Category: Covid-19 Vaccine

Programs in countries around the world have begun quietly compensating people who have been injured by or died as a result of the COVID-19 vaccines.

Humans are biologically diverse, with respect to both genetic makeup and past environmental exposures. Because of this, explained neurologist Dr. Robert Lowry, people can react very differently to the same medication or vaccination. Whenever a new drug or biologic hits the market, some people will have bad reactions and others may even suffer serious adverse events as a result.

Even under the best testing conditions, rare reactions will be missed. This is especially true for any product which is fast-tracked or authorized for emergency use before all the phases of necessary testing are complete.

COVID-19 vaccines are no exception. Despite the fact that we are constantly and consistently assured that COVID-19 vaccines are safe, and that severe adverse reactions are very rare, the FDA and the CDC with its Advisory Committee on Immunization Practices, as well as the scientists and executives at each of the participating drug companies, know that some people will become permanently disabled or even die as a result of vaccination.

In fact, in 2011 the Supreme Court of the United States (pdf) reiterated the idea that vaccines, like other pharmaceutical products, are unavoidably unsafe.

In many countries around the world, consumers who are injured as a result of vaccines are covered by government compensation programs. In the United States there are two government-funded programs that are designed to compensate consumers for injuries, at the same time shielding vaccine manufacturers from liability for any serious injuries their products cause: The National Vaccine Injury Compensation Program (VICP) and the Countermeasures Injury Compensation Program (CICP).

As of July 1, 2022, not a single claim has been compensated by the CICP. However, 31 COVID-19 countermeasure claims have been denied, because the standard of proof for causation was not met and/or a covered injury was not sustained, according to the CICP website. One COVID-19 countermeasure claim, a COVID-19 vaccine claim due to an anaphylactic reaction, has been determined eligible for compensation and is pending a review of eligible expenses.

At the same time, countries around the world are quietly compensating families whose loved ones have been injured or have died as a result of COVID-19 vaccines.

The Japan Times reported this week that a 91-year-old woman who died after suffering an allergic response and sudden heart attack is the first person in Japan to be compensated for a COVID vaccine injury.

A ministry of health panel ruled that a causal relationship could not be denied in her case. Her family will receive a lump sum worth approximately $325,000.

The panel reviewed another 11 cases ranging in age from 20s to 90s but did not reach any other ruling.

So far in Japan, according to the article, 3,680 people have applied for compensation, 820 have been approved and 62 denied, with decisions on another 16 being postponed.

On June 24, 2022, Taiwans National Vaccine Injury Compensation Program held a meeting to review 65 cases, according to the Taipei Times. The Taiwanese program awarded compensation to 10 claimants. These awards included a lump sum worth $116,877 to the family of someone who died after receiving the AstraZeneca vaccine.

This patient was hospitalized 10 days after receiving the vaccine due to a headache and vomiting. Testing revealed thrombocytopenia, a sometimes-lethal blood disorder that is characterized by low platelets.

However, the patient was discharged the next day, only to return that evening after losing consciousness. The patient died of intracerebral hemorrhage, a common cause of stroke.

When the vaccination program first rolled out in the United States, in December of 2020, an otherwise healthy obstetrician-gynecologist, Dr. Gregory Michael, 56, of Miami Beach, Florida, also died of thrombocytopenia.

Although his death occurred approximately two weeks after he got Pfizers COVID-19 vaccine, and prompted an article exploring this side effect in the New York Times, the coroner deemed that there was no medical certainty that the complications from immune thrombocytopenia was vaccine-induced.

Vicki Spit was the first of a handful of people in the United Kingdom to be awarded compensation for injuries due to COVID vaccines, according to a June 24, 2022 article in the British Medical Journal.

Spits 48-year-old partner, Zion, became ill eight days after receiving the AstraZeneca vaccine and died. The victims were awarded the maximum: $150,000. As of May 2022, 1,681 claims for vaccine injury following COVID-19 vaccinations had been filed.

