Only one company, Pfizer, has been granted a license to manufacture and distribute an FDA approved COVID vaccine. Pfizer’s FDA licensed vaccine must be labelled “Comirnaty” and include licensing information. To date, Pfizer has not allowed distribution of “Comirnaty” in the United States.
Liability is not the issue. Regardless of whether or not a vaccine is distributed under full FDA license or Emergency Use Authorization (EUA), the manufacturer still enjoys liability immunity thanks to the National Childhood Vaccine Injury Act of 1986 as well as subsequent legislation further strengthening legal protections for drug makers. Yet there are very important differences when it comes to compensation programs for vaccine related injuries between EUA and FDA licensed products
Here’s what everyone should know:
There are two distinct government administered programs that can pay compensation to individuals for vaccine related injuries or death. The program that administers claims/compensation for an EUA vax is called the “Countermeasures Injury Compensation Program” (CICP).
The CICP is a fully government funded program. Drug manufacturers are required to pay nothing into this fund. Claims for medical expenses sustained by a vaccine administered under EUA are evaluated by the Health Resources & Services Administration. Benefits are limited to the “un-insured” and/or certain medical expenses not covered by other insurance and/or lost employment. (See eligibility requirements for filing claims on the CICP website).
“The U.S. Department of Health and Human Services is the payer of last resort, which means CICP covers what remains unpaid or unpayable by other third parties, e.g., health insurance. If eligible, you may be compensated for:
Medical Expenses. The unreimbursed medical items or services used to treat a covered countermeasure injury may qualify for reimbursement. Please Note: These items and services must be reasonable and necessary, and not fully paid or reimbursed by insurance or government programs such as Medicaid or Veterans Benefits.
Lost Employment Income: If you were unable to work because of a covered countermeasure injury, you may qualify for lost employment income. Please Note: You must have been unable to work for more than 5 days to receive benefits.”
https://www.hrsa.gov/cicp/types-of-benefits
When it comes to an injury from an FDA licensed vaccine, compensation is provided through the “Vaccine Injury Compensation Program” (VICP). The VICP is a public Trust Fund under the jurisdiction of the U.S. Treasury and is funded by an excise tax of $.75 cents per dose for any FDA licensed vaccine as required by the aforementioned National Childhood Vaccine Injury Act of 1986. This per dose tax is collected from the vaccine manufacturer and paid to the U.S. Treasury.
From the HRSA website:
“The National Vaccine Injury Compensation Program (VICP) is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions. It was created in the 1980s, after lawsuits against vaccine companies and health care providers threatened to cause vaccine shortages and reduce U.S. vaccination rates, which could have caused a resurgence of vaccine preventable diseases. Any individual, of any age, who received a covered vaccine and believes he or she was injured as a result, can file a petition. Parents, legal guardians and legal representatives can file on behalf of children, disabled adults, and individuals who are deceased.”
https://www.hrsa.gov/vaccine-compensation/index.html
Individuals injured by a fully approved FDA licensed vax, or their family members or legal representatives, can file a petition to the VICP resulting in an award of up to $250,000 for a vaccine related injury or death. The VICP is also known as “Vaccine Court” because plaintiffs may actually bring in witnesses and present testimony before a judge to substantiate or validate their claims. The VICP allows claims to be filed up to 2 to 4 years after vaccination and is not dependent on employment or insurance status. Whereas, the CICP has a one year filing deadline and only covers lost wages and medical expenses AFTER ALL OTHER INSURANCE AND/OR EMPLOYMENT BENEFITS ARE EXHAUSTED!
Pfizer is saving tens of millions of dollars in excise taxes by continuing to distribute their vaccine under EUA. Likewise, individuals harmed by the current EUA vax are not eligible to file a compensation claim to the VICP. After all, no one can be harmed by an FDA approved vaccine that no one has received.
By avoiding distribution of the FDA licensed vaccine, (which must be labelled “Comirnaty” and include licensing information), Pfizer also avoids a lot of negative publicity. Judging by the number of serious adverse reactions reported to the VAERS website, the VICP Trust Fund would quickly become exhausted if even a small percentage of VAERS claims proved legitimate. There simply isn’t enough money in the fund to cover the anticipated flood of injury claims.
