A new CDC-funded study confirms increased risk of heart problems in young men.
A new large, multi-country study has confirmed what previous smaller studies found: Covid-19 vaccines have risks. In particular, the messenger RNA (mRNA) vaccines from Pfizer and Moderna were associated with increased risk of heart problems for males under 40, and the viral vector vaccine from Astra Zeneca was associated with a significant increase in neurological and hematologic problems. This information ought to be used to update U.S. vaccination recommendations, particularly for young people who have little risk of severe Covid-19 disease or death.
Covid vaccines reduce the diseases severity and risk of death and provide partial, short term measured in a few months protection against infection. But those benefits are less important for groups with a low baseline risk, and they must be balanced against the risks associated with vaccination.
The new study, conducted by the CDC-funded Global Covid Vaccine Safety Project, evaluated the risk of adverse events from the three original Covid-19 vaccines with the highest numbers of doses administered in 99 million vaccinated individuals across eight developed countries Argentina, Australia, Canada, Denmark, Finland, France, New Zealand, and Scotland between December 2020 and August 2023. It calculated observed versus expected ratios for 13 different conditions that previous studies had indicated might be increased following Covid-19 vaccinations.
The study found multiple statistically significant associations among the vaccines and various adverse events. The researchers then applied strict statistical criteria beyond the usual standard of statistical significance to select which of the associations had the highest likelihood of being true, what the authors termed a prioritised safety signal.
The two mRNA vaccines met the prioritized-safety-signal criteria for increased risk of myocarditis (inflammation of the heart muscle) following first, second, or third doses. Both vaccines were statistically associated with an increased risk of pericarditis (inflammation of the sac surrounding the heart), although only the Moderna vaccine met the prioritized-safety-signal criteria.
The Astra Zeneca vaccine was associated with various neurological conditions. But only Guillain-Barr syndrome where a persons immune system attacks their nerves, resulting in tingling, muscle weakness, and sometimes paralysis that usually (but not always) resolves over several weeks met the prioritized-safety-signal criteria. A prioritized safety signal was also found for the Astra Zeneca vaccine and the hematologic condition called cerebral venous sinus thrombosis formation of a blood clot in the brains venous sinuses that prevents blood from draining out of the brain and sometimes leads to a hemorrhage into the brain.
The association of Astra Zenecas viral vector vaccine and neurological and hematologic conditions is of limited significance to the U.S. because Astra Zenecas vaccine was not used in this country. The Johnson & Johnson Covid-19 vaccine was a viral-vector vaccine approved and used here. However, it only accounted for about 3 percent of the vaccines approved in 202021 and administered in the U.S. against the original viral variant; it has been discontinued. The mRNA vaccines from Pfizer (59 percent) and Moderna (38 percent) accounted for nearly all the vaccines administered against the original variant.
The studys confirmation of previous publications finding an association of the two mRNA vaccines with heart problems is important for informing the debate about recommending vaccines in younger people, where the risk/reward balance appears to be different than for older people. The U.S. has moved on from vaccines against the original Covid-19 viral strain. However, the vaccines against newer strains are nearly all made with the same mRNA technology. And while the CDC acknowledges a causal association between mRNA COVID-19 vaccines. . . and myocarditis and pericarditis, it continues to recommend vaccination for everyone six months and older.
The increased risk of cardiac events associated with the two mRNA vaccines is concentrated in younger people, primarily adolescent and young adult males. The U.S. Vaccine Adverse Event Reporting System (VAERS) found cases of post-mRNA vaccination myocarditis were predominantly in young men (82 percent) with the highest risk in males aged 16 to 17 years, followed by males aged 12 to 15 years, and young men aged 18 to 24 years. Cases in individuals of either sex above age 40 were extraordinarily rare.
The cardiac risk to younger people must be balanced against the extremely low risk this group has from Covid-19. From January 1, 2020, to December 21, 2023, children under 17 accounted for less than two-tenths of 1 percent of U.S. Covid-19 deaths. The 1829 age group accounted for just 0.6 percent of Covid deaths. Covid-19 hospitalization rates for younger people have also been a tiny fraction of rates for older people.
Some have justified the recommendations to vaccinate younger people by claiming the risk of myocarditis is greater following Covid-19 infection than after Covid-19 vaccination.But the relevant studies suffer from various flaws. For example, one widely cited systemic review and meta-analysis from Penn State University concluded that the risk of developing myocarditis is seven times higher with a Covid-19 infection than with the Covid-19 vaccine. But the median age of subjects was 49 years old, far above the age of those most likely to have vaccine-related adverse reactions. And the study reviewed findings with all types of vaccines, not just the mRNA vaccines that are most closely associated with myocarditis and that are the predominant vaccine type in the U.S.
An English study is similarly cited often to show that the risk from infection outweighs the risk from the vaccine. It too studied almost all ages (13 and up) and vaccine types. But when the researchers looked at males under 40, they found the risk as measured by excess cardiac events per million vaccinated with a first dose of Moderna or a second dose of Pfizer were roughly equal to the excess cardiac events per million infected. And the excess events per million vaccinated following a second Moderna dose were about six times the excess events per million infected. Even though women appear to be at far less cardiac risk than men, the researchers found the excess events per million after a second Moderna dose in women under 40 was about equal to the excess events per million infected.
Importantly, these studies comparing post-vaccine and post-infection rates never acknowledge that their ratios are conditional on certain events taking place, i.e., receiving a vaccine or becoming infected. If the recommendation is that everyone six months or above be vaccinated, then everyone will be subjected to the risk of myocarditis and pericarditis. But not every unvaccinated person will be infected and exposed to cardiac risks.
The best method of assessing what percentage of people were infected is serological studies to detect specific antibodies against SARS-CoV-2, the virus that causes Covid-19.Antibodies against the nucleocapsid-protein, as opposed to different antibodies resulting from vaccination, signify previous infection.
