Category: Covid-19 Vaccine

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Excess deaths since pandemic need to be ‘thoroughly’ investigated: study – New York Post

June 12, 2024

US News

By Emily Crane

Published June 6, 2024, 7:27 a.m. ET

COVID vaccines could have contributed to excess deaths in the US and other Western countries in the three years since the pandemic took hold, according to a new study that argues that world leaders and policymakers need to thoroughly investigate the aftermath of the contagion.

Analyzing mortality data from 47 Western countries, scientists from the Netherlands Vrije Universiteit found that excess mortality has remained high since 2020 despite the widespread rollout of COVID vaccines and various containment measures.

The researchers said the trend raised serious concerns as they urged government leaders to thoroughly investigate the underlying causes of persistent excess mortality, according to the study published in BMJ Public Health.

Although COVID-19 vaccines were provided to guard civilians from suffering morbidity and mortality by the COVID-19 virus, suspected adverse events have been documented as well, the researchers wrote.

Both medical professionals and citizens have reported serious injuries and deaths following vaccination to various official databases in the Western World, they continued.

The study found there had been more than 3 million excess deaths across the US, Europe and Australia since 2020.

Of those excess deaths, more than 1 million occurred in 2020 at the height of the pandemic, according to the study.

Those figures, however, remained high in the following years, with 1.2 million in 2021 and 800,000 in 2022, researchers added.

The death toll figures include fatalities directly linked to the virus, as well as indirect effects of the health strategies to address the virus spread and infection. The researchers added that serious side effects of the vaccines had been documented, including ischemic strokes, acute coronary syndromes and brain hemorrhages.

While the study does not establish a link between COVID vaccinations and excess mortality, it argues that more research is needed in order to help better dictate future health policy.

Consensus is also lacking in the medical community regarding concerns that mRNA vaccines might cause more harm than initially forecasted Despite these concerns, clinical trial data required to further investigate these associations are not shared with the public. Autopsies to confirm actual death causes are seldom done, it noted.

Governments may be unable to release their death data with detailed stratification by cause, although this information could help indicate whether COVID-19 infection, indirect effects of containment measures, COVID-19 vaccines or other overlooked factors play an underpinning role, it added.

Meanwhile, various studies have shown that COVID-19 vaccinations saved millions of lives throughout the pandemic.

The shots are estimated to have saved 14 million lives worldwide within their first year alone, according to Science Feedback.

There are many possible explanations for the remaining excess deaths that were not directly caused by COVID-19; however, the evidence is clear that the vaccines saved millions of lives and they are not associated with excess deaths, the non-profit organization said of the study, noting that the researchers didnt analyze the impact of vaccination, nor did it examine the relationship between mortality and vaccination status.

Jeffrey S Morris, Professor of Public Health and Preventative Medicine at the University of Pennsylvania, questioned the study on X.

[T]his study does not accurately represent the existing understanding about sources of excess deaths, downplaying the COVID-19 deaths that are clearly the driving factor throughout 2020-2022, Morris wrote.

I am not sure why this article is classified as original research and not a narrative review or commentary. There is no primary data collection or original data analysis in this paper, he added.

More than 1.1 million Americans have died from COVID since the pandemic broke out, according to the US Centers for Disease Control and Prevention.

During the pandemic, it was emphasized by politicians and the media on a daily basis that every Covid-19 death mattered and every life deserved protection through containment measures and Covid-19 vaccines. In the aftermath of the pandemic, the same moral should apply, the Vrije Universiteit researchers wrote in the study.

Vrije Universiteit ranks 150th out of more than 20,000 universities globally, according to the Center for World University Rankings.

Editors Note: An earlier version of this article did not reflect that the study did not analyze the impact of vaccination nor establish a link between mortality and vaccination status.

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Excess deaths since pandemic need to be 'thoroughly' investigated: study - New York Post

Moderna’s combination Covid, flu vaccine is more effective than existing shots in late-stage trial – CNBC

June 12, 2024

Moderna plans to file for regulatory approval for its combination jab this summer in the U.S. and hopes it can enter the market in 2025, the company's CEO Stephane Bancel said in an interview.

