6 things parents need to know about COVID-19 vaccines for babies, kids under 5

 On Saturday, CDC Director Rochelle Walensky announced a new recommendation to vaccinate all 20 million children 6 months to 5 years of age. Here are some things left out of the announcement that parents should know.

1. The research was inconclusive

The studies were too small to achieve statistical significance when evaluating efficacy against mild or severe COVID-19 infection. As a result, the FDA allowed both companies to extrapolate effectiveness by measuring antibody levels, pointing to data from older children and adults.

There were no cases of severe COVID illness in either the vaccine or placebo group. The Moderna vaccine had 4,774 children and the Pfizer vaccine had 4,526 (including those who received the placebo).

Pfizer concluded that their vaccine was 80% effective in preventing symptomatic COVID-19, but based it on 3 cases in the vaccine group and 7 cases in the placebo group in a subset of children who received a third dose. 

Even this was not statistically significant. In fact, it had a confidence statistic so wide, you could drive an aircraft carrier through it. (They reported the largest confidence interval I have ever seen in my 20-year research career). At one end of the range of possibilities indicated by the confidence interval, the vaccine could be associated with a 370% increased risk of getting COVID-19. The Moderna trial reported a short-term efficacy of 38% in preventing symptomatic illness–an effect well-known to be transient. 

Ironically, there were more overall hospitalizations (unspecified) in the vaccine group. Out of a total of 7 children requiring hospitalization, 6 were in the vaccine group and 1 was in the placebo group, which was half as large. 

The CDC even said in its own slides at their deliberation meeting that data assessing efficacy were poor, characterizing them as "very low certainty" and noting that there are "very serious concerns for imprecision due to study size". They also noted the very short follow-up time of 1.3 months.

2. The FDA lowered their standards for acceptable vaccine efficacy needed to approve

In 2020, the FDA and public health officials said they would authorize a COVID vaccine that showed at least a 50% efficacy. But weeks before the vaccines were authorized for babies and toddlers, the FDA’s Dr. Peter Marks lowered the pre-set bar, saying on May 6, "If these vaccines seem to be mirroring efficacy in adults and just seem to be less effective against Omicron like they are for adults, we will probably still authorize."

3. Most children have natural immunity

The CDC reported reported that, as of February 2022, 75% of children 0-17 years-old already had COVID-19. Given how rampant the Omicron strain has circulated since then, upwards of 80-90% of children have likely had COVID-19. There is absolutely zero clinical evidence to support vaccinating healthy children who already had COVID. Natural immunity, inexplicably ignored by public health officials, confers strong protection against severe disease.

4. Safety was based on a small sample 

 The small size of the studies in children under 5 makes it nearly impossible to observe rates of rare complications such as myocarditis, which occurs in 1 in 2,650 12-17 year-old boys after the 2nd dose. This complication has been associated with EKG changes in children and even concerning MRI findings months after recovering from myocarditis. 

The New England Journal of Medicine reported one case of vaccine-associated myocarditis death in a 22-year-old in an Israeli population study. Keep in mind that babies can’t tell you when they have myocarditis.

Each of the Moderna and Pfizer COVID studies in children under 5 reported one serious adverse event after receiving the vaccine. Less serious adverse events (pain, swelling, local reactions) were similar across the vaccine and placebo groups (7.7% vs 4.1% for Moderna; 1% vs 1.5% for Pfizer). These data do suggest a good safety profile, likely due to the low dose given. However, time will tell. 

As Dr. Eric Rubin, the editor-in-chief of the New England Journal of Medicine, said in October 2021, "But we’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes." 

Establishing safety takes time. The infant rotavirus vaccine, Rotashield, was first thought to be safe. In the original trial, the adverse event (an intestinal malfunction requiring surgery) had been noted in 5 of 10,054 vaccine recipients, but the side effect was not deemed statistically significant. Ultimately, that vaccine was pulled from the market after many more complications were observed. Similarly, J&J’s vaccine was bannered to be safe until the FDA said otherwise.

By comparison, the polio vaccine was tested in 1.8 million children over a year before it was broadly recommended.

