Category: Covid-19 Vaccine

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FIRST ON FOX: The House Armed Services Committee is circulating a memo to fellow lawmakers stressing the conservative wins in this yearsannual defense policy bill in a bid to unite Republicans around the bipartisan legislation.

The 3,000-page text of the National Defense Authorization Act (NDAA) was released late on Wednesday night, a product of lengthy negotiations between the GOP-controlled House and Democrat-held Senate.

A 17-page document of suggested talking points, obtained by Fox News Digital, was sent around to House Republicans on Thursday morning before an expected chamber-wide vote next week.

The compromise bill includes several key victories for the GOP on issues like COVID-19 vaccines and "woke ideology," among other topics, according to the memo.

TUBERVILLE ENDS BLOCKADE OF MOST MILITARY PROMOTIONS AFTER MONTHS-LONG ABORTION FIGHT

U.S. Secretary of Defense Lloyd Austin would be mandated to review discharges of troops who refused to take the COVID vaccine, under the new NDAA, a House GOP memo states. (Photo by Kevin Dietsch/Getty Images)

"The FY24 NDAA pushes back against the radical woke ideology being forced on our servicemen and women and restores the focus of our military on lethality," the memo told members.

It encouraged lawmakers to emphasize the fact that the NDAA would stop funding from being used to teach Critical Race Theory in the military, as well as in service academies and Pentagon-run schools, and it would similarly prevent any funds from being used to hold drag shows or drag story hours.

TUBERVILLE NOT BUDGING ON MILITARY HOLDS OVER ABORTION POLICY AS DEMS EYE RULES CHANGE

This years NDAA would also freeze hiring for Diversity, Equity and Inclusion (DEI) roles at the Pentagon until a watchdog investigation into the Department of Defenses DEI practices is completed.

Rep. Mike Rogers, R-Ala., is chairman of the House Armed Services Committee

The memo also encourages Republicans to point out that the NDAA would not include any of the Biden administrations climate policy goals.

On the COVID-19 vaccine, the NDAA would force the Pentagon to review its discharge policies for troops forced out for not taking the shot.

Defense Secretary Lloyd Austin would have to ensure that service members who have been discharged for refusing it are fully aware of how to return to active duty, if they so choose, according to the memo.

GOP SENATORS RAIL AGAINST TUBERVILLE'S MILITARY HOLDS NEARLY ALL NIGHT

Troops discharged for not taking the vaccine would also be entitled to full retirement benefits, the memo said.

"The FY24 NDAA protects current servicemembers and provides a path back to service for the 8,000 servicemembers discharged for failing to take the COVID-19 vaccine," the memo said.

Senate Majority Leader Charles Schumer, D-N.Y., ushered the bipartisan NDAA through its first legislative hurdle on Thursday. (Tom Williams/CQ-Roll Call, Inc via Getty Images)

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For national security hawks, other proposed talking points highlight measures in the NDAA to help Israel in its war against Hamas, and to deter the Chinese Communist Partys influence at home and abroad.

The NDAA was advanced by the Senate in an 82-to-15 vote on Thursday afternoon, teeing up a formal vote next week. The House is expected to act on it afterward.

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Defense bill scores big wins for GOP on drag shows, DEI and COVID vaccines, internal House memo says - Fox News

WASHINGTON The U.S. has entered a new normal for COVID-19, with lower but consistent levels of infection. But experts fear that the new normal may include people skipping vaccines that are still needed for protection.

So few people are getting this new booster that is specifically targeting the new circulating strains of the Omicron virus, said Will Humble, executive director of the Arizona Public Health Association.

The Arizona Department of Health Services no longer posts regular updates of vaccination rates, but the Centers for Disease Control and Prevention said that just 17% of Arizona residents were up to date with their COVID-19 vaccinations as of Sept. 12, the most recent date for which numbers were available.

Arizona was about in the middle of states when it came to being up to date on boosters, with rates ranging from 3.7% in Texas to 35.4% in Vermont.

It comes as the rate of COVID-19 infections is seeing a seasonal surge, but cases are a mere fraction of the highs seen during the pandemic.

Health officials worry that not enough Americans are keeping their COVID-19 vaccinations up to date with vaccines targeting the newest strains of the virus. A Air Force Reservist holds up a first-generation vial of Moderna COVID-19 vaccine in this Feb. 4, 2021, photo. (Photo by Joshua J. Seybert/U.S. Air Force)

For the week of Nov. 26, the most recent date for which it has numbers, ADHS reported 3,627 confirmed coronavirus cases in Arizona. That compares to 44,974 cases reported at roughly the time three years ago, and the current numbers are dwarfed by the 157,540 cases reported in the first week of 2022, the peak of the pandemic.

We are very well below the three-year average at a 74% decrease, said Siman Qaasim, the ADHS assistant director of policy and intergovernmental affairs.

