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When will the coronavirus arrive in the US? (Disease: COVID-19; Virus: SARS-CoV-2) Login/Join 
Member
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quote:
Originally posted by BamaJeepster:
Get it or be terminated. Within 5 weeks of the FDA rubber stamp, which is expected coming up in September.

https://chicago.cbslocal.com/2...-mandate-us-workers/

United Airlines Announces Vaccine Mandate For U.S. Workers


CHICAGO (CBS/AP) — United Airlines is requiring its U.S. employees to get vaccinated against COVID-19, becoming the first major airline to institute a vaccine mandate for its staff.
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[SNIP]

Yeah. Ask me how I feel about this TOTAL BULLSHIT...




"If you’re a leader, you lead the way. Not just on the easy ones; you take the tough ones too…” – MAJ Richard D. Winters (1918-2011), E Company, 2nd Battalion, 506th Parachute Infantry Regiment, 101st Airborne

"Woe to those who call evil good, and good evil... Therefore, as tongues of fire lick up straw and as dry grass sinks down in the flames, so their roots will decay and their flowers blow away like dust; for they have rejected the law of the Lord Almighty and spurned the word of the Holy One of Israel." - Isaiah 5:20,24
 
Posts: 11066 | Location: NW Houston | Registered: April 04, 2012Reply With QuoteReport This Post
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I have guy works for me, likely had it in Feb 2020; vaxxed; now has it again. He and another guy in the office caught it at a bar that I was supposed to meet them at but canceled last minute. Glad I did...



quote:
Originally posted by V-Tail:
quote:
Originally posted by jljones:

Am I the only one one that knows multiple people that have “tested positive” multiple times?
We have a SIGforum member who was hit hard by The Virus in December 2020, then hit again, a year later.


---------------------------------------
It's like my brain's a tree and you're those little cookie elves.
 
Posts: 3625 | Location: Cary, NC | Registered: February 26, 2013Reply With QuoteReport This Post
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Hey guys, Joe says 350 million Americans have been vaccinated and they are doing fine, so get out there and get the vaccine!!


https://twitter.com/CalebJHull.../1423671168020660224

***Minor, inconsequential note: There are only 328 million Americans



“Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passions, they cannot alter the state of facts and evidence.”
- John Adams
 
Posts: 29408 | Location: In the red hinterlands of Deep Blue VA | Registered: June 29, 2001Reply With QuoteReport This Post
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Judge Emmet Sullivan Roll Eyes



More Illegal Immigrants, Border Agents Testing Positive for COVID-19: DHS Official

https://www.theepochtimes.com/...fficial_3936335.html

The rate at which illegal immigrants are testing positive for COVID-19 has “increased significantly” in recent weeks, a Department of Homeland Security official said this week.

The number of Customs and Border Protection (CBP) officers who have tested positive has also risen, despite more and more of them getting vaccinated against the virus that causes COVID-19.

“The rates at which encountered noncitizens are testing positive for COVID-19 have increased significantly in recent weeks. And although the rate of infection among CBP officers had been declining, this rate recently began increasing again, even though the percentage of officers and agents who have been fully vaccinated has grown significantly since January. This has led to increasing numbers of CBP personnel being isolated and hospitalized,” David Shahoulian, assistant secretary for border and immigration policy, said in a court filing.

Shahoulian included the information as he warned a federal judge of “adverse consequences” if the judge decides to block enforcement of Title 42, an order the Centers for Disease Control and Prevention has in place that enables border agents to immediately expel illegal aliens who cross into the United States because of the ongoing COVID-19 pandemic.

Federal officials have been releasing COVID-19 positive immigrants in Texas and other border states, stoking concern that the illegal immigrants are spreading the CCP (Chinese Communist Party) virus, which causes COVID-19.

The city of McAllen said Wednesday that over 7,000 COVID-19 positive aliens have been released into the city by CBP since February, including 1,500 in the previous week. That prompted them to set up an emergency shelter.