Moderna, Pfizer and Novavax have said that combination shots will simplify how people can protect themselves against respiratory viruses that typically surge around the same time of the year. The added convenience is critical as fewer Americans roll up their sleeves to get vaccinated against Covid.

Bancel added that combination shots could reduce the burden of respiratory viruses on pharmacists and the broader U.S. health-care system, which has been grappling with a labor shortage that has many workers stretched thin.

Moderna's messenger RNA combination shot, called mRNA-1083, is made up of both the company's vaccine candidate for seasonal influenza and a newer, "next-generation" version of its Covid shot. Both of those experimental vaccines mRNA-1010 and mRNA-1283 have shown positive results in separate phase three trials.

The ongoing late-stage trial on mRNA-1083 examined the combination shot in 8,000 patients.

The study compared the combination shot with an enhanced flu vaccine called Fluzone HD and Moderna's currently licensed Covid shot, Spikevax, in one group of patients ages 65 and above. The trial also compared Moderna's combination jab with a standard flu shot called Fluarix and Spikevax in another group of participants between the ages of 50 and 64.

In both age groups, a single dose of Moderna's combination vaccine produced "statistically significantly higher" immune responses against three strains of influenza and the Covid omicron variant XBB.1.5.

Moderna said the safety of the combination shot, along with how well patients could tolerate it, was acceptable. The most common side effects were injection site pain, fatigue, muscle pain and headache. The majority of those effects were mild to moderate in severity.

Moderna is also developing a combination shot targeting the flu and RSV, and another vaccine targeting all three respiratory viruses: Covid, flu and RSV.

Meanwhile, Pfizer and BioNTech also are studying a vaccine that targets both Covid and the flu in a late-stage trial. Novavax is developing a combination for those viruses as well, but its Covid shot uses protein-based technology.

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Moderna's combination Covid, flu vaccine is more effective than existing shots in late-stage trial - CNBC

Updated COVID-19 Vaccines for Use in the United States Beginning in Fa – FDA.gov

June 10, 2024

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 5, 2024, to discuss and make recommendations on the selection of the 2024-2025 Formula for COVID-19 vaccines for use in the United States beginning in the fall of 2024.

The committee unanimously voted to recommend a monovalent JN.1-lineage vaccine composition. Following the vote, the committee discussed considerations for the selection of a specific JN.1 lineage SARS-CoV-2 strain (e.g., JN.1 or KP.2) and expressed a strong preference for JN.1.

During this meeting, the advisory committee was informed of the manufacturing timelines, and they reviewed the available data. These data included information on the circulation of SARS-CoV-2 virus variants, current vaccine effectiveness, human immunogenicity data of current vaccines against recently circulating virus variants, the antigenic characterization of circulating virus variants, animal immunogenicity data on new candidate vaccines expressing or containing updated spike components, and preliminary human immunogenicity data on JN.1 candidate vaccines.

Based on the totality of the evidence, FDA has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines for use in the United States beginning in fall 2024 should be monovalent JN.1 vaccines to more closely match currently circulating SARS-CoV-2 viruses.

FDA will continue to monitor the safety and effectiveness of the COVID-19 vaccines and the evolution of the SARS-CoV-2 virus.

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Updated COVID-19 Vaccines for Use in the United States Beginning in Fa - FDA.gov

Moderna flu/COVID beats immune responses for approved shots – Fierce Biotech

June 10, 2024

Modernas combo flu and COVID-19 vaccine zipped through a late-stage trial this winter, and the results are showing a higher immune response than licensed comparatorsincluding the famed biotechs own Spikevax.

MRNA-1083 is made up of Modernas flu shot mRNA-1010 and the next-generation COVID-19 vaccine mRNA-1283. Both components have individually shown efficacy in late-stage trials.

But together, Moderna hopes to create a product that can reduce the burden on patients and caregivers each season.

One of the things that we learned from the COVID experience is that there is a certain, let's say, fatigue to COVID-19 vaccine, and the difference between the vaccine coverage rates of influenza and COVID is quite substantial, Francesca Ceddia, M.D., Modernas chief medical affairs officer, said in an interview.

