FDA restricts J&J’s COVID-19 vaccine due to blood clot risk

Authrsors: Associated Press

WASHINGTON (AP) — U.S. regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to the ongoing risk of rare but serious blood clots.

The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J’s vaccine. U.S. authorities for months have recommended that Americans starting their COVID-19 vaccinations use the Pfizer or Moderna shots instead.

FDA officials said in a statement that they decided to restrict J&J’s vaccine after taking another look at data on the risk of life-threatening blood clots within two weeks of vaccination.

J&J’s vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. But the single-dose option proved less effective than two doses of the Pfizer and Moderna vaccines.

Under the new FDA instructions, J&J’s vaccine could still be given to people who had a severe allergic reaction to one of the other vaccines and can’t receive an additional dose. J&J’s shot could also be an option for people who refuse to receive the mRNA vaccines from Pfizer and Moderna, and therefore would otherwise remain unvaccinated, the agency said.

A J&J spokesman said in an emailed statement: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”

Despite the restriction, FDA’s vaccine chief Dr. Peter Marks said J&J’s vaccine “still has a role in the current pandemic response in the United States and across the global community.”

The FDA based its decision on “our safety surveillance systems and our commitment to ensuring that science and data guide our decisions

Nearly 15 million deaths associated with COVID-19, WHO says

The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. At that time, U.S. regulators decided the benefits of J&J’s one-and-done vaccine outweighed what was considered a very rare risk — as long as recipients were warned.

COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they’re made. It forms in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea.

The New Brunswick, New Jersey-based company announced last month that it didn’t expect a profit from the vaccine this year and was suspending sales projections.

The rollout of the company’s vaccine was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas.

Additionally, regulators added warnings about the blood clots and a rare neurological reaction called Guillain-Barré syndrome.

Pfizer and Moderna have provided the vast majority of COVID-19 vaccines in the U.S. More than 200 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 17 million Americans got the J&J shot.

Vascular and organ damage induced by mRNA vaccines: irrefutable proof of causality

Authors: Michael Palmer, MD and Sucharit Bhakdi, MD August 19, 2022 Popular Science

This article summarizes evidence from experimental studies and from autopsies of patients deceased after vaccination. The collective findings demonstrate that

  1. mRNA vaccines don’t stay at the injection site by instead travel throughout the body and accumulate in various organs,
  2. mRNA-based COVID vaccines induce long-lasting expression of the SARS-CoV-2 spike protein in many organs,
  3. vaccine-induced expression of the spike protein induces autoimmune-like inflammation,
  4. vaccine-induced inflammation can cause grave organ damage, especially in vessels, sometimes with deadly outcome.

We note that the damage mechanism is which emerges from the autopsy studies is not limited to COVID-19 vaccines only but is completely general—it must be expected to occur similarly with mRNA vaccines against any and all infectious pathogens. This technology has failed and must be abandoned.

While clinical case reports (e.g. [1,2]) and statistical analyses of accumulated adverse event reports (e.g. [3,4]) provide valuable evidence of damage induced by mRNA-based COVID-19 vaccines, it is important to establish a causal relationship in individual cases. Pathology remains the gold standard for proof of disease causation. This short paper will discuss some key findings on autopsy materials from patients who died within days to several months after vaccination. For context, some experimental studies are briefly discussed as well.

1. Most of the evidence presented here is from the work of pathologist Prof. Arne Burkhardt, MD

  • Dr. Burkhardt was approached by the families of patients deceased after “vaccination”
  • Autopsy materials were examined by standard histopathology and immunohistochemistry
  • Based on the findings, most deaths were attributed to “vaccination” with a high to very high degree of likelihood

Prof. Burkhardt is a very experienced pathologist from Reutlingen, Germany. With the help of his colleague Prof. Walter Lang, he has studied numerous cases of death which occurred within days to several months after vaccination. In each of these cases, the cause of death had been certified as “natural” or “unknown.” Burkhardt became involved only because the bereaved families doubted these verdicts and sought a second opinion. It is remarkable, therefore, that Burkhardt found not just a few but the majority of these deaths to be due to vaccination.

While all four major manufacturers of gene-based vaccines were represented in the sample of patients studied by Burkhardt and Lang, most patients had received an mRNA vaccine from either Pfizer or Moderna. Some of the deceased patients had received both mRNA- and viral vector-based vaccines on separate occasions.

2. Pfizer’s own animal experiments show that the vaccine quickly distributes throughout the body

In order to cause potentially lethal damage, the mRNA vaccines must first distribute from the injection site to other organs. That such distribution occurs is apparent from animal experiments reported by Pfizer to Japanese authorities with its application for vaccine approval in that country [5]. Rats were injected intramuscularly with a radioactively labelled model mRNA vaccine, and the movement of the radiolabel first into the bloodstream and subsequently into various organs was followed for up to 48 hours.

The first thing to note is that the labelled vaccine shows up in the blood plasma after a very short time—within only a quarter of an hour. The plasma level peaks two hours after the injection. As it drops off, the model vaccine accumulates in several other organs. The fastest and highest rise is observed in the liver and the spleen. Very high uptake is also observed with the ovaries and the adrenal glands. Other organs (including the testes) take up significantly lower levels of the model vaccine. We note, however, that at least the blood vessels will be exposed and affected in every organ and in every tissue.

The rapid and widespread distribution of the model vaccine implies that we must expect expression of the spike protein throughout the body. For a more in-depth discussion of this biodistribution study, see Palmer2021b.

3. Expression of viral proteins can be detected with immunohistochemistry

While the distribution of the model vaccine leads us to expect widespread expression of the spike protein, we are here after solid proof. Such proof can be obtained using immunohistochemistry, which method is illustrated in this slide for the vaccine-encoded spike protein.