As quoted in the BMJ, Sarah Moore, a spokeswoman for the law firm representing the victims or their families, pointed out that though the awards will not do much to alleviate the financial hardships caused by the injuries, they constitute the clearest statement yet, by the government, that in some rare instances the COVID-19 vaccines have caused very significant injury or death.

Moore believes most of the compensation awards were for vaccine-induced thrombotic thrombocytopenia (VITT) or cerebral venous sinus thrombosis.

At the same time, Yahoo News has reported that 444 cases of VITT have been recorded in the United Kingdom from 49 million doses of the vaccine, with 81 deaths.

According to Canadas Vaccine Injury Support Program (VISP), from June 1, 2021 to June 1, 2022, 774 claims have been received. Eight of these claims were approved by the Medical Review Board, meaning these claims represent cases where it has been determined by the Medical Review Board that there is a probable link between the injury and the vaccine and that the injury is serious and permanent.

According to the VISP website, eligible individuals may receive income replacement indemnities; injury indemnities; death benefits; coverage for funeral expenses; reimbursement of eligible costs such as otherwise uncovered medical expenses.

Thrombocytopenia can lead to blood clots as well as hemorrhaging. Thrombosis is another word for blood clots. Since it is very unusual for an otherwise healthy younger person to suffer from blood clots, the connection between the vaccines and this injury are difficult to refute.

Scandinavian countries have paid more attention to COVID-19 vaccine injuries than other countries. Norway compensated its first three victims in July of last year, a woman in her 40s who died, as well as a man and a woman in their 30s who both survived their vaccine injuries.

All three were healthcare workers who received the AstraZeneca vaccine, which Norway stopped administering on March 11, 2021, due to reports of serious blood clots, low platelet counts, and abnormal bleeding.

In fact, Norwegian doctors were among the first to point out the connection between the vaccine and these injuries.

Denmark, too, has been quickly and quietly processing vaccine injury claims. The Danish government awarded compensation for their first case of VITT in May of 2021.

At the time, 158 people had filed claims for COVID-19 vaccine injuries. The director of the patient compensation board, Karen Inger-Bast, said, Generally, we often see injuries from vaccination. We also see them from, for example, vaccination against influenza and childrens diseases. Thats also how it will be with COVID-19, with up to 5 million people being vaccinated.

Yet, while other countries are compensating people who have been injured by COVID-19 vaccines, America has yet to financially assist a single claimant. According to the Health Resources and Service Administration, as of July 1, 2022, the CICP had yet to award compensation to anyone for damages due to a COVID-19 vaccine.

Thirty-one claims have been denied compensation because the standard of proof for causation was not met and/or a covered injury was not sustained.

A single claim on behalf of someone who suffered an immediate anaphylactic reaction has been deemed eligible for compensation but is pending a review of eligible expenses. For the majority of claims, the CICP is still waiting for records and documentation to be submitted, the website claims.

The AstraZeneca vaccine associated with so many of the injuries quietly compensated has not been made available in the United States.

At the same time, as of July 22, 2022, 86,604 serious adverse events from COVID-19 vaccines administered in the United States have been reported to the Vaccine Adverse Event Reporting System (VAERS), including 13,805 deaths.

Its difficult to determine exactly how many of those involve blood clots, abnormal bleeding, or low platelets because each of those conditions can be coded in many different ways, but a search by The Epoch Times retrieved 2,609 cases that included some mention of thrombosis or thrombocytopenia, including 420 deaths.

These conditions account for only a small portion of the adverse events that have been reported to the CDC and the FDA. In order for people who have suffered from these adverse events to make a claim, a temporal association between the vaccine and the injury or some kind of causation must be established, as the Norwegian doctors and others did for VITT.

In the United States, we may wait a long time for science that establishes causation with respect to vaccine injuries.

In 2011, the Institute of Medicine conducted a detailed investigation into the science available on 158 suspected links between vaccines and specific adverse outcomes. In this report, the IOM ruled that the science was not sufficient to determine whether a causal link existed or not for 135 of the vaccine injuries patients had sustained.

A 2014 Associated Press investigation found that many families with medically documented non-COVID vaccine injuries have been waiting for yearssome over a decadefor the government to help them.

