Will we get the data necessary to be able to make informed choices about COVID vaccination? Action Alert!
A number of weeks ago, our friends at ANH International released a white paper detailing how autoimmune patients are at an increased risk of serious adverse events from COVID vaccination. As such, autoimmune patients have a legitimate medical reason to seriously consider not receiving the COVID vaccine, despite strong societal pressure to do so in order to fully participate in the re-opening of the country. Part of the reason for this caution is that there is still so much we don’t know, as these vaccines were developed and authorized under an accelerated timeframe. This lack of data makes informed decisions about risk and benefit difficult, if not impossible, for many patients, including autoimmune patients.
This position is reinforced by a petition submitted to the FDA by a group of highly respected, credentialed experts asking for at least two years of data before the FDA considers granting full approval to COVID vaccines (current COVID vaccines are currently operating under emergency use authorization, or EUA). Among other things, the petition urges the FDA to ensure that there is substantial evidence for safety and effectiveness that outweighs harms in special populations such as infants, children, adolescents, the immunocompromised, those with cancer, pregnant women, frail older adults, and patients with autoimmune disorders. These patients were excluded from the ongoing phase III trials of COVID vaccines, and the experts point out that “there is reason to believe the effects of the product may differ from the populations enrolled in the trial.”
Our white paper explains the danger of COVID vaccines sparking an autoimmune disease through the process of molecular mimicry: the modified spike protein of the vaccine shares 26 peptide sequences with the human genome, which can cause a compromised immune system to attack “friendly” cells. This can take months or years to manifest, and we simply need more data and follow-up to know more about these dangers.
On the subject of needing more data, others have similarly pointed out that it is incumbent upon health authorities to acknowledge and follow up with large studies regarding the trends in adverse events we’re seeing related to COVID vaccines, including clusters cases of low platelets (thrombocytopenia); noninfectious myocarditis, or heart inflammation, especially for those under 30; deep-vein thrombosis; and death. Closer scrutiny can bring results that benefit patients safety: the FDA just indicated it will add a warning about the risk of heart inflammation to the Moderna and Pfizer vaccines for adolescents and young adults.
Yet despite the lack of data, the CDC, while falling short of recommending the vaccine to above-mentioned populations, largely says that these patients “may receive” the COVID vaccine.
The petition also calls for additional study of the safety of the spike protein, which the COVID vaccines instruct human cells to produce. This is in light of recent evidence of systemic circulation of the lipid nanoparticles we reported on recently. These nanoparticles carry the instructions for cells to make the spike protein of the COVID virus. There is evidence that the spike protein on its own can damage endothelial cells (the cells that line blood vessels). There may be differences in how wild virus spike proteins and vaccine-induced spike proteins behave in the body, but to dismiss the concern without further evidence would be irresponsible.
These and many other questions must be answered before the FDA even considers granting full approval to COVID vaccines, which Pfizer and Moderna have already applied for. There seems to be a consensus that, while it is an open question as to whether the government or businesses can mandate COVID vaccines while they operate under EUA, full approval from the FDA could spur more businesses, schools, and other entities to require the shot. We’ve already seen a number of universities say that they will require the shots for students only after they receive full approval.
Mandates usually come with exemptions for religious or medical reasons. But medical exemptions are notoriously narrow. According to the CDC’s guidelines, they are mostly limited to having a serious allergic reaction to a previous vaccine. It is unlikely that autoimmune patients would qualify for exemptions should mandates go into effect.
We don’t need mandates, though, to create a discriminatory environment for patients who have medical concerns about receiving the COVID vaccine. We’ve mentioned the example of Israel, where the government issues “green passes” allowing access to social, cultural, sporting events, gyms, restaurants, etc., to individuals who have either recovered from COVID or have had the vaccine. Green passes must be renewed every six months. More and more we’re seeing businesses, sports venues, and cruise lines fully open to vaccinated individuals, sometimes excluding the unvaccinated. This places undue pressure on those with legitimate medical concerns.
Part of ANH’s core mission and identity are the principles of bodily autonomy and freedom of choice. There are not mandates for the COVID vaccine that eliminate choice. Choice in this instance for autoimmune patients is being more subtly undermined by a society that is increasingly conferring more privileges to the vaccinated than the unvaccinated. That isn’t right, particularly when safety and efficacy data for patient populations like the autoimmune are incomplete, and what data there is points to increased danger and reduced effectiveness.
It isn’t anti-science to ask for more data on vaccines that were approved on an abbreviated timeline, particularly when there are danger signals for certain populations of patients. More data gives us a more complete profile of their safety and efficacy, which allows true informed consent—a basic tenet of medical ethics.
Action Alert! Write to the FDA, telling them you support the petition calling for more data before COVID vaccines receive full approval. Please send your message immediately.
22 thoughts on “The Future of COVID Vaccines”
More data before COVID vaccines get full approval!
I am 66 yo and in fair health for my age. I have chosen not to get the vaccine. I do not like putting chemicals in my body that have been tested on animals, but also we don’t know long term effects. It happened too fast and needs to use reliable, technology and testing to ensure people’s safety.