DHS Secretary Alejandro Mayorkas told senators during a recent congressional hearing that federal officials do not always notify local jurisdictions before releasing illegal immigrants.

The number of illegal border crossings keeps rising during the Biden administration, coming in at over 200,000 in July. That surge has strained Department of Homeland Security (DHS) operations and filled DHS facilities well beyond their capacity, according to the recent filing.

As of Aug. 1, Border Patrol was at 389 percent of its COVID-19 adjusted capacity along the southwest border.

Border Patrol facilities on that date were holding 17,778 illegal immigrants, including 2,223 immigrant children without parents, known as unaccompanied minors.

The adjusted capacity is 4,706.

Facilities were overfilled in seven of nine sectors at the southwest border, including holding 10,002 illegal immigrants in the Rio Grande Valley sector, the epicenter of the current surge.

That was 783 percent over the COVID-19 adjusted capacity and 287 percent above its normal capacity.

“These capacity figures are extremely worrisome, particularly because of the continued spread of the highly transmissible Delta variant,” Shahoulian said.

U.S. officials have said recently that the variant is more transmissible and early research indicates it is better at breaking through vaccine protection than other variants.

Migrants Housed In Donna, TX As Border Facilities Struggle To Handle Surge
Young children lie inside a pod at the Department of Homeland Security holding facility run by the Customs and Border Patrol

If Title 42 is blocked, DHS officials would not be able to safely hold and process all the illegal immigrants who are entering the United States, according to Shahoulian.


The Centers for Disease Control and Prevention issued the original Title 42 order in October 2020. A new version of the order issued in August came after officials evaluated “the particular risks of COVID-19 transmission” in DHS facilities, including “the significant increase in CBP encounters that has caused DHS facilities to exceed COVID-constrained capacity and to routinely exceed even non-COVID capacity” and the emergence of the Delta variant, government officials said in another filing in the same case this week.

The August order was extended this week indefinitely.

Shahoulian and other officials are trying to convince U.S. District Judge Emmet Sullivan not to block temporarily or permanently use of Title 42.

Three families who were expelled under the order sued the government in January, arguing that they were blocked illegally from asserting claims for humanitarian protection like asylum.

The parties said in two joint filings this week that they were negotiating for about six months but that talks broke down.

Sullivan proposed mediation, but that wouldn’t be beneficial, the parties said in a joint filing on Wednesday. Instead, they said the case should move forward.

A reply to the government’s filings by plaintiffs, who are being represented by groups including the American Civil Liberties Union, was expected by the end of the week.


_________________________
"Sometimes I wonder whether the world is being run by smart people who are putting us on or by imbeciles who really mean it."
Mark Twain
 
Posts: 12684 | Registered: January 17, 2011Reply With QuoteReport This Post
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Well, I'd say the coordinated propaganda effort is pretty much a success a this point. My father sent me a text message today telling me how much he and my mother were worried about me being unvaccinated and encouraging me to consider my personal responsibilities and take the poke. Dad's in his 80's and a past Navy man, so it pains me he's succumbed to the BS. I guess I won't be invited to come visit until this ridiculous bug completely disappears the planet or reality and common sense return to this country. As such, I guess I'm relegated to talking to mom and dad on the phone from here on out. Nah, I'm not totally furious with this illegitimate government and the cabal of media liars on TV. Nah, not at all.


-----------------------------
Guns are awesome because they shoot solid lead freedom. Every man should have several guns. And several dogs, because a man with a cat is a woman. Kurt Schlichter
 
Posts: 33845 | Location: Orlando, FL | Registered: April 30, 2006Reply With QuoteReport This Post
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quote:
Originally posted by bigdeal:
I guess I won't be invited to come visit until this ridiculous bug completely disappears the planet or reality and common sense return to this country.


My prediction is that it is not going to go away. At least not in the next 5 years, or possibly forever. I think there will be the yearly Covid booster to cover the new variants, just like you have the yearly flu shot.