For now, while other countries are quietly making amends, American families who have lost loved ones and Americans who have seen sharp declines in their health following COVID-19 vaccination have nowhere to turn.

Views expressed in this article are the opinions of the author and do not necessarily reflect the views of The Epoch Times. Epoch Health welcomes professional discussion and friendly debate. To submit an opinion piece, please follow these guidelines and submit through our form here.

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COVID Vaccine Injuries Quietly Being Compensated Around the World, Are You Eligible? - The Epoch Times

Pediatrician on COVID-19 vaccines and back-to-school

Updated: 5:29 PM EDT Jul 28, 2022

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>> BELIEVE IT OR NOT THE START OF THE SCHOOL YEAR WILL BE HERE BEFORE WE KNOW IT. AND A NEW ANALYSIS SHOWS MANY KIDS ARE STILL NOT PROTECTED AGAINST COVID 19. >> HERE TO ANSWER YOUR QUESTIONS IS DR. KRISTIN MOFFITT, AN INFECTIOUS DISEASES EXPERT AT BOSTON CHILDRENS HOSPITAL. DR. MOFFITT, THANKS FOR BEING HERE. CNN LOOKED AT THE DATA AND FOUND THAT LESS THAN HALF OF CHILDREN AND TEENS ARE FULLY VACCINATED NATIONWIDE AND ONLY A TENTH HAVE BEEN BOOSTED. EVEN WHERE STATES LIKE MASSACHUSETTS 80% GENERALLY HAVE IT BUT NOT AND THAT AGE BRACKET. DOES THIS SURPRISE YOU? >> ITS NOT SURPRISING THAT THE VACCINE UPTAKE RATES ARE HIGHER THAN HIGH SCHOOL -- HIGHER IN HIGH SCHOOL THEN MIDDLE SCHOOL AND ELEMENTARY SCHOOL. MUCH OF THIS IS DUE TO THE PERCEPTION THAT IF YOU HAVE BEEN INFECTED BY COVID AND YOU HAVE HAD THE PRIMARY VACCINES, THAT YOU DONT NEED A BOOSTER. WE KNOW THAT BOOSTERS ARE SAFE AND THOSE WHO HAVE BEEN INFECTED AND THEY ENHANCE OUR PROTECTION. THEY WILL DO EVEN MORE TO PROTECT US AGAINST SEVERE INFECTION, SO KIDS SHOULD GET BOOSTED IF THEY ARE ELIGIBLE. >> MASSACHUSETTS HAS CONSISTENTLY HAD A HIGHER VACCINATION RATE OVERALL. BUT, ANECDOTALLY, WE UNDERSTAND THERE HASNT BEEN HUGE DEMAND FOR VACCINATIONS FOR THE YOUNGEST KIDS. IS THAT WHAT YOURE SEEING? >> UNFORTUNATELY, YES. MASSACHUSETTS IS ONLY VACCINATED 10% OF CHILDREN UNDER THE AGE OF FIVE. THAT PUTS MASSACHUSETTS IN THE THIRD HIGHEST RANK FOR VACCINATION RATES IN THIS AGE ONLY BEHIND THE DISTRICT OF COLUMBIA AND VERMONT BUT THAT IS A LOW PERCENTAGE ESPECIALLY FOR THESE VACCINES HAVING BEEN AVAILABLE FOR 90 DAYS NOW. >> IF PARENTS ARE STILL ON THE FENCE ABOUT GETTING YOUNG KIDS THAT FIRST DOSE, WHAT DO YOU WANT THEM TO KNOW? >> I WOULD WANT PARENTS TO KNOW THAT WE KNOW THAT THESE VACCINES WILL HELP ATTACKED YOUNG CHILDREN AGAINST SEVERE INFECTION AND HOSPITALIZATION FROM COVID-19. WHILE ITS TRUE THAT PEDIATRIC HOSPITALIZATIONS ARE LESS LIKELY THAN FOR ADULTS, BUT THEY DO HAPPEN. THE RATES HAVE BEEN RISING BECAUSE OF SO MUCH TRANSMISSION RIGHT NOW. PEDIATRIC RATES FOR HOSPITALIZATION ARE HIGHER FOR KIDS UNDER FIVE AND KIDS OF OTHER AGES AND WE KNOW THIS CAN BE PREVENTED BY VACCINATION. >> FROM YOUR PERSPECTIVE, WHATS THE BEST PLAN OF ATTACK RIGHT NOW FOR GIVING KIDS THE BEST PROTECTION ONCE SCHOOL STARTS? >> FOR KIDS WHO HAVE NOT STARTED OR COMPLETED THE PRIMARY SERIES, GET IT STARTED, GET IT COMPLETED . IF YOUR CHILD IS OLD ENOUGH TO BE ELIGIBLE FOR A BOOSTER, GET THE BOOSTER. BEING IS IMMUNIZED AS POSSIBLE IS STILL VERY EFFECTIVE AT PREVENTING SEVERE INFECTION REGARDLESS OF THE VARIANT CIRCULATING. WE DONT KNOW WHERE WERE GOING TO BE IN ONE MONTH WHEN THE SCHOOL DOORS OPEN. >> DR. MOFFITT, THANK YOU. AND TO OUR VIEWERS IF YOU HAVE YOUD LIKE OUR EXPERTS TO ANSWER EMAIL THEM TO ASK AT WCVB.CO