Moderna is hoping to offer a one-and-done shot that provides protection for both flu and COVID.

That is really a big advantage for not only pharmacists, but for health systems. And, of course, there is also a reduced burden in terms of cost for the hospitals, because if you're able to uplift vaccination rates because of the improved compliance, you are likely to prevent more hospitalization and other severe consequences due to COVID and influenza, Ceddia said.

These combo shots have become a central pillar of Modernas next act, as has the recently approved respiratory syncytial virus shot, which will be marketed as mRESVIA.

In the ongoing phase 3 trial, mRNA-1083 was tested in two groups of 4,000 adults each. One group featured adults 65 years or older and compared Modernas offering with co-administered Fluzone HD (Sanofi) and Spikevax. The second group had adults aged 50 to 64 years and compared mRNA-1083 to co-administered Fluarix (GSK) and Spikevax.

Across both groups, Modernas combo demonstrated noninferiority to the comparators and elicited statistically significantly higher immune responses against three influenza virus strainsH1N1, H3N2 and B/Victoriaand against SARS-CoV-2, Moderna said.

Ceddia said the COVID-19 portion of the combo showed higher responses because its an updated vaccine compared to Spikevax.

The fascinating thing is that we have developed a shorter version of the sequence of the mRNA which is currently available in the licensed vaccine, she said. The idea was to have a more stable version that could provide also better storage conditions.

That would mean mRNA-1083 could be made available at more locations without the complicated storage requirements that proved tricky in the early days of the pandemic. The combo can be stored in a refrigerator, Ceddia explained. The COVID-19 portion of the vaccine also has a lower dose than the approved shot.

Moderna also measured immunogenicity against the B/Yamagata flu strain, meeting noninferiority there as well. However, the World Health Organization has recommended that this strain not be included in vaccines for the 2024/25 flu season as it has disappeared from circulation.

Safety and tolerability for mRNA-1083 was acceptable, according to Moderna, with the majority of adverse reactions listed as grade 1 and 2 and consistent with the licensed products.

The combo vaccine advanced into phase 3 in fall 2023 after phase 1/2 data similarly showed thatmRNA-1083 matchedor beat two already approved shots for flu and the companys own Spikevax COVID shot in terms of developing antibody titers. Vaccine trials based on seasonal flu are quick to enroll, Ceddia said.

MRNA-1083 could soon become Modernas third marketed product, although Ceddia was mum on exactly what the next steps are beyond bringing the data to the FDA.

The approval of mRESVIA means Moderna is hard at work rolling out a shot. Ceddia sees that, plus Spikevax and eventually mRNA-1083, as a highly complementary portfolio for the marketing team to advance. It also marks Modernas move beyond being a one-trick COVID-19 company.

The beauty about the fact that they are all respiratory vaccines is that there is potential for a synergistic approach, she said. You're targeting the same stakeholders, you are targeting the same population. I see more potential for synergies than complexity.

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Moderna flu/COVID beats immune responses for approved shots - Fierce Biotech

A Combined Flu and COVID-19 Shot May Be Coming – TIME

June 10, 2024

As much as wed like to think that COVID-19 is behind us, the virus isnt going anywhere. Health officials continue to recommend that people get vaccinated for both COVID-19 and influenza every year for the foreseeable future, and high hospitalization rates for COVID-19 in the past winter were a reminder that SARS-CoV-2 can still cause serious disease.

Soon, that may be possible with one shot instead of two. On June 10, Moderna reported that its combination COVID-19/influenza shot generated even better immune responses against SARS-CoV-2 and influenza than those elicited by existing, separate vaccines.

Both of the shots used in the study are experimental. The COVID-19 portion relies on a slightly different form of SARS-CoV-2s spike protein than the existing vaccine. Instead of encoding for the entire spike protein, the combination vaccine includes two key parts of it in a way that streamlines the shot to require a lower dosewhich is useful for a combination vaccine, and also potentially extends its shelf life. The influenza component of the vaccine uses the same mRNA technology behind the existing COVID-19 vaccine but targets influenza proteins in the three strains that circulated during the past season: H1N1 and H3N2 from the influenza A group, and an influenza B strain.