Deaths are falling as well. The CDC reported just 438 COVID-19 deaths nationwide in the week preceding Nov. 25, and just 12 for that week in Arizona. Those compare to 25,974 nationally and 971 in Arizona during the worst week of the pandemic.

But with all those numbers down, the possibility that cases may begin to rise becomes more likely, due to the lack of updated vaccinations. Humble attributes the low vaccination to several reasons, including that its just human psychology.

Part of it is political, Humble said, noting that people are not as reluctant to roll up their sleeves for a seasonal flu shot. Part of it is just, people are in the habit of getting the influenza vaccine. Its more familiar to them over the course of even decades.

Dr. Georges Benjamin, executive director at the American Public Health Association, says those factors can be described as COVID fatigue.

If history tells us anything you do tend to have a fall-off, as people begin to see, at least currently, the disease is not as deadly as it has been in the past, Benjamin said.

He and other health care professionals say that is a mistake.

I think the best medical advice that we can give people for their health is to go ahead and get fully vaccinated based on the current recommendations, Benjamin said.

The latest vaccines, from pharmaceutical companies Moderna, Pfizer-BioNTech and Novavax, target XBB.1.5, a version of the omicron variant of the coronavirus that has been present since November 2021. The CDC said the updated vaccines should also work against currently circulating variants of the virus many of which descended from, or are related to, the XBB strain.

Health care professionals say the best protection is getting vaccinated, but that there are additional ways to halt the spread of the disease.

Of course, staying at home when youre sick to protect others, to protect people who are vulnerable older Arizonans as well as those who may have a condition, Qaasim said.

With the holiday season underway, experts say the uptick in travel and people gathering could potentially lead to a rise as well.

The social mixing that happens in the holiday season amplifies the virus, Humble said. The more people are in closed, indoor environments Those are great environments to spread both influenza and COVID-19.

But theres an easy way to keep from doing that while still enjoying the holidays, Humble said.

It couldnt be any simpler, just get the vaccines, he said. Thats it.

Alexandria Cullen expects to graduate in December 2023 with a bachelors degree in journalism and mass communication. Cullen has interned as a reporter at Ability360 and was news director and a reporter for CTV at Colorado State University.

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COVID-19 cases down from pandemic; so are vaccinations, worrying experts - Cronkite News

CLAIM

the COVID vaccines have killed millions of people worldwide, an estimated 1 death per 1,000 doses on average in a standard population

DETAILS

Factually inaccurate: New Zealands excess mortality statistics contradict the claim that COVID-19 vaccines have killed one in a thousand people. Over 90% of adults in New Zealand were vaccinated in 2021, a year that actually saw negative excess mortality, or fewer deaths compared to the pre-pandemic baseline.

KEY TAKE AWAY

Unlike many other countries during the COVID-19 pandemic, New Zealand experienced fewer deaths compared to the pre-pandemic baseline in 2020 and 2021, as a result of COVID-19 restrictions. Since the restrictions were lifted, mortality rates in the elderly have risen. This is likely due to a return of respiratory viruses like the flu, and likely represents a return to baseline mortality, not an increase in excess mortality due to COVID-19 vaccines. Published studies so far have found no association between COVID-19 vaccines and an increased mortality risk.

The video recording of Kirschs talk has been archived here and the slides he presented during the talk can be found here. The Rumble video of the talk has been viewed more than 217,000 times.

The New Zealand data used by Kirsch turned out to be personal health information taken from government databases without authorization by Barry White, a database administrator who worked for Te Whatu Ora, New Zealands public health agency.

The New Zealand Herald reported that White was arrested on 3 December 2023 in connection with the privacy breach and has been charged with accessing a computer system for dishonest purposes. Prior to his arrest, White had appeared in a video with Liz Gunn, a former TV presenter and anti-vaccine campaigner, which revealed that he had taken the data from the database.

Kirsch uploaded the illegally acquired data online and signaled to his Substack readers that they could download the data for themselves, although he also claimed to have anonymized the data. Te Whatu Ora has since been granted an injunction to prevent any publication of the data to protect the privacy of those affected by the breach. Kirsch and other individuals have had their accounts on private hosting services taken down after using these services to host the data.

In this review, we examine the claims made by Kirsch and explain why the claims cannot be substantiated by the New Zealand data that he obtained. We will also present the evidence showing that, contrary to the claim, COVID-19 vaccination isnt responsible for millions of deaths worldwide.

According to a Substack post published by Kirsch on 1 December 2023, the New Zealand data he used consisted of health records linked to four million doses of COVID-19 vaccine, out of the 12 million administered in the country so far.

The data came from the pay-per-dose program and included information such as the type of vaccine the person received, as well as their date of birth and death, if death occurred.

Kirschs analysis used what he called a time-cohort series analysis, which he considered the gold standard, a claim that wasnt substantiated with evidence. To do this, he plotted the number of deaths that occurred in the months after COVID-19 vaccination.

