Category: Covid-19 Vaccine

Dawn Bowdish, PhD

Credit: McMaster University

A Canadian study examined how serologic responses to COVID-19 vaccination and infection are affected by time since last vaccination, among other factors, in a cohort of patients with immune-mediated inflammatory disease (IMID).

Results indicated positive associations for log-transformed Receptor Binding Domain (anti-RBD) titers were linked to the number of doses, self-reported COVID-19 infection, and female sex, while negative associations were seen with prednisone and rituximab use, according to research published in The Journal of Rheumatology.1

Between 2022 and 2023, 4 times as many people in the US were hospitalized for COVID-19 compared with influenza. Currently, the COVID-19 mortality risk is double that of influenza.2 Further, patients with IMID may be unsure about the potential benefits of additional booster vaccinations, and this hesitancy could potentially put these patients at a higher risk for infection.

Vaccine hesitancy in general is a huge problem, particularly for people with IMID, wrote a team of investigators led by Dawn Bowdish, PhD, associate professor at McMaster University and a Canada Research Chair in Aging & Immunity. As the necessity for multiple COVID vaccine doses became clear, social vaccine fatigue has caused many individuals to decline additional COVID boosters after the primary series. Since COVID-19 infection is a potentially fatal and vaccine-preventable co-morbidity, it is vital that individuals with IMID have access to relevant information that will help them decide when to get their next COVID vaccination.

Dried blood spots/sera and other data were obtained from adults with rheumatoid arthritis (RA), systemic lupus, psoriasis and psoriatic arthritis (PsA), ankylosing spondylitis and spondyloarthritis, and inflammatory bowel disease post-vaccination. The first sample was collected at enrollment and again at 24 weeks, 3 months, 6 months, and 12 months post-vaccine. The serologic response was determined using multivariate generalized estimating equation regressions, such as medication use, vaccination history, and demographics.

Among the cohort, 64.7% patients were female, the mean age was 53.2 years, and 88.4% were white. The most common inflammatory condition was inflammatory bowel disease followed by RA.

In patients with IMID, positive associations for log-transformed anti-RBD titers were shown in self-reported COVID-19 infections between 2021 and 2023, female sex, and number of vaccinations. Negative associations were demonstrated in patients who received prednisone, rituximab, and tumor necrosis factor (TNF) inhibitors.

Most (94%) anti-nucleocapsid positivity was linked to a self-reported COVID-19 infection within the prior 3 months. Between March 2021 and February 2022, 515% of samples exhibited anti-nucleocapsid positivity. This positivity increased to 3035% or higher in the post-Omicron era (March 2023). The anti-nucleocapsid positivity among patients with IMID was lower when compared with Canadas general population seroprevalence (> 50% in 2022 and > 75% in 2023.

Negative associations with log-transformed anti-RBD titers were seen in the time since last vaccination, especially after 210 days.

Investigators noted the comprehensive inclusion of factors related to serologic COVID-19 vaccine response among a large cohort of patients with IMID strengthened the study. However, the lack of detailed drug exposure information hindered their ability to determine certain issues, including if a patient received a particular drug in the week prior- or post-vaccination. Additionally, they were unable to evaluate interactions between drugs, IMID type, or vaccination type and its impact on COVID-19 infection.

Ensuring adequate vaccination against SARS-CoV-2 in IMID can be difficult, investigators concluded. If individuals have access to relevant information that will help them decide when to get their next COVID vaccine, they may be more open to receiving additional doses. We believe that our findings will help patients, clinicians, and other stakeholders make personalized vaccination decisions, including consideration of additional doses when more than 6 months has elapsed since last COVID vaccination/infection.

References

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Study Investigates Optimal COVID-19 Vaccination Timing in Inflammatory Disease - MD Magazine

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Immune response stability to the SARS-CoV-2 mRNA vaccine booster is influenced by differential splicing of HLA ... - Nature.com

Claim:

The Centers for Disease Control and Prevention has warned that COVID-19 vaccines have caused at least a 14,000% increase in "turbo cancer" cases across the United States.

Myriad publications have falsely warned readers about "turbo cancer," a purportedly aggressive form of cancer caused by mRNA vaccines like the Pfizer and Moderna COVID-19 vaccines. A recent rash of headlines on the topic assert that the Centers for Disease Control and Prevention (CDC) had warned the public about turbo cancer, an assertion thatoriginatedfrom disreputable websites including the conspira-satirical The People's Voice.