Read More: An mRNA Melanoma Vaccine Shows Promise

In a study of more than 8,000 adults ages 50 and older, about half received the combination vaccine. The other halfthe control groupreceived two separate shots: Moderna's latest COVID-19 vaccine, which targets the XBB.1.5 variant, and a flu shot (either Fluarix, if people were 50 to 64 years old, or Fluzone HD for those 65 and older).

In the younger group, the combo vaccine generated about 20% to 40% higher levels of antibodies to the influenza strains, and 30% higher levels to XBB.1.5, compared to the control group. Among older people, antibodies were 6% to 15% higher against the flu strains and 64% higher against XBB.1.5 compared to older people in the control group.

The real advantage of a single shot is that people only need to get one needle," says Dr. Jacqueline Miller, senior vice president and head of development in infectious diseases at Moderna. There's a public-health advantage, too, she says, since U.S. vaccination rates for both diseases are relatively low. "When we are able to give the two vaccines as one, it could increase vaccine compliance rates, especially for those at highest risk."

Read More: How to Navigate the New World of At-Home Testing

Moderna is continuing to study the COVID-19 vaccine and the flu shot used in the combo as separate shots as well. That data will also help the U.S. Food and Drug Administration (FDA) when it reviews the companys request for approval of the combination shot, which could come by the end of the year. The specific strains targeted in the shot will depend on which forms of the viruses are circulating at the time. (The company also filed a request to the FDA on June 7 to update its COVID-19 vaccine to target the JN.1 variant.)

The combination vaccine will likely not arrive in time for the flu and COVID-19 season this fall. But in coming years, a two-in-one vaccine could help to increase vaccination rates, which in turn could contribute to lower hospitalization rates for both diseases.

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A Combined Flu and COVID-19 Shot May Be Coming - TIME

Moderna combi flu and Covid jab gives better protection, study finds – The Guardian

June 10, 2024

Vaccines and immunisation

Clinical trials show two-in-one jab may bring about higher immune responses than separate inoculations

Mon 10 Jun 2024 10.14 EDT

A combined flu and coronavirus vaccine brings about a higher immune response to both diseases than when the vaccines are administered separately, a clinical trial has shown.

Moderna, the biotech firm behind the Spikevax vaccine used in NHS booster programmes, is trialling a two-in-one jab that can also protect from the flu. Initial results have shown it may be better at protecting against them than what is now being used.

The results showed that the antibody response in the participants brought about higher immune responses against flu and Covid-19 than when the vaccines were administered separately.

The company said they hoped the vaccine would be made widely available as early as next year.

The results came from a randomised controlled phase 3 trial of 8,000 people split into two groups.

The first group were aged 65 and over, and were testing the new jab in comparison with the flu vaccine and the Spikevax jab, while the second group were adults aged 50 to 64.

Stphane Bancel, the chief executive of Moderna, said: Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses.

He added: Moderna is the only company with a positive phase 3 flu and Covid combination vaccine. Building on the momentum of positive phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health.

Earlier this year, Boots said the retailer would offer the Pfizer-BioNTech vaccine to healthy customers in England aged 12 and over from next week, at a cost of 98.95 a jab.

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Moderna combi flu and Covid jab gives better protection, study finds - The Guardian

Spikeopathy Speculative Fiction Contaminates the Blood Supply | Office for Science and Society – Office for Science and Society

June 10, 2024

We have to talk about the word spikeopathy, not to be confused with psychopathy.

Our office recently celebrated its 25thanniversary25 years of, among other things, separating sense from nonsense on scientific matters. I would argue that our work is harder now than it has ever been: as the dance of science becomes ever more convoluted, pseudoscience follows in its footsteps, imitating its complexity and looking more and more convincing.