If a vaccine particle—composed of the spike-encoding mRNA, coated with lipids—enters a body cell, this will cause the spike protein to be synthesized within the cell and then taken to the cell surface. There, it can be recognized by a spike-specific antibody. After washing the tissue specimen to remove unbound antibody molecules, the bound ones can be detected with a secondary antibody that is coupled with some enzyme, often horseradish peroxidase. After another washing step, the specimen is incubated with a water-soluble precursor dye that is converted by the enzyme to an insoluble brown pigment. Each enzyme molecule can rapidly convert a large number of dye molecules, which greatly amplifies the signal.

At the top right of the image, you can see two cells which were exposed to the Pfizer vaccine and then subjected to the protocol outlined above. The intense brown stain indicates that the cells were indeed producing the spike protein.

In short, wherever the brown pigment is deposited, the original antigen—in this example, the spike protein—must have been present. Immunohistochemistry is widely used not only in clinical pathology but also in research; it could readily have been used to detect widespread expression of spike protein in animal trials during preclinical development. However, it appears that the FDA and other regulators never received or demanded such experimental data [6].

4. Expression of spike protein in shoulder muscle after vaccine injection

This slide (by Dr. Burkhardt) shows deltoid muscle fibres in cross section. Several (but not all) of the fibres show strong brown pigmentation, again indicating spike protein expression.

While the expression of spike protein near the injection site is of course expected and highly suggestive, we would like to make certain that such expression is indeed caused by the vaccine and not by a concomitant infection with the SARS-CoV-2 virus. This is particularly important with respect to other tissues and organs which are located far away from the injection site.

5. Coronavirus particles contain two prominent proteins: spike (S) and nucleocapsid (N)

To distinguish between infection and injection, we can again use immunohistochemistry, but this time apply it to another SARS-CoV-2 protein—namely, the nucleocapsid, which is found inside the virus particle, where it enwraps and protects the RNA genome. The rationale of this experiment is simple: cells infected with the virus will express all viral proteins, including the spike and the nucleocapsid. In contrast, the mRNA-based COVID vaccines (as well as the adenovirus vector-based ones produced by AstraZeneca and Janssen) will induce expression only of spike.

6. Infected persons express the nucleocapsid protein (and also the spike protein)

This slide simply illustrates that the method works: lung tissue or cells from a nasal swab of a person infected with SARS-CoV-2 stain positive for nucleocapsid expression, whereas cultured cells exposed to the vaccine do not (but they stain strongly positive for the spike protein; see inset at the top right of Slide 3).

7. Injected persons express only the spike protein, which implicates the vaccine

Here, we see immunohistochemistry applied to heart muscle tissue from an injected person. Staining for the presence of spike protein causes strong brown pigment deposition. In contrast, only very weak, non-specific staining is observed with the antibody that recognizes the nucleocapsid protein. The absence of nucleocapsid indicates that the expression of the spike protein must be attributed ot the vaccine rather than an infection with SARS-CoV-2.

We will see shortly that the strong expression of spike protein in heart muscle after vaccination correlates with significant inflammation and tissue destruction.

8. Expression of spike protein within the walls of small blood vessels

We see spike protein expression in arterioles (small arteries; left) as well as in venules (small veins) and capillaries (right). Expression is most prominent in the innermost cell layer, the endothelium. This makes the endothelial cells “sitting ducks” for an attack by the immune system.

9. Endothelial stripping and destruction of a small blood vessel after vaccination

We now turn to the evidence of immune attack on the endothelial cells which produce the spike protein. On the left, a normal venule, delimited by an intact endothelium and containing some red blood cells and few white blood cells (stained blue) inside.

The image on at the centre shows a venule that is being attacked and destroyed by the immune system. The outline is already dissolving, and the spindle-shaped (and swollen) endothelial cells have peeled off from the vessel wall. Furthermore, we see lymphocytes—the small cells with dark, round nuclei and with very little cytoplasm around them; a single lymphocyte (at much higher magnification) is shown on the right.

Lymphocytes are the backbone of the specific immune system—whenever antigens are recognized and antibodies are produced, this is done by lymphocytes. Also among the lymphocytes we find cytotoxic T cells and natural killer cells, which serve to kill virus-infected cells—or ones that look to them as if infected, because they have been forced to produce a viral protein by a so-called vaccine.

A crucial function of the endothelium is to prevent blood clotting. Thus, if the endothelium is damaged, as it is in this picture, and the tissues beyond it make contact with the blood, this will automatically set off blood clotting.

10. A crack in the wall of the aorta, lined by clusters of lymphocytes, leading to aortic rupture

On the left, a section through the wall of an aorta. This picture is taken at an even lower magnification than the one before; the lymphocytes now appear as just a cloud of tiny blue specks. To the left of this blue cloud, we see a vertical crack running through the tissue. Such a crack is also visible macroscopically in the excised specimen of an aorta shown on the right.

The aorta is the largest blood vessel of the body. It receives the highly pressurized blood ejected by the left ventricle of the heart, and it is thus exposed to intense mechanical stress. If the wall of the aorta is weakened by inflammation, as it is here, then it may crack and rupture. Aortic rupture is normally quite rare, but Prof. Burkhardt found multiple cases in his limited number of autopsies. Some of the affected aortas were also shown to have expressed the spike protein.

11. Healthy heart muscle tissue, and lymphocytic myocarditis

In Slide 7, we saw that heart muscle cells strongly expressed the spike protein after vaccine injection. Here, we see the consequences. The picture on the shows a sample of healthy heart muscle tissue, with regularly oriented and aligned heart muscle fibres. On the right, we see a heart muscle sample from one of the autopsies. The muscle fibres are disjointed and disintegrating, and they are surrounded by invading lymphocytes. Burkhardt found myocarditis in multiple of his deceased patients.

12. Lymphocytic infiltration and proliferative inflammation in lung tissue

On the left, we see healthy lung tissue, with air-filled spaces (the alveoli), delimited by delicate alveolar septa with embedded, blood-filled capillaries. We also see some larger blood vessels.

On the right hand side, we see lung tissue overrun by lymphocytes. The air-filled spaces have largely disappeared and been filled with scar (connective) tissue. This vaccine-injected patient would obviously have had very great trouble breathing.