These stories all cite data from the CDC's Vaccine Adverse Events Reporting System (VAERS) compiled by the anti-vaccine outlet Expos News. That outlet's story claims that a comparison between the raw number of "cancer cases" reported to VAERS following the influenza vaccine could serve as a baseline for which to compare cancer cases occurring after COVID-19 vaccination.

The headline used by The People's Voice stems from such a comparison, but it misleadingly omits mention that it concerns only people in their 30s:

People in their 30s reported just 1 cancer case due to influenza vaccination between 1st Jan 21 and 29 March 24, whereas 141 cancer cases were reported among people in their 30's due to COVID-19 vaccination. This equates to a shocking 14,000% increase in cancer cases due to COVID-19 vaccination.

These and all other comparisons of VAERS data are inherently flawed. For one thing, the link provided by The Expos to its data is dead, so we have no way to know which of the thousands of filters were used to determine "cancer cases." Snopes was unable to recreate The Expos's numbers.

More significant than the issue of our having to take The Expos's data in blind faith is the fact that the story claims that raw VAERS data show causation between a vaccine and an adverse event.

This is an explicit misuse of the sometimes unverified data in VAERS. The data have not been corrected in the ways required by the types of epidemiological studies capable of addressing a causal link, and the data portal from which The Expos claims they got its numbers comes with this disclaimer:

VAERS accepts reports of adverse events that occur following vaccination. Anyone, including healthcare providers, vaccine manufacturers, and the public, can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.

Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS even if they are not sure if the vaccine was the cause. In some situations, reporting to VAERS is required of healthcare providers and vaccine manufacturers.

As Snopes has writtenaboutextensively, the misuse of VAERS data to argue causation has been a staple of the anti-vaccine movement since well before the COVID-19 pandemic. Any claim purporting to do so is not credible.

The Expos regularly posts unvetted scientific claims that ignore basic study design, including the promotion of a study Snopes reported on in February 2024 that misrepresented the meaning of "statistical significance."

The Expos piece does not use the term "turbo cancer" (though it uses the term in other articles). The outlet's story was turbo-charged by the website The People's Voice, which has a history of blending quasi-factual information with conspiratorial themes to produce what it calls "satire." An April 15, 2024, story on the websitesaid:

The CDC has warned that COVID-19 vaccines have caused at least a 14,000% increase in turbo-cancer cases across the United States.

The misuse of data made public by the CDC does not constitute a CDC warning, and "turbo cancer" does not exist.

A video of a purportedly significant Swedish pathologist, Ute Kruger, is largely responsible for the term, which was produced by a group of COVID-19 vaccine skeptics known as Covid Doctors for Ethics. According to that video interview and an associated blog post, Kruger saw an increase in aggressive, tumor-causing cancers coincident with the introduction of COVID-19 vaccines:

Dr. Kruger initially thought that these turbo cancers, as she calls them, were due to delayed doctor appointments from Covid lockdowns, but that period is long over, and the tumors are still growing aggressively, and in younger patients. She reported some of these cases to the FDA, and while some higher-ups initially agreed to meet with her, they canceled the meeting with no explanation the next day and sent a phone agent to take her report instead.

As Lead Stories reported during an earlier batch of turbo cancer headlines, epidemiologist-analyzed and corrected VAERS data do not suggest any causal link between any cancer and mRNA vaccination. A representative for the U.S. Food and Drug Administration (FDA) told the fact-checking outlet in an Aug. 16, 2023, email that:

Extensive monitoring of adverse events reported after vaccination with authorized and approved COVID-19 vaccines to the Vaccine Adverse Event Reporting System (VAERS) does not show a safety signal for any type of lymphoma or other cancers, including aggressive tumors.

COVID Doctors for Ethics appears to be a mouthpiece for anti-vaccine conspiracy theoristSucharit Bhakdi. As Snopes previously reported, Bhakdi is an overtly antisemiticpolitical figure who has been a repeated source of demonstrably false information about the COVID-19 pandemic since March 2020. In February 2023, he was responsible for the false claim that a member of the Thai royal family had died from a Pfizer vaccine, leading the country to ban its use.

Because turbo cancer is not a clinically recognized condition, because the purported data suggesting a 14,000% increase in this not-real condition involves only a subset of individuals aged 30-39, and because the data from which that subset was derived is incapable of assessing causation for any condition, including fictional ones, we rate the claim as "False."