When a panic-inducing claim is made about a serious topic, like the COVID-19 vaccines, some will be reassured when an expert they trust simply tells them not to worry. Others, however, find the evidence for the claim so detailed and academic-looking that, even if they do not understand it, they require a deeper debunk. As Brandolinis law states, the amount of energy (and the number of words, I would add) required to refute nonsense is an order of magnitude bigger than was needed to produce it. Defecating on a pasture is easy; shoveling it out of there is a slog.

You may have heard from unscrupulous sources that our blood supply is now contaminated by the blood of the vaccinated, that the spike protein encoded by the COVID-19 vaccines is dangerous on its own and could now make the unvaccinated ill through transfusions. A prominent anti-vaxxer, the American Del Bigtree, even flew to Mexico to get a transfusion ofunvaccinated bloodfollowing a substantial blood loss from hemorrhoids.

As we slide down this rabbit hole, you will see why scientists have had to write multiple 10,000-word refutations on this subject. Those of us trying to fairly explain our understanding of the science of vaccines are at a major disadvantage: we cant simply make stuff up.

I am indebted to the work of medical doctors and scientists likeDavid Gorski,Ed NirenbergandDan Wilson, who regularly tackle bad COVID studies and perform their extensive pre-mortem autopsies. Its messy work. I will try to clean it up and summarize.

The tainted blood supply claim recently resurfaced thanks toa Japanese pre-print, meaning a scientific manuscript that has yet to be reviewed by other scientists. It paints a horrifying picture of studies apparently showing that the spike proteinitself, divorced from the coronavirus, stays in the body and takes on weird shapes that are infectious much like the prions of mad cow disease. The alleged disease caused by the spike protein has been called spikeopathy. And now the blood of vaccinated people has infected blood banks. The twist is that these fears arent voiced by an inmate in a madhouse; they come with citations to actual scientific papers, making them appear credible.

Lets look at the claim that the spike protein from the vaccine stays in the body for weeks, if not months. You will remember that the COVID vaccines contain molecular instructions, in the form of messenger RNA (mRNA) for the Pfizer and Moderna vaccines, for our bodies to make the coronavirus spike protein, which adorns the virus like a crown and helps it bind to the cells lining our airway. These instructions are read by some of our cells, the spike protein is made, and our immune system learns to recognize it in case it encounters it in the wild.

Anti-vaxxers claim this process, which was only supposed to last a few days, goes on for much longer in the body. We were lied to, they say. Onestudy, coming out of Harvard and the Universit de Montral, reported seeing the spike proteinin the bloodof 11 people who had been vaccinated, and the spike protein was not even supposed to end up in the blood but to stay inside of immune cells. How much of this spike protein was detected? A fewtrillionths of a gramper millilitre of blood, almost nothing, because the authors used a highly sensitive method and they managed to detect a signal at the edge of the assays limit. It is likely that some of the immune cells now displaying the spike proteina desirable thing for vaccines to workwerekilled by other cells or simply died, and these bits and parts of dead cells were picked up by this incredibly sensitive test. This is similar to apaperfrom Italy and the United Kingdom in whichfragmentsof the spike protein were found in the blood of vaccinated people up to 187 days post-vaccination. We have become the victims of our laboratory-enhanced eyes: we can now detect parts per quadrillion of chemicals, traces of traces. Its not far from spotting a single grain of rice on a beach and thinking the sand is getting contaminated.

When its not the spike protein itself that is seen, its the mRNA coding for it. ADanish studyshowed that this mRNA molecule could be found in the blood up to a month after receiving either the Pfizer or Moderna vaccine. But what the researchers found weeks after vaccination were, again,smallfragmentsof the mRNA, which cannot result in the production of the spike protein, like how a few lines from a recipe book arent enough to produce a cake. None of these findings are alarming once we contextualize them.

But can the spike protein make us sick divorced from the rest of the coronavirus?

The RNA instructions we get from the vaccines to make the spike protein are different from the ones found in the coronavirus. The RNA molecule is a string of bases, so-called letters, like beads on a string, and some of these bases have been modified for the vaccine through a process known as methylpseudouridylation. Without it, the RNA in the vaccines would have been recognized as foreign by our body and immediately destroyed, causing a bad immune reaction in the process. The vaccines would have failed. Scientists, knowing this, made these alterations so the RNA would be treated the same as human-made RNAs and would remain in cells long enough to be translated into the spike protein.