A CDC seroprevalence study in the United States showed variance across different regions, but in nearly all jurisdictions, less than 10 percent of people in the U.S. had antibody evidence of previous SARS-CoV-2 infection through September 2020 the first year of the pandemic when there was no vaccine. A seroprevalence study in Germany over January-November 2020 found just 1.7 percent of residents were infected. A later study with repeated samplings over time found infection-induced SARS-CoV-2 seroprevalence in the U.S. increased from 8.0 percent in November 2020 to 58.2 percent in February 2022, likely reflecting the emergence of the new, more transmissible Delta and Omicron viral variants. Still, after three years of pandemic (January 2020 to December 2022), one in four Americans ages 16 and above had not yet been infected.
Covid-19 vaccines are being promoted for annual administration, hence the myocarditis risk from vaccines should be compared to the risk of being infected over a year. This annual infection percentage will vary depending on the transmissibility of the particular variant then circulating. The studies discussed above suggest this could range from 10 percent, as in the first pandemic year, up to about a 50 percent infection rate in years with particularly transmissible variants. In other words, somewhere between one in ten and one in two people will be subject to the myocarditis and pericarditis risks associated with infection in a given year.
If half of unvaccinated people would be infected over a year, the post-infection myocarditis rate would have to be more than twice the post-vaccination rate to justify recommending that all people (including younger people) be vaccinated. And if only one in ten people would be infected, the post-infection myocarditis rate would have to be ten times the post-vaccine rate. Yet we know from the English study cited above that for woman and especially men under 40, the myocarditis risks from the mRNA vaccines are equal to or higher than the risk after infection.
This new study confirms that the CDC should revise its Covid-19 vaccine guidelines. The children at highest Covid-19 infection risk are newborns, for whom vaccines are neither approved nor recommended. Vaccination recommendation for those aged six months to 18 should be limited to the subpopulation within this age group that is most at risk, such as children with chronic medical conditions (such as Type 1 diabetes, obesity, and cardiac and circulatory congenital anomalies) who are far more likelythan otherwise healthy children to experience severe Covid-19 illness, hospitalization, and death.And CDC should advise particular caution before using the mRNA vaccines in adolescent and young men who are most susceptible to post-vaccination cardiac events. Ultimately, all patients, but especially those with complex medical histories, should consult their physicians to balance the risks and benefits of Covid vaccination.
Much of the world hasdecidedthat healthy young people do not need Covid-19 vaccinations, that the costs outweigh the benefits. The time has come for the U.S. to reach the same conclusion.
City health officials say New York Citys child vaccination rates still arent up to pre-pandemic levels reflecting public health officials struggles with outreach, even as some states grapple with measles outbreaks.
The city has recorded two measles cases so far this year, although both were travel-related and not due to local transmission, the city health department told Gothamist on Thursday.
Department spokesperson Patrick Gallahue said a few measles cases a year isnt unusual, but there were none in the city from 2020 through 2022, which he attributed to limited travel during the pandemic. There was one reported case in 2023.
Nationally, cases are on the rise this year. There have been 35 reported cases of measles across the United States from Jan. 1 through Feb. 22, compared with 58 cases during all of last year, according to the Centers for Disease Control and Prevention. This years cases include an outbreak of nine cases over six weeks in Philadelphia and at least one case in South Jersey.
As of this week, 95.3% of students in K-12 public and charter schools throughout New York City are up to date with all vaccine requirements, compared with 98.5% before the COVID-19 pandemic, testified Dr. Celia Quinn, the city's deputy commissioner for disease control, at a City Council hearing on childhood vaccination rates on Thursday afternoon.
We are working closely with New York City public schools, providers and parents to bring up that number even further to ensure students and schools remain safe, Quinn said.
Quinn said immunization rates are down between 2 and 16 percentage points from 2019, depending on vaccine type and age group. She noted that 4- to- 6-year-olds, who were infants or toddlers during the pandemic's height, have to play catchup.
Vaccination rates dropped during the first years of the pandemic partly because many parents put off routine doctors visits, leading small children to fall behind on their vaccine schedules, Quinn said. The CDC recommends that children get about 10 different vaccines some of which require multiple doses on different schedules before the age of 2.
Quinn also cited other factors for the decline in vaccination rates. Certainly, we have seen a lot of vaccine misinformation and disinformation and that accelerated during the pandemic, she said. I also think that there are definite access issues and various barriers to people prioritizing getting all of the vaccines on the recommended schedule.
She noted that the city doesnt track vaccination by immigration status but said the city health department is working to make sure new arrivals know how to get vaccinated for instance, by informing families about community health centers where kids can get the shots.
City shelters for recent arrivals have also provided vaccination onsite to ensure school-aged children are up to date. Still, workers with one company hired to provide those shots, Affiliated Physicians, reported some early mix-ups with vaccine records, among other errors, last year.
During the hearing, some councilmembers suggested that the city should send out more direct reminders to families to get young children vaccinated. Quinn said that effort is largely up to their primary care providers, but noted the health department works closely with the city education department to make sure families are informed about vaccine requirements. She added that children are forced to stay home if they fall out of compliance.
When it comes to measles, Quinn said, a 95% vaccination rate is sufficient for herd immunity. But wherever there are pockets of lower vaccine coverage, the risk of an outbreak is going to increase depending on how low that coverage gets," she said.
There were 649 confirmed measles cases during a particularly bad outbreak in the city between 2018 and 2019, according to a study in the New England Journal of Medicine. Most of those affected were members of the Orthodox Jewish community. Among those whose vaccination history was known, about 85% were unvaccinated, according to the study.
Children are supposed to get their first MMR shot short for measles, mumps and rubella between 12 and 15 months of age, and their second shot by the age of 6, per the CDC. The city health department said 97.3% of local children had received both doses during the 2022-2023 school year.
Former New York Gov. Andrew Cuomo eliminated any religious exemption for vaccination for students amid the measles outbreak in 2019. Fewer than .01% of schoolchildren currently have an approved medical exemption, Quinn said.
CLAIM
No childhood vaccine has ever been through a double blind placebo controlled trial.
DETAILS
Factually inaccurate: There are several blinded, placebo-controlled randomized trials for vaccines that appear in the childhood vaccine schedules of many countries, like the U.S. and Canada. Such trials have been conducted for the vaccines against measles, polio, flu, pneumococcus, human papillomavirus and more.