Follow this link:

CDC Said mRNA Jabs Have Caused a '14000% Increase in Turbo Cancer'? - Snopes.com

In Sierra Leone almost 59% of the population live in remote, rural areas. Roads may be non-existent or in bad condition, making it very difficult for rural dwellers to access healthcare. This is one of the key reasons why COVID-19 vaccination rates in the country are low.

During an innovative vaccine programme mobile vaccine clinics were dispatched to the furthest parts of the country, sometimes on motorcycles and boats. The results showed COVID-19 vaccination rates tripled in three days.

Development Economist Niccol F. Meriggi tells Nadine Dreyer about the programmes potential to become a blueprint for future healthcare delivery in the country and other remote regions in Africa.

By 10 March 2022, more than a year after COVID-19 vaccines arrived on the market, 80% of people living in high-income countries had received at least one dose. In stark contrast, only 15% of people had been vaccinated in low-income countries.

Fast-forward to November 2023 and still only 33% of the population in Africa had received at least their first dose of a COVID-19 vaccine.

The hardships Sierra Leoneans face are typical of the obstacles people in low-income countries have to overcome to access healthcare.

In the early days of the COVID-19 vaccination campaign in Sierra Leone, it took the average Sierra Leonean living in a rural community three-and-a-half hours each way to the nearest vaccination centre.

Things improved as more clinics started offering the vaccine, but the cost of reaching clinics remained high and, in many cases, prohibitive. In Sierra Leone 60% of the rural population live on less than US$1.25 a day. Getting to a clinic would cost more than one weeks wages.

A team of researchers designed a COVID-19 vaccination drive that was implemented in March and April 2022 by the Ministry of Health and Sanitation and their technical partner Concern World Wide, an international humanitarian agency.

The primary aim of this intervention was to take vaccine doses and nurses to administer vaccines to remote, rural communities, preceded by seeking permission and community mobilisation.

At the time, only 6% to 9% of the adults who took part in the programme were already immunised.

Just over 20,000 Sierra Leoneans, living in 150 rural towns outside the countrys national clinic network, took part in the vaccination campaign.

The first step was to approach village leaders including the chief and the mammy queen, the most important woman in the village. Youth and religious leaders were also consulted. They were briefed about the purpose of the visit and the vaccination team answered questions about the available vaccines.

The leaders were asked for their cooperation in encouraging eligible community members to take the COVID-19 vaccine.

That evening, when labourers returned home from farms, the health team talked directly to all villagers about vaccine efficacy and safety and the importance of getting vaccinated. They also addressed villagers questions and concerns.

Finally, vaccine doses and healthcare workers arrived at the villages to administer the doses. Some travelled on motorbikes or on boats because of the lack of any road access.

This last-mile vaccine intervention tripled vaccination rates within three days in treated communities.

Large numbers of people from neighbouring communities also showed up to receive vaccines at the temporary vaccination sites.

These results suggest that people who live far from clinics are less likely to seek healthcare and that last mile delivery is a cost-effective intervention capable of overcoming that problem.

The intervention cost in this campaign was US$33 per person vaccinated. This approach proved 76% more cost-effective than other vaccination campaigns.

Transport accounted for a large share of the costs, so the cost-effectiveness of last mile delivery can be increased by offering a bundle of health products. The bundle could include routine child immunisation, as well as human papillomavirus and malaria vaccines, combined with other important health supplies such as deworming tablets, vitamin A supplements, oral rehydration solutions and chlorine for drinking water.

The World Health Organization reported that between 2020 and 2021, 5.42 million people died of COVID-19.

Other estimates put the death toll for the same period at 14.83 million, which is 2.74 times higher.

Developing cost-effective strategies to make vaccines easily accessible to everyone, everywhere, is the most promising solution to prevent future pandemics. This blueprint could also be used to address obstacles to other life-saving medical care.

