Thursday, December 24, 2020

Are we getting all information on the vaccine?

 Sidenote.  Much has been said about conservatives being leery of the new vaccine.  What isn't getting much attention is how the Black and Latino community are viewing this thing.  The numbers I've seen are 60% of Blacks are anti-vaccine (until proven safe) and for Latinos about 45% (numbers are from memory...they could be off!).

via Daily Mail

*CDC confirms at least six have had adverse reactions to COVID-19 vaccine 

*So far, some 272,000 shots of Pfizer-BioNTech vaccine have been given in US  

*In Alaska, three health care workers needed medical attention after getting shot 

*In Chicago suburb, hospital stopped inoculations after four had severe reaction 

*FDA official says allergic reactions could be due to polyethylene glycol (PEG) 

*PEG is a chemical compound present in both Pfizer and Moderna vaccines

*PEG is also found in laxatives as well as creams, ointments, and solvents

*In industrial use, PEG is also a binding agent that can be found in antifreeze 

*FDA insists most Americans with allergies should be safe to get the vaccine 


Now check this out from ScienceMag

Severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks may be due to a compound in the packaging of the messenger RNA (mRNA) that forms the vaccine’s main ingredient, scientists say. A similar mRNA vaccine developed by Moderna, which was authorized for emergency use in the United States on Friday, also contains the compound, polyethylene glycol (PEG).

PEG has never been used before in an approved vaccine, but it is found in many drugs that have occasionally triggered anaphylaxis—a potentially life-threatening reaction that can cause rashes, a plummeting blood pressure, shortness of breath, and a fast heartbeat. Some allergists and immunologists believe a small number of people previously exposed to PEG may have high levels of antibodies against PEG, putting them at risk of an anaphylactic reaction to the vaccine. 


I KNOW that 99% of the audience here is all in favor of this vaccine but from my chair it sure likes a massive science experiment.  Did anyone monitor the news when they approved this thing?

The talk was dry as hell and I admit that I couldn't follow it, but the vote was interesting.

Not the people that voted yeah, not even those that abstained.  It was the wording of the approval.


Emergency Use Authorization (EUA)

The issuance of an EUA is different than an FDA approval (licensure) of a vaccine. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits, and if the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.

The company has submitted a pharmacovigilance plan to FDA to monitor the safety of Pfizer-BioNTech COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Pfizer-BioNTech COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The EUA for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

All of the above along with the fact that these companies cannot be held legally liable for "bad outcomes" makes me wonder about this thing.

People that are vulnerable SHOULD BE vaccinated!

But why the entire population?  Especially with a drug that has so many unknowns.

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