He concluded that COVID-19 vaccines were responsible for millions of deaths based on the fact that his analysis showed deaths rose in the first six months after vaccination after vaccination in those aged 60 and above after vaccination. The same trend was also seen in an overall analysis for all ages (shown in slides 136 to 140).

If the COVID-19 vaccines were safe, he argued, then mortality in vaccinated people should have fallen or remain unchanged, with the exception of the first three weeks post-vaccination. According to Kirsch, a rise in mortality in the first three weeks post-vaccination could be explained by the healthy vaccinee effect (asserted in slide 13), but not for any later rise in mortality. For Kirsch, a later increase in deaths could only be due to vaccines.

The healthy vaccinee effect can come about because vulnerable people who are more likely to get vaccinated are also more likely to die compared to the general population. But Kirsch provided no reliable evidence to support the assumption that this effect can only last for three weeks or that only COVID-19 vaccines can explain later deaths.

He previously applied the same method to U.S. Medicare data to claim COVID vaccines increase your risk of dying, which Health Feedback analyzed back in March 2023. This Medicare analysis also appeared during his talk at MIT. In our earlier review, we found that Kirschs Medicare data analysis didnt account for the effects of seasonality and COVID-19 waves. As such, his analysis incorrectly attributed deaths from COVID-19 and seasonal illnesses to COVID-19 vaccines.

There are more important caveats and weaknesses associated with Kirschs analysis.

Firstly, we dont know if the data he used represents a random selection of the general population. In his Substack post, Kirsch asserted that whether someone is in the pay-per-dose program is pretty random, but this is an assumption that Kirsch didnt test or demonstrate to be true.

Secondly, by Kirschs own admission, the data wasnt complete. On Substack, he wrote that Many people will not have all their doses in this database, e.g., there may just be dose 3 data for someone. This means we dont have a full picture of vaccination outcomes for every individual with records in the pay-per-dose data, which makes it even more difficult to calculate an accurate mortality rate in this population.

David Gorski, a surgical oncologist and editor at Science-Based Medicine, who discussed Kirschs analysis at length in this article, countered that:

[I]f you are going to assert that, for purposes of your analysis, incomplete records and uneven sampling in the dataset dont matter, you really do need to show the receipts and mathematically prove that these deficiencies in the dataset dont affect the results of your analysis.

In particular, he highlighted how epidemiologists would test their data using multiple approaches in order to determine if the assumptions used in their analyses are sound (also called sensitivity analysis).

Thirdly, the data contained no information on mortality in unvaccinated people. Kirsch also didnt compare mortality rate with that of the pre-pandemic baseline. Without this information, its impossible to establish whether the mortality rate in vaccinated people is actually different from that of unvaccinated people.

Fourthly, Kirschs analysis emphasized deaths in the elderly, glossing over some important mortality trends in New Zealand over the past three years, which we discuss in the next section.

Jeffrey Morris, biostatistician and professor at the University of Pennsylvania, was among the experts who analyzed Kirschs claims.

On X/Twitter, he pointed out that the rise in mortality Kirsch observed in the months after vaccination was only present in senior citizens, but not in children or younger adults. However, Kirschs choice to show only deaths in those aged 60 and above and the all-ages mortalitywith the latter primarily representing deaths in the elderlyobscured this fact.

This left one with the impression that this rise in mortality occurred across the entire population, when this only affected the elderly.

New Zealands official data agency, Stats NZ, reported in February 2023 that:

Deaths are gradually increasing over time, despite a generally increasing life expectancy. This is because of population growth, and more people in older ages where most deaths occur. Four out of every five deaths in 2022 were to people aged 65 years and older, and just over half (53 percent) were to those 80 years and older. The number of people in the population reaching these older ages is increasing, which will therefore increase the number of deaths occurring.

Health Feedback also obtained population mortality data from Stats NZs Infoshare website, which provides this data stratified by age (see Figure 1 below). The data show that in groups below the age of 60, there was no substantial change in mortality rate between 2020 and 2022. This is sufficient to refute the implication that COVID-19 vaccines have caused widespread deaths across New Zealands entire population.

Figure 1 Age-specific mortality rates for groups aged 59 and below (A) and groups aged 60 and above (B). Note that the mortality rates for those below 60 are substantially lower than those aged 60 and above; the maximum value for the y-axis (that is needed to display data fully) in A is five, but 300 in B. Additionally, the y-axis interval in A is one, but 50 in B. Mortality rates in A show no significant increase between 2020 and 2022, but increases can be seen in B, particularly for those 80 years old and above. Source: Stats NZ Infoshare.

The next question is why mortality in elderly groups has risen and whether this could be plausibly attributed to COVID-19 vaccines.

To answer this question, we need to account for the fact that New Zealand actually experienced negative excess mortality in the first two years of the pandemic (see Figure 2 below), meaning that there were fewer deaths compared to the historical baseline, unlike most other countries during the pandemic. This has been attributed to New Zealands strict elimination policy, enacted in 2020 and 2021.