The research team has since been awarded funds from the International Growth Centre and the Social Science Research Council through its Mercury Project. These grants will be used to expand the model in this paper to a bundle of health products and services, including additional vaccines (HPV and Malaria) and maternal and child health interventions, and further explore its feasibility and cost-effectiveness

The rest is here:

How to get vaccines to remote areas? In Sierra Leone they're delivered by foot, boat or motorbike - The Conversation

At the beginning of the pandemic, many people hoped that infections with SARS-CoV-2, the virus that causes COVID-19 or vaccines against the virus would providedurable lifetime immunity, as is the case with diseases likemeaslesor mumps. Instead, the COVID virus is more akin to the influenza virus, which mutates constantly and confers only short-term immunity. Both COVID and the flu require new and different vaccine formulas aimed at defeating newly circulating variants of the viruses. The inevitable result of this has been, for most of us, increasing vaccine fatigue.

But what if it were possible to protect against COVID and the flu, and other unknown viruses that haven't yet emerged, with just one shot? If that became reality, seasonal or annual boosters would be part of the past. And what if such vaccinations didn't even require a needle?

While those possibilities may sound far in the future, scientists at the University of California, Riverside, believe they could become reality relatively soon perhaps within the next five to 10 years. As illustrated in a paper justpublished in the Proceedings of the National Academy of Sciences, a new, RNA-based vaccine strategy could be effective against any viral strain to emerge in the future. This next generation of vaccines would theoretically offer protection against viruses we arent even aware of yet, and could be used safely on infants and people with compromised immune systems, who today must often opt out of vaccination to protect their health.

This new RNA-based technology, the research paper reports, would target a part of the viral genome that is common to all strains of any virus and would depend on a second immune system response.

We have a very strong reason to believe that all these other human viruses, like dengue virus and COVID-19, produce a protein that we can target to make a vaccine, Shouwei Ding, distinguished professor of microbiology at UC Riverside and lead author of the paper, told Salon in a phone interview. With any future virus, "all we need to do is to identify the protein that can suppress RNAi.

Here's what Ding was talking about. Traditional vaccines work by training the body to recognize and combat specific molecules found on a particular pathogen. For example, live-attenuated vaccines often use a weakened form of a virus to train the immune system. Once the weakened form of the virus is in the body, the immune system learns to recognize the antigen and develop immunity to it.

Another type of vaccine, based on "viral vectors," uses DNA and RNA to give cells a blueprint, rather than a piece of the pathogen itself, to build immunity. MRNA vaccines, like the best-known vaccines against COVID-19, use a synthetic version of single-stranded RNA to create a bespoke version of the mRNA within the body. This creates cells that can produce proteins like those found in a virus, and which then train the immune system to fight a disease before it enters a persons bloodstream.

The new vaccine technology proposed in this paper would still use a live, modified version of a virus. But its effectiveness would not depend on the body's traditional immune response, which produces T-cells and memory B-cells. Instead, it would produce proteins that block a pathogens RNAi response, which is something all viruses create.

Researchers tested their theory in mice with a virus called Nodamura. The mice lacked T and B cells, but after one injection with the test vaccine, the mice were protected against the virus for at least 90 days.

This new vaccine tech could be key to fighting bird flu, researchers say: "We are actively seeking funding to do just that.

In 2013, this same group of researchers at UC Riverside published a paper showing that flu infections also cause people to produce RNAi molecules. Ding said their next step will be to generate a universal, one-time-use influenza vaccine that would be safe for very young infants. Current flu vaccines are only recommended for infants over the age of six months. Furthermore, this new vaccine would likely be delivered as a spray. As Salon has previously reported, vaccines that dont require needles may one day become standard.

This intriguing report arrives at a moment when the bird flu virus, known as H5N1, has reportedly begun to spread among cattle. There has also been at least one confirmed human case. As Salon has reported, infectious disease experts do not expect bird flu to become a pandemic this year, that's a definite possibility in the future. One virologist told Salon she would recommend public vaccination against bird flu right now. No avian flu vaccines have yet been approved for use in humans, however, although several areunder development, none have been approved for use in humans yet.

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Ding said the vaccine his team is developing could be a contender:That's what we're aiming for. We are actively seeking funding to do just that.

Among the additional implications of this new vaccine technology, Ding said, could be more rapid protection than is now typical. What we find is that two days after the shot, you are already fully protected, he said. With current vaccines, "it will often take two weeks or more to be effective, and that's not very good for an emerging infection.

Ding said his team anticipates having a vaccine candidate ready for human clinical trials in about a year. After that, the traditional regulatory would likely take 5 to 10 years although a new public health emergency, like the COVID pandemic, could speed that up considerably.

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A one-shot vaccine for COVID, flu and future viruses? Researchers say it's coming - Salon

Proof of routine childhood vaccinations would no longer be required before kids are enrolled in child care, under a bill being considered by New Hampshire lawmakers.

