Moderna

mRNA Vaccines Significantly Associated With Deadly Blood Clots, Major Study Finds

Blood-clotting condition cerebral venous thrombosis (CVT), which can cause serious neurological damage, is significantly associated with mRNA Covid vaccination, a major study in leading medical journal Vaccines has found.

The research team analysed 1,154,023 adverse event reports from more than 130 countries logged with VigiBase, the World Health Organisation’s global deduplicated database, and found a “potential safety signal for CVT occurrence after COVID-19 mRNA vaccination”.

The authors note many reports were in younger people and the conditions were serious: “CVTs were commonly reported in patients aged 18-44 and 45-64 years, more frequently in women, and mainly in Europe and America… More than 90% of the patients were in serious condition, and 33% did not recover or died.”

The researchers take into account under-reporting to produce estimates of increased risk above a baseline: around 3.5 times greater risk for mRNA vaccines and seven times greater risk for AstraZeneca. This means the CVT risk from mRNA vaccines, while high, is around half that of AstraZeneca.

Covid Vaccines Impair Immune Response to Infection, U.S. Government Study Shows

A pre-print study (not yet peer-reviewed) by U.S. Government researchers shows vaccinated people produce a less comprehensive immune system response following SARS-CoV-2 infection than unvaccinated people.

The researchers examined data from the Moderna Covid vaccine trial and found that, compared to unvaccinated controls, vaccinated participants produced far fewer N-antibodies. These are antibodies against the nucleocapsid protein inside the virus particle, in contrast to S-antibodies against the spike protein that the vaccines target. N-antibodies were detected in 40% (21 of 52) of infected vaccine recipients versus 93% (605 of 648) of placebo recipients. This means those infected after being vaccinated produced N-antibodies at less than half the rate of the unvaccinated.

The researchers found that N-seroconversion (producing N-antibodies following infection) was more likely for infections with higher viral loads. So they checked to see if the difference was due to the vaccinated having milder infections with lower viral loads owing to the vaccine. They found that it wasn’t: for the same viral load the unvaccinated were around 14 times (13.67, 95% confidence interval 5.17-36.16) more likely to have detectable N-antibodies following infection than the vaccinated. Look at the contrasting curves below: the yellow unvaccinated curve is much higher than the blue vaccinated curve, showing that for any given viral load (x-axis) the probability of detecting N-antibodies following infection (y-axis) is much lower for vaccinated than unvaccinated.

“Safe and Effective”: MHRA Approves Moderna Covid Vaccine for Six to 11 Year-Olds and Valneva Vaccine

The U.K. medicines regulator, the MHRA, has approved the Moderna Covid vaccine for six to 11 year olds, describing it as “safe and effective”.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an update to the current U.K. approval of the Moderna COVID-19 Vaccine, or ‘Spikevax’, that allows its use in Great Britain (GB) in six to 11 year-olds.

This approval takes into account the extension to use in children aged six to 11 years already approved by the European Medicines Agency on March 2nd 2022, as the original GB licence for Spikevax in adults was approved by relying on the EU decision.

Spikevax is authorised in children aged six to 11 in Northern Ireland under the update granted by the European Medicines Agency on March 2nd.

Dr June Raine, MHRA Chief Executive, said:

Coronavirus: Key Genetic Sequence for Furin Cleavage Site Patented by Moderna in 2016

In a strange twist in the investigation into the origins of the virus, it has been discovered that a key genetic sequence in the virus – one which codes for the unique furin cleavage site, which helps make the virus highly transmissible in humans – was patented by Moderna in 2016, though for an unrelated purpose. MailOnline has the story.

Fresh suspicion that Covid may have been tinkered with in a lab emerged today after scientists found genetic material owned by Moderna in the virus’s spike protein.

They identified a tiny snippet of code that is identical to part of a gene patented by the vaccine maker three years before the pandemic.   

It was discovered in SARS-CoV-2’s unique furin cleavage site, the part that makes it so good at infecting people and separates it from other coronaviruses.

The structure has been one of the focal points of debate about the virus’s origin, with some scientists claiming it could not have been acquired naturally.  