Figure 2 Excess mortality in New Zealand from March 2020 to October 2023. Note the large negative excess mortality spanning from March 2020 to around early 2023. Source: Our World in Data.

In October 2021, New Zealand switched to a mitigation policy and relaxed restrictions. This was followed by the introduction of the Omicron variant into the country, which led to a wave of infections in early 2022 (see Figure 3 below). By comparing Figures 2 and 3, we can see that the rise in mortality in New Zealand corresponds to the wave of COVID-19.

Figure 3 Confirmed new COVID-19 cases in New Zealand from March 2021 to October 2023. Note the spike in COVID-19 cases beginning around March 2022. Source: Our World in Data.

A letter to The Lancet, in which scientists from the Medical Research Institute of New Zealand analyzed weekly all-cause mortality in 2020, 2021, and 2022[1].

They found that:

In 2020, there was a negative excess mortality with 439.4 fewer deaths per million, potentially due to several factors including the elimination of COVID-19, markedly reduced burden of influenza and other respiratory viruses, and fewer deaths from road traffic accidents, occupational causes, air pollution, and post-surgical complications.

2021 also saw negative excess mortality, with less than a quarter of the population diagnosed with COVID-19, and weekly mortality rates fluctuated around the historical mean with a negative excess mortality of 76 fewer deaths per million population.

By early 2022, 93% of the eligible population in New Zealand had already been fully vaccinated. However, a relaxing of restrictions came hand in hand with the spread of Omicron, leading to excess mortality of 662.4 deaths per million population, predominantly due to COVID-19-attributable deaths.

When all of these data and findings are taken together, it suggests that the huge negative excess mortality was due to COVID-19 restrictions, which have since been lifted. And with the lifting of restrictions, deaths due to causes like flu and other respiratory viruses, as well as other causes like car accidents, have made their return.

Therefore, the later rise in mortality in the elderly that Kirsch observed very likely represents a return to baseline mortality, rather than excess mortality caused by the vaccines, Morris pointed out in an exchange with Gorski.

In a separate thread on X/Twitter, Morris emphasized the importance of considering multiple potential explanations for a certain observation, due to confounding factors and bias inherent to observational data:

As I would emphasize, any genuine attempt to assess potential causal effects of vaccines requires consideration of controls and adjust for confounding and other sources of bias inherent to these observational data in the pandemic (as may published studies do), but it might be useful for some to consider looking at these data as a basic plausibility filter for assessing whether they think the excess deaths are primarily driven by vaccination or by covid.

Published studies in the U.S. and Hungary havent found COVID-19 vaccination to be associated with a greater risk in mortality[2-4].

The observation that there was negative excess mortality in 2021, coupled with the fact that more than 90% of those eligible for the vaccine had already received at least one dose in 2021, means that Kirschs claim simply doesnt hold up under scrutiny. If COVID-19 vaccines were as deadly as Kirsch claimed, with a mortality rate of one in a thousand vaccinated people, then we would have seen this manifest as excess mortality in 2021.

A similar claim related to the New Zealand dataset, made by the X/Twitter account Leading Report which we investigated, is that it showed 20% of New Zealanders died from the COVID-19 vaccines. USA Today covered this claim in a fact-check, speaking to experts who explained the math simply didnt add up:

Nearly 4 million people in New Zealand have received two doses of an mRNA COVID-19 vaccine as of Dec. 1, according to public health agency Te Whatu Ora. For the claim to be true, at least 800,000 of those vaccinated people would have had to have died. But from the start of 2020 through June 2023, there were about 125,000 total deaths attributed to all causes, according to Statistics New Zealand, the countrys government data agency.

Kirsch told USA Today that he stood by his analysis.

Kirschs analysis of a subset of New Zealand vaccination data is methodologically flawed and makes unjustified assumptions about the data, such as by claiming the data represent a random sample, when no evidence was provided to show this was the case. It also cherry-picked the data it presented, implying that the rise in mortality seen in the elderly also applied to other age groups.

In fact, this rise was limited to the elderly; no significant changes in mortality in children and younger adults occurred in New Zealand between 2020 and 2022.

New Zealands strict elimination policy during the first two years of the COVID-19 pandemic produced a huge negative excess mortality, as it didnt only minimize COVID-19 deaths, but also reduced deaths from causes like respiratory illnesses, traffic accidents, and surgical complications.

This policy later shifted to a more relaxed mitigation policy. This also meant that the causes of death diminished by COVID-19 restrictions made a comeback, in tandem with a rise in mortality rate in the elderly. While this rise is genuine, it doesnt represent excess mortality from vaccines as some have claimed, but a return to baseline mortality.

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Steve Kirschs claim that New Zealand data shows COVID-19 vaccines killed millions is based on a flawed analysis - Health Feedback

New global survey data published in Health Affairs shows that half of unvaccinated respondents said they wanted a COVID-19 vaccine but were not able to obtain the shots, suggesting that unmet supply needs still drives low vaccine uptake in many low- and middle-income countries.