KEY TAKE AWAY
Randomized controlled trials are commonly held up as the gold standard for determining the safety and efficacy of a medical intervention, like a vaccine or a drug. Saline placebo-controlled trials are sometimes used to test a new vaccine, but such trials arent always practical or ethical to do. For instance, when testing a new vaccine against a disease for which there are existing, effective vaccines, such a trial would leave the placebo group unprotected from the disease. In such cases, it is considered acceptable to compare the new vaccine with an existing one.
Its important to be aware that this claim commonly goes hand in hand considering only saline solution (a solution of salt and water) as a valid placebo, rather than a solution of vaccine adjuvant without the active ingredient. The basis for this belief is that only saline has no effect on living beings, per the definition of a placebo. This is incorrect, as pediatrician Paul Offit pointed out in this article.
In any event, this provides those opposed to vaccination with a justification for ignoring existing studies on vaccine safety that didnt use a saline placebo. It also enables them to undermine confidence in vaccine safety, by implying that the true safety of childhood vaccines has never been properly evaluated.
There are circumstances in which using a saline placebo isnt the ideal choice for a vaccine trial, which this review will delve into later. That said, the claim is inaccurate. As we will show, there are actually numerous childhood vaccine trials that compared the vaccine to a saline placebo.
Double-blind, placebo-controlled randomized trials are commonly considered the gold standard for determining whether a medical intervention, like a vaccine or a drug, is safe and effective.
Double-blind means that neither the researchers nor the trial participants know whether they received the placebo or the treatment. This is done because the knowledge that one group or another received the treatment may influence the way researchers interpret the results and the way that participants behave.
Placebo-controlled means that the trial includes a group that doesnt receive the treatment being tested. Instead, this group may receive an injection of saline or a formulation of the tested intervention that lacks the active ingredient. This helps to reduce the influence of the placebo effect on the trial. If the placebo group and the treatment group both show the same outcome, then the treatment is considered to be ineffective.
Randomized means that participants in the trial are assigned to the placebo or treatment group in a random manner. This helps to reduce differences between the two groups, such as age, sex, and state of health, that could potentially influence the effect being observed. This way, any effect observed can be more reliably attributed to the treatment given, rather than differences between the groups characteristics.
The Instagram post didnt specify which childhood vaccine schedule it was referring to, but childhood vaccine schedules across the world generally tend to include many of the same vaccines. Some of these are the measles, mumps and rubella vaccine, the polio vaccine, and the flu vaccine. However, differences in the age at which a vaccine is given, the vaccine manufacturers, and the number of doses do exist from country to country.
For readers interested in comparing childhood vaccine schedules in different countries, the World Health Organization offers a tool to do so.
Dan Freedman, a pediatric neurologist at UT Health Austin, refuted the claim in a Twitter thread from 2019. He pointed to several blinded, saline placebo-controlled trials for various childhood vaccines, such as measles, polio, flu, pneumococcus, and human papillomavirus (HPV)[1-8]. None of the trials detected health problems associated with the tested vaccines.
And a search on PubMed, a repository of studies in health and medicine that is maintained by the U.S. Library of Medicine, will also turn up multiple studies showing that several vaccines on the childhood vaccination schedule have indeed been tested in double-blind, saline placebo-controlled randomized trials.
In summary, the claim that there are no blinded, saline placebo-controlled randomized trials for childhood vaccines is inaccurate.
Those opposed to vaccines sometimes change tack, asking why there exists no double-blind, saline placebo-controlled trial for the entire childhood vaccine schedule.
In a 2013 review of the U.S. childhood vaccination schedule, the U.S. Institute of Medicine had considered the feasibility of conducting such a trial. But they concluded that it would not only be unfeasible but highly unethical[9].
Firstly, this would consign unvaccinated children to an elevated risk of severe illness and even possible death should the child contract a vaccine-preventable disease. Secondly, this would also place other unprotected people in the community at risk of diseasesuch as immunocompromised people and babies too young to be vaccinated. Thirdly, the existing evidence doesnt show that the current vaccine schedule is unsafe, raising questions about the necessity of doing such a trial.
Overall, the committee that authored the review considered that a saline-controlled randomized trial of the childhood vaccination schedule would pose an unacceptable risk for children and the community at large, while offering no clear benefit.
There are times when saline placebo-controlled trials arent practical or ethical to do. A WHO expert panel delved into this topic at length in this article, documenting their recommendations regarding the use of a placebo in vaccine trials[10].
For example, among the most common side effects of vaccination are fever, soreness at the injection site, and headache. However, a saline placebo doesnt produce these effects, meaning it will be obvious to both the researchers and participants which group did receive the vaccine. This makes blinding difficult to maintain.
And as epidemiologist Ren Najera explained in his article for the website History of Vaccines, having a saline placebo-controlled group means that the placebo group will be left unprotected from a potentially serious disease.
This would be acceptable if no intervention against the disease existedas was the case during the 1954 polio vaccine field trialbut would be unethical to do if an effective vaccine against the disease already exists.
This is why new formulations of existing vaccines can be compared to an earlier formulation that was previously tested and found to be safe and effective, rather than to a saline placebo. This was the case for a study of Prevnar-13, which was compared to its predecessor Prevnar-7[11]. Both are pneumococcal conjugate vaccines against the bacterium Streptococcus pneumoniae.
In fact, comparing a new vaccine to an earlier one can also make the trial better equipped to answer certain questions about the usefulness of the new vaccine.
When we already have existing interventions that are safe and effective, we dont just want to find out if a newly developed intervention works better than saline. We also want to know whether it works better than what we already have. Therefore, testing a new vaccine against an existing one can provide more useful information than testing it against a saline placebo.
The Instagram post also references the book Turtles All The Way Down. Written anonymously, it was co-edited by Mary Holland, the president of anti-vaccine organization Childrens Health Defense. The book propagates numerous anti-vaccine talking points, which were debunked by cardiologist Francis Han. His debunking is compiled in this Twitter thread.
Back in the summer of 2020, people could hardly wait for COVID-19 vaccines to be developed so that the pandemic would end. Within a few months, people were starting to report side effects such as Bells palsy or a false-positive result on mammograms. A new study published in the journal Vaccine reveals some interesting discoveries about the side effects of COVID-19 vaccines (Vaccine, Feb. 12, 2024).