The international team of researchers suggest[s] the virus may have mutated to have a furin cleavage site during experiments on human cells in a lab.

They claim there is a one-in-three-trillion chance Moderna’s sequence randomly appeared through natural evolution. 

But there is some debate about whether the match is as rare as the study claims, with other experts describing it as a “quirky” coincidence rather than a “smoking gun”. 

Vaccines Have Failed to Prevent the Spread of Covid, Israeli Study Concludes

An Israeli study has looked at how much difference a fourth Covid vaccine dose makes compared with a third dose.

The study was restricted to triple-jabbed healthcare workers, and more specifically to those whose antibody levels were in the bottom 40% of the antibody levels in the cohort (a group comprising around 29% of the cohort). Of the 1,050 eligible healthcare workers, 154 were given a Pfizer fourth dose and 120 Moderna. The rest formed a triple-jabbed control group.

Measuring antibody levels, the researchers found an increase by around 10-fold following the fourth dose, restoring antibodies to the peak levels they hit following the third dose, though no higher.

The study was originally intended just to measure antibody levels and other indicators of immunogenicity. However, the Omicron surge in the country was so large that despite being a small study, enough infections occurred within the study groups to allow an estimate of vaccine effectiveness. The participants were PCR tested each week. The researchers reported that ‘breakthrough’ infections were common and, though mild, had high viral loads. During the study period, 25% of the control groups (triple-dosed) tested positive compared with 18-20% of the four-dose groups. This gave a fourth-dose versus three-dose vaccine effectiveness against PCR-positive infection of just 11-30% – though the small population size led to wide confidence intervals ranging from minus-43% to 55%.

Among the four-dose groups, there were 52 ‘breakthrough’ infections, of which 39 (75%) were classed as symptomatic. The vaccine effectiveness against symptomatic disease was estimated at 31-43%, though again with wide confidence intervals.

The symptoms of all PCR-positive infections were typically “negligible”, the researchers report, and in many cases the infections “would not have been tested or reported, without the active surveillance”. Yet they had relatively high viral loads (Ct around 25), so were presumably infectious. Thus, with a quarter of triple-vaccinated and a fifth of quadruple-vaccinated healthcare workers becoming infected and apparently infectious during the wave, the researchers conclude the vaccine programme is a failure as it is not preventing the spread of Covid: “The major objective for vaccinating [healthcare workers] was not achieved.” However, the apparent efficacy against severe disease and death means older and vulnerable people may benefit from a fourth vaccine dose, they say.

The study also looked at safety. It found that 80% of Pfizer recipients and 40% of Moderna recipients reported some kind of adverse reaction, though none were classed as serious. The adverse reactions are summarised in the chart below.

Larger studies on the efficacy and safety of the fourth dose, which has now been rolled out (having gone ahead without waiting for studies such as this one), are forthcoming, the researchers note.

Joe Rogan is Right That mRNA Vaccines Are Gene Therapy – And Other Ways the BBC’s ‘Fact Check’ Fails

The BBC has used some of its taxpayer funding to ‘reality check‘ Joe Rogan’s Covid ‘misinformation’. The state-funded broadcaster claims some episodes of the popular podcast have featured “false and misleading claims” and states: “Here are four of them fact-checked,” implying all are false. Let’s see.

Claim: A vaccine can alter your genes

Mr Rogan said: “This is not a vaccine, this is essentially a gene therapy.” But this is not true.

None of the Covid vaccines change your genetic material or DNA – essentially the recipe book containing the instructions of how to build your body.

The vaccines made by Pfizer and Moderna harness a different molecule called messenger RNA.

If DNA is the blueprint, RNA is the messenger, carrying instructions to your cells.

In the case of the Covid vaccine, the message to your cells is to turn the RNA into copies of the virus’s spike protein.

That’s what fires your immune system up to start producing antibodies and other cells to fight off the virus.

When the message has been received, the RNA is broken down and disposed of.