The survey came from 15,696 respondents in 17 countries in Africa and the Western Pacific. Surveys were conducted from May 2022 to January 2023.

The authors of the report said the finding sheds light on accessibility and acceptability, what they call the twin barriers to COVID-19 vaccination.

Nationally representative surveys included 8,518 responses from 10 Western Pacific countries (Cambodia, Fiji, Laos, Malaysia, Mongolia, the Philippines, Solomon Islands, Tonga, Vanuatu, and Vietnam), collected in May 2022 and January 2023, and 7,179 responses from 7 African countries (Cameroon, the Democratic Republic of the Congo [DRC], Kenya, Nigeria, Senegal, South Africa, and Uganda), collected in August 2022, the authors said.

Respondents were asked about vaccine status and number of doses.

"We estimated unmet immunization demand, as the dependent variable for regression, by using the question asking whether respondents would receive available COVID-19 vaccines for themselves," the authors wrote. "Respondents who replied 'definitely yes' or 'unsure but leaning towards yes' were treated as being willing to vaccinate."

Those questions were given only to participants who said they were unvaccinated.

African countries had the highest rate of respondents who said they wanted to be vaccinated but were unable to obtain a vaccine. Unmet immunization demand was highest in the DRC (43%), Nigeria (39%), Cameroon (36%), Senegal (30%), and Kenya (27%).

In contrast, unmet demand was lower than 7% in Western Pacific countries, the authors said.

Among all survey respondents, 72% of people reported having received at least one vaccine dose. Again, African countries had the lowest percentage of people reporting at least one dose of COVID-19 vaccine, and in all seven African nations, less than 20% of the population had received a booster shot.

The findings, the authors wrote, shift the narrative away from vaccine hesitancy and development to vaccine access in low- and middle-income countries.

This proportion was substantially higher in sub-Saharan Africa, with unmet demand ranging from 11percent to 43percent.

"Across all seventeen countries, the percentage of the population with unmet demand for COVID-19 vaccination made up about 14percent of the sample. However, this proportion was substantially higher in sub-Saharan Africa, with unmet demand ranging from 11percent to 43percent," the authors wrote.

"This suggests that a substantial proportion of nonvaccination is due to uneven accessibility of vaccines, as opposed to hesitancy, and it suggests that there is still much work to be done to build health care infrastructure and distribution capacity in low- and middle-income countries, especially in sub-Saharan Africa."

The rest is here:

Report spotlights inequalities in COVID vaccine access in poorer nations - University of Minnesota Twin Cities

Self-amplifying RNA vaccines will add to the arsenal of conventional messenger RNA jabs.Credit: Pascal Pochard-Casabianca/AFP via Getty

The approval of yet another RNA-based vaccine for COVID-19 might not seem momentous. But the endorsement last week by Japanese authorities of a jab against SARS-CoV-2 constructed using a form of RNA that can make copies of itself inside cells the first self-amplifying RNA (saRNA) granted full regulatory approval anywhere in the world marks a pivotal advance.

The new vaccine platform could provide potent defence against various infectious diseases and cancers. And because it could be used at a lower dose, it might have fewer side effects than other messenger RNA (mRNA) treatments have.

Why rings of RNA could be the next blockbuster drug

When used as a booster in clinical testing, the newly authorized vaccine, ARCT-154 developed by Arcturus Therapeutics in San Diego, California, and its partner CSL, a biotechnology firm headquartered in Melbourne, Australia triggered higher levels of virus-fighting antibodies1 that circulated the body for longer than did a standard mRNA COVID-19 vaccine.

Researchers have been trying to make saRNA vaccines a reality for more than 20 years. Being the first to bring an approval for this platform is pretty huge, says Roberta Duncan, RNA-programme leader at CSL and vice-chair of the Alliance for mRNA Medicines, an advocacy organization that launched last month to advance the sectors policy priorities.

Its incredibly validating to the field, says Nathaniel Wang, chief executive and co-founder of Replicate Bioscience in San Diego, California, a company that develops saRNA vaccines. He anticipates that, with continuing advancements, saRNA technology will increasingly replace conventional mRNA in a diverse array of therapeutic contexts. It has more versatility in its potential, Wang says.

That versatility emerges from its unique features.

Conventional mRNA-based COVID-19 shots consist mainly of the genetic instructions for a viral protein that are surrounded by regulatory sequences. A cells machinery produces the protein for as long as these instructions persist, and that protein known as an antigen stimulates an immune response. By contrast, saRNA jabs go a step further by integrating the genes needed for the replication and synthesis of the antigen-encoding RNA, effectively establishing a biological printing press for fabricating the vaccine inside cells (see Vaccine strategies compared).