5. Healthy children have a very low risk of a serious consequence from COVID-19

Healthy children have a radically different risk profile and a different need for vaccination compared to children with comorbid conditions.  A German population study found that all deaths in children 5-17 were in children with a comorbidity.  That is, no healthy child 5-17 died in that country unvaccinated. 

Alasdair Munro analyzed UK data and determined that 75% of deaths of children from COVID in the UK occurred in the 8% of children who have other serious health issues. That’s why the risk-benefit ratio is radically different for a child with comorbidity than a healthy child.

The CDC’s risk analysis lumps all children together. It also makes the mistake of counting hospitalizations and death where COVID was an incidental finding. An NHS report found that up to 68% of COVID hospitalization are not "for" COVID.

For children with a medical condition such as diabetes or immune suppression, I would recommend COVID vaccination with two doses 8 to 12 weeks apart, if the child does not already have natural immunity. The case to vaccinate healthy children is not compelling. 

6. CDC’s announcement lacked humility

On Saturday, a beaming Dr. Walensky said "We now know based on rigorous scientific review that the vaccines….can be used safely and effectively in children under 5." The review might have been rigorous, but the underlying data was not.

A more appropriate announcement would have been "We approved the COVID vaccine for babies and toddlers based on very little data. While we believe it is safe in this age group, the study size was too low to make a definitive conclusion about safety. Moreover, the studies were conducted in children who did not have COVID previously."

Less absolutism and more humility by public health officials would go a long way in rebuilding public trust. Not surprisingly, only 18% of parents said they were planning give the COVID vaccine to their child under five anytime soon.

Marty Makary, M.D., is a professor of surgery and health policy at the Johns Hopkins University School of Medicine and a Fox News medical contributor. He is the bestselling author of "The Price We Pay."  The opinions presented are his and do not represent the views of Johns Hopkins University.

https://www.foxnews.com/opinion/cdc-recommends-covid-19-vaccines-babies-kids-under-5-6-things-parents-need-know

Reactivation Of Chickenpox Virus Following COVID-19 Injections On The Rise

 by Meiling Lee via The Epoch Times (emphasis ours),

Doctors and scientists are seeing an increase in the reactivation of the chickenpox virus, known as varicella-zoster virus (VZV), following the COVID-19 injections.

The chickenpox virus is one of the eight herpes viruses known to infect humans. After a person contracts and recovers from chickenpox, the virus never leaves the body but lies dormant in the nervous system years later until it gets reactivated as shingles, or herpes zoster (HZ).

Federal health authorities claim that there’s no correlation between COVID-19 injections and shingles, but studies show that there is a higher incidence of shingles in people who’ve received the vaccine.

Israel was one of the earlier countries to publish a case series of six women (out of 491 participants) with an autoimmune disorder who developed shingles 3 to 14 days after receiving the first or second dose of Pfizer COVID-19 shot. None of the 99 participants in the control group developed shingles. The study was published in the journal Rheumatology in April 2021.

“To our knowledge, there were no reports of varicella-like skin rash or HZ in the mRNA-based vaccines COVID-19 clinical trials and our case series is the first one to report this observation in patients within a relatively young age range: 36–61, average age 49 ± 11 years,” the authors wrote.

They hoped that publishing the case series would “raise awareness to a potential causal link between COVID-19 vaccination as a trigger of HZ reactivation in relatively young patients with stable AIIRD [autoimmune inflammatory rheumatic diseases].”

In a different case study from Taiwan, researchers reported three healthy men ages 71, 46, and 42 who developed shingles two to seven days following the first dose of the Moderna or AstraZeneca COVID-19 injection.

“HZ does not often appear after the administration of other kinds of vaccinations,” the researchers wrote. “But we believed that there might be a link between COVID-19 vaccine and HZ emergence.”

“One of the reasons is the short delay of onset after vaccination. The other reason is that these three patients were immunocompetent,” they added.

The largest study to date, based on real-world data (pdf) of more than two million patients, found that there was a higher incidence of shingles among the vaccinated (who received a COVID-19 shot within 60 days) than in the unvaccinated cohort, who were diagnosed with shingles within 60 days of visiting a healthcare office for any other reason.