Lymphocytic infiltration, inflammation and destruction were also observed in many other organs, including the brain, the liver, the spleen, and multiple glands. However, instead of illustrating them all, we will conclude the pathological evidence with another immunohistochemistry result, which strikingly shows the long duration of spike protein expression.

13. Vaccine-induced expression of spike protein in a bronchial biopsy nine months after vaccination

The slide shows a sample of bronchial mucous membrane, from a patient who is alive but has suffered respiratory symptoms ever since being vaccinated. We see several cells in the uppermost cell layer that strongly express spike protein—and this even nine months after his most recent vaccine injection! While this is indeed the most extreme case of long-lasting expression, there is evidence both from Burkhardt’s autopsies and from published studies on blood samples [7] or lymph node biopsies [8] to indicate that expression does last several months.

14. The Pfizer vaccine mRNA gets copied (“reverse-transcribed”) into DNA and inserted into the cellular genome

The official mRNA vaccine narrative maintains that the modified mRNA contained in the vaccine will not be replicated in vivo; expression of the spike protein should therefore cease once the injected RNA molecules have been degraded.

The limited experimental studies available [9,10] suggest that the injected modified mRNA should be degraded within days to a few weeks of the injection. This is obviously difficult to square with the observed long-lasting expression; in some form or other, the genetic information appears to be perpetuated in vivo.

A recent experimental study from Sweden [11] has shown that human-derived cells can copy the Pfizer mRNA vaccine into DNA and then insert it into their own chromosomal DNA. The image shows the key evidence from this study. The cells were exposed to the vaccine for the lengths of time indicated. Cellular DNA was then isolated, and inserted DNA copies of the vaccine mRNA detected by PCR amplification of a fragment 444 base pairs (bp) in length.

All samples labelled with “BNT” had been treated with the vaccine, and they all show a PCR product of the expected length, as is evident from comparison to a DNA fragment length standard (“L”). Samples labelled with “Ctrl n” were controls: Ctrl 1– 4 contained DNA from cells not incubated with vaccine, Ctrl 5 contained RNA (not DNA) from vaccine-treated cells; Ctrl 6 contained the same but was additionally treated with RNAse, which step was also performed in the purification of DNA samples. As expected, none of the control samples contain the PCR product.

Considering Aldén’s observation of DNA insertion in every single experimental sample, it seems highly likely that this will also occur in vivo. Beyond providing a plausible mechanism for perpetuating the expression of spike protein, DNA insertion also poses risks of genetic damage, leading to cancers and leukemias.

15. Summary

The evidence presented here clearly demonstrates a chain of causation from vaccine injection to

  • rapid distribution of the vaccine through the bloodstream,
  • widespread spike protein expression, prominently in blood vessels, and
  • autoimmune-like inflammation and organ damage.

Vaccine-induced vascular damage will promote blood clotting, and clotting-related diseases such as heart attack, stroke, lung embolism are very common in the adverse events databases [4,12].

In addition to autoimmune-like inflammation, other disease mechanisms, including prion-mediated CNS degeneration [13], aberrant vascular protein deposition (amyloidosis) [14,15], and lipid nanoparticle toxicity [16], are plausible but require further study and corroboration. Overall, these vaccines can no longer be considered experimental—the “experiment” has resulted in the disaster that many medical doctors and scientists predicted from the outset [17]. The vaccination must be stopped, and all approvals and authorizations of their use must be revoked.


  1. Bozkurt, B. et al. (2021) Myocarditis With COVID-19 mRNA Vaccines. Circulation 144:471-484
  2. Ehrlich, P. et al. (2021) Biopsy-proven lymphocytic myocarditis following first mRNA COVID-19 vaccination in a 40-year-old male: case report. Clinical research in cardiology official journal of the German Cardiac Society 110:1855-1859
  3. Rose, J. and McCullough, P.A. (2021) A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products. Current problems in cardiology p. 101011
  4. Shilhavy, B. (2022) 43,898 Dead, 4,190,493 Injured Following COVID Vaccines in European Database of Adverse Reactions.
  5. Anonymous, (2020) SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary statement of the pharmacokinetic study [English translation].
  6. Latyopva, A. (2022) Did Pfizer Perform Adequate Safety Testing for its Covid-19 mRNA Vaccine in Preclinical Studies? Evidence of Scientific and Regulatory Fraud.
  7. Bansal, S. et al. (2021) Cutting Edge: Circulating Exosomes with COVID Spike Protein Are Induced by BNT162b2 (Pfizer-BioNTech) Vaccination prior to Development of Antibodies: A Novel Mechanism for Immune Activation by mRNA Vaccines. J. Immunol. 207:2405-2410
  8. Röltgen, K. et al. (2022) Immune imprinting, breadth of variant recognition and germinal center response in human SARS-CoV-2 infection and vaccination. Cell (preprint)
  9. Andries, O. et al. (2015) N1-methylpseudouridine-incorporated mRNA outperforms pseudouridine-incorporated mRNA by providing enhanced protein expression and reduced immunogenicity in mammalian cell lines and mice. J. Control. Release 217:337-344
  10. Pardi, N. et al. (2018) Nucleoside-modified mRNA vaccines induce potent T follicular helper and germinal center B cell responses. J. Exp. Med. 215:1571-1588
  11. Aldén, M. et al. (2022) Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line. Curr. Issues Mol. Biol. 44:1115-1126
  12. Anonymous, (2021) OpenVAERS.
  13. Perez, J.C. et al. (2022) Towards the emergence of a new form of the neurodegenerative Creutzfeldt-Jakob disease: Twenty six cases of CJD declared a few days after a COVID-19 “vaccine” Jab. ResearchGate (preprint)
  14. Charnley, M. et al. (2022) Neurotoxic amyloidogenic peptides in the proteome of SARS-COV2: potential implications for neurological symptoms in COVID-19. Nat. Commun. 13:3387
  15. Nyström, S. and Hammarström, P. (2022) Amyloidogenesis of SARS-CoV-2 Spike Protein. J. Am. Chem. Soc. 144:8945-8950
  16. Palmer, M. and Bhakdi, S. (2021) The Pfizer mRNA vaccine: Pharmacokinetics and Toxicity.
  17. Bhakdi, S. et al. (2021) Urgent Open Letter from Doctors and Scientists to the European Medicines Agency regarding COVID-19 Vaccine Safety Concerns.