Credit: Nik Spencer/Nature, adapted from How COVID unlocked the power of RNA vaccines

In the case of ARCT-154, the antigen is a surface protein called spike that is expressed by SARS-CoV-2. The replication machinery is taken from a naturally occurring virus, a mosquito-borne pathogen known as Venezuelan equine encephalitis virus that causes deadly brain swelling in horses and humans. Notably, scientists at Arcturus have removed key genes from the viral sequence backbone, thus rendering the system non-infectious and safe for use in humans.

People often think that the saRNA vaccine platform is simply a variation on conventional mRNA shots, but in practice its really not, says Anna Blakney, a bioengineer who studies the technology at the University of British Columbia in Vancouver, Canada. saRNA is a totally different beast.

Because of its virus-like nature, saRNA interacts with the immune system in distinctive ways that could prove beneficial across a range of disease scenarios. When it comes to preventing infections, for instance, its self-amplifying capabilities could enable the use of lower vaccine doses.

ARCT-154 requires one-tenth to one-sixth as much vaccine per person as other RNA-based COVID-19 booster jabs. Reducing the amount of vaccine administered in each injection should result in lower production costs. And although the side-effect profile of ARCT-154 seems comparable to that of a conventional mRNA shot1, it is conceivable that the benefits of the platforms smaller doses will help to mitigate the severity of aches, fevers, chills and other loathsome symptoms collectively known as reactogenicity.

These unpleasant reactions remain a considerable impediment for people to take mRNA-based vaccines. Consider the seasonal influenza vaccine. Existing jabs that use older vaccine technology cause only mild reactions. At present, several conventional mRNA-based flu jabs are progressing through clinical trials and these are showing promising signs of eliciting more protective antibodies than existing shots. Yet their side-effect profiles still leave room for improvement, notes Christian Mandl, co-founder and chief scientific officer of Tiba Biotech in Cambridge, Massachusetts. The saRNA vaccines lower dose could help to solve some of the reactogenicity issues, he says.

The saRNA vaccine platform does have some downsides. Because of the added genetic instructions, the jabs tend to contain longer sequences typically at least three times the length of what is used in conventional mRNA shots which adds complexity to the manufacturing process.

Pioneers of mRNA COVID vaccines win medicine Nobel

They also engage with the immune system in intricate ways for example, by forming replication intermediates that help to stimulate beneficial immune-signalling pathways. However, excessive stimulation can backfire, including when the vaccine prompts the immune system to block RNA replication, thereby nullifying its benefits.

It is a delicate needle to thread, says Niek Sanders, a gene-therapy researcher at Ghent University in Belgium and a scientific founder of Ziphius Vaccines, a company in Merelbeke, Belgium, that develops saRNA-based medicines. You have to find the optimal dose of the self-amplifying RNA in combination with the right delivery system.

The biotech industry has tried for decades to get the balance right. From 2003 to 2010, for instance, a company called AlphaVax, based in Research Triangle Park, North Carolina, conducted trials of saRNA vaccine candidates for a range of infectious diseases and cancers. AlphaVax ultimately wound down for business reasons after failing to secure further investment, says the firms co-founder Jonathan Smith, who continues to develop saRNA vaccines as the chief scientific officer of VLP Therapeutics in Gaithersburg, Maryland.

With approval for ARCT-154 secured in Japan, its developers are now seeking authorization in Europe; a regulatory decision is expected next year.

This will hopefully begin to put a nail in the coffin of the idea that self-amplifying RNA is not a viable platform, says Corey Casper, president and chief executive of the Access to Advanced Health Institute in Seattle, Washington. (Another saRNA jab for COVID-19 was approved on an emergency-use basis in India last year; however, that vaccines less-impressive clinical data, the provisional nature of the products authorization, and Indias less stringent regulatory requirements have all led industry insiders to consider ARCT-154s approval to be the fields true watershed moment.)

The tangled history of mRNA vaccines

More than a dozen saRNA vaccine candidates are currently in clinical trials for a range of applications from shots for shingles and the flu to therapeutic vaccines for cancer. But researchers are already considering the platforms broader applications.

For example, the technology might one day be used to produce therapeutic proteins inside the body, says Mark Grinstaff, a biochemist at Boston University in Massachusetts and a co-founder of Keylicon Biosciences in Brookline, Massachusetts.

Manufacturing plants currently use bioreactors to produce such proteins, which are then injected into people who need the treatment. Over the past few months, two independent groups one involving Smiths team at VLP Therapeutics2, the other involving Grinstaff and his colleagues at Boston University3 have posted preprints that describe how altering the chemical backbone of saRNA can diminish the technologys immune-triggering effects in a positive way. Similar chemical tweaks are commonly used in conventional mRNA vaccines, but not in ARCT-154 or most other saRNA products.

People are working pretty hard to expand the platforms scope, says Smith. There are some inherent advantages of saRNA if were smart enough to take advantage of them.

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Self-copying RNA vaccine wins first full approval: what's next? - Nature.com

December 05, 2023

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SAN DIEGO Patients with primary systemic vasculitis who received a third or additional doses of a COVID-19 vaccine demonstrated a reduced risk for breakthrough infection, according to data presented at ACR Convergence 2023.