According to the researchers, the risk of developing shingles was calculated as 0.20 percent for the vaccinated group and 0.11 percent for the unvaccinated, and the “difference was statistically highly significant.”

“Reactivation of the varicella-zoster virus appears to be a potential ADR [adverse drug reaction] to COVID-19 vaccines, at least for mRNA LNP-based formulations,” the authors wrote, adding that “vaccination against COVID-19 seems to potentially raise the risk of precipitating HZ [herpes zoster].”

Dr. Richard Urso, an ophthalmologist, and drug design and treatment specialist, told EpochTV’s “American Thought Leaders” program in April 2022 that of the three to five patients he sees a week with long COVID or problems after receiving the COVID-19 shot, “a huge number of them have reactivated Epstein-Barr, herpes simplex, herpes zoster, CMV.”

Regardless of the rise in reports of shingles after the rollout of the COVID-19 shots, the U.S. Food and Drug Administration (FDA) claims that it has not detected any safety signal between the two.

“FDA has not seen a safety signal for shingles/herpes zoster following administration of the approved or authorized COVID-19 vaccines,” Abby Capobianco, FDA press officer told The Epoch Times via email last month, adding that the agency “will continue to closely monitor the safety of these vaccines.”

The Centers for Disease Control and Prevention (CDC) also alleges that “there is no current connection” between COVID-19 vaccines and the reactivation of the chickenpox virus.

CDC spokesperson Scott Pauley said that any adverse reactions experienced after receiving a COVID-19 shot are temporary and a positive sign that the vaccine is working.

“Some people have side effects from the vaccine, which are normal signs that their body is building protection,” Pauley wrote in an email to The Epoch Times. “These side effects may affect their ability to do daily activities, but they should go away in a few days. Some people have no side effects, and allergic reactions are rare.”

https://www.zerohedge.com/covid-19/reactivation-chickenpox-virus-following-covid-19-injections-rise

DHS warns in memo of ‘likely’ violent extremism after SCOTUS Roe overturn

 The intelligence branch of the Department of Homeland Security is warning officials on Friday of what it says is the likelihood of domestic violent extremism in the wake of the Supreme Court’s ruling that eliminates federal-level abortion protections, multiple news outlets reported.

The department’s Office of Intelligence and Analysis reportedly sent a memo to law enforcement, private sector partners, first responders and others that was obtained by Axios and CNN.

The DHS memo warned that government officials, including judges, were at the greatest risk of violent extremism following the Supreme Court’s decision, while noting that faith-based organizations and reproductive health care centers were also at risk, Axios noted. 

With some states in the process of undergoing changes to abortion protections, the memo noted that states for multiple weeks could face threats of violent extremism, according to Axios.

“Americans’ freedom of speech and right to peacefully protest are fundamental Constitutional rights. Those rights do not extend to violence and other illegal activity,” a DHS spokesperson said in a statement to The Hill. 

“DHS will continue working with our partners across every level of government to share timely information and to support law enforcement efforts to keep our communities safe.” 

The department in a memo last month, which was first reported by Axios and obtained by The Hill, warned of violent threats following the publication of the leaked draft opinion indicating the court was poised to overturn the constitutional right to an abortion. The memo said those threats were likely to continue and could grow in number.

Following that leak, some protested outside of the homes of some Supreme Court justices, which was criticized by Republicans and some Democrats.

Earlier this month, a man who told authorities he wanted to kill conservative Justice Brett Kavanaugh was arrested near the justice’s home. 

https://thehill.com/policy/national-security/3536652-dhs-warns-in-memo-of-likely-violent-extremism-following-supreme-court-overturning-roe-v-wade-reports/

House appropriators move to extend Title 42 through DHS budget

 House appropriators voted Friday to extend a Trump-era border policy, adding a six-month extension of Title 42 to the Department of Homeland Security Budget.

The amendment, sponsored by Rep. Dan Newhouse (R-Wash.), was passed by voice vote, leaving unclear which Democrats voted in support of the effort.