But panic erupted in anti-vaccine circles when it was discovered that this alteration meant the spike protein may not always be produced correctly. Rather, it was shown that the protein-producing apparatus wouldslipon this altered RNA molecule and read it differently. This is known as a frameshift. RNA is read three bases at a time and each triplet corresponds to a specific building block in the nascent protein. Imagine the phrase BAD JAB, where each triplet forms a word. If you slip and miss the initial B, you end up with ADJ AB, which is meaningless. Methylpseudouridylated RNA can slip in this way and produce nonsensical proteins. Could these nonsensical proteins, let loose in our cells, harm us?

We actually know, from using an artificial construct based on the vaccine mRNA, that these nonsensical proteins are much fewer in numbers compared to the actual spike protein (see the starred bands in figure 1E ofthis paper), and we also know from looking at the proteins made when we expose the Pfizer vaccine to the molecules in our cells that translate it into a protein thatonly the expected spike protein is easily detected. Anomalous versions of it, if they are there, are often too rare to be seen. Our bodies have already evolved to deal with the occasional wrong protein, so this is unlikely to be an issue.

Anti-vaxxers will tell you that frameshifting mutations can causesome diseases(many of which canalsobe caused by other types of mutations, by the way). But there is a vital difference here. In the case of the disease, the DNA itself has the frameshift mutation. The correct protein cannot be made from that bit of DNA. In the case of the COVID vaccines, frameshiftcanhappen occasionally, but it is not baked into the molecule and the correct spike protein is almost always produced in the end.

All of these individual claims are now routinely packaged into narrative reviews, often written by anti-vaccine celebrities like computer scientist Stephanie Seneff and ivermectin guru Peter McCullough, that scare the reader with speculative and decontextualized findings like these and that benefit from getting published in academic journals. These papers sneakily take findings in the coronavirus itself and the disease that it causes and speculate that it must also apply to the vaccine, as if our understanding of the damage the influenzaviruscan do was relevant to the safety of the fluvaccine. One suchinfamous reviewcontains 29 instances of the word potential or potentially and another 29 occurrences of could outside of its bibliography. With this much imaginary obsession over the spike protein, its no longer speculation; its spikulation.

One of these bits of spikulation is that the spike protein itself behaves like a prion. You may remember the scare over mad cow disease. Prion-based diseases are peculiar: they are caused by misshapen proteins whose altered shape is infectious. They corrupt our own version of the same protein and can cause nasty, degenerative conditions like Creutzfeldt-Jakob disease. But calling the spike protein a prion is a stretch: its because looking at the proteins sequence, scientists foundregions that are commonly found in prions. This is not evenin vitrowork; this isin silicostuff, done on the computer. This is then combined with areportthat 26 people were diagnosed with a prion disease within weeks of receiving a COVID vaccine. These oddities get repackaged in review articles to sound the alarm about mass harm.

So how do these fantastical, pseudoscientific review articles even get published in the first place? When the one with 29 uses of the word potential was published in the journalFood and Chemical Toxicology(the one which, appropriately enough, had publishedthe infamous Seralini studywrongfully linking GMOs and the commercial pesticide Roundup to cancer in rats, before retracting it), an emeritus professor in oncology wrote to the editor-in-chief, calling the paper amilitant, agitational tract.The editor did not take the paper down; in fact, you canstill read ittwo years after its publication. Through either naivet or kinship, some journal editors actually let anti-vaccine crusaders publish their sloppy work. Much of it gets published in journals that look predatory, with a quick turnaround time and little scrutiny. Then there is the impressive-soundingInternational Journal of Vaccine Theory, Practice, and Research, which appears to be a journal recently set up specifically to launder COVID-19 anti-vaccine speculation. Its editor-in-chief hasa doctorate in general linguistics, and associate editors include noted anti-vaxxers like Seneff and Brian Hooker.