We know immunosuppression is a very important part of the management of patients with primary systemic vasculitis, Michael Chen-Xu, MD, of theUniversity of Cambridge, in the United Kingdom, told attendees. However, we know these patients are at high risk for contracting COVID-19. Also, we know that vaccine responses, particularly humoral responses, in patients who are receiving B-cell depleting agents or anti-proliferative agents, are significantly worse.

It was in this context that Chen-Xu and colleagues sought to answer two key questions.

We wanted to know how effective these vaccines have been, he said. We also wanted to know what are the risk factors for COVID-19 infection in this group of patients.

To address these questions, Chen-Xu and colleagues enrolled 239 patients with primary systemic vasculitis who had received two doses of a COVID-19 vaccine between Jan. 2, 2021, and April 1, 2023. The multicenter observational cohort study excluded those with previous documented COVID-19 infection. A first confirmed symptomatic breakthrough infection more than 14 days after the second vaccine dose served as the primary endpoint.

The cohort was 48.5% men, with a median age of 58.8 years. The majority of patients had ANCA-associated vasculitis. The median follow-up duration was 400 days (range, 78-756).

According to the researchers, 49% of the cohort experienced a first COVID-19 infection, representing a crude incidence rate of 12 per 10,000 person-days. Fourteen patients required inpatient hospital admission. Two of these patients were admitted to intensive care. There was one fatality associated with COVID-19 infection.

The median duration between second vaccination and first breakthrough infection was 35 days (interquartile range, 285-442). Adjusted demonstrated that seroconversion reduced the likelihood of breakthrough infection (HR = 0.48; P = .012), as did receiving a booster dose (HR = 0.43; P < .001).

The key finding is that those who had seroconverted with subsequent doses of vaccine were associated with reduction in subsequent COVID-19 infection, Chen-Xu said.

In addition, chronic kidney disease also reduced the likelihood of breakthrough infection (P = .01), while a history of malignancy (P = .033) and the presence of IgA vasculitis (P = .002) and large vessel vasculitis (P = .009) increased the risk for breakthrough SARS-CoV-2 infection.

Overall, in our U.K. cohort of patients with vasculitis, boosting COVID vaccination has led to protecting these patients from severe COVID-19, Chen-Xu said.

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Chen-Xu M. Abstract 2568. Presented at: ACR Convergence 2023; Nov. 10-15, 2023; San Diego.

Disclosures: Chen-Xu reports financial associations with GlaxoSmithKline.

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Booster COVID-19 vaccine dose protects against breakthrough infection in vasculitis - Healio

In last terms decision in Groff v. DeJoy, the U.S. Supreme Court significantly increased employers obligation to consider religious exemption requests under Title VII. Rather than the previous de minimus burden standard, employers cannot deny such requests absent a substantial burden on their business. Among other accommodation requests, healthcare employers wondered whether this decision changed their ability to require mandatory vaccinations of personnel in contact with patients. Last month in an unpublished opinion, the Second Circuit upheld a hospitals termination of a resident who refused to take the COVID-19 vaccination for religious and health reasons.

In DCunha v. Northwell Health Systems, the plaintiff alleged that she was denied the requested exemption based on her religion and pregnancy. The hospital contended that allowing the exemption would create an undue hardship because the plaintiff worked directly with patients, and because a New York state mandate required healthcare workers to be vaccinated.

The Second Circuit agreed, affirming dismissal of the claim. In addition to recognizing the effect of the state mandate, the court noted that the plaintiff requested a blanket exemption with no modifications to her duties or measures to avoid potential exposure to vulnerable persons. The employer, however, was not required to provide the accommodation requested by the employee, only one that would have effectively met her religious beliefs.

While not all states had COVID-19 vaccination mandates in place, this decision supports employers arguments that simply exempting workers with religious objections to the vaccine mandate is not a required accommodation, or would present an undue hardship based on the risk presented to patients. While the Groff decision breathed new life into many vaccine mandate lawsuits, healthcare employers still have the ability to make reasoned decisions based on risks presented and potential alternative accommodations.

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Second Circuit Rejects Religious Discrimination Claim Based on COVID-19 Vaccination Mandate - JD Supra

While the pandemic may be behind us, we may not want to hear it, but COVID-19 is still hanging around. The risks are very real for pregnant people. But there's new research that shows promise for those pregnant people who get the COVID vaccine.

As researchers who study factors that shape health at birth, Florencia Torche, PhD, Dunlevie Family Professor of Sociology at Stanford University, and Jenna Nobles, PhD, Professor of Sociology at the University of Wisconsin-Madison, soon realized after the onset of the pandemic that one of the most enduring legacies of COVID may be its effect on infant health.

Pregnant people are considered a vulnerable population which means COVID can have serious effects on them and their fetuses. Pregnant people are more at risk for preeclampsia, ICU hospitalization, and death, Torche says, and babies are more likely to be born before 37 weeks and need intensive care.