Pediatrician on COVID-19 vaccines and back-to-school

Updated: 5:29 PM EDT Jul 28, 2022

Kristin Moffitt, an infectious disease specialist with Boston Children's Hospital, talks about COVID-19 vaccines as kids prepare to go back to school.

Kristin Moffitt, an infectious disease specialist with Boston Children's Hospital, talks about COVID-19 vaccines as kids prepare to go back to school.

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Pediatrician on COVID-19 vaccines and back-to-school - WCVB Boston

1. Young childrens Covid-19 vaccinations lag behind other age groups  vtdigger.org
2. KFF COVID-19 Vaccine Monitor: July 2022  Kaiser Family Foundation
3. Study continues on COVID-19 as does state's coercive vaccine mandate on state employees  Washington Policy
4. State health officials urge parents to get kids vaccinated for COVID-19 before school starts  WNEM
5. More than 40% of parents of young kids say they will not get their child a Covid-19 vaccine, survey finds  CNN
6. View Full Coverage on Google News

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Young childrens Covid-19 vaccinations lag behind other age groups - vtdigger.org

In a recent article posted to thebioRxiv* preprint server, investigators studied a linear deoxyribonucleic acid (linDNA) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine option in felines.

SARS-CoV-2, the Coronavirusdisease 2019 (COVID-19) pandemic's etiologic agent, has afflicted a broad range of animal species, particularly mammals, globally from its initial discovery in late 2019 in China. The American Veterinary Medical Association noted that in addition to human-to-human transmission, some pets and wild animals, particularly cats, have shown evidence of human-to-animal SARS-CoV-2 spread.

According to several priorstudies, cats are receptive to COVID-19 and are vulnerable to airborne infections, which hasshown the value of using animal models in the study of infectious illnesses and emphasized that SARS-CoV-2's intermediate animal source is still unidentified. Finding ways to break the chain of transmission and lessen the threat of spillover to vulnerable species is essential considering the high transmissibility capability of SARS-CoV-2 to many host species, and the close interaction between animals and humans.

In the current research, the scientists presented findings from a randomized Phase 1/2 clinical trial in domestic cats using a nucleic acid-based COVID-19 vaccine made of polymerase chain reaction (PCR)-based linDNA. They evaluated the immunogenicity and safety of the linDNA vaccine that contained the SARS-CoV-2 receptor-binding domain (RBD). Moreover, the vaccine was delivered utilizing electro-gene transfer (EGT).

The expression sequence harboring the RBD region of the SARS-CoV-2 spike (S) protein found in the pTK1A-TPA-RBD plasmid was amplified using PCR primers. The template for the PCR-centered linDNA amplicon expression vector production was pTK1A-TPARBD, a plasmid DNA that encodes the RBD area of the SARS-CoV-2 S protein. The authors included a tissue plasminogen activator (tPA) leader sequence for stimulating protein production.