The bill, which passed the New Hampshire House last month, is one of several attempts lawmakers have made to roll back public health measures in recent years.

New Hampshire currently requires kids to be immunized against certain diseases before they can be enrolled in child care. Depending on their age, that includes polio, measles, chickenpox and hepatitis B. (The COVID-19 vaccine is not required, and exceptions are made for religious or medical reasons.)

During a Senate hearing Wednesday, health officials warned against lifting vaccination requirements for child care enrollment, saying that could lead to fewer kids getting routine childhood immunizations and contribute to outbreaks of preventable diseases.

Infectious diseases that were once eliminated from the U.S., such as measles and polio, are now making a comeback because of under-immunization, said Dr. Benjamin Chan, the state epidemiologist.

He pointed out that measles was eliminated from the United States in 2000. But this year, there have been over 120 cases nationwide.

None of those cases were in New Hampshire. But Chan said the state has seen a concerning drop in the number of children getting the measles, mumps and rubella, or MMR, vaccine.

In the 2022-23 school year, 89.4% of New Hampshire kindergartners had the MMR vaccine the lowest rate in New England and below the national average.

Because measles is so contagious, at least 95% of a population needs to be vaccinated to create herd immunity and prevent outbreaks, according to the Centers for Disease Control and Prevention.

As vaccination levels decrease, this is putting our children and our communities and our child care agencies at risk, Chan said.

The current state law says no child can be admitted or enrolled in any school or child care agency without documentation theyve had the required vaccinations or qualify for an exemption. The bill would remove child care agencies from that requirement, as well as a requirement that they keep immunization records for every child.

Republican Rep. Ross Berry of Manchester, one of the sponsors, said the bill is about eliminating a needless paperwork requirement that he called burdensome for child care providers. Berry, who runs a child care center, disputed the idea that the bill removes the vaccination requirement itself, as opposed to just the reporting requirements.

But Chan and other officials with the Department of Health and Human Services disagreed.

They said that, in their reading, the bill actually does get rid of vaccination requirements for child care enrollment and even if it didnt, they argued those requirements would be meaningless without any way of ensuring compliance.

Health officials said lifting vaccination requirements could also put federal funding for child care at risk.

The bill is currently in the New Hampshire Senates Health and Human Services Committee.

Since the onset of the COVID-19 pandemic, New Hampshire lawmakers have proposed various measures to limit public health powers at the state or local level.

On Wednesday, state senators also heard testimony on a bill that would prohibit school districts from imposing mask mandates, which has also passed the House. Gov. Chris Sununu vetoed a similar bill in 2022, citing the importance of local control.

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NH public health officials warn against changing child care vaccination rules - Valley News

It hasnt been even a week since Gov. Phil Murphy was singing Essex Countys praises.

There may be no county in America thats better run than Essex County, he said during WNYCs Ask Governor MurphyprogramWednesday night. There are a handful of the best-run counties in America that are in New Jersey, and Essex happens to be one of them.

But in anew report released Tuesday, a state watchdog says Essex County, which is run by six-term Democrat and Murphy ally Joe DiVincenzo, colossally fumbled oversight of its $40 million COVID-19 vaccination program. County officials flouted federal, state, and local procurement rules and exercised so little control over spending that one politically connected vendor pocketed an identical six-figure payment twice while at least eight workers regularly got paid despite logging full-time hours with other government agencies, the report says.

Acting State Comptroller Kevin D. Walsh found that Essex County officials improperly awarded millions of dollars as emergency contracts continuing to do so long after vaccines were widely available and bypassed the competitive bidding process, public review, and approvals required to guard against overspending and abuse.

The governments obligation to protect taxpayer funds doesnt go away during an emergency, Walsh said in a statement. As we found in Essex County, overusing emergency contracts and failing to monitor vendors and implement basic financial controls increases the likelihood of fraud, waste, and abuse risks that can and should be avoided.

Investigators in the comptroller offices COVID-19 compliance and oversight project launched the probe after an anonymous tipster reported concerns about the program, which administered more than 622,000 vaccines from December 2020 through August 2023 at five sites in Newark, West Caldwell, Livingston, and West Orange, plus from a mobile clinic that traveled around the county.