We are going to have to learn to live with it, just as we live with the flu.



“Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passions, they cannot alter the state of facts and evidence.”
- John Adams
 
Posts: 29408 | Location: In the red hinterlands of Deep Blue VA | Registered: June 29, 2001Reply With QuoteReport This Post
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I do not see how someone catching C19 2x in a year is unusual. I know people who get the Flu year in and year out like it was prescheduled - and they get the Flu vax every Fall.
 
Posts: 4979 | Registered: April 20, 2010Reply With QuoteReport This Post
Lawyers, Guns
and Money
Picture of chellim1
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quote:
My father sent me a text message today telling me how much he and my mother were worried about me being unvaccinated and encouraging me to consider my personal responsibilities and take the poke.

Same thing happened with my son.
My wife (works for a hospital, took the jab back in January) is going to visit him in California and he doesn't think I should travel. Good! I didn't really want to go anyway.
BTW: I recently drove and spent a week on the East Coast. No issues. Also, recently drove to Louisville for a few days and Tennessee for a few days. No issues. Both of my daughters have NOT taken the jab either and have no problem inviting me to their homes.
It's only the people who have taken the jab who seem to think everyone else should too.



"Some things are apparent. Where government moves in, community retreats, civil society disintegrates and our ability to control our own destiny atrophies. The result is: families under siege; war in the streets; unapologetic expropriation of property; the precipitous decline of the rule of law; the rapid rise of corruption; the loss of civility and the triumph of deceit. The result is a debased, debauched culture which finds moral depravity entertaining and virtue contemptible."
-- Justice Janice Rogers Brown

"The United States government is the largest criminal enterprise on earth."
-rduckwor
 
Posts: 24117 | Location: St. Louis, MO | Registered: April 03, 2009Reply With QuoteReport This Post
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The unvaccinated have only begun to be vilified. The persecution yet to come our way will be epic in scale. First it will be segregation then isolation then persecution while all the others will mindlessly cheer it on. As if it won’t happen to them.


"Fixed fortifications are monuments to mans stupidity" - George S. Patton
 
Posts: 8532 | Location: Minnesota | Registered: June 17, 2007Reply With QuoteReport This Post
Tinker Sailor Soldier Pie
Picture of Balzé Halzé
posted Hide Post
quote:
Originally posted by jljones:
I know that this has largely become the vaccine news article thread, but I was wondering something.

Am I the only one one that knows multiple people that have “tested positive” multiple times? I know one guy that has “tested positive” and been quarantined five times in 18 months????

Anyone else seeing this?


My sister tested positive twice about a year apart.


~Alan

Acta Non Verba
NRA Life Member (Patron)
God, Family, Guns, Country

Men will fight and die to protect women... because women protect everything else. ~Andrew Klavan

"Once there was only dark. If you ask me, light is winning." ~Rust Cohle
 
Posts: 30409 | Location: Elv. 7,000 feet, Utah | Registered: October 29, 2012Reply With QuoteReport This Post
I kneel for my God,
and I stand for my flag
posted Hide Post
quote:
Originally posted by bigdeal:
Well, I'd say the coordinated propaganda effort is pretty much a success a this point. My father sent me a text message today telling me how much he and my mother were worried about me being unvaccinated and encouraging me to consider my personal responsibilities and take the poke. Dad's in his 80's and a past Navy man, so it pains me he's succumbed to the BS. I guess I won't be invited to come visit until this ridiculous bug completely disappears the planet or reality and common sense return to this country. As such, I guess I'm relegated to talking to mom and dad on the phone from here on out. Nah, I'm not totally furious with this illegitimate government and the cabal of media liars on TV. Nah, not at all.


I haven't seen my folks in Utah in over a year despite visiting my in laws who live 10 miles from them four times. My mom won't leave the house and they don't want anyone visiting who hasn't been jabbed. Not happening with me, so I guess it'll be Duo Video visits from here on out.
 
