Chempost : Going down the rabbit hole: FDA Approved Pfizer Vaccine For Covid-19

The World Health Organisation (WHO) has an Emergency Use Listing (EUL) protocol that assesses the suitability of novel health products during public health emergencies. At the moment, the EUL of Covid-19 vaccines consists of Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Astra Zeneca EU, Johnson & Johnson (Janssen), Moderna and Sinopharm.

All countries are solely responsible for their own national vaccination policy. State health agencies generally take their cues from WHO guidelines.

The US Food and Drug Agency has its own Emergency Use Authorisation (EUA) protocol. At the moment, Pfizer-BioNTech Covid-19 Vaccine, Moderna Covid-19 Vaccine and Janssen Covid-19 Vaccine are the 3 approved labels for emergency use in US by FDA. As regards drugs and food generally, many countries also take their cues from the FDA.

On 23 August 2021, Pfizer received approval for their label Comirnaty to be used as vaccine for Covid-19. It is very clear FDA fast-tracked the approval process as Pfizer submitted its application recently some 3 or 4 months ago. The approval has been given without the required third clinical trial. This development comes with legal conundrum and questions ought to be raised.

EUA regulations mandate that a drug can only be authorised for emergency use if "There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life-threatening disease or condition."

There have been claims by many medical practitioners that some alternative theraupetic treatments have proven effective against Covid-19. Most often mentioned are Ivermectin, Hydroxychloroquine and Regeneron. Ivermectin is an anti-parasite medication, hydroxychloroquine is an anti-malarial drug which is also used to treat autoimmune diseases, and Regeneron is a monoclonal antibody drug. High success rates have been reported for those who received treatment early.

The FDA does not authorise the use of Ivermectin, Hydroxychloroquine and some other theraupetic treatments for Covid-19. Many have claimed the ban on the use of these alternatives in US for Covid-19 patients have been made against evidenciary proof that they actually worked very well. Whether this FDA position is in order for the emergency use of the 3 Covid-19 vaccines to remain in compliance with EUA laws is up for conjecture.

Of all alternative theraupetics, only Regeneron has been approved by FDA for emergency use. Regeneron is the drug used on President Trump in October 2020 that had him back on his feet within a week. Merck received EUA for Regeneron in November 2020 but this fact has largely remained out of public talking heads and mainstream media.

What difference does it make to Pfizer whether their vaccine has FDA approval or not? Approved vaccine comes with high liability risks. Under emergency use, the EUA provides non-liability protection. It goes without saying Pfizer would prefer to market with no liability risks. So the question has to be asked of Pfizer as to why they submitted their application for approved use, especially before the 3rd clinical trial.

The approval for Pfizer's Comirnaty presents the FDA with a dilemma. Since Comirnaty has received approval, all other EUA vaccines and drugs are required by law to be withdrawn. With power lobbies and a powerful Bill Gates to contend with, FDA will continue with the EUA. No big pharma should be denied their golden opportunity to make billions. If the FDA has no intention to withdraw the EUA, why approve Comirnaty years ahead of usual pathway to authorisation?

The puzzling actions of both FDA and Pfizer for the early approval of Comirnaty can only make sense as a political expediency. An approved vaccine advances the justification for mandating vaccination and service denial for those who refuse to take the jab. Biden's target of 160 million vaccinated is stalling. With an approved vaccine, a tougher approach to vaccinate looms.

How then will FDA resolve the dilemma of having both an approved vaccine (Comirnaty) and EUA ( Pfizer-BioNTech, Moderna, Janssen Covid-19 vaccines and Regneron drug) at the same time? They need to monkey around the system. Comirnaty and Pfizer-BioNtech Covid-19 Vaccine are one and the same thing. Pfizer needs to specially re-label Comirnaty to market it. For as long as Pfizer has no Comirnaty-labelled products, ie, it is not available, then the EUA laws have not been breached. Pfizer will play ball. So for all intents and purposes, Comirnaty will not be available in the market for the foreseeable future. Why should Pfizer re-label and sell as Comirnaty and take on liability risks when they can sell Pfizer-BioNTech Covid-19 Vaccine without liability. The monkeys say caveat emptor, 'approved' and 'available' are not one and the same.

Comirnaty and Pfizer-BioNTech Covid-19 Vaccine are exactly they same. But here's the twist. Pfizer-BioNTech Covid 19 Vaccine is authorised for emergency use for ages 12 and above. Comirnaty is approved for use for ages 16 and above. It's an anomaly when the one that is approved has more restrictive use than the unapproved one. What it means is that in light of lack of data, Pfizer is more risk averse (for liability, not for public safety) whereas the FDA has a more eugenic outlook.

Nowadays, one can never be certain of what is in the public domain. Players doctor data and information, even to the extent where lives and public safety are involved. Take New York Governor Cuomo for example. For some assurance I wrote to the chair of our Multi-Ministry Task Force for Coronavirus to guage the impact of this FDA approval. My primary concern is are we to expect a tougher stance against the unvaccinated. I have no delusion of a reply, but nevertheless one can only try.