The Japanese preprint about the tainted blood supply is similarly speculative and alarmist. It calls for the suspension of the vaccination campaign against COVID, using the same repackaged half-truths and fictions that so many other anti-vaccine review articles spew. One of its authors, Masanori Fukushima, hasalready publishedwith Seneff and McCullough.

But if the mRNA vaccines were so dangerous, inoculating us with a prion protein comparable to what we see in mad cow disease, we would know by now. The intense scrutiny these vaccines are under resulted in the detection of a one-in-a-million blood clot risk with the Johnson&Johnson vaccine six weeks after it started to be widely distributed. Anti-vaxxers will thenturn to the VAERS websiteand other databases dedicated to the reporting of illness following vaccination as proof of harm, but they refuse to understand how these databases work to protect the public. Just because I get a headache the day after receiving a vaccine does not mean the vaccine gave me the headache. We have to look at how common headaches are in general and see if there has been an increase. The same goes for prion diseases.

The COVID vaccines, administeredover 13 billion times, are really, really safe. Amassive reviewlooking at 41 randomized controlled trials of 12 different COVID-19 vaccines on a total of nearly half a million participants concluded that there was probably little to no difference between most vaccines and placebos when it came to serious side effects. Yes, rare serious side effects do happen, and scientists are trying to figure out why, with their early clues misused by anti-vaccine activists to paint these vaccines as genocidal. But if the spike protein encoded by these vaccines was so deadly, you would not survive receiving 217 of these injections. Yet a German man did. Why? Thearticlereporting on this oddity mentions private reasons, but his immune system was fine and he did not die.

I wouldnt worry if he offered to donate some of his blood.

Take-home message: - The claim that the spike protein or its messenger RNA can be detected for weeks or months after vaccination is based on studies where fragments were barely detectable, often trillionths of a gram, which is in keeping with our understanding of biology - The fears around the wrong protein being made because the vaccine RNA has been modified is not backed up by the evidence, which shows that those wrong proteins are few and far in between and are likely destroyed by the cell like most malformed proteins we naturally produce - The idea that the spike protein would behave like a prion and cause disease is not based on laboratory studies in cells and animals, but rather on computer analyses of its sequence - Over 13 billion doses of the COVID-19 vaccines have been administered, with robust data showing they are overwhelmingly safe

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Spikeopathy Speculative Fiction Contaminates the Blood Supply | Office for Science and Society - Office for Science and Society

Moderna COVID-flu vaccine combo beats existing shots in trial – Quartz

June 10, 2024

The experimental combo shot could also assist Moderna offset declining demand for COVID-19 vaccines caption Image: Dado Ruvic (Reuters )

Moderna said on Monday that its experimental combination vaccines against COVID-19 and the flu produced a higher immune response than existing, standalone vaccines in a late-stage trial.

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The combo shot could become the companys third product on the market, after the U.S. Food and Drug Administration (FDA) in May approved Modernas mRNA-based respiratory syncytial virus (RSV) vaccine for people 60 and older.

It could also help Moderna offset declining demand for COVID-19 vaccines.

Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses, said Moderna CEO Stphane Bancel in a statement. Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine.

Modernas experimental mRNA-1083 is made of up the companys flu vaccine candidate and its next-gen COVID-19 shot, Spikevax.

The combo vaccine is being tested in an ongoing phase 3 trial involving 8,000 people 50 and older.

In half the group, the shot was compared with patients receiving Modernas Spikevax and GSKs flu shot Fluarix. In the other half, the shot was compared with patients receiving Spikevax and Sanofis Fluzone HD, a high-dose flu shot for older people.

In both groups, mRNA-1083 produced a statistically significantly higher immune responses against three strains of the flu (H1N1, H3N2, and B/Victoria) and COVID-19. The shot was also found to be safe, with most common side effects being injection site pain, fatigue, myalgia and headaches.

Pfizer and Novovax are also developing their own combo vaccines.

Additionally, Moderna is testing a combo shot that would protect from COVID, RSV and the flu.

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Moderna COVID-flu vaccine combo beats existing shots in trial - Quartz

Moderna files application for review of updated Covid-19 vaccine – Pharmaceutical Technology

June 10, 2024

Moderna has filed an application with the US Food and Drug Administration (FDA) to review its updated Spikevax formula, designed to combat the SARS-CoV-2 variant JN.1, for the 2024 to 2025 season.

