Pfizer Vaccine Got FDA Approved, so What?
The Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) got FDA approval. Politicians and policymakers are tumbling over each other to stress that there now really is no excuse not to take the jab, and Biden is thrilled with this news because it distracts people from the terrible things happening in Afghanistan. But what is the real significance of this approval? Is the vaccine suddenly safe now?
Consequences of FDA Approval
Now the vaccine is approved, Pfizer can now advertise the jab, and it can now continue to vaccinate people even after the COVID `emergency´ is over. Pfizer can also now raise the price of the vaccine, which they already did in the EU. The Pentagon could not wait one more day and immediately stated that all troops across the armed services are required to get the vaccine. Similar mandates are expected in the private sector as well, with companies like Wal-Mart, along with thousands of smaller businesses, expected to require proof of vaccination for all workers. This approval is an unprecedented emergency authorization. Notably, the FDA requires Pfizer to conduct more research on the risks of myocarditis and pericarditis and other potential side effects. Pfizer will also develop a registry to help monitor outcomes for infants after vaccinated women give birth.
No Doubts Left?
So now we have an approved vaccine, of which we know that compared with a natural COVID infection, it gives you a seven times higher chance of getting COVID again. We don´t know how long the protection lasts; should we have a booster after three months, six months, a year? Even worse, we don´t even know how many jabs you need, one is not enough (by the way, very convenient for Pfizer, how to improve your sales…), two might be enough, but probably three is better, or even five. It starts to sound like the joke from Fauci that two mouth masks protect better than one…
The approval will convince some people to take the vaccine. But the most significant part of the people who didn´t take the vaccine will NOT be convinced by the approval, and the distrust against the vaccine will not be taken away by FDA approval. Another part of the group who doesn´t take the vaccine are people who are not in one of the risk groups, and they rather prefer natural immunity; this FDA approval will not change their choice.
All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective. Nothing could be further from the truth. We learn tremendous amounts about a product only once it’s on the market and only after use among a broad population.
Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness
FDA Approved, so It Is Safe?
We know that the vaccine has severe side effects, and we even know the mechanism behind it. Unfortunately, these issues have not been solved. This is not the only problem; researchers at the Yale School of Medicine found that nearly a third of drugs approved from 2001 through 2010 had major safety issues years after the medications were made widely available to patients. They are talking about years, and remember, Comirnaty is approved only after eight months of use. It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted `accelerated approval´ and drugs that were approved near the regulatory deadline for approval. The FDA approves drugs faster than the EMA does, and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less. Drugs ushered through the FDA’s accelerated approval process were among those with higher safety interventions rates.
Conclusion
The FDA approval of the Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) will give politicians and policymakers another excuse to make the vaccine mandatory. But this is a fallacy; the approval of the vaccine doesn´t address any of the safety issues there are with the vaccine and changes nothing. We still do not have a clear picture of the severe short-term side-effects, and we don´t know anything about the long-term effects; many questions are still open and not answered by the approval by the FDA.
Interesting links:
Before You Take the COVID-19 Vaccine, Read This, It Will Blow Your Mind!
Why Mandatory Vaccination Is a Very Bad Idea
Vaccine Fanatics Have Achieved More Than The Anti-vaxxers Have Ever Been Able To Do
The COVID Vaccine Can Make You Very Sick, And Now We Know Why
References
Downing, N., Shah, N., Aminawung, J., et al. (2017, May 9). Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA, 317(18), 1854–1863. doi:10.1001/jama.2017.5150
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