FDA limits use of J&J vaccine over rare blood clots

Authors:  PETER SULLIVAN – 05/05/22 THE HILL

The Food and Drug Administration (FDA) on Thursday announced that it is limiting the authorization for the Johnson & Johnson COVID-19 to people who cannot or will not get other versions of the vaccine, citing the risk of rare blood clots.  

The authorization for the J&J vaccine, also known as the Janssen vaccine, is now limited to people for whom the Pfizer or Moderna vaccines “are not accessible or clinically appropriate,” or “who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.” 

That is, people can still get the J&J vaccine if they are allergic to the mRNA vaccines from Pfizer or Moderna, or if personal concerns with the other vaccines mean they would otherwise go without any inoculation.  

The agency said it was making the decision after “conducting an updated analysis, evaluation and investigation of reported cases” of the blood clots, which “warrants limiting the authorized use of the vaccine.” 

Importantly, the Pfizer and Moderna vaccines do not carry the same risks of blood clots, given they use a different technology than the Johnson & Johnson vaccines.  

Blood clots also remain rare among J&J recipients. The FDA has identified 60 confirmed cases of the blood clots following receipt of the J&J vaccine and nine deaths, it said. That is about three cases of blood clots for every million J&J vaccines administered, and 0.48 deaths per million doses of the J&J vaccine. 

The blood clots are formally known as thrombosis with thrombocytopenia syndrome (TTS).  

This is not the first time that the risk has affected distribution of the vaccine. Regulators caused shockwaves, and some controversy, early last year, when they paused the administration of the J&J vaccine for several days to allow time to investigate the blood clots.  

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions,” said Peter Marks, a top FDA official. “We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the [authorization].” 

The J&J vaccine already had far lower usage than the Pfizer or Moderna vaccines. About 18 million doses have been administered, according to the Centers for Disease Control and Prevention, compared to more than 200 million for Moderna and more than 300 million for Pfizer.  

In making its decision, the FDA noted the availability of other vaccines from Pfizer and Moderna, “which provide protection from COVID-19 and have not been shown to present a risk for TTS.”

Pfizer-BioNTech Vaccine Much Weaker in Kids Against Omicron and More

Authors: Mark Terry Published: Mar 01, 2022  BIOSPACE

Pfizer-BioNTech Vaccine Only 12% Effective Against Omicron in 5-11-Year-Olds 

In a new study that is yet to be peer-reviewed, the New York State Department of Health found that the PfizerBioNTech vaccine was only about 12% effective for children ages 5 to 11 years against the Omicron variant. In that age group, it was about 68% effective against Delta, but the effectiveness dropped significantly during the Omicron surge from Dec. 13, 2021, to Jan. 24, 2022. Protection against hospitalization also plummeted from 100% to 48% in the same period. 

The authors of the report think this drop may be the result of the lower dosage the children received. They were dosed with two 10-microgram shots, compared to 30-microgram doses for children 12 to 17 years of age.  

“Given rapid loss of protection against infections, these results highlight the continued importance of layered protections, including mask-wearing, for children to prevent infection and transmission,” the authors wrote. 

Pfizer-BioNTech Vaccine Integrates into Liver Cells in Cell Cultures 

Researchers at Lund University in Sweden conducted research into the Pfizer-BioNTech COVID-19 vaccine and human liver cell lines to determine what kind of effect the vaccine might have on liver cells. The research was published in Current Issues in Molecular Biology. The authors, noting the safety and efficacy of the vaccine against COVID-19, also point out that long-term studies have not been conducted. They note pharmacokinetics data provided by Pfizer to the European Medicines Agency (EMA) showed that the “injection site and the liver were the major sites of distribution, with maximum concentrations observed at 8-48 hours post-dose.

Furthermore, in animals that received the BNT162b2 injection, reversible hepatic effects were observed, including an enlarged liver, vacuolation, increased gamma-glutamyl transferase levels, and increased levels of aspartate transaminase (AST) and alkaline phosphatase (ALP).” They add that transient liver effects caused by the lipid nanoparticle (LNP) delivery systems used with mRNA vaccines have been previously reported, although LNP with no mRNA in it doesn’t cause any significant liver injury. 

Working with the specific human liver cell line Huh7 and the Pfizer-BioNTech vaccine, they found that the vaccine was able to enter the cell line as quickly as six hours after exposure. They cite a report saying some people who received the vaccine developed autoimmune hepatitis, and they question if the human liver cells, integrating the vaccine mRNA, produce SARS-CoV-2 spike protein that then catches the attention of the body’s immune system, inadvertently attacking the liver.

However, there does not appear to have been many other cases of this happening, which would make it extremely rare, assuming it was actually caused by the vaccine and not something else. 

The researchers note, “At this stage, we do not know if DNA reverse transcribed from BNT162b2 is integrated into the cell genome. Further studies are needed to demonstrate the effect of BNT162b2 on genomic integrity, including whole genome sequencing of cells exposed to BNT162b2, as well as tissues from human subjects who received BNT162b2 vaccination.” 

Adamis’ COVID-19 Trial Surpasses Enrollment Expectations 

San Diego-based Adamis Pharmaceuticals reported that due to the acceleration of enrollment in its Phase II/III study for Tempol for COVID-19, its Data Safety Monitoring Board (DSMB) decided the study could continue. No safety or clinical problems were observed. The data from the first 50 participants will be reviewed again in March as part of the first planned interim analysis. 

Tempol has strong, broad in vitro anti-cytokine activity, and in animal studies, appeared to have anti-inflammatory effects in the lungs. 

“We are pleased with the progress of the trial, which has already exceeded the required number of subjects (124) for the second planned interim DSMB analysis,” said Dr. Dennis J. Carlo, president and CEO of Adamis. “We appreciate the feedback from the DSMB. Following the first planned interim analysis, if the DSMB advises for the study to continue, we will also report on the second planned DSMB review following its completion, which may provide additional insight into the safety and clinical results at that time.” 