Title 42 contravenes asylum law, allowing border officials to rapidly expel migrants without allowing them to seek protection in the U.S.

The Biden administration continued the policy during the first year of its administration but moved in April to rescind the policy. The Centers for Disease Control and Prevention (CDC) determined the pandemic conditions that Trump used to justify his emergency order were no longer necessary as the U.S. learns to live with COVID-19.

A federal judge blocked the Biden administration from lifting Title 42, which the administration has appealed.

But the Newhouse amendment would require the Biden administration to keep the policy in place for another 180 days beyond the date that Title 42 is eventually terminated.   

The House Appropriations Committee contains a number of Democrats in vulnerable districts, and a source told The Hill a whip count found more than half a dozen Democrats serving on the committee were willing to support Newhouse’s amendment.

While the majority of Democrats had long called for Biden to abandon Title 42, the CDC’s rescission of the order has put some Democrats in a difficult spot.

After the April 1 recession announcement, some in the Senate became particularly vocal.

Sen. Joe Manchin (D-W.Va.) called it a “frightening decision.” Sen. Mark Kelly (D-Ariz.), one of the more vulnerable senators up for reelection, called it “wrong.” And Sen. Maggie Hassan (D-N.H.), who is also in a close race, said the Biden administration “does not appear to be ready” for the surge in migration that could result.

https://thehill.com/policy/national-security/3535787-house-appropriators-move-to-extend-title-42-through-dhs-budget/

West Coast states vow to protect abortion access in multistate commitment

 Three West Coast states signed a multistate commitment to protect abortion access on Friday after the Supreme Court ruled earlier to overturn Roe v. Wade.

The governors of California, Oregon and Washington — all of whom are Democrats — vowed to expand abortion access for those seeking the medical procedure, refuse to extradite individuals to other states who receive or aide in abortion services and protect abortion providers. 

“Reproductive freedom — including the choice of when and whether to have children — is foundational to a person’s autonomy, dignity, and ability to participate fully in economic, social, and civic life,” the commitment reads. 

“The U.S. Supreme Court’s decision to overturn half a century of settled precedent and rescind the U.S. Constitution’s protection of reproductive freedom jeopardizes safe access to reproductive healthcare across the United States.”

The governors also issued a video that featured all of them in promoting the multistate commitment, which has been described as the “West Coast offensive.”

The development shows the potentially adversarial relationship that states may begin to have with one another following fallout from the Supreme Court’s decision to eliminate federal-level abortion protections. 

Some states already have “trigger” laws in place to immediately or very soon ban the medical procedure. Those bans are now effective in several states, including Missouri, Kentucky, Louisiana and South Dakota.

A group of prosecutors have said they will not enforce the abortion bans, putting some of them at odds with laws already on the books that may determine otherwise. 

https://thehill.com/homenews/state-watch/3536517-west-coast-states-vow-to-protect-abortion-access-in-multi-state-commitment/

New model sheds light on how we learn motor skills

 Researchers from the University of Tsukuba have developed a mathematical model of motor learning that reflects the motor learning process in the human brain. Their findings suggest that motor exploration -- that is, increased variability in movements -- is important when learning a new task. These results may lead to improved motor rehabilitation in patients after injury or disease.

Even seemingly simple movements are very complex to perform, and the way we learn how to perform new movements remains unclear. Researchers from Japan have recently proposed a new model of motor learning that combines a number of different theories. A study published this month in Neural Networks revealed that their model can simulate motor learning in humans surprisingly well, paving the way for a greater understanding of how our brains work.

For even a relatively simple task, such as to reach out and pick up an object, there are a huge number of potential combinations of angles between your body and the different joints that are involved. The same goes for each of your muscles -- there is an almost endless combination of muscles and forces that can be used together to perform an action. With all of these possible combinations of joints and muscles -- not to mention the underlying neuronal activity -- how do we ever learn to make any movements at all? Researchers at the University of Tsukuba aimed to address this question.