Posts: 1813 | Location: Oregon | Registered: September 25, 2001Reply With QuoteReport This Post
Glorious SPAM!
Picture of mbinky
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quote:
Am I the only one one that knows multiple people that have “tested positive” multiple times? I know one guy that has “tested positive” and been quarantined five times in 18 months????


I have seen this multiple times. A guy will "test positive" and be required to quarantine for 10 days. Then they want him to get three negative tests in a row before he comes back.

So if you don't exactly believe the "negative" test, why the hell do you believe the "positive" test? Especially since not a single guy I know who has had this happen has ever had any symptoms.
 
Posts: 10635 | Registered: June 13, 2003Reply With QuoteReport This Post
Altitude Minimum
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I have a friend who had it last year before being vaccinated and then again early this year after being vaccinated. Sick both times, not just tested positive. Second time not as bad.
 
Posts: 1224 | Location: Shalimar, FL | Registered: January 24, 2007Reply With QuoteReport This Post
I kneel for my God,
and I stand for my flag
posted Hide Post
quote:
Originally posted by BOATTRASH1:
I have a friend who had it last year before being vaccinated and then again early this year after being vaccinated. Sick both times, not just tested positive. Second time not as bad.


I've had the flu twice in a year too.
 
Posts: 1813 | Location: Oregon | Registered: September 25, 2001Reply With QuoteReport This Post
Void Where Prohibited
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Everything I've seen indicates the test is completely unreliable and pretty much useless.



"If Gun Control worked, Chicago would look like Mayberry, not Thunderdome" - Cam Edwards
 
Posts: 16517 | Location: Under the Boot of Tyranny in Connectistan | Registered: February 02, 2005Reply With QuoteReport This Post
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Natural immunity is better protection than the damn vaccines...your body will make antibodies against the entire virus in response to infection, whereas the vaccines only elicit an antibody response against a small part of the virus. The Delta variant (from what Ive read) evolved due to "immune evasion" or "vaccine evasion" in vaccinated people. The virus mutated in such a way as to be able to more easily survive in vaccinated individuals and thus spread easily.

https://www.forbes.com/sites/j...sts/?sh=56f7345e1ac5


---------------------------------------
It's like my brain's a tree and you're those little cookie elves.
 
Posts: 3625 | Location: Cary, NC | Registered: February 26, 2013Reply With QuoteReport This Post
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posted Hide Post
quote:
Originally posted by V-Tail:
quote:
Originally posted by jljones:

Am I the only one one that knows multiple people that have “tested positive” multiple times?
We have a SIGforum member who was hit hard by The Virus in December 2020, then hit again, a year later.


*Tap, tap*
I think my watch battery died.*Tap, tap*


____________________
 
Posts: 15894 | Location: Florida | Registered: June 23, 2003Reply With QuoteReport This Post
Sigforum K9 handler
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posted Hide Post
quote:
Originally posted by RichardC:
quote:
Originally posted by V-Tail:
quote:
Originally posted by jljones:

Am I the only one one that knows multiple people that have “tested positive” multiple times?
We have a SIGforum member who was hit hard by The Virus in December 2020, then hit again, a year later.


*Tap, tap*
I think my watch battery died.*Tap, tap*


Glad I wasn’t the only one. Cool




www.opspectraining.com

"It's a bold strategy, Cotton. Let's see if it works out for them"



 
Posts: 37117 | Location: Logical | Registered: September 12, 2004Reply With QuoteReport This Post
Lost
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posted Hide Post
quote:
Originally posted by mbinky:
quote:
Am I the only one one that knows multiple people that have “tested positive” multiple times? I know one guy that has “tested positive” and been quarantined five times in 18 months????


I have seen this multiple times. A guy will "test positive" and be required to quarantine for 10 days. Then they want him to get three negative tests in a row before he comes back.

So if you don't exactly believe the "negative" test, why the hell do you believe the "positive" test? Especially since not a single guy I know who has had this happen has ever had any symptoms.

