer review or concrete evidence, are compared to the fallacy of assuming causation based on correlation. These are not about real-world scientific and medical practices and, in fact, ignore them.
The impact of this approach extends beyond immediate health concerns. It fosters a climate of distrust, eroding public faith in scientific institutions and the vaccine development process. This is especially dangerous given the historical success of vaccines in eradicating diseases and saving lives. The introduction of these strict requirements is presented as a deliberate move with potential consequences, which is the exact opposite of what the process should do.
Critics suggest that the situation could become a self-fulfilling prophecy. Overly strict standards could effectively shut down vaccine development by making it financially and practically unfeasible. The intention might be to improve safety, but the effect would be to limit access to these life-saving products. A lot of the evidence for vaccine safety has already been available for decades. The new rules appear to create arbitrary roadblocks, further complicating the problem.
The potential for political influence within the FDA itself is a recurring theme. The fact that many top FDA officials move on to high-paying jobs in the pharmaceutical industry after approving products raises suspicions of conflicts of interest. More oversight and review should be welcome. The covid vaccines were approved with only some questionable and quick studies by the companies, and no independent confirmations. Now one can say RFK Jr is also suspect in his motivations, but so is the FDA.
Some of the concerns expressed relate to a failure to keep up with scientific and medical advancements. The lengthy delays in approving new sunscreen ingredients in the US, while other countries have moved forward with more advanced technology, serve as an example of this. It’s suggested that these regulatory hurdles create an environment in which it becomes more challenging to deliver effective solutions to existing challenges.
Ultimately, the argument boils down to this: While safety is paramount, an overly cautious approach can be as harmful as a reckless one. The experts seem to be saying that the new FDA protocols, as they currently stand, may be a dangerous and irresponsible path that puts lives at risk and undermines the public’s trust in scientific institutions. The core criticism appears to be that the proposed changes are not based on sound scientific evidence, that the process is more about appearances than actually promoting public health.