First of all, note that the claim the heading says is being ‘fact checked’ is not the same as the claim it quotes Joe Rogan making, which is: “This is not a vaccine, this is essentially a gene therapy.” Perhaps the Reality Check team think gene therapy is synonymous with altering genes, as their ‘fact check’ implies they think if they show the mRNA in the vaccine does not alter genes they have successfully proved it is “not true” to say it is gene therapy. This assumption is false – though it does appear to have become the official line and has started appearing in every ‘fact check’ on the topic. A Reuters fact check‘ from August, for instance, concludes: “Scientists told Reuters that while mRNA vaccines can be considered ‘genetic-based therapy’ because they use genetic code from COVID-19, they are not technically gene therapy. This is because the mRNA does not change the body’s genetic makeup.”

If you think this sounds like dancing on the head of a pin, you’d be right. In fact, it represents a sleight of hand introduced during the pandemic, in part at the behest of vaccine-maker Moderna in order to avoid the new vaccines having the negative associations of gene therapy. And while it’s awfully nice of media corporations like the BBC and Reuters to do the bidding of pharmaceutical companies, it doesn’t make the claim true. You might have thought the fact that virologist and mRNA expert Dr. Robert Malone is one of the people implicated in their ‘fact checks’ as referring to the vaccines as a form of gene therapy would have given them pause for thought. But he is persona non grata and they have their alternative experts to do the requisite pin-dancing, so they plough on regardless.

It isn’t actually hard to show that mRNA vaccine technology comes under the field of gene therapy, and that the attempt to distinguish the two has been invented in the very recent past as a way of making the vaccines look better. For instance, a 2011 article entitled “mRNA as gene therapeutic: How to control protein expression“, in a section headed “Applications for mRNA as a drug molecule: mRNA vaccination”, says this:

Myocarditis Risk Increases Up To 133-FOLD Following Covid Vaccination, Study Finds

A study published this week in the Journal of the American Medical Association (JAMA) has found that the risk of myocarditis (heart inflammation) after receiving an mRNA Covid vaccine (Pfizer or Moderna) was dramatically increased across many age groups and was highest after the second vaccination dose in young men.

The study found myocarditis reports were highest after the second vaccination dose in males aged 12 to 15 years at 70.7 per million Pfizer doses, compared to an expected rate of 0.53 per million, amounting to a 133-fold increase; in males aged 16 to 17 years at 105.9 per million Pfizer doses, compared to an expected rate of 1.34 per million, amounting to a 79-fold increase; and in young men aged 18 to 24 years at 52.4 per million Pfizer doses and 56.3 per million Moderna doses, compared to an expected rate of 1.76 per million, amounting to a 30-fold and 32-fold increase respectively. The full results are shown in the table below and a selection are depicted in the chart above.

Sweden Suspends Use of Moderna Covid Vaccine in Under-30s Due to Concerns about Side Effects

Swedish health authorities have suspended the use of the Moderna Covid vaccine in people aged 30 and under due to concerns about side effects, including inflammation of the heart muscle. The Independent has the story.

The reason for the pausing is “signals of an increased risk of side effects such as inflammation of the heart muscle or the pericardium” – the double-walled sac containing the heart and the roots of the main vessels, Sweden’s Public Health Agency said in a statement. “The risk of being affected is very small.” 

Anders Tegnell, Sweden’s Chief Epidemiologist, said they “follow the situation closely and act quickly to ensure that vaccinations against Covid are always as safe as possible and at the same time provide effective protection” against the disease.

In July, the European Medicines Agency recommended authorising Moderna’s Covid vaccine for children ages 12 to 17, the first time the shot has been authorised for people under 18.

Moderna’s vaccine was given the green light for use in anyone 18 and over across the 27-nation European Union in January. It has also been licensed in countries including Britain, Canada and the U.S., but so far its use hasn’t been extended to children. To date, the Pfizer vaccine is the only one approved for children under 18 in Europe and North America.

Hundreds of millions of Moderna doses already have been administered to adults. In a study of more than 3,700 children ages 12 to 17, the vaccine triggered the same signs of immune protection, and no Covid diagnoses arose in the vaccinated group compared with four cases among those given dummy shots.