The investigators found that officials continued to flout the rules around spending federal vaccination funds even though they followed appropriate procedures for other emergencies during the pandemic, such as responses to Tropical Storm Isaias and Hurricane Ida and the handling of indigent burials due to COVID-19, according to the report.

Investigators determined officials failed to document the need for emergency contracts or execute vendor contracts that spelled out the terms required by federal grants, as required. These failures expose the county to the possibility that the federal government could act to recoup the funds, Walshs report notes.

In a statement, DiVincenzo called the comptrollers report an unbalanced, unfair, and inaccurate gotcha document that identifies issues with a small fraction of the funds Essex County spent fighting COVID-19. DiVincenzo also chided Walshs office for not helping local officials prevent the misuse of public funds in the early months of the pandemic.

It would have been helpful to have them stand shoulder to shoulder with us back then rather than have them unfairly criticize our performance years later, the statement says.

The investigators also discovered lax oversight of the 93 outside vendors the county hired to carry out its vaccination program, including 15 payments totaling $871,211 that were made without invoices, making it impossible to validate what goods or services were provided.

In one case, officials paid a vendor $264,000 for advertising services but couldnt confirm those services were performed.

In another case, the county paid Dunton Consulting almost $1.3 million for robocall services from May 2020 through August 2021 without verifying the calls occurred, and even though the firms invoices were riddled with errors and charged fees that varied wildly, without explanation. The company also charged far more 2.8 to 9.8 cents a minute than county officials paid when they eventually put the contract out for competitive, public bidding, the report notes. The county paid less than 1 cent per minute under the newer contract.

County officials also erroneously paid Dunton $110,514.41 twice for the same services, but the East Orange-based firms owner Rasheida Smith and county officials said they didnt notice the error until the Comptrollers office brought it to their attention, according to the report. Instead of ordering the immediate return of the full overpayment, officials agreed Smith could repay a discounted amount, which they characterized as a loan, over five years without interest, the report notes.

Thats a flawed response because the state constitution prohibits governments from loaning public funds to private companies, the loan wasnt signed by any county officials, county commissioners didnt approve it at a public meeting, and the county hasnt shown it has the proper internal controls to monitor a long-term loan, investigators wrote.

Smith is a Democratic political operative and former campaign manager who has worked for U.S. Sen. Cory Booker, former Rep. Charles Rangel, and other prominent politicians. She co-founded Dunton with Leroy Jones Jr., a former state assemblyman who now chairs the Essex County and statewide Democratic parties. Jones is no longer affiliated with Dunton, NorthJersey.com reported in 2022.

The Countys contract with Dunton demonstrates that excessive emergency contracting without competitive bidding can result in a shocking price tag for taxpayers, investigators wrote in the report.

Smith could not be reached to comment.

More than 850 people worked in the vaccination program, and county officials allowed them to log their hours remotely and didnt enforce on-site sign-in sheets meant to confirm their presence, investigators found.

As a result, the county spent $17 million on staffing without verifying that workers worked the hours they logged, investigators said.

Eight workers routinely worked other public jobs at the same time they worked for the countys vaccination program, meaning they got paid by both public entities for the same hours including one woman who collected $130,000 over 11 months under the vaccine program, even though the county health officer didnt know who she was or what she did, according to the report.

Even after firing three workers who were found to have fudged their hours, officials didnt tighten its timekeeping system or bother to investigate more broadly, according to the report. Officials also classified the vaccination workers as independent contractors, meaning the county then didnt pay into unemployment funds or provide benefits.

Investigators shared their findings with the state Department of Labor and Workforce Development and other authorities for follow-up action.

DiVincenzos statement says Essex County immediately fired no show employees and when possible, funds were repaid.

Im not saying that we were perfect. But when any wrongdoing was identified, we acted swiftly, it says.

Natalie Hamilton, a Murphy spokeswoman, said the governor is aware of the comptrollers findings but also recognizes that the speed of establishing a fully operational vaccine program in late 2020 and early 2021 was directly correlated with saving lives.

Under the leadership ofCounty Executive Joe DiVincenzo, Essex County had one of the most efficient vaccine programs anywhere in America, helping establish New Jersey as a national leader in vaccine distribution, Hamilton said.

Walsh and his investigators issued three recommendations, urging Essex County officials to:

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Feeble oversight of Essex County's $40M vaccine program spurred abuses, watchdog finds New Jersey Monitor - New Jersey Monitor

International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine strain updates that was organised by the International Coalition of Medicines Regulatory Authorities and the World Health Organization (WHO).