The move follows guidance from the FDA recommending an update to Covid-19 vaccines to include the monovalent JN.1 composition.

The recommendation was unanimously supported by the Vaccines and Related Biological Products Advisory Committee during a meeting held on 5 June 2024.

It aligns with theguidance from the World Health Organization Technical Advisory Group on Covid-19 Vaccine Composition and the European Medicines Agencys Emergency Task Force on the use of Covid-19 vaccines targeting the JN.1 variant.

The most common local adverse event linked to the updated Covid-19 vaccine of Moderna was pain at the injection site.

Systemic adverse events reported include headache, fatigue, myalgia and chills.

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These findings are critical as Moderna aims to secure global regulatory approval and supply the vaccine in time for the next vaccination season.

While the updated Spikevax vaccine for the 2024 to 2025 season is under review, the current 2023 to 2024 formula has been authorised for emergency use in individuals aged six months to 11 years.

The Spikevax vaccine is indicated for active immunisation against Covid-19 in individuals aged 12 years and above.

Moderna CEO Stphane Bancel stated: For four years, Moderna has consistently delivered vaccines that offer protection against Covid-19, and work is well underway to provide a vaccine targeting JN.1.

Staying up to date with your Covid-19 vaccine remains one of the best ways to protect yourself during the upcoming respiratory illness season.

The latest submission comes on the heels of Modernas recent success in securing FDA approval for its mRNA-based respiratory syncytial virus (RSV) vaccine, mRESVIA, for adults aged 60 and above.

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Moderna files application for review of updated Covid-19 vaccine - Pharmaceutical Technology

Quick takes: US COVID-19 levels, H5N1 in cows, polio in 3 nations – University of Minnesota Twin Cities

June 10, 2024

NIAID

Astudy in Texas found higher rates of antimicrobial-resistant (AMR) organisms in areas with higher levels of economic deprivation, researchers reported today in Clinical Infectious Diseases.

Using electronic health records from two large healthcare systems in the Dallas-Fort Worth metropolitan area, a team led by researchers from the University of Texas Southwestern Medical Center collected select patient bacterial culture results from 2015 to 2020. They chose five AMR organisms to represent potential community- and healthcare-associated acquisition, used residential addresses to geocode cultures and link them to socioeconomic index values, and identified geographic clusters of high and low AMR organism prevalence.

Among the 43,677 unique cultures collected, 43.5% were identified as methicillin-resistant Staphylococcus aureus (MRSA), 31% as extended-spectrum beta-lactamase (ESBL)producing organisms, 11.3% as carbapenem-resistant Enterobacterales, 8.2% as vancomycin-resistant Enterococcus, and 5.9% as AmpC beta-lactamase producers. Significant clusters of all five organisms were found in areas with high levels of economic deprivation, as measured by the area deprivation index (ADI), and there was significant spatial autocorrelation between ADI and AMR prevalence.

The strongest correlation was observed for MRSA and AmpC, with 14% and 13%, respectively, of the variability in prevalence rates attributed to their relationship with the ADI values of the neighboring locations.

The study authors say several factors could explain why AMR organisms are more prevalent in areas with greater socioeconomic disparities. For example, people in areas with higher ADI may have poorer sanitation due to utility disruptions or poor plumbing and therefore be more likely to be exposed to bacteria, or may live in overcrowded settings that can contribute to the spread of infection. The practice of sharing "leftover" antibiotics with friends and family could also select for resistant organisms.

While further research is needed to delineate the relationship, they say the findings highlight the importance of addressing these disparities.

"This finding that ADI is associated with higher prevalence of AMR supports the need for tailored, local interventions for small neighborhoods including social programs that increase access to health insurance, along with public health campaigns discussing proper hygiene techniques to prevent the spread of disease within a household," they wrote.

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Quick takes: US COVID-19 levels, H5N1 in cows, polio in 3 nations - University of Minnesota Twin Cities

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