This study, called the Global Vaccine Safety Project, included 99 million people from eight countries. Australia, Canada, Argentina, Denmark, Finland, France, New Zealand and Scotland participated. All vaccinated large numbers of people and have good health records for tracking the outcomes.
In general, serious side effects were rare. The researchers predicted how frequently a severe complication might occur based on the rates before the pandemic began. For example, they estimated rates of myocarditis, or inflammation of the heart muscle, in a healthy unvaccinated population. This problem was twice as common following vaccination. Nonetheless, there were relatively few cases.
Guillain Barr syndrome, a neurological complication that causes temporary paralysis, was more common after the AstraZeneca vaccine. The researchers predicted 76 cases of Guillain Barr in healthy unvaccinated people. They actually observed 190 cases. Thats about 2.5 times more than baseline.
Another serious, but rare complication was acute disseminated encephalomyelitis following the Moderna vaccination. Scientists expected 2 cases among 10 million people vaccinated. Instead, they reported 7.
The conclusion seems to be that COVID vaccines do indeed cause vascular and neurological adverse reactions, but the overall incidence is low. An independent study of COVID-19 vaccines demonstrated that vaccinated individuals have a reduced risk for severe outcomes, including Long COVID (Vaccines, Feb. 2024).
Alzheimer's
Studies suggest the BCG jab discovered a century ago could provide a cheap and effective way of boosting the immune system to protect people from developing the condition
Sun 25 Feb 2024 08.00 EST
Scientific discoveries can emerge from the strangest places. In early 1900s France, the doctor Albert Calmette and the veterinarian Camille Gurin aimed to discover how bovine tuberculosis was transmitted. To do so, they first had to find a way of cultivating the bacteria. Sliced potatoes cooked with ox bile and glycerine proved to be the perfect medium.
As the bacteria grew, however, Calmette and Gurin were surprised to find that each generation lost some of its virulence. Animals infected with the microbe (grown through many generations of their culture) no longer became sick but were protected from wild TB. In 1921, the pair tested this potential vaccine on their first human patient a baby whose mother had just died of the disease. It worked, and the result was the Bacille Calmette-Gurin (BCG) vaccine that has saved millions of lives.
Calmette and Gurin could have never imagined that their research would inspire scientists investigating an entirely different kind of disease more than a century later. Yet that is exactly what is happening, with a string of intriguing studies suggesting that BCG can protect people from developing Alzheimers disease.
If these preliminary results bear out in clinical trials, it could be one of the cheapest and most effective weapons in our fight against dementia.
According to the World Health Organization, 55 million people now have dementia, with about 10 million new cases each year. Alzheimers disease is by far the most common form, accounting for about 60%-70% of cases. It is characterised by clumps of a protein called amyloid beta that accumulate within the brain, killing neurons and destroying the synaptic connections between the cells.
Exactly what causes the plaques to develop has been a mystery, but multiple lines of evidence implicate problems with the immune system. When we are young, our bodys defences can prevent bacteria, viruses or fungi from reaching the brain. As we get older, however, they become less efficient, which may allow microbes to work their way into our neural tissue. According to this theory, the amyloid beta is produced to kill those invaders as a short-term defence against infection. If the brains own immune cells known as microglia were working optimally, they could clear away the protein once the threat has passed. But in many cases of Alzheimers disease, they seem to malfunction, triggering widespread inflammation that leads to further neural carnage.
A wealth of evidence now supports this theory. Autopsies have revealed brains of people with Alzheimers are more likely to be home to common microbes such as the herpes simplex virus, the cause of cold sores. Crucially, these germs are often entrapped in the amyloid, which has been proven to have antimicrobial properties.
If this theory is correct, attempts to boost the immune systems overall functioning could prevent the development of the disease.
New approaches are certainly needed. After decades of research on ways to clear the plaques, only two new drugs have been approved by the US Food and Drug Administration. Both are based on antibodies that bind to the amyloid beta proteins, triggering an immune response that clears them out of the brain. This appears to slow disease progression in some patients, but the improvement in overall quality of life is often limited.
Anti-amyloid antibodies also come with a hefty price tag. The cost of treatment is likely to lead to an enormous health equity gap in lower-income countries, says Marc Weinberg, who researches Alzheimers at Massachusetts general hospital in Boston. (He emphasises his opinions are personal and do not reflect those of his institution.)
Could existing vaccines such as BCG offer an alternative solution?
* * *
The idea may sound far-fetched, but decades of research show that BCG can have surprising and wide-ranging benefits that go way beyond its original purpose. Besides protecting people from TB, it seems to reduce the risk of many other infections, for instance. In a recent clinical trial, BCG halved the odds of developing a respiratory infection over the following 12 months, compared with the people receiving a placebo.
BCG is also used as a standard treatment for forms of bladder cancer. Once the attenuated bacteria have been delivered to the organ, they trigger the immune system to remove the tumours, where previously they had passed below the radar. It can result in remarkable disease-free recoveries, says Prof Richard Lathe, a molecular biologist at Edinburgh University.
These remarkable effects are thought to emerge from a process called trained immunity. After an individual has received BCG, you can see changes in the expression of genes associated with the production of cytokines small molecules that can kick our other defences, including white blood cells, into action. As a result, the body can respond more efficiently to a threat be it a virus or bacteria entering the body, or a mutant cell that threatens to grow uncontrollably. It can be likened to upgrading the security system of a building to be more responsive and efficient, not just against known threats but against any potential intruders, says Weinberg.
There are good reasons to believe that trained immunity could reduce the risk of Alzheimers. By bolstering the bodys defences, it could help keep pathogens at bay before they reach the brain. It could also prompt the brains own immune cells to clear away the amyloid beta proteins more effectively, without causing friendly fire to healthy neural tissue.
Animal studies provide some tentative evidence. Laboratory mice immunised with BCG have reduced brain inflammation, for example. This results in notably better cognition, when other mice of the same age begin to show a steady decline in their memory and learning. But would the same be true of humans?