The research team first created a mathematical model to imitate the learning process that occurs for new motor tasks. They designed the model to reflect many of the processes that are thought to occur in the brain when a new skill is learned. The researchers then tested their model by attempting to simulate the results of three recent studies that were conducted in humans, in which individuals were asked to perform completely new motor tasks.

"We were surprised at how well our simulations managed to reproduce many of the results of previous studies in humans," says Professor Jun Izawa, senior author of the study. "With our model, we were able to bridge the gap between a number of different proposed mechanisms of motor learning, such as motor exploration, redundancy solving, and error-based learning."

In their model, larger amounts of motor exploration -- that is, variability in movements -- were found to help with the learning of sensitivity derivatives, which measure how commands from the brain affect motor error. In this way, errors were transformed into motor corrections.

"Our success at simulating real results from human studies was encouraging," explains first author Lucas Rebelo Dal'Bello. "It suggests that our proposed learning mechanism might accurately reflect what occurs in the brain during motor learning."

The findings of this study, which indicate the importance of motor exploration in motor learning, provide insights into how motor learning might occur in the human brain. They also suggest that motor exploration should be encouraged when a new motor task is being learned; this may be helpful for motor rehabilitation after injury or disease.

This work was supported by KAKENHI (Scientific Research on Innovative Areas 19H04977 and 19H05729). LD was supported by a Japanese Government (Monbukagakusho: MEXT) Scholarship.

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Story Source:

Materials provided by University of Tsukuba. Note: Content may be edited for style and length.

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Journal Reference:

1. Lucas Rebelo Dal’Bello, Jun Izawa. Computational role of exploration noise in error-based de novo motor learning. Neural Networks, 2022; DOI: 10.1016/j.neunet.2022.06.011

https://www.sciencedaily.com/releases/2022/06/220624092344.htm

Automated screening of common eye disorders

 A new deep learning (DL) model that can identify disease-related features from images of eyes has been unveiled by a group of Tohoku University researchers. This 'lightweight' DL model can be trained with a small number of images, even ones with a high-degree of noise, and is resource-efficient, meaning it is deployable on mobile devices.

Details were published in the journal Scientific Reports on May 20, 2022.

With many societies aging and limited medical personnel, DL model reliant self-monitory and tele-screening of diseases are becoming more routine. Yet, deep learning algorithms are generally task specific, and identify or detect general objects such as humans, animals, or road signs.

Identifying diseases, on the other hand, demands precise measurement of tumors, tissue volume, or other sorts of abnormalities. To do so requires a model to look at separate images and mark boundaries in a process known as segmentation. But accurate prediction takes greater computational output, rendering them difficult to deploy on mobile devices.

"There is always a trade-off between accuracy, speed and computational resources when it comes to DL models," says Toru Nakazawa, co-author of the study and professor at Tohoku University's Department of Ophthalmology. "Our developed model has better segmentation accuracy and enhanced model training reproducibility, even with fewer parameters -- making it efficient and more lightweight when compared to other commercial softwares."

Professor Nakazawa, Associate Professor Parmanand Sharma, Dr Takahiro Ninomiya, and students from the Department of Ophthalmology worked with professor Takayuki Okatani from Tohoku University's Graduate School of Information Sciences to produce the model.

Using low resource devices, they obtained measurements of the foveal avascular zone, a region with the fovea centralis at the center of the retina, to enhance screening for glaucoma.

"Our model is also capable of detecting/segmenting optic discs and hemorrhages in fundus images with high precision," added Nakazawa.

In the future, the group is hopeful of deploying the lightweight model to screen for other common eye disorders and other diseases.

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Story Source:

Materials provided by Tohoku University. Note: Content may be edited for style and length.

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Journal Reference:

1. Parmanand Sharma, Takahiro Ninomiya, Kazuko Omodaka, Naoki Takahashi, Takehiro Miya, Noriko Himori, Takayuki Okatani, Toru Nakazawa. A lightweight deep learning model for automatic segmentation and analysis of ophthalmic images. Scientific Reports, 2022; 12 (1) DOI: 10.1038/s41598-022-12486-w

https://www.sciencedaily.com/releases/2022/06/220624105121.htm