Despite media reports to the contrary, Alaskans who’ve been waiting for the FDA’s “fully approved” Pfizer COVID shot – now renamed “Comirnaty” – will likely find it impossible to get at any location currently providing COVID shots. This presents a serious problem to those who have intentionally waited for the “fully approved” version, which could afford far greater legal protections for those who may suffer injuries or death following the shot.
On Aug. 23, the FDA issued “full approval” for a COVID vaccine called “Comirnaty.” This approval extends to those ages 16 years and older. The Comirnaty shot, however, is actually just a repackaged version of the current Pfizer shot, which is still under the FDA’s emergency use authorization (EUA) and not fully approved because it has not gone through adequate testing. In fact, the FDA and Alaska’s state health officials say there is no physical difference between Comirnaty and the experimental Pfizer jab. Both share the same biological formulation. The only divergence is the name, and important legal protections.
The fact that Comirnaty shots are not available means little has changed for those who were waiting for a shot that has “full FDA approval.”
Speaking during an Aug. 26 media briefing, Alaska’s Chief Medical Officer Dr. Anne Zink reiterated the misleading claim that the two vaccines are “the same,” apart from the names.
“So, it is now allowed to have a brand name and it’s allowed to be marketed, but it is the exact same thing,” Zink said of Comirnaty and the EUA Pfizer shots. “So don’t worry about calling and asking for brand name. It’s the same stuff and it’s available across the state.”
This is only partially true. Under federal law, fully licensed vaccines typically offer considerably more legal options to people who suffer injury or death from the shot.
The previously approved Pfizer shot, which the FDA has only ever authorized for “emergency use,” requires people who suffer adverse reactions to file a legal petition within one year of getting the shot. Since Comirnaty, however, falls under the “fully approved” category, people could have a three-year window to pursue legal options regarding injuries and a two-year window for deaths. Additionally, a court could extend that deadline even further.
These additional legal protections would become available once the U.S. Dept. of Health & Social Services lists Comirnaty under he National Vaccine Injury Compensation Program (VICP) – a government-run and funded entity that pays out compensation to people who suffer from vaccine injuries or who lost a loved one due to injury from a fully-licensed vaccine. The program pays out hundreds of millions of dollars each year.
To date, the U.S. Dept. of Health & Human Services has not yet listed Comirnaty among the vaccines covered in this program, but since it is “fully-licensed” there is a good chance it will eventually be a covered vaccine which comes with additional legal options for those injured by the shot. The process, however, is not automatic. Part of the hold up may be due to the fact that Comirnaty is primarily for adults (ages 16 and older). Adult-only vaccines do not fall under the VICP protection. Once Comirnaty is approved for general use in children its status could change.
The State of Alaska’s COVID vaccine clinic locator, does not provide any information on where to find Comirnaty-labeled shots.
With regard to the types of injuries covered, fully licensed vaccines offer more protections in the case of a lawsuit. The EUA approved Pfizer only covers “serious physical injuries” and deaths. Conversely, those who receive a fully-licensed shot could seek damages for “injuries with effects lasting for more than six months after the vaccine was given or resulted in inpatient hospitalization and surgery or deaths.”
Attorney fees are another major difference. Cases involving the emergency-use Pfizer shots do not pay for attorneys’ fees, while those who file suit after taking a fully-licensed jab could have their fees covered.
Perhaps the biggest contrast is that those who suffer injuries after taking a fully-licensed vaccine would have recourse to a judicial appeal process to resolve their claims, whereas EUA Pfizer recipients must rely on the Dept. of Health and Human Services to resolve their case. Once HHS has ruled, those who filed claims after taking the EUA Pfizer shot have no further recourse to appeal.
Ultimately, the fact that Comirnaty shots are not available means little has changed for those who were waiting for a shot that has “full FDA approval.” Without access to Comirnaty, the only option is to take the previously available experimental shots, which includes the EUA Pfizer jab.
ALASKA WATCHMAN DIRECT TO YOUR INBOX
The Alaska Watchman confirmed that Comirnaty is not currently offered at any of the COVID clinics listed at anchoragecovidvaccine.org, a website run by the Municipality of Anchorage and the Alaska health department. A staffer at the clinic had no idea when (or if) Comirnaty would be available. She merely explained that there is no physical difference between the Pfizer and Comirnaty shots.
Similarly, Alaska’s COVID vaccine clinic locator, does not provide any information on where to find Comirnaty-labeled shots.
The fact that politicians and health officials are now using the FDA’s “fully approved” Comirnaty shot to encourage (and even mandate) more people to get vaccinated with the emergency use Pfizer shots, has created controversy and allegations that the FDA’s actual motivation is to simply get as many people vaccinated with experimental shots that have known serious side effects, while falsely claiming these experimental jabs are “fully licensed.”