To find out, Ofer Gofrit of the Hadassah-Hebrew University Medical Centre in Jerusalem and his colleagues collected the data of 1,371 people who had or had not received BCG as part of their treatment for bladder cancer. They found that just 2.4% of the patients treated with BCG developed Alzheimers over the following eight years, compared with 8.9% of those not given the vaccine.
Since the results were published in 2019, other researchers have replicated the findings. Weinbergs team, for instance, examined the records of about 6,500 bladder cancer patients in Massachusetts. Crucially, they ensured that the sample of those who had received BCG and those who hadnt were carefully matched for age, gender, ethnicity and medical history. The people who had received the injection, it transpired, were considerably less likely to develop dementia.
The precise level of protection varies between studies, with a recent meta-analysis showing an average risk reduction of 45%. If this can be proven with further studies, the implications would be huge. Simply delaying the development of Alzheimers by a couple of years would lead to tremendous savings both in suffering and our money, says Prof Charles Greenblatt of the Hebrew University of Jerusalem, who was a co-author of Gofrits original paper.
* * *
Plenty of caution is necessary. The existing papers have all examined patients with bladder cancer, but as yet there is little data on the general population. One obvious strategy may be to compare people who have received the BCG vaccine during childhood with those who hadnt, but the effects of BCG may dwindle over the decades long before most people would be in danger of developing Alzheimers.
We can, however, examine the effects of other vaccines delivered in old age. With its live (but attenuated) bacteria, BCG is thought to provide the most potent immune training, but other vaccines may also stimulate the bodys defences. Consider the flu jab. Nicola Veronese of the University of Palermo in Italy and her colleagues recently analysed the results of nine studies, many of which controlled for lifestyle factors, including income, education, smoking, alcohol consumption and hypertension. The team found that the influenza vaccine was associated with a 29% reduced risk of dementia. Two studies also showed an association between the number of doses, over previous years, and the incidence of dementia, says Veronese.
Such studies still cannot prove causality. In this kind of epidemiological research, it may be that theres a confounding factor thats lurking that isnt properly accounted for, says Jeffrey Lapides of Drexel University College of Medicine in Pennsylvania, though he agrees that the vaccine effects on dementia are plausible and deserve more research.
The clinching evidence would come from a randomised controlled trial in which patients are either assigned the active treatment or the placebo. Since dementia is very slow to develop, it will take years to collect enough data to prove that BCG or any other vaccine offers the expected protection from full-blown Alzheimers compared with a placebo.
In the meantime, scientists have started to examine certain biomarkers that show the early stages of disease. Until recently, this was extraordinarily difficult to do without expensive brain scans, but new experimental methods allow scientists to isolate and measure levels of amyloid beta proteins in blood plasma, which can predict a subsequent diagnosis with reasonable accuracy.
A pilot study by Coad Thomas Dow of the University of Wisconsin-Madison and his colleagues suggests that BCG injections can effectively reduce plasma amyloid levels, particularly among those carrying the gene variants associated with a higher risk of Alzheimers. Although the sample size was small just 49 participants in total it has bolstered hopes that immune training will be an effective strategy for fighting the disease. These results were encouraging, says Weinberg, who was not involved in the study.
Weinberg has his own grounds for optimism. Working with Dr Steven Arnold and Dr Denise Faustman, he has collected samples of the cerebrospinal fluid that washes around the central nervous system of people who have or have not received the vaccine. Their aim was to see whether the effects of trained immunity could reach the brain and that is exactly what they found. The response to pathogens is more robust in specific populations of these immune cells after BCG vaccination, says Weinberg.
We can only hope that these early results will inspire further trials. For Weinberg, its simple. The BCG vaccine is safe and globally accessible, he says. It is also incredibly cheap compared with the other options, costing just a few pence a dose. Even if it confers just a tiny bit of protection, he says: It wins the cost-effectiveness contest hands down.
As Calmette and Gurin discovered with their potato slices more than a century ago, progress may come when you least expect it.
This article was amended on 26 February 2024 to correct an instance of a misspelling of Marc Weinbergs surname.
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West Virginia would join 45 other states that allow religious exemptions from childhood vaccines required for school attendance under a bill that passed the House of Delegates on Monday.
The religious exemption is included in a bill that would let private schools decide whether to implement vaccine mandates. It was added to the bill as an amendment that passed on Friday. The overall bill was approved Monday on a 57-41 vote and now goes to the state Senate, where its chances of passage are uncertain. But the Senate will have to act quickly: the 60-day regular session ends on March 9.
Some medical experts in West Virginia, one of the unhealthiest states in the nation among adults, called the bill archaic.
WEST VIRGINIA SENATE PASSES BILL THAT WOULD REMOVE MARITAL EXEMPTION FOR SEXUAL ABUSE
"Legislators want to turn the clock back nearly 100 years and remove some of the safeguards in our vaccination policies," said Dr. Steven Eshenaur, the health officer for the Kanawha-Charleston health department. "It escapes sound reasoning why anyone would want to weaken childhood immunization laws. Our children are more important than any agenda that would bring these horrific diseases back to the Mountain State."
The bills original intent was to eliminate vaccine requirements for students in public virtual schools. It was expanded in committee to allow private schools to set their own vaccination standards. Then came the religious exemption added in last week's amendment.
Amendment sponsor Todd Kirby, a Raleigh County Republican, said the exemption sends a message about existing guarantees of religious freedom. Kirby, who said his children are fully vaccinated, added that it would allow unvaccinated children to be welcomed into schools and day-care facilities and "to have the camaraderie and social interactions that we all know are so important."
Last year, Kirby co-sponsored a bill later signed by Republican Gov. Jim Justice that would create a test for courts to apply when people challenge government regulations they believe interfere with their constitutional right to religious freedom. About two dozen other states have similar laws.
Seen here is West Virginia's Capitol dome in Charleston, West Virginia. (AP Photo/Jeff Gentner, File)
A federal appeals court last August upheld a 2021 Connecticut law that eliminated the states longstanding religious exemption from childhood immunization requirements for schools, colleges and day care facilities. And in Mississippi, a federal judge ruled in April 2023 that the state must allow such exemptions.
Other states that currently dont have religious exemptions for school immunization requirements are California, Maine and New York, according to the National Conference of State Legislatures.