Currently authorised vaccines, particularly those that have already gone through adaptation of the composition, continue to be effective at preventing hospitalisation, severe disease and death due to COVID-19. However, protection wanes over time and as new SARS-CoV-2 variants emerge. For this reason, update of vaccine composition has to be considered on a regular basis. Meeting participants stressed that international convergence on the process and timing of COVID-19 vaccine strain updates are therefore critical in view of the continuous evolution of SARS-CoV-2.

The meeting report provides an overview of key regulatory considerations related to updated COVID-19 vaccine composition. It also highlights data requirements for authorised vaccines to support the approval of strain changes. Workshop participants also discussed virus evolution and circulation in different regions of the world.

The conclusions detail how international regulators and WHO will put in place a structured process to support and optimise timing around COVID-19 vaccine antigen recommendations.

The workshop brought together representatives of national regulatory authorities, WHO, scientists, and industry to present their perspectives and experience with the updating of the COVID-19 vaccine composition and to propose a way forward. Participants acknowledged that regular meetings with key stakeholders, including vaccine manufacturers, will contribute to timely regulatory approvals and the use of updated COVID-19 vaccines in national vaccination programmes.

The two-day workshop was held virtually on 26 and 27 February 2024. The meeting aimed to identify a structured and aligned process to optimise timely vaccine antigen composition recommendations and regulatory approval for vaccines with an updated composition. Delegates representing more than 35 medicines regulatory authorities globally, as well as experts from WHO, the European Commission and industry engaged in the scientific discussions.

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COVID-19 vaccine strain updates: Global regulators agree on timing and data requirements | European Medicines ... - European Medicines Agency |

Because COVID-19 vaccinations have been associated with myocarditis (inflammation of the heart muscle) in teens and young adults, concerns have been raised about possible vaccine-related cardiac fatalities in this age group.

[1]

Although the rate [of myocarditis] was higher during the pandemic year of 2021, myocarditis remained an infrequent cause of death among persons in this age group [between 15 and 34 years old], wrote study authors Juventila Liko, MD, and Paul Cieslak, MD, with the Oregon Health Authority.

Misinformation from anti-vaccination groups including unfounded speculation onsocial mediathat the shots contributed to the collapse of Buffalo Bills safetyDamar Hamlin last year has only served to fuel doubts surrounding vaccination.

There are a lot of anti-vaxxers out there who have promoted the concept that the vaccine will cause myocarditis and kill young men, says Robert A. Kloner MD, director of of the Cardiovascular Research Institute at Huntington Medical Research Institutes in Pasadena, California, who was not involved in the research.

[2]

In this analysis, scientists reviewed death certificates from more than 1,200 previously healthy young people, aged 16 to 30 years old, who died from COVID-19, heart-related issues, or unknown causes between June 1, 2021 and December 31, 2022. A total of 925 (72 percent) were male and 367 (28 percent) were female.

For 30 of these individuals, COVID-19 was listed as the cause of death.

For 101 others, a cardiac cause of death could not be excluded. Immunization records were available for 88 people in this group. Of 40 deaths that occurred among people who had received an mRNA COVID-19 vaccine, three occurred within 100 days after getting the shot.

Two of these deaths were attributed to chronic underlying conditions, and for one death, the cause was undetermined. None of the deaths were attributed to vaccination.

These data do not support an association between receipt of mRNA COVID-19 vaccine and sudden cardiac death among previously healthy young persons, concluded the study authors. Detection of a small difference in mortality rate from myocarditis would require a larger sample size.

For Edward Jones-Lopez, MD, an infectious disease specialist with Keck Medicine of USC in Los Angeles, the results provide further confirmation of the vaccines safety, and should encourage all people 6 months and older to get the shot to prevent COVID-19 complications, including death.

Theres no doubt whatsoever that the benefits of the vaccination outweigh the risks, says Dr. Jones-Lopez, who was not involved in the research. This study confirms that mRNA COVID vaccines are not leading to any serious cardiac events or deaths, and they continue to be among the safest vaccines that have ever been produced.

[3]

[4]

The vaccine does not necessarily prevent someone from getting infected, but it lessens the severity of the disease and reduces hospitalizations and death, says Kloner.