Study into mRNA vaccine death rates sends ‘danger signals’

A new Danish study reveals disparities in all-cause mortality between mRNA and adenovirus vaccines

Do the covid vaccines save lives? That is the question on many people’s minds, that has led to heated discussions across the world.

A bombshell new study by a distinguished team of Danish researchers led by Prof. Christine Stabell-Benn suggests a surprisingly nuanced answer. In the randomized trials of the covid vaccines, the adenovector-based vaccines, including the AstraZeneca and Johnson & Johnson vaccines, reduced all-cause mortality of study participants relative to people randomly assigned a placebo. Indeed, the reduction in mortality is larger than expected from the Covid effect and may suggest additional beneficial “non-specific effects” from those vaccines against other health threats.

On the other hand, Stabell-Benn and her colleagues found no statistically meaningful evidence in the trial data that the mRNA vaccines reduced all-cause mortality. The numbers of deaths from other causes including cardiovascular deaths appear to be increased in this group, compensating for the beneficial effect of the vaccines on Covid. Stabell-Benn is keen to stress that the sample is relatively small and is calling for further investigation, and also that the study took place during very low levels of Covid, so the relative advantage of protection against Covid would have been smaller at that time compared to at other points in the pandemic.

However, these preliminary results stand in sharp contrast to the unambiguous message from public health agencies and governments worldwide, which granted emergency authorization to the vaccines based on evidence from the trials that the vaccines reduce the likelihood of getting symptomatic covid. From a purely scientific perspective, preventing symptomatic covid is an interesting outcome to study. From a public health perspective, prevention of covid symptoms is not as important as prevention of death or disease transmission, which the randomized trials did not study. Dr. Stabell Benn and her colleagues have now looked at overall mortality for the first time.

At the very least, the plain implication (since both sets of vaccines are available) is that public health authorities should have recommended the cheaper adenovector vaccines over the mRNA vaccines all along for most patients.

In other words, the international move to de-authorise the AstraZeneca vaccine across Europe and elsewhere looks like it may have been a mistake, and that AZ was actually a better option than the Pfizer or Moderna vaccines.

It offers a potential contributory explanation for the better overall mortality outcomes in the UK (which overwhelmingly used the AZ vaccine) than much of continental Europe (which phased out the AZ vaccine) after the vaccine programme in the second half of 2021. 

Since its publication in pre-print, the Stabell-Benn study has received very little coverage in the media. As Dr Stabell-Benn told Freddie Sayers in her UnHerd interview, she has become used to this reticence: I have been in this game for now almost thirty years, studying vaccines and finding these non-specific effects which have been very controversial. There are strong powers out there that don’t really want to hear about them. But to me this is good news: it means that we can optimize the use of vaccines to not only be strong protective effects against vaccine disease, but we can also optimize their use in terms of overall health. – PROFESSOR CHRISTINE STABELL-BENN, UNHERD

The reaction 

For a study with such a consequential conclusion, review from independent experts is crucial. In the past, such peer-review took place in anonymity, behind the closed doors of a scientific journal, with a single editor or associate editor serving as an umpire. Because of the small number of people involved in the review, the peer-review process is subject to well-known biases and long delays (months or longer). Worse, the public never had access to these deliberations and was asked to take it as an article of faith that a published peer-reviewed paper presented accurate conclusions.

A better process for the scientific review of some important papers has emerged during the pandemic – open peer review whereby the public can see the conversation among scientific experts. Though the Danish team released their paper in early April, it was an online review by vaccine safety expert and world-renowned epidemiologist Martin Kulldorff that catalyzed a discussion by scientists about it.

In his review, Kulldorff pointed to the clear implication of the results of the Danish paper. When both mRNA and adenovector vaccines are available, it’s better to take the vaccine with good randomized evidence of reductions in all-cause mortality rather than taking a vaccine where we cannot tell from the best evidence whether it reduces mortality. Kulldorff called for a new randomized controlled trial of the mRNA vaccine to find out if they can compete with the adenovirus-vector vaccines – as should occur in medicine whenever an effective intervention exists and another intervention seeks to show that it is as good or better. He also suggested that it is inappropriate to mandate vaccines for which the randomized clinical trials show a null result for mortality. 

Kulldorff’s open peer-review stoked some discussion among scientists about the feasibility of running a randomized trial comparing the vaccines. Mortality rates from covid infection – due partly to high levels of population immunity from covid recovery – are low, so a large sample size would be necessary to detect a difference. Whether such a study is even feasible is an open question, as is the importance of such a study. This kind of constructive discussion happens all the time in science.

However, some scientists – including zero-covid advocate Deepti Guradsani – reacted to Kulldorff’s article with public smears, false accusations of spreading vaccine misinformation, and the usual claims about right-wing connections. Even Jeremy Farrar, the head of the Wellcome Trust and a prominent architect of the pandemic policy in the UK, joined the fray by promoting such smears on his Twitter feed. 

Kulldorff is a prominent vaccine scientist who has presented his honest views on the covid vaccines, even when they go against the established narrative. In March 2021, he lost his position as an advisor to the US CDC for recommending against pausing the Johnson & Johnson vaccine for older Americans – an action that effectively killed the demand for the adenovirus vector vaccines in the US. He is the only person I know who the CDC has fired for being too pro-vaccine.  

When scientists slander prominent vaccine scientists, that damages vaccine confidence. Scientists should be encouraged to evaluate, compare and discuss the strengths and weaknesses of different vaccines, and to be free to advocate for one vaccine over another. Farrar’s promotion of the lies is particularly insidious because it sends a signal to scientists who might be interested in funding from the Wellcome Trust to shy away from voicing their honest thoughts about the Danish study or vaccines in general.