Unless they have a valid medical excuse, children entering school for the first time in West Virginia currently must be immunized against nine diseases or infections, including chickenpox, measles, whooping cough and tetanus.
Kanawha County Republican JB Akers said he supports the religious exemption but doesnt like how the bill would let private schools decide on student vaccine requirements while public school students currently must be immunized.
"I think we are potentially creating an equal protection problem," he said in voting against the bill.
Students who compete in state-sponsored athletic competitions must be immunized and cannot receive a religious exemption under the bill.
Kanawha County Democrat Mike Pushkin chided the House for meddling with the current school vaccine law.
"We do not have the right to harm others," Pushkin said. "This bill does harm."
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According to the Centers for Disease Control and Prevention, West Virginias life expectancy in 2020 was 72.8 years. Only Mississippis was lower at 71.9. West Virginia has the nations highest death rate from diabetes and heart disease, and has long had the nations highest drug-related death rate. It was among three states with an obesity prevalence of 40% or greater in adults in 2022, the CDC said.
SciCheck Digest
An international study of around 99 million people confirmed known serious side effects of COVID-19 vaccination. It also identified a possible relationship between the first dose of the Moderna vaccine and a small risk of a neurological condition. Social media posts about the study left out information on the vaccines benefits and the rarity of the side effects.
COVID-19 vaccines like allvaccinesand other medical products come with side effects, includingserious side effectsin rare cases. The vaccines were rolled out to protect people from a novel virus that haskilledmillions of people globally and would likely have killed millions more without the arrival of the vaccines. There is a broad consensus fromexpertsandgovernmentalhealthagenciesthat the benefits of COVID-19 vaccination outweigh the risks.
Researchers havescrutinizedthe COVID-19 vaccines safety and continue to do so. Astudypublished Feb. 12 in the journal Vaccine reported on an international group of more than 99 million people who received COVID-19 vaccines, primarily finding links to known rare side effects. The study largely focused on the Pfizer/BioNTech and Moderna vaccines, which have beenwidely givenin the U.S., as well as the AstraZeneca vaccine, which wasnever authorizedin the U.S.
What we take away, is that the Covid-19 vaccination campaigns have been very effective in preventing severe disease, study co-authorAnders Hviid, head of the department of epidemiology research at the Statens Serum Institut in Denmark, told us in an email. The few serious side effects that we have observed in this and other studies have been rare.
Many popular posts on social media have shared results from the study, some lacking the context that the identifiedhealth problemsarerare, thatmostarentnewand that the vaccines have proven benefits. Various posts made unfounded claims, stating or implying that peopleshould nothavereceivedthevaccines, that the risksoutweighthe benefits or that theriskof the rare side effects isgreaterthan was reported in the study.
Hundreds of millions of people were used as lab rats and now the truth that WE ALL ALREADY KNEW can no longer be denied, said one popularpost, referring to the vaccines as experimental and UNTESTED. The post shared a screenshot of the headline of a New York Postarticleabout the new study, which read, COVID vaccines linked to slight increases in heart, brain, blood disorders: study.
This thing was forced on people who faced almost no risk from Covid, said another widely readpost. It is completely unacceptable. The post shared statistics from the paper without making it clear that serious health problems after vaccination were rare and that risk varied by vaccine type and dose.
The Vaccine study confirmed that the Moderna and Pfizer/BioNTech vaccines are linked in rare cases to myocarditis and pericarditis, conditionsinvolvinginflammation of the heart muscle and lining. The rate of myocarditis was most elevated after the second dose of the Moderna vaccine. Myocarditis risk which is greatest in men in their late teens and early twenties wasidentifiedvia vaccine safety monitoring and first reported in 2021. Based on the current evidence, theCDCsays, the benefit of vaccination outweighs the risk of these conditions, which improve for most people after medical treatment and rest.
The study confirmed neurological and blood clotting conditions associated with the AstraZeneca vaccine. In the U.S., theseproblemswerelinkedto the Johnson and Johnson vaccine, contributing to this vaccine no longer being recommended or available.
The study also identified a new possible safety signal indicating a potential link between the first dose of the Moderna and AstraZeneca vaccines and rare neurological conditions. This included an association between the first doses of the vaccines and acute disseminated encephalomyelitis, or ADEM, an autoimmuneconditionthatcausesinflammation of the brain and spinal cord.
Hviid emphasized that the researchers only saw these neurological events after first doses of the two vaccines. We did not see these signals following further doses of these two Covid-19 vaccines, nor did we see them after any dose of the Pfizer/BioNTech vaccine which has been more widely used, he said.
We are also talking about very rare events, Hviid continued. As an example, the association between the first dose of Moderna and acute inflammation of the brain and spine would, if causal, correspond to 1 case per 1.75 million vaccinated. It is only due to the sheer scale of our study, that we have been able to identify this minute potential risk.
The Vaccinestudydrew on national or regional health records from eight countries with institutions participating in theGlobal Vaccine Data Network, an international group that studies vaccine safety. The researchers analyzed health outcomes after around 184 million doses of the Pfizer/BioNTech vaccine, 36 million doses of the Moderna vaccine and 23 million doses of the AstraZeneca vaccine.
The researchers focused on 13 health problems that either had a known association with vaccination or for which there was some rationale to investigate whether there was an association. To determine whether the health problems were associated with vaccination, they compared the expected rates of the health problems or the number of health events that should occur based on background rates in the regions studied with the number of events they observed in the 42 days after vaccination.
This study confirms the primary already detected and validated side effects established by previous literature,Jeffrey S. Morris, director of the division of biostatistics at the University of Pennsylvanias Perelman School of Medicine, told us via email, referring to the rare heart conditions associated with the Moderna and Pfizer/BioNTech vaccines, as well as the rare conditions associated with the AstraZeneca and Johnson and Johnson vaccines.
Morris said that findings on ADEM the rare autoimmune neurological condition linked to first doses of the Moderna and AstraZeneca vaccines might be a new safety signal.
ADEMinvolvesinflammation to the brain and spinal cord, arising most often in children following an infectious illness. It has asudden onsetand typically eventually improves, with a full recovery in many, although not all, cases.