One of the biggest concerns with these experimental biological agents is that they HAVEN’T been tested on animals–at least, not enough. They got them to the public by SKIPPING the test that resulted in a “no go” for EVERY other coronavirus vaccine they attempted!
I just left a comment that I see right above this blank area.
I support the petition calling for more data before COVID vaccines receive full approval!
ANH – you are drifting away from the truth – covid is all about population control, manipulation, but most of all, about obscene pharma profits.
Big Pharma profits is a different article (and video). And while “population control” might indeed be true, pounding that drum too hard turns off even otherwise reasonable people to the dangers of the vaccine.
No vaccination should ever be approved without thorough testing. Since 2002 mRNA vaccines have been produced, but all of them failed due to the number of deaths during animal testing. In addition This mRNA can potentially damage your DNA thus resulting in a modified human organism, what are the modifications???? Finally there are so many reports of thrombosis, heart attacks, strokes, mental confusion and mental disorders, lethargy, sterility, spontaneous abortions, and other catastrophic events, These new mRNA vaccines need to be tested for many years, and be proven safe, before they are ever allowed an FDA approval.
It is well known that the COVID vaccines are dangerous to all people, having caused miscarriages, severe side effects and deaths. This is despite the lies provided by the CDC, FDA, Fauci, Bill Gates, and especially the pharmaceutical companies that have created them. These COVID vaccines are not even true vaccines, but were developed as bioweapons for the purpose of causing many deaths of many people around the world. These “vaccines” should not be given to people of any age and should not be required. These so-called “vaccines” should be outlawed and those individuals who have created them and who are trying to enforce these to be given to all people should be arrested and be forced to pay significant fines to those who have lost loved ones because of these dangerous drugs. They should be taken totally off the market. Laws should be passed so that people have the right to refuse them, as well as parents have the right to refuse their children from receiving these drugs.
Legally, we have the right to refuse to participate in a medical experiment, which is what this covid-craziness is. And legally, there were no “laws” requiring anyone to wear facemasks, despite several people getting three-figure fines for not following “guidelines.” Laws are just paper tigers the government re-folds at will whenever they want to do anything to us.
This is a well thought out written petition I just don’t understand people not respecting a human health rights if you can’t get fully vaccinated that’s our right to do so so we won’t harm ourselves. I support this petition 100% it would be good to partially vaccinate and get therapeutic treatments what’s wrong with this idea if you have antibodies it’s good to have both your own natural immunity being helped by non natural one. This is also dividing the human race up so let’s not allow this to happen. Wasn’t there a pandemic of kids being killed by dental accidents the cdc didn’t stop that. Oh I forgot about the flint Michigan water crises did that ever get resolved before the pandemic can you imagine how many people were stuck home bathing in that water suffocating in stress should not be a governor that don’t look after your residents health.
Informed consent? Still questions about these jabs? I think not. We’ve seen enough of the thousands who have died and become maimed from these injections to know the answer is NO. If anyone’s concerned about their immune system, take Vit C, Vit D, a good multi vit/min and more.
It seems like every month a new side affect of the Covid-19 vaccines is found, or at least suspected. There needs to be more comprehensive and long term testing before the FDA gives approval to any of these vaccines.
I support needing more data prior to approval. In particular, I am questioning neurological issues that occur following vaccination.
We need long term monitoring and studies of how the population will respond to the mRNA vaccines, particularly before they are deemed fully approved. We need long term studies on those who already have autoimmune disease and any propensity toward undue side effects, as well as monitoring the general population for any increase in heart attacks, strokes and the onset of autoimmune disorders. To mandate any medical treatment should become a crime against humanity as all beings should have a right to body autonomy and medical freedom.
Thank you for making this information available for everyone, we should be able to make “choices” in our lives, not pressured just because and not even realizing that “one size doesn’t fit all”
I don’t know how I got on your mailing list but I’m an actual REAL health care front-line provider who believes and trusts the science. Your fear-mongering is literally killing people. Shut up and get the vaccine. If you have autoimmune problems, discuss with your specialist and if you can’t get it, so be it. But stop trying to prevent others.
Require more testing!!!!! More data is needed. Stop the media storm and pressure to vaccinate until we know more
If the FDA, CDC, WHO and BigPharma want to say that all must be vaccinated while discounting legitimate medical concerns, then they are committing acts of violence against those people. This has to be stopped.
Autoimmunity is not the sole vulnerability. What about people with detox compromise?
My body, my health, my right to refuse!
These vaccines which Dr Fauci and with monetary support from the Gates foundation are inline with the WEF they want depopulation This is mass murder and sterilization The horrible truth won’t be completely known for years. The data shows spontaneous abortions, heart inflammation, and a range of neurological and other disorders Now they want to give it to children. If all the vaccinated girls grow up to be sterile that would certainly drop the population but how will they feel? We must be prepared to take care of the sick and dying