Unfortunately, a negative result is not nearly as reliable as a positive one. Why? Simple logic, actually. It's easier to miss something you're looking for, than actually find it.

Example: suppose a DEA team is searching a room for illicit drugs.

Agent A gives the room what he considers a thorough search, and comes up with nothing.

Agent B searches the same room, but manages to find a plastic baggie filled with some kind of capsules. She tests it, and it tests positive for [the controlled substance of your choice].

Case A is a negative result. You can't say it with a high degree of confidence. There's simply a chance that he missed something, which it turns out he did.

Case B is a positive result. Here you do have a high degree of confidence. There's not a big chance that someone would take the trouble to hide legal drugs, and it did end up testing positive. It is almost certainly what they were looking for.

In the case of viral tests, many things can generate a false negative. Where and how deeply you take the sample, how advanced the infection is, poor testing protocols or procedures.

A false positive is much more unlikely. The test looks for a long series of genetic coding. Mathematically nearly impossible to get a false match. False positives do occur, but are extemely rare.



ACCU-STRUT FOR MINI-14
"First, Eyes."
 
Posts: 16355 | Location: SF Bay Area | Registered: December 11, 2003Reply With QuoteReport This Post
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Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645850/

Timothy Cardozocorresponding author 1 and Ronald Veazey 2
Author information Copyright and License information Disclaimer

1 Department of Biochemistry and Molecular Pharmacology, NYU Langone Health, New York NY, USA,

2 Division of Comparative Pathology, Department of Pathology and Laboratory Medicine, Tulane University School of Medicine, Tulane National Primate Research Center, Covington LA, USA,


Timothy Cardozo, Department of Biochemistry and Molecular Pharmacology, NYU Langone Health, 550 First Avenue, MSB 222, New York, NY 10016, USA.


Abstract

Aims of the study

Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID‐19 vaccines could worsen disease upon exposure to challenge or circulating virus.

Methods used to conduct the study

Published literature was reviewed to identify preclinical and clinical evidence that COVID‐19 vaccines could worsen disease upon exposure to challenge or circulating virus. Clinical trial protocols for COVID‐19 vaccines were reviewed to determine if risks were properly disclosed.

Results of the study

COVID‐19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID‐19 disease via antibody‐dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID‐19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

Conclusions drawn from the study and clinical implications

The specific and significant COVID‐19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.

1. THE RISK OF ADE IN COVID‐19 VACCINES IS NON‐THEORETICAL AND COMPELLING

Vaccine‐elicited enhancement of disease was previously observed in human subjects with vaccines for respiratory syncytial virus (RSV), dengue virus and measles. 1 Vaccine‐elicited enhancement of disease was also observed with the SARS and MERS viruses and with feline coronavirus, which are closely related to SARS‐CoV‐2, the causative pathogen of COVID‐19 disease. The immune mechanisms of this enhancement have invariably involved antibodies, from direct antibody‐dependent enhancement, to immune complex formation by antibodies, albeit accompanied by various coordinated cellular responses, such as Th2 T‐cell skewing. 2 , 3 , 4 , 5 , 6 , 7 Notably, both neutralising and non‐neutralising antibodies have been implicated. A recent study revealed IgG‐mediated acute lung injury in vivo in macaques infected with SARS that correlated with a vaccine‐elicited, neutralising antibody response. 8 Inflammation and tissue damage in the lung in this animal model recapitulated the inflammation and tissue damage in the lungs of SARS‐infected patients who succumbed to the disease. The time course was also similar, with the worst damage occurring in delayed fashion in synchrony with ramping up of the immune response. Remarkably, neutralising antibodies controlled the virus in the animal, but then would precipitate a severe, tissue‐damaging, inflammatory response in the lung. This is a similar profile to immune complex‐mediated disease seen with RSV vaccines in the past, wherein vaccinees succumbed to fatal enhanced RSV disease because of the formation of antibody‐virus immune complexes that precipitated harmful, inflammatory immune responses. It is also similar to the clinical course of COVID‐19 patients, in whom severe COVID‐19 disease is associated with the development of anti‐SARS‐CoV‐2 serum antibodies, 9 with titres correlating directly with the severity of disease. 10 Conversely, subjects who recover quickly may have low or no anti‐SARS‐CoV‐2 serum antibodies. 11