After the first dose of the Moderna vaccine, researchers observed seven ADEM cases, when they expected two. As weve said, Hviid calculated the rate of this side effect if ultimately shown to be related to vaccination to be 1 in 1.75 million following the first dose of the Moderna vaccine.
The data show this was indeed an EXTREMELY rare adverse event, Morris said, referring to ADEM. It is understandable at this incidence rate why it may not have been detected before now, and why a study with 99 million participants like this is important to find even the most rare serious adverse events that are potential minority harm risks of these vaccines.
The authors of the study wrote that more research is needed into ADEM following COVID-19 vaccination, saying that the number of cases of this rare event were small and the confidence interval wide, so results should be interpreted with caution and confirmed in future studies. The authors also wrote that neurologicaleventshave been found to occur at a much higher rate after COVID-19 than after COVID-19 vaccination.
The study means that early warning systems are solid, saidMarc Veldhoen, an immunologist at the Instituto de Medicina Molecular Joo Lobo Antunes in Portugal, in aposton X, formerly known as Twitter. To avoid any adverse reaction is not possible, but, identifying those at higher risk may be possible.
Identifying those at greater risk of side effects can help guide decisions on which vaccines to recommend and what problems doctors should watch for in their patients.
Editors note: SciChecks articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation hasno controlover FactCheck.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.
How do we know vaccines are safe? FactCheck.org. Updated 8 Jul 2021.
Selected Adverse Events Reported after COVID-19 Vaccination. CDC website. Updated 12 Sep 2023.
Yandell, Kate. Tucker Carlson Video Spreads Falsehoods on COVID-19 Vaccines, WHO Accord. FactCheck.org. 13 Jan 2024.
Safety of COVID-19 Vaccines. CDC website. 3 Nov 2023.
How safe are the COVID-19 vaccines? FactCheck.org. Updated 17 May 2022.
Faksova, K. et al. COVID-19 Vaccines and Adverse Events of Special Interest: A Multinational Global Vaccine Data Network (GVDN) Cohort Study of 99 Million Vaccinated Individuals. Vaccine. 12 Feb 2024.
COVID Data Tracker. COVID-19 Vaccinations in the United States. CDC website. Updated 11 May 2023.
Liu, Angus. AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments. Fierce Pharma. 10 Nov 2022.
Hviid, Anders. Email with FactCheck.org. 22 Feb 2024.
TheBlaze. Blood clots, neurological disorders, and swollen hearts: Multinational study on COVID vaccines paints a damning picture. Facebook. 20 Feb 2024.
Dr. Anthony G. Jay (@anthonygjay). I post a lot of vids but rarely PLUG them WATCH my YouTube vid on this its 6 minutes before it gets taken down . Instagram. 20 Feb 2024.
bikinibottom_fish (@bikinibottom_fish). Global Study Links COVID-19 Vaccines to Heart and Brain Issues! Instagram. 20 Feb 2024.
PatrioticBabe (@babedoesthenews). . Instagram. 20 Feb 2024.
RASPY RAWLS (@raspy_rawls2). We told yall not to take that shyt but hey wat dew we know . Instagram. 20 Feb 2024.
Jaimee Michell (@thegaywhostrayed). I want to know if you think Trump holds any blame, and if not, why not? COMMENT your thoughts BELOW! Instagram. 20 Feb 2024.
Liberty Counsel (@libertycounsel). Based on conservative assumptions, the estimated harms of the COVID-19 mRNA vaccines greatly outweigh the rewards, the article stated, noting that for every life saved, there were nearly 14 times more deaths caused by the modified mRNA injections. Instagram. 20 Feb 2024.
Shemeka Michelle (@theshemekamichelle). Remember when they called them rare breakthrough cases? Yeah, me too. #slight. Instagram. 20 Feb 2024.
Malaki (@awake.the.mind). Slight will turn to significant soon enough. We tried to warn you all but were just crazy conspiracy theorists. Instagram. 20 Feb 2024.
Steinbuch, Yaron. COVID vaccines linked to slight increases in heart, brain, blood disorders: study. New York Post. 20 Feb 2024.
Vogel, Gretchen and Couzin-Frankel, Jennifer. Israel reports link between rare cases of heart inflammation and COVID-19 vaccination in young men. Science. 1 Jun 2021.
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By Sheain Fernandopulle
In the wake of disquieting findings on the health risks associated with certain COVID-19 vaccines, the Sri Lankan health authorities seem to be turning a blind eye as they go unresponsive to the queries.
Despite Daily Mirrors efforts to prompt the authorities to articulate their position on the recent findings, responsible officials have failed to respond, leaving the masses in dilemma.
The global study
The world faces rising concerns about certain COVID-19 vaccines safety, echoing global discussions following a study suggesting potential risks. While the absolute risk remains low, a cautious approach is warranted.
The study mentioned in Forbes Magazine sheds light on some occurrences of heart, brain, and blood disorders potentially linked to Pfizer, Moderna and AstraZeneca COVID-19 vaccines. The study involving nearly 100 million vaccinated individuals across eight countries, including Argentina, Australia, Canada, Denmark, Finland, France, New Zealand, and Scotland, revealed alarming associations between COVID vaccines and 13 medical conditions. Published in the journal Vaccine, the research found an increase in neurological, blood, and heart-related issues post-vaccination.
Besides, its noteworthy that vaccination campaigns have played a pivotal role in controlling the spread of COVID-19 and mitigating its impact on public health. However, the emergence of potential adverse effects necessitates a proactive approach to ensure the safety and well-being of vaccine recipients.
Over 4 million Sri Lankans administered with vaccines in question
Sri Lanka used all three vaccines in question in its vaccination drive. The breakdown of recipients for each vaccine in question is as follows: AstraZeneca/Covishield - 1,479,631 recipients, Pfizer - 2,645,395 recipients, and Moderna - 804,801 recipients.
Accordingly, nearly five million (4,929,833) Sri Lankans have been administered the vaccines in question.
Medical experts believe that while some recipients of the aforementioned vaccines may be vulnerable to complications, the majority may be out of the woods. Nevertheless, experts maintain that without conclusive study findings, the local situation cannot be accurately determined.
Its in this backdrop that the Health Ministry in collaboration with relevant stakeholders should chip in and clear the doubts of the locals in the form of a comprehensive study.