Sore arms, headache and fatigue were the most common side effects in the young vaccine recipients, the same ones as for adults.

U.S. and European regulators caution, however, that both the Moderna and Pfizer vaccines appear linked to a rare reaction in teenagers and young adults — chest pain and heart inflammation.

The Swedish health authorities said that the heart symptoms “usually go away on their own,” but they must be assessed by a doctor. The conditions are most common among young men, in connection with, for example, viral infections such as Covid. In 2019, approximately 300 people under the age of 30 were treated in hospital with myocarditis.

Data point to an increased incidence also in connection with vaccination against Covid, mainly in adolescents and young adults and mainly in boys and men.

Worth reading in full.

Third Man Dies in Connection To Contaminated Moderna Vaccine Doses in Japan

The suspension of over two and a half million doses of the Moderna Covid vaccine in Japan following the discovery of contaminants in a number of batches did not come soon enough, with yet another death having been reported after vaccination of a potentially dodgy dose. This time, a man approaching his 50s died just one day after receiving his second dose. The Guardian has the story.

The 49 year-old man had his second shot on August 11th and died the following day. His only known health issue was an allergy to buckwheat, the Health Ministry said on Monday. As with the previous two deaths, the ministry said it had yet to establish if the latest fatality was linked to the vaccine.

The shot came from one of the three batches that were part of a recall of 1.63 million doses of the Moderna vaccine on August 26th, but not from one of the batches found to have fragments of stainless steel in them. The three batches were manufactured in Spain under contract by Moderna.

The company said: “This is a tragic event, and the loss of life is something that we take very seriously. We offer our sincerest condolences to their loved ones.”

Last week Moderna issued a joint statement with local distributor Takeda Pharmaceutical, saying: “The rare presence of stainless steel particles in the Moderna Covid vaccine does not pose an undue risk to patient safety and it does not adversely affect the benefit/risk profile of the product.”

Early last month, two men in their 30s with no underlying health conditions died within days of getting their second dose of the Moderna vaccine.

Contaminants believed to be pieces of rubber fragments from vial stoppers that entered the vaccine liquid due to incorrectly inserted needles were found in Okinawa, Gunma and Kanagawa in late August and early September. No problems were reported among those injected with the contaminated vaccines, which came from different batches to the previously recalled ones.

Worth reading in full.

Another Million Doses of the Moderna Covid Vaccine Suspended in Japan Over Contamination Fears

The recent deaths of two Japanese men in their 30s after being given potentially dodgy doses of the Moderna Covid vaccine was not the end of Moderna’s troubles in the country, with another million doses having now been temporarily suspended following the discovery of contaminants in more batches. Reuters has the story.

The suspension of Moderna supplies, affecting more than 2.6 million does in total, comes as Japan battles its worst wave of Covid yet, driven by the contagious Delta variant, with new daily infections exceeding 25,000 this month for the first time amid a slow vaccine roll-out.

The latest reports of vaccine contamination came from Gunma prefecture near Tokyo and the southern prefecture of Okinawa, prompting the suspension on Sunday of two more lots in addition to the 1.63 million doses already pulled last week.

A tiny black substance was found in a Moderna vaccine vial in Gunma, an official from the prefecture said, while in Okinawa, black substances were spotted in syringes and a vial, and pink material was found in a different syringe.

Japan’s Health Ministry said some of the incidents may have been due needles being incorrectly inserted into vials, breaking off bits of the rubber stopper. Other vials from the lots can continue to be used, the ministry said on Monday.

The contamination cases followed a Government report on Saturday that two people died after receiving Moderna shots that were among lots later suspended.

The Government had said that no safety or efficacy issues had been identified and that the suspension was a precaution. The causes of death are being investigated.

“It is unlikely, in my opinion, that contamination of foreign substances led directly to sudden deaths,” said Takahiro Kinoshita, a Physician and Vice Chair of Cov-Navi, a vaccine information group.

“If the contaminated substances were dangerous enough to cause death for some people, probably many more people would have suffered from some symptoms after the vaccination.

“However, further investigations are definitely needed to evaluate the harm of the particular doses in question.”

Worth reading in full.