The elicitation of antibodies, specifically neutralising antibodies, is the goal of nearly every current SARS‐CoV‐2 vaccine candidate. The prior evidence that vaccine‐elicited, antibody‐dependent enhancement (ADE) of disease is likely to occur to some degree with COVID‐19 vaccines is vertically consistent from controlled SARS studies in primates to clinical observations in SARS and COVID‐19. Thus, a finite, non‐theoretical risk is evident in the medical literature that vaccine candidates composed of the SARS‐CoV‐2 viral spike and eliciting anti‐SARS‐CoV‐2 antibodies, be they neutralising or not, place vaccinees at higher risk for more severe COVID‐19 disease when they encounter circulating viruses. Indeed, studies in mice of prior SARS vaccines revealed this exact phenotype, with four human vaccine candidates eliciting neutralising antibodies and protecting against SARS challenge, but viral re‐challenge of thus vaccinated animals resulting in immunopathologic lung disease. 5 Independently, SARS/MERS vaccine candidates, commonly exhibited ADE associated with high inflammatory morbidity in preclinical models, obstructing their advancement to the clinic. 4 , 12 SARS ADE of both disease in non‐human primates and viral infection of cells in vitro was clearly mapped to specific antibody‐targeted SARS viral spike epitopes. 6 This phenomenon was consistent across a variety of vaccine platforms, including DNA, vector primes and virus‐like particles (VLP), irrespective of inoculation method (oral, intramuscular, subcutaneous, etc). An unknown variable is how long this tissue damage lasts, possibly resulting in permanent morbidity (eg, diabetes from pancreatic damage 7 ).

Current data on COVID‐19 vaccines is limited, but does not so far reveal evidence of ADE of disease. Non‐human primate studies of Moderna's mRNA‐1273 vaccine showed excellent protection, with no detectable immunopathology. 13 Phase 1 trials of several vaccines have not reported any immunopathology in subjects administered the candidate vaccines. However, these subjects were unlikely to have yet encountered circulating virus. 14 Nevertheless, all preclinical studies to date have been performed with the Wuhan or closely related strains of the virus, while a mutant D614G virus is now the most prevalent circulating form. Several observations suggest that this alternative form may be antigenically distinct from the Wuhan derived strain, not so much in composition, but in conformation of the viral spike and exposure of neutralisation epitopes. 15 , 16 , 17 , 18 Similarly, Phase 1 and 2 clinical trials of vaccine candidates have only been designed around immunogenicity as an efficacy end point and have not been designed to capture exposure of subjects to circulating virus after vaccination, which is when ADE/immunopathology is designed to occur. Thus, the absence of ADE evidence in COVID‐19 vaccine data so far does not absolve investigators from disclosing the risk of enhanced disease to vaccine trial participants, and it remains a realistic, non‐theoretical risk to the subjects.

2. CHALLENGES TO INFORMED CONSENT FOR COVID‐19 VACCINE STUDIES

Informed consent procedures for vaccine trials commonly include disclosure of very minor risks such as injection site reactions, rare risks from past, unrelated vaccines/viruses, such as Guillain‐Barre syndrome for swine flu (interest in which is likely behind the interest in Astra Zeneca's recent vaccine transverse myelitis event) and generic statements about the risk of idiosyncratic systemic adverse events and death. Specific risks to research participants derived from biological mechanism are rarely included, often because of ambiguity about their applicability. 19