A local study on COVID vaccines welcome- Expert
Dr Vinya Ariyaratne, a public health specialist and the immediate past President of the Sri Lanka Medical Association (SLMA), said that the spread of the pandemic brought the world to a halt, with no scientific principles followed.
However, the vaccines were later introduced following WHO procedures and contributed to containing the pandemic. In any public health emergency, risks versus benefits are weighed, he said. At the time of vaccination, the benefits seemed to far outweigh the possible risks, considering the higher chance of death from COVID compared to not being vaccinated. All vaccines do come with rare reactions, and a small probability of complications exists, he said.
While certain studies may later reveal vaccine adverse effects, making judgments on efficacy now is too premature, he said. He said that the world coming to normalcy amply demonstrated the effectiveness of the protocols followed globally during the pandemic.
He also noted that the COVID-19 pandemic may not be the last, emphasizing the importance of learning from the experience and being prepared for future outbreaks. The expert also stated that, in the face of another pandemic, individuals might still be compelled to take a vaccine without full knowledge.
Regarding a similar study on the side effects of COVID-19 in the Sri Lankan context, the expert supports it as a learning experience. The intention is not to discredit vaccines but to detect early signs of complications, allowing for timely intervention, he added.
Maintaining vigilance on side effects of COVID vaccines paramount
Media Spokesman for the Government Medical Officers Association (GMOA) Dr Chamil Wijesinghe, emphasizes the importance of maintaining vigilance and observation regarding potential side effects associated with COVID vaccines within the local context.
It is imperative that Sri Lanka maintains continued vigilance and observation of any potential side effects associated with Covid vaccines within the local context, Dr Wijesinghe emphasized.
However, he cautioned against directly applying the studys findings to Sri Lanka, noting the differences in data and genetic patterns between regions. Despite this, he stressed the need for the Health Ministry to closely monitor the situation and consider conducting a local survey to assess the situations specifics.
In response, Sri Lankas COVID-19 Coordinator Dr Anwar Hamdani acknowledges the absence of any proven studies conducted within the country regarding the side effects of COVID vaccines.
In general, vaccines take ages to be perfected. Covid vaccines were developed within a short period of months. It was built on the knowledgebase of years of human knowledge in creating vaccines, one report said.
Nonetheless, sceptics challenge this and say developing vaccines in such a short period is dangerous.
As the global community continues to navigate the complexities of the COVID-19 pandemic, monitoring adverse reactions, ongoing research and surveillance efforts are crucial in identifying and addressing emerging concerns related to COVID-19 vaccines. Furthermore, proactive measures such as the establishment of comprehensive vaccine monitoring systems and robust pharmacovigilance programmes can enhance the early detection of adverse events and enable timely intervention.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine-related problem. In conclusion, it is fitting to note that although the risk posed by the virus itself remains considerably higher, the latest findings serve as a catalyst, urging medical experts and health authorities to maintain unwavering vigilance and take proactive measures in scrutinizing complications associated with the vaccines.
BrazzavilleCervical cancer poses a significant burden in sub-Saharan Africa, with 120,000 cases annually out of the global total of 690,000, further exacerbated by the HIV epidemic.
In an effort to accelerate progress against cervical cancer, the WHO Africa Regional Immunization Technical Advisory Group (RITAG) during a meeting held 7 9 November 2023 has urged countries to adopt a single-dose schedule for the human papillomavirus vaccine (HPV) in Africa, in line with the World Health Organization's (WHO) recommendations in 2022. Implementation of this recommendation represents a significant step forward in the region's fight against cervical cancer.
Currently, 27 African nations have incorporated the HPV vaccine into their routine immunization programmes, with a primary focus on girls aged 9-14. In November 2023, Togo became the latest country to introduce the human papillomavirus vaccine to protect adolescent girls from the leading cause of cervical cancer, following Nigeria which rolled out the HPV vaccine in October 2023. Overall, HPV vaccine coverage remain low. As of 2022, coverage of first dose in the African Region stands at only 33%, falling short of the global target of 90%. Increasing coverage is essential to reduce the burden of cervical cancer and improve public health outcomes.
However, challenges such as limited vaccine supply have hindered efforts to catch up with older age groups in certain areas.
In response to evolving evidence and challenges, countries like Cameroon and Cabo Verde have demonstrated adaptability by transitioning to a single-dose regimen and expanding vaccination to include boys. Additionally, the endorsement of a single-dose schedule by National Immunization Technical Advisory Groups (NITAGs) in 16 African countries highlights the importance of streamlined and cost-effective strategies. To accelerate progress, WHO emphasizes a strategic approach that includes political advocacy, comprehensive coordination, resource optimization, multisectoral partnerships, and strengthening health systems.
By integrating HPV vaccination with other health programmes and ensuring equitable access, we can accelerate progress towards protecting people against cervical cancer, says Dr Matshidiso Moeti, WHO Regional Director for Africa.
RITAG recommends several key actions, including adopting a single-dose schedule, extending vaccination to older age groups and boys where feasible, prioritizing immunocompromised individuals, strengthening advocacy and communication efforts, and promoting peer-to-peer learning for optimal service delivery strategies.
RITAG's endorsement of a single-dose HPV vaccine schedule marks a pivotal moment in Africa's fight against cervical cancer. By implementing these recommendations and adopting a strategic approach, the region can make significant progress in preventing this disease and ensuring a healthier future for its population.
LEXINGTON, Mass. New obesity drugs like Wegovy and Zepbound are currently taken once a week, indefinitely. But what if they could be taken once a year instead, like a vaccine?
Thats a question that Novo Nordisk, the pharma company behind Wegovy, is exploring as it faces increased competition from other drugmakers aiming to develop similar GLP-1-based treatments for obesity.
We have a very early think tank on: what would it take us, from a technology point of view and from an ecosystem point of view, to make long-lasting GLP-1 molecules? Marcus Schindler, Novos chief scientific officer, said in an interview with STAT Wednesday. Could we think about vaccine-like properties, where imagine you had, once a year, an injection with an equivalent of a GLP-1 that really helps you to maintain weight loss and have cardiovascular benefits?
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