Editor’s note: The Watchman is working on a follow up story about the legal process related to vaccine injuries and deaths.
20 Comments
Can we get some sources for the liability coverage info?
Yeah, this is an eyebrow-raising claim for which no corroborating evidence is provided… smacks of misinformation. Maybe the author should call a lawyer and get their take before going to print with this kind of thing? A link to a federal website that does nothing to explain its relevance to the argument is useless. Reminds me of the VAERS reporting this website did (before having to walk back their baseless claims). Big credibility problems for this site — the burden of proof is pretty high with a claim like this.
Nurenburg 1947 brings clarity.
There is more substantial evidence of these claims on Mercola.com and ChildrensHealthdefense.org today.
The claims are true but because of FDA’s trickery, they are hard to follow. You have to read their authorization letters and understand the limits on liability shields given under the PREP Act to get it.
Stay away from the jab until there is further data.
Exactly they have no long term data for possible side effects. Until the data is there I will continue to be a NO for any experimental vaccine that offers no better protection then the current Vitamin Regiment I take daily.
The socalled experts seem to ignor the status of the natural imminity of recovered Covid 19 patients ! Why is that?
The so called experts seem to ignor the natural immune status of recovered Covid 19 patients. Why is that ?
T
The so called experts seem to totally ignor the natural immunity status of recovered Covid 19 patients . Why is that?
I went to fda.gov and looked at Pfizers regulatory information. The “approval” issued on the 23rd of August is actually and extension of the EUA issued back in December of 2020. It was quit clear when you read the authorization letter that it wasn’t actually “fully approved”
When are you going to report the truth on this?
Go look for yourself. No joke
I’m Not getting the shot. So shut up and leave us alone to live are life’s.
Sheep follow your leader to the cliffs edge.
Stop the madness
Thank You for writing this ! It is the Truth and the Truth always is revealed… the Truth about all this covid, voting, everything will be revealed.
Shady as hell, smoke n mirrors, no thank you.
The FDA acknowledges that while Pfizer has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — still available for use.
The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.
https: //www.fda.gov/media/150386/download
https: //www.fda.gov/media/150386/download
Good article, may help dispel some of the issues surrounding “FDA Approved” vs EUA. Perhaps an in-depth report on the actual serious adverse reactions to the Vaccine is in order. Not a sore arm or local reaction, common to any vaccine and most Intramuscular injections. Please report on serious adverse outcomes, incidence of Guilian Barre Syndrome (usually self limited), Heart Attack, Stroke, life altering adverse reactions, including death, directly attributable to the vaccine. Compare and contrast that to the increasingly known and well reported risks of hospitalization due to COVID infection, including Long Haul Covid. This is about Risk reduction. Thousands of people are being admitted daily to hospitals around the country with serious disease who are not vaccinated. Some will die, and many will experience long term consequences. We are not seeing that many among those who are vaccinated.
Prior to Covid I’m aware of a case of long intubation with long-term deficits as a result. It could be easily labeled long covid today.
Whether this article can back up any of the claims it presents or not, I think it is clear that the vaccines are all still well within the experimental stage leaving only one question to ask yourself, are you willing to take the chance. Clint Eastwood said it best, “Do You Feel Lucky Punk”
From the Miami Herald 8/26/21
The upgrade from an emergency use authorization also means the developers are now allowed to market their product to the public via television, print and radio advertisements
When you have something to promote, you need a brand name. That’s where “Comirnaty” (pronounced koe-mir’-na-tee) comes in. The shot has been called the “Pfizer vaccine” because that’s the name of one of the companies that developed it.
However, the name change led some people to believe the Food and Drug Administration-approved Comirnaty is a different version of the Pfizer vaccine — it’s not.
Alaska needs to pay attention to Governor DeSantis!!!!
Ron DeSantis
@GovRonDeSantis
There are now 21 state monoclonal antibody treatment sites across Florida. If you’re at risk of COVID-19, this treatment can be accessed free of charge. For more information about any of the monoclonal sites, including state-run sites, visit: http://floridahealthcovid19.gov
ALASKA NEEDS TO PAY ATTENTION TO GOVERNOR RON DeSANTIS IN FLORIDA!!!
There are now 21 state monoclonal antibody treatment sites across Florida. If you’re at risk of COVID-19, this treatment can be accessed free of charge.
Thank you! Yes, let us offer treatment for those who test positive(and have actual symptoms)
Instead of giving people no treatment options and waiting for them to show up with more severe symptoms.