The stakes in the discussion about this paper are tremendously high. Of course, for the public at large, what covid vaccine is best for them is literally a life-and-death question. For scientists, at stake is the ability to participate honestly in open scientific reviews of hot button topics without having to face smears and reputational damage based on lies by other prominent scientists. If scientists lose their ability to reason publicly about studies like the ground-breaking Danish study, physicians will have no solid basis for their advice to patients on this topic or much else, and the public will have no reason to trust physicians and scientists.

Age- and Sex-Specific Incidence of Cerebral Venous Sinus Thrombosis Associated With Ad26.COV2.S COVID-19 Vaccination

Authors: Aneel A. Ashrani, MD, MS1Daniel J. Crusan, BS2Tanya Petterson, MS2et al

JAMA Intern Med. 2022;182(1):80-83. doi:10.1001/jamainternmed.2021.6352

Recent reports14 suggest a possible association between Ad26.COV2.S (Johnson & Johnson/Janssen) COVID-19 vaccination and cerebral venous sinus thrombosis (CVST). Estimates of postvaccination CVST risk require accurate age- and sex-specific prepandemic CVST incidence rates; however, reported rates vary widely.5 We compared the age- and sex-specific CVST rates after Ad26.COV2.S vaccination with the prepandemic CVST rate in the population.Methods

In this population-based cohort study, to estimate the risk of CVST after Ad26.COV2.S vaccination, we first identified all incident cases of CVST in Olmsted County, Minnesota from January 1, 2001, through December 31, 2015 (eMethods in the Supplement). Sex-and age-adjusted incidence rates were adjusted to the 2010 US census population. We used CDC Vaccine Adverse Event Reporting System (VAERS) data from February 28, 2021 (vaccine approval date) to May 7, 2021, to estimate the incidence of CVST after Ad26.COV2.S vaccination assuming 3 (15, 30, and 92 days) plausible postvaccination periods during which individuals were considered to be at risk of CVST. We then compared post-Ad26.COV2.S vaccination CVST rates with prepandemic rates to estimate postvaccination CVST risk. This study was approved by the Mayo Clinic institutional review board. Medical records of Olmsted County residents with CVST were reviewed only if the residents had signed an authorization for accessing their medical records for research purposes. SAS, version 9.4 (SAS Institute Inc) and R, version 4.0.3 (R Project for Statistical Computing) were used for statistical analyses. Significance was set at a 2-sided P < .05.Results

From 2001 through 2015, 39 Olmsted County residents developed acute incident CVST. A total of 29 patients (74.4%) had a predisposing venous thromboembolism risk factor (eg, infection, active cancer, or oral contraceptives [for women]) within 92 days before the event. The median age at diagnosis was 41 years (range, 22-84 years); 22 residents with CVST (56.4%) were female. The overall age- and sex-adjusted CVST incidence was 2.34 per 100 000 person-years (PY) (95% CI, 1.60-3.08 per 100 000 PY). Age-adjusted CVST rates for female and male individuals were 2.46 per 100 000 PY (95% CI, 1.43-3.49 per 100 000 PY) and 2.34 per 100 000 PY (95% CI, 1.22-3.46 per 100 000 PY), respectively. Men aged 65 years or older had the highest CVST rate (6.22 per 100 000 PY; 95% CI, 2.50-12.82 per 100 000 PY), followed by women aged 18 to 29 years (4.71 per 100 000 person-years; 95% CI, 2.26-8.66 per 100 000 PY) (Table 1).

As of May 7, 2021, 8 727 851 Ad26.COV2.S vaccine doses had been administered in the US; 46 potential CVST events occurring within 92 days after Ad26.COV2.S vaccination were reported to VAERS. Eight events were excluded because they were potentially duplicate reports (4) or were not objectively diagnosed (4). Twenty-seven of 38 objectively diagnosed cases of CVST after Ad26.COV2.S vaccination (71.1%) occurred in female individuals. The median patient age was 45 years (range, 19-75 years). The median time from vaccination to CVST was 9 days (IQR, 6-13 days; range, 1-51 days); 31 of 38 cases of CVST (81.6%) occurred within 15 days after vaccination, and 36 (94.7%) occurred within 30 days.

The overall incidence rate of post–Ad26.COV2.S vaccination CVST was 8.65 per 100 000 PY (95% CI, 5.88-12.28 per 100 000 PY) at 15 days, 5.02 per 100 000 PY (95% CI, 3.52-6.95 per 100 000 PY) at 30 days, and 1.73 per 100 000 PY (95% CI, 1.22-2.37 per 100 000 PY) at 92 days (Table 2). The 15-day postvaccination CVST incidence rates for female and male individuals were 13.01 per 100 000 PY (95% CI, 8.24-19.52 per 100 000 PY) and 4.41 per 100 000 PY (95% CI, 1.90-8.68 per 100 000 PY), respectively. The postvaccination CVST rate among females was 5.1-fold higher compared with the pre-COVID-19 pandemic rate (13.01 vs 2.53 per 100 000 PY; P < .001) (Table 2). This risk was highest among women aged 40 to 49 years (29.50 per 100 000 PY; 95% CI, 13.50-55.95 per 100 000 PY), followed by women aged 30 to 39 years (26.50 per 100 000 PY; 10.65-54.63 per 100 000 PY).Discussion

In this population-based cohort study, we found that the CVST incidence rate 15 days after Ad26.COV2.S vaccination was significantly higher than the prepandemic rate. However, the higher rate of this rare adverse effect must be considered in the context of the effectiveness of the vaccine in preventing COVID-19 (absolute reduction of severe or critical COVID-19 of 940 per 100 000 PY).6

Most CVST events occurred within 15 days after vaccination, which is likely the highest at-risk period. The postvaccination CVST rate among females was higher than the prepandemic rate among females. The highest risk was among women aged 30 to 49 years, but the absolute CVST risk was still low in this group (up to 29.5 per 100 000 PY among women aged 40-49 years). The reason that women had a higher incidence of postvaccination CVST is unclear; concomitant CVST risk factors or autoantibody production might have been involved.2 The overall prepandemic CVST incidence rate was slightly higher in our study than in other studies (0.22-1.57 per 100 000 PY)5 likely because we captured all objectively diagnosed incident CVST cases in a well-defined population, including those discovered at autopsy.