Understanding the differences between the injury compensation programs is critical in understanding how we are being played for fools. Don’t believe me? Call your local pharmacy or health care provider and ask if they are administering the FDA licensed COVID vaccine. When they say, “Yes, we are administering the Pfizer vaccine, which is FDA approved”, ask them to prove it by providing you with FDA licensing and labelling information. Odds are, they won’t even know what you are talking about.
Sources for this article include:
https://www.hrsa.gov/vaccine-compensation/about/index.html
https://www.hrsa.gov/cicp/about
https://www.hrsa.gov/vaccine-compensation/covered-vaccines/index.html
https://www.hrsa.gov/cicp/cicp-vicp
https://dailymed.nlm.nih.gov/dailymed/dailymed-announcements.cfm
- “Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename. At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.” https://dailymed.nlm.nih.gov/dailymed/dailymed-announcements.cfm
omots page 
I first saw this info on a Senator’s letter to the FDA. I read both the EUA renewal and the Comirnity approval letters, every page. When my employer mandated the vax, I argued, “It’s NOT ‘fully approved’, this shot you’re mandating!” I got crickets from all of my management and at least four HR reps. Nobody that I talk to who’s for the vax believes me. I think even the people who aren’t for it listen but think I’m mistaking something. A friend went to the CDC site, after I said at least 8 times that the info was on the FDA site, and then told me I was wrong because it wasnt on the CDC site. I told two doctors, who both said I was mistaken. It’s insane that this info is RIGHT THERE, and nobody will here you when you say it.
There is literally billions of dollars in profits at stake. I suggest continuing to contact your state reps with the information. For fun, try calling several pharmacies. Tell them you’ve been waiting for the FDA approved vaccine to become available. Ask them if they have it yet. They will likely tell you something like, “Yes, that’s the Pfizer product which we’ve been administering for over a year.” Then ask them what it says on the vials, or the boxes. Ask them if it says “Comirnaty” and has the FDA license number on it. Deer in headlights response every time.
And it’s ‘happened’ again, this time with Moderna:
https://lc.org/newsroom/details/013122-no-fdaapproved-covid19-shot-is-available
A small number of “Comirnaty” and “Spikevax” COVID vaccines are finally available here in the U.S. for the first time, well more than a year after the bait and switch.
Article: “Comirnaty, Spikevax Become Available for 1st Time in United States”
By Zachary Stieber August 20, 2022 Updated: August 21, 2022
Excerpt from the article (link at bottom to read full article):
“A small number of Comirnaty and Spikevax COVID-19 vaccine doses have become available in the United States in recent weeks, according to court filings and U.S. health departments.”
“Vials of vaccines labeled Comirnaty started being available to members of the U.S. military in May and tens of thousands of the vials have since been ordered, according to military officials. Dozens of vials were spotted at a clinic in Alaska in June, according to a Coast Guard officer.”
“Several states, meanwhile, confirmed to The Epoch Times that providers are now able to order the vials.”
“Comirnaty is the approved version of Pfizer’s COVID-19 vaccine. Spikevax is the approved version of Moderna’s COVID-19 vaccine. Approval means drug regulators granted a biologics license application (BLA). The U.S. Food and Drug Administration (FDA) in 2021 approved Comirnaty for adults 16 and older, and in January approved Spikevax for individuals 18 and up. Before that, the vaccines were available under emergency use authorization (EUA).”
“The differences matter due to federal law. A biologics license requires a higher threshold of evidence, and certain aspects of emergency clearance don’t apply to approved products.”
“Even after the approvals were issued, no approved versions were available in the United States, according to the vaccine makers and federal and state officials.”
“Military members, among others, have cited the unavailability of Comirnaty and Spikevax in legal actions against COVID-19 vaccine mandates.”
“One lawsuit, for instance, said that “the only currently available COVID-19 vaccines are authorized under EUA only, and therefore cannot be mandated.”
https://www.theepochtimes.com/comirnaty-spikevax-become-available-for-first-time-in-the-united-states_4677575.html?est=wID4FmVrIR3M%2BzesWWDr8D4fNu7qPE4yJDJw3btvES3zr4t%2FFgqOwQNmG4m9948w