Signed consent forms from the COVID‐19 vaccine trials are not publicly available because of privacy concerns. They also vary from clinical site to clinical site, and sample consent forms on which they are based are not required to be disclosed until after the trial is over, if at all. However, these consent forms are usually very similar in content to the “Risks to participants” section of the trial protocols, which have been released publicly by Pfizer, Moderna and Johnson & Johnson for their COVID‐19 vaccine trials ( 20 & Supplement). As these three vaccines are representative of the diversity of vaccines being tested, it is very likely that the consent form inferred from these protocols is similar or identical to those from any and all of the vaccine trials currently underway. All three protocols mention the risk of disease enhancement by the vaccine, but all three list this risk last or next to last in the list of risks, after risks from the Ad26‐Cov2 vector, adenovirus vectors in general, risks of vaccination in general, risks for pregnancy and birth control (which are said to be “unknown”), risks of blood draws and risks from collection of nasal swab samples (for the Johnson and Johnson vaccine), after allergy, fainting, local site injection reaction, general systemic adverse reactions and laboratory abnormalities for the Moderna vaccine and after local site injection reactions and general systemic adverse events for the Pfizer vaccine. In addition, both Moderna and Johnson and Johnson term the risk of vaccine‐elicited disease enhancement as “theoretical.” Finally, in citing the risk, Pfizer and Moderna note prior evidence of vaccine‐elicited disease enhancement with RSV and dengue, as well as feline coronavirus (Pfizer) and measles (Moderna), however, SARS and MERS are not mentioned. Johnson and Johnson discusses SARS and MERS, but make an unusual scientific argument that vaccine‐elicited disease enhancement is because of non‐neutralising antibodies and Th2‐skewed cellular responses and that Ad26 vaccination does not exhibit this profile.Blank consent forms for AstraZeneca and Johnson and Johnson are also available online at https://restoringtrials.org/20...otocolandstudydocs/, and while the AstraZeneca form clearly discloses the specific risk of ADE, the disclosure is listed last among risks only in an attached information sheet. In all, the evidence from the Pfizer, Moderna and Johnson & Johnson protocols for their COVID‐19 vaccine trials and the sample consent forms, when contrasted with the evidence for antibody‐dependent enhancement of disease presented by this report and widely available to any skilled practitioner in the field, establishes that patient comprehension of the specific risk that receiving the COVID‐19 vaccine could convert a subject from someone who experiences mild disease to someone who experiences severe disease, lasting morbidity or even death is unlikely to be achieved by the informed consent procedures planned for these clinical trials.

Medical ethics standards required that, given the extent of evidence in the medical literature reviewed above, the risk of ADE should be clearly and emphatically distinguished in the informed consent from risks observed rarely as well as the more obvious risk of lack of efficacy, which is unrelated to the specific risk of ADE. Based on the published literature, it should have been obvious to any skilled medical practitioner in 2019 that there is a significant risk to vaccine research subjects that they may experience severe disease once vaccinated, while they might only have experienced a mild, self‐limited disease if not vaccinated. The consent should also clearly distinguish the specific risk of worsened COVID‐19 disease from generic statements about risk of death and generic risk of lack of efficacy of the vaccine.

3. CONCLUSION

Given the strong evidence that ADE is a non‐theoretical and compelling risk for COVID‐19 vaccines and the “laundry list” nature of informed consents, disclosure of the specific risk of worsened COVID‐19 disease from vaccination calls for a specific, separate, informed consent form and demonstration of patient comprehension in order to meet medical ethics standards. The informed consent process for ongoing COVID‐19 vaccine trials does not appear to meet this standard. While the COVID‐19 global health emergency justifies accelerated vaccine trials of candidates with known liabilities, such an acceleration is not inconsistent with additional attention paid to heightened informed consent procedures specific to COVID‐19 vaccine risks.


_________________________
"Sometimes I wonder whether the world is being run by smart people who are putting us on or by imbeciles who really mean it."
Mark Twain
 
Posts: 12684 | Registered: January 17, 2011Reply With QuoteReport This Post
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