The present study avoided referral bias and included only objectively diagnosed and confirmed cases. Only cases with adequate details or imaging findings reported on VAERS were used. Study limitations include possible ascertainment bias by including only objectively diagnosed CVST cases. VAERS reporting is voluntary and subject to reporting biases. VAERS monitors vaccine adverse events but does not prove causality.Back to topArticle Information

Accepted for Publication: September 12, 2021.

Published Online: November 1, 2021. doi:10.1001/jamainternmed.2021.6352

Corresponding Author: Aneel A. Ashrani, MD, MS, Division of Hematology, Department of Internal Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905 (ashrani.aneel@mayo.edu).

Author Contributions: Dr Ashrani and Mr Crusan had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Ashrani, Petterson, Bailey, Heit.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Ashrani, Crusan, Petterson.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Crusan, Petterson, Bailey.

Obtained funding: Ashrani, Heit.

Administrative, technical, or material support: Ashrani, Heit.

Supervision: Ashrani, Petterson, Bailey, Heit.

Conflict of Interest Disclosures: Dr Ashrani reported receiving grants from the National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH) during the conduct of the study. Mr Crusan reported receiving grants from the NIH during the conduct of the study. Dr Heit reported receiving grants from the NHLBI, NIH during the conduct of the study. No other disclosures were reported.

Funding/Support: This study was supported in part by grant R01HL66216 from the NHLBI, NIH (Drs Ashrani and Bailey), the Rochester Epidemiology Project (grant R01AG034676 from the National Institute on Aging, NIH), and the Mayo Foundation.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.


1.Centers for Disease Control and Prevention. Cases of cerebral venous sinus thrombosis with thrombocytopenia after receipt of the Johnson & Johnson COVID-19 vaccine New release. April 13, 2021. Accessed April 21, 2021.  https://emergency.cdc.gov/han/2021/han00442.asp

2.See  I, Su  JR, Lale  A,  et al.  US case reports of cerebral venous sinus thrombosis with thrombocytopenia after Ad26.COV2.S vaccination, March 2 to April 21, 2021.   JAMA. 2021;325(24):2448-2456. doi:10.1001/jama.2021.7517
ArticlePubMedGoogle ScholarCrossref

3.Shay  DK, Gee  J, Su  JR,  et al.  Safety monitoring of the Janssen (Johnson & Johnson) COVID-19 vaccine—United States, March-April 2021.   MMWR Morb Mortal Wkly Rep. 2021;70(18):680-684. doi:10.15585/mmwr.mm7018e2PubMedGoogle ScholarCrossref

4.Shimabukuro  T. Update: thrombosis with thrombocytopenia syndrome (TTS) following COVID-19 vaccination. Paper presented at: Advisory Committee on Immunization Practices; May 12, 2021.

5.Devasagayam  S, Wyatt  B, Leyden  J, Kleinig  T.  Cerebral venous sinus thrombosis incidence is higher than previously thought: a retrospective population-based study.   Stroke. 2016;47(9):2180-2182. doi:10.1161/STROKEAHA.116.013617PubMedGoogle ScholarCrossref

6.Sadoff  J, Gray  G, Vandebosch  A,  et al; ENSEMBLE Study Group.  Safety and efficacy of single-dose Ad26.COV2.S vaccine against COVID-19.   N Engl J Med. 2021;384(23):2187-2201. doi:10.1056/NEJMoa2101544PubMedGoogle ScholarCrossref

CDC Study: Side Effects Of Covid Far More Dangerous Than Any Of Vaccines

The possibility of experiencing a serious adverse effect from the covid shots approved in the U.S. is significantly lower than the chances of severe illness, hospitalization or death from contracting covid, new research from the Centers for Disease Control and Prevention shows. Other studies show covid’s pregnancy impact and vaccine protection against the delta variant.

Bay Area News Group: COVID-19 Far Riskier Than Vaccines, New CDC Study SaysHow risky are the COVID-19 vaccines? A new study by the U.S. Centers for Disease Control and Prevention found that the risk of illness, hospitalization and death following the shots is far lower than the danger from becoming infected with the highly contagious and often deadly virus. Three health threats have surfaced among some vaccinated people: Blood clots and the Guillain-Barre Syndrome neurologic disorder after the Johnson & Johnson shot, and heart inflammation after the Pfizer or Moderna shots, which use a messenger-RNA technology. But the CDC analysis found that the risk in adults from the vaccines to be minimal compared to the virus that causes COVID-19, which has infected 35 million Americans and killed more than 614,000. (Woolfolk, 8/10)

San Francisco Chronicle: Devastating Impact Of COVID On Pregnancy Highlighted By Large UCSF StudyPregnant women infected with the coronavirus are at significantly higher risk for adverse complications, including preterm birth, according to a University of California San Francisco analysis of all documented births in the state between July 2020 and January 2021. In the largest study of its kind, researchers found the risk of very preterm birth, which occurs at less than 32 weeks of gestation, was 60% higher for people infected with the coronavirus during their pregnancy. The risk of giving birth at less than 37 weeks — which is any preterm birth — was 40% higher. (Vaziri, 8/10)

USA Today: Study Showing Antibody Levels Protecting Against COVID-19 Could Speed Creation Of New Vaccines, BoostersEagerly anticipated new research pinpoints antibodies scientists can test for to see if a COVID-19 vaccine is effective. These “correlates of protection” could speed the development of new vaccines or boosters without requiring the enormous clinical trials used to create the first COVID-19 vaccines. Instead, researchers could vaccinate people with a new vaccine or booster, measure their antibodies over the course of several months, and know if it worked. This is “the Holy Grail” in terms of vaccines, and one that hasn’t yet been set for the virus that causes COVID-19, said Peter Gilbert, co-author of the study posted Tuesday to medRxiv, a preprint site where scientific articles can be published prior to being accepted by peer-reviewed journals. (Weise, 8/10)