COVID-19 affects multiple biological systems and there are likely several processes in play, Torche says. We know that infections trigger immune and inflammation responses, and we have evidence now that COVID-19 can cause disintegration of the placenta. These, among other processes, can lead to preterm birth."

When the COVID vaccine became available, it was a significant moment for vulnerable populations, pregnant people included.

"So we set out to understand how the availability of vaccines and the decision to use them may have reduced a serious health burden for the next generation of U.S. children, Nobles says.

Preterm birth is defined as a birth that occurs before 37 weeks gestation and is one of the leading causes of infant mortality in the United States. Not having enough time in the womb can also lead to more costly medical procedures and attention once born.

Preterm birth is associated with immediate health risks for newborns; conditions like respiratory problems, infection, and neurological issues in the first days, weeks, and months of life, saysKimberly B. Glazer, PhD, MPH, the Director of OBGYN Resident and Fellow Research at the Blavatnik Family Womens Health Research Institute. Critically, racial disparities in preterm birth drive persistent and alarming infant health inequities in the U.S., with the highest rates of preterm birth among Black and Indigenous infants.

Rates of preterm birth increased by 4% from 2020 to 2021, the height of the pandemic. In general, Black women were more likely than white or Hispanic women to experience a preterm birth, and the presence of COVID only exacerbated that disparity.

The rate of preterm births may have increased significantly in 2021 as COVID continued to wreak havoc on the world. But by 2022, as the COVID vaccine became widely available, Torche and Nobles noticed that those numbers were dropping again. So they set out to study if and how the vaccine had anything to do with the decrease.

The researchers chose to use birth records data based on birth certificates in California. That's because the state provides information on all births that occur so they did not have to worry about selectivity of small samples skewing their findings. The duo compared birth record data with vaccination rate data across the state to see if preterm birth rates were lower in communities with higher vaccination rates.

Our analysis compared the probability of preterm birth between siblings, says Torche. That is, it compared newborns whose mothers had a COVID-19 infection during pregnancy with their siblings who did not experience a maternal COVID infection. Because this method compares births to the same mother, it 'controls for' any differences between women that could otherwise account for differences in preterm births.

Their findings show the risk for pregnant people in California of having preterm birth was as high as 12.3% between July and November 2020, compared to a 6.9% risk among older siblings born to the same mother pre-pandemic. By January 2022, the impact of COVID on preterm birth significantly decreased, but people who lived in areas with high vaccination rates saw those effects a year earlier compared with zipcodes with lower vaccination rates.

Our findings suggest what will actually be harmful to newborns is [pregnant people] not receiving a vaccine.

Jenna Nobles, PhD

The main takeaway for pregnant people is to get the COVID vaccine and updated boosters, when available. But despite the availability of vaccines to prevent serious complications from the infection, there are barriers some pregnant people face with receiving the shots.

Dr. Glazer says that includes "misinformation and misperceptions" about the safety of the vaccine, despite the support from major professional obstetric and pediatric organizations.

It is really important to remember that vaccination rates are lowest among minoritized and marginalized communities, who face maternal and infant health crises in the United States," says Dr. Glazer. "Vaccine uptake overall, and specifically for the most recent boosters, is much lower among Black and Hispanic pregnant people compared to white individuals. Entrenched racism and bias in the health care system have contributed to distrust of and lower engagement in medical care among these communities. Issues of access are also criticalsuch as having time off work or transportation to health centers. We can do more to address these barriers to improve equity in vaccine coverage.

Barriers aside, many pregnant people express worries about the safety of the vaccine itself. As Dr. Glazer explains, pregnant people are already being told so much about what they should or shouldnt do, and sorting through misinformation about the vaccine can be overwhelming.

Pair this with the fact that pregnant individuals were not included in initial COVID-19 vaccine trials, and the considerable mixed messaging about safety for pregnancy and reproductive health in the earlier stages of vaccine rollout, and the hesitancy is understandable, Dr. Glazer says. However, substantial evidence supports the safety of vaccination in reproductive age and pregnant populations.

Nobles also points out that another reason for pregnant peoples hesitancy with receiving the vaccine is its safety for the unborn baby.

Our findings suggest what will actually be harmful to newborns is not receiving a vaccine, Nobles says. This is useful information that could be shared by healthcare providers with pregnant patients and people intending pregnancy.

While more research needs to be done on COVIDs impact on birthing people overall, but also on how preterm labor can continue to be prevented, Torche, Nobles and Dr. Glazer all agree that the COVID vaccine is a safe and effective option for pregnant people.

Beyond safety, COVID-19 vaccines offer effective protection against major risks to both mom and baby, Dr. Glazer explains. Getting vaccinated is something everyone can do to increase their chances of a healthy pregnancy and birth.

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COVID-19 Vaccination May Lower Risk of Preterm Birth - Parents

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