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COVID-19 Vaccine Doesn't Lead to Heart-Related Deaths in Young People - Everyday Health

A new study found no evidence of a potential complication of the COVID-19 vaccine myocarditis in cardiac deaths in the state

A study by the Oregon Health Authority found reassuring evidence that a complication of the COVID-19 vaccine myocarditis was not associated with cardiac deaths among previously healthy young people, in the 19 months following the initial vaccine rollout.

However, due to its limitations, the study could not rule out the possibility that in very rare cases, cardiac death may be a complication of the vaccine.

The study was published this week in the Centers for Disease Control and Preventions public health bulletin Morbidity and Mortality Weekly Report.

Myocarditis, which is essentially inflammation of the heart muscle, is a known but rare complication of the COVID-19 vaccine. It happens most often to adolescents and young males within seven days after the second dose of an mRNA COVID-19 shot.

The OHA study looked at deaths in Oregon that occurred following the initial rollout of the COVID-19 vaccine, from June 1, 2021, to Dec. 31, 2022.

The authors used the Oregon death certificate database to look for people aged 16-30 years old who died of cardiac causes or of undetermined causes during that time.

They found a total of 1,292 deaths among people in that age range. Of those, none had COVID-19 vaccination listed as a cause of death on their death certificate.

The authors then narrowed their focus to 66 males and 35 females whose deaths were due to cardiac events or unknown causes, according to their death certificates.

The researchers used the states vaccination records to see whether any of those young people had died within 100 days of receiving a mRNA COVID-19 vaccine dose. They found three deaths that met that criteria.

One male died 21 days after COVID-19 vaccination. His cause of death was listed as congestive heart failure attributed to hypertension and other chronic conditions. A second male died 45 days after vaccination, of an undetermined natural cause. One female died of undetermined causes four days after COVID-19 vaccination. Her death certificate listed chronic respiratory failure as a factor.

Lars Grosse-Wortmann, a pediatric cardiologist at Oregon Health & Science University and an expert on COVID-19 vaccine myocarditis, was not involved in the study.

He said that combining big datasets, as the study did, is a helpful approach to better understand a rare vaccine complication like myocarditis.

To me, the study is reassuring in the way that they didnt find a big smoking gun, Grosse-Wortmann said. They didnt all of a sudden identify a dozen patients where it had that close chronological association with their vaccine.

On the other hand, its neither big enough nor detailed enough for me to say, This study leads me to think theres no risk for sudden cardiac death, he added.

Without detailed medical records for the three patients the study identified who died within 100 days of vaccination, it was hard to draw firm conclusions in those cases.

In particular, the death of the female could plausibly have been vaccine-related, given the timeline in that case, Grosse-Wortmann said.

I would say we dont know, he said. The conclusion from the paper is correct, the data does not support the association, but it does not lay the question to rest whether sudden cardiac death could occur.

Grosse-Wortmann, at the Federal Drug Administrations request, has been leading an effort to compile research and better characterize myocarditis following mRNA vaccination.

That effort has found the prognosis of young patients with myocarditis related to the mRNA COVID-19 vaccine is generally positive. People with myocarditis after vaccination typically have mild cases of it, and they tend to recover quickly.

However, Grosse-Wortmann said, some show signs of heart injury and scarring in imaging scans that seem somewhat at odds with the mild clinical presentation of their cases.

Because the first cases were reported in 2021, the longest any patient has been followed is three years.

Thats long enough to say these patients do clinically well, but probably too short to say if the scars that some of them carry in their hearts have any significance for their long term health and survival, Grosse-Wortmann said.

Any risk due to a rare vaccine side-effect, Grosse-Wortmann said, has to be weighed against the benefits of vaccination. In the case of the COVID-19 shots, the potential benefits include protection against death, long ICU and hospital stays, long COVID, and the long-term cardiovascular risk factors of a COVID-19 infection.

The OHA study authors also looked at COVID-19 deaths among adolescents and young people during the same time period in 2021 and 2022. COVID-19 was cited as the cause of death for 30 Oregon residents in that age group. Almost all were unvaccinated.

It is clear that the risk, if any, of cardiac death linked to COVID-19 vaccination is very low, while the risk of dying from COVID-19 is real, said Paul Cieslak, co-author of the study. We continue to recommend COVID-19 vaccination for all persons 6 months of age and older.

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Oregon study: COVID-19 vaccine not associated with cardiac deaths in healthy young people - The Lund Report