Reuters: Moderna May Be Superior To Pfizer Against Delta; Breakthrough Odds Rise With TimeThe mRNA vaccine from Pfizer and BioNTech may be less effective than Moderna’s against the Delta variant of the coronavirus, according to two reports posted on medRxiv on Sunday ahead of peer review. In a study of more than 50,000 patients in the Mayo Clinic Health System, researchers found the effectiveness of Moderna’s vaccine against infection had dropped to 76% in July – when the Delta variant was predominant – from 86% in early 2021. Over the same period, the effectiveness of the Pfizer/BioNTech vaccine had fallen to 42% from 76%, researchers said. While both vaccines remain effective at preventing COVID hospitalization, a Moderna booster shot may be necessary soon for anyone who got the Pfizer or Moderna vaccines earlier this year, said Dr. Venky Soundararajan of Massachusetts data analytics company nference, who led the Mayo study. (Aug. 9)

Also —

The Washington Post: Johnson & Johnson Coronavirus Vaccine Recipients Worry They Chose The Wrong Brand New research offers encouraging evidence about how the Johnson & Johnson vaccine stacks up against its competitors — and the delta variant — according to infectious-disease specialists. However, there are still lingering questions about booster shots. Earlier clinical trials showed the Johnson & Johnson vaccine was 66 percent effective overall in preventing moderate to severe disease four weeks after the shot, with effectiveness varying depending on location. Its competitors from Pfizer and Moderna, on the other hand, recorded 90 percent-plus effectiveness against the coronavirus. Anthony S. Fauci, the nation’s leading infectious-disease expert, has said all three vaccines are effective. (Beachum, Bever and Iati, 8/10)

CIDRAP: Viral COVID-19 Detected In Singing, Talking, Breathing Between breathing, singing, and talking, researchers detected SARS-CoV-2 RNA copies mostly from talking and singing (94%), and 85% of all viral particles were detected in fine aerosols, according to a small study late last week in Clinical Infectious Diseases. The researchers had 22 COVID-19 patients at Singapore’s National Centre for Infectious Diseases breathe for 30 minutes, talk for 15 minutes, or sing for 15 minutes into a G-II exhaled breath collector. Thirteen patients (59%) had detectable SARS-CoV-2 levels, of whom three were asymptomatic and one was presymptomatic. Variables such as age, sex, virus variant, and clinical symptoms were not significantly associated with detectable viral RNA in aerosols, but median day of illness was, with a higher likelihood earlier on in a patient’s illness (median, 3 vs 5 days after illness onset). (8/9)

Here’s Why Viral Vector Vaccines Don’t Alter DNA

— It’s pretty simple — they can’t

Authors: by Veronica Hackethal, MD, MSc, Enterprise & Investigative Writer, MedPage Today March 12, 2021

Adenoviral vector vaccines have been in development for decades, but very few have been approved for use in humans. What does the history of adenoviral vector vaccine development tell us about their safety and their potential to alter DNA?

How Do Adenoviral Vector Vaccines Work?

Essentially, these types of vaccines act like delivery shuttles. They use an adenovirus — which has been engineered to be incapable of replicating and causing disease — to deliver the genes for making the antigen; in this case, that’s the SARS-CoV-2 spike protein. That in turn elicits an immune response and provides protection against the coronavirus.

Adenoviruses are basically common cold viruses that can cause illnesses ranging from cold-like symptoms to bronchitis, gastroenteritis, and conjunctivitis.

“I think people are unfortunately familiar with adenoviruses … [A]t far too many points, you know, you’ve had the sniffle. You’ve had the cough. You felt crummy. If it’s a cold it’s often adenovirus,” Daniel Griffin, MD, PhD, said on a recent episode of MedPage Today‘s “Track the Vax” podcast. Griffin is chief of infectious disease at ProHEALTH Care, an Optum unit.

Humans are infected with multiple different types of adenoviruses throughout their lifetimes. Most serotypes cause mild illness, although adenovirus serotype 7 has been associated with more severe illness. Older adults and people who are immunocompromised or have pre-existing respiratory or cardiac disease may have worse illness.

Precisely because adenoviruses are so common, one problem with using them in vaccines is that people may already have antibodies to them, overwhelming them before they can do their assigned work. Researchers get around that issue by using adenoviruses that humans are unlikely to have encountered before.

Currently, five adenovirus vector vaccines for COVID-19 are in use worldwide.

Each works on the same basic principle, although delivery platforms differ. The AstraZeneca/Oxford vaccine uses the ChAdOx1 platform, which is based on a modified version of a chimpanzee adenovirus.

The Johnson & Johnson vaccine uses a proprietary AdVac platform, made up of a recombinant human adenovirus (adv26). It’s the same platform used in the company’s Ebola virus vaccine (which is approved in Europe) and its investigational Zika, RSV, and HIV vaccines.

Russia’s Sputnik V uses recombinant human adenoviruses Ad26 and Ad5 for the first and second doses, respectively. Finally, China’s CanSino vaccine uses the recombinant human adenovirus Ad5.

For More Information: https://www.medpagetoday.com/special-reports/exclusives/91604

What Do We Really Know About Adenovirus Vectors for Vaccines?

Authors: By Serena Marshall and Lara Salahi February 24, 2021

— The newest COVID shot uses an existing technology but one with lingering questions

As the U.S. hits the half-million death mark from COVID-19 — a grim milestone that is equal to roughly the entire population of Atlanta and more than that of Miami — a new weapon is being added to the COVID-19 vaccine arsenal.

Johnson & Johnson is seeking emergency use authorization for what would become the U.S.’s first one-dose and non-mRNA COVID vaccine. It employs adenovirus vectors, a technology that has been used in labs for decades and was approved for the Ebola vaccine by the FDA in December 2019. It’s the same technology that AstraZeneca/Oxford and Sputnik V use.

Still, questions remain on how these vaccines may be different than mRNA or similar enough to other existing shots to encourage vaccine uptake. To explain how adenovirus vectors work and what to expect from the new products.

For More Information: https://www.medpagetoday.com/podcasts/trackthevax/91323