By electroporating either linDNA or a plasmid expressing the RBD region of the SARS-CoV-2 S protein across the skeletal muscle of BALB/c mice, the researchers evaluated thein vivoimmunogenicity of the linDNA COVID-19 vaccine. The vaccination protocol involved injecting 6-week-old BALB/c mice with 20 g of plasmid DNA, i.e., 10 g per quadriceps, or an equimolar linDNA dose, i.e., 4,3 g per quadriceps at day 0 as prime and day 28 as boost with a sacrifice at day 38.

Further, the investigators conducted a randomized phase 1/2 clinical investigation comprising 11 domestic cats to evaluate the effectiveness of the linDNA vaccine in an animal species predisposed to SARS-CoV-2 infection. The vaccination protocol involved administering 1 mg of linDNA intramuscularly twice, on days 0 and 28, and then immediately electroporating the co-localized intramuscular region of each rear leg's tibialis cranialis.

The team used an enzyme-linked immunosorbent assay (ELISA) to measure anti-RBD immunoglobulin G (IgG) titers after the prime and the boost. Thereby analyzed the immunogenicity of the linDNA vaccine towards the RBD region of SARS-CoV-2 S protein among domestic cats. They investigated the cellular immune reaction generated by the linDNA vaccine in 10 of11 felines immunized with the prime-boost regimen by using an enzyme-linked immunosorbent spot (ELISpot) analysis on PBMCs procured on days 28 and 56.

The authors noted that the preclinical findings have demonstrated that a linDNA vaccine expressing the SARS-CoV-2 RBD region was immunogenic in mice when given in a prime-boost vaccination regimen because it consistently elicits cellular and humoral immune reactions. The linDNA vaccine was safe and lacked any detrimental side effects when given to cats as part of a prime-boost vaccination program.

Notably, the linDNA COVID-19 vaccine option demonstrated immunogenicity by inducing binding and neutralizing antibodies, the latter of which is necessary to safeguard against live viral infection shortly after priming against the S RBD of the SARS-CoV-2 ancestral strain and three SARS-CoV-2 variants (P.1, B.1.1.7, and B.1526). In addition, compared to those found against the B.1.526 and P.1 variants, neutralizing titers evaluated against the ancestral SARS-CoV-2 and B.1.1.7 strains were drastically elevated. Furthermore, an RBD-specific T cell reaction comparable to humoral immunity was found shortly after the prime.

Collectively, the study data illustrated that immunizing cats with the current linDNA-based COVID-19 vaccine candidate induces an RBD-selective T cell reaction and produces neutralizing antibodies towards SARS-CoV-2 and its variants. Additionally, there were no notable adverse events. These findings promote the establishment of vaccines for avoiding viral transmission in SARS-CoV-2-vulnerable animals, specifically those in close contact with people, and show the immunogenicity and safety of a genetic vaccination delivered to cats towards COVID-19.

The team mentioned that even though the present cat data support further research, more experiments are required to show that the linDNA vaccination effectively shields larger animals against SARS-CoV-2 challenges.

In conclusion, the current study indicated that the SARS-CoV-2 linDNA vaccine provides an excellent vaccination platform triggering substantial protective T cell reactions and neutralizing antibodies among felines and possibly other vulnerable animal species.

bioRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

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Investigating an effective linear deoxyribonucleic acid COVID-19 vaccine option for domestic cats - News-Medical.Net

Cardiologist and author Peter A. McCullough, MD, has once again caught the attention of AFP, a fact-checking organization with offices all over the world, for speaking out about COVID-19 vaccines.

Video footage of McCullough is being used on social media to promote a fake COVID-19 recall, according to a new analysis from AFP. The footage comes from a June 2022 testimony McCullough gave to the Texas Senate Committee on Health and Human Services. In the clip, he testifies that a global recall of all vaccines is now in place, adding that 40,000 vaccine-related deaths have already been reported around the world.

The post was liked by thousands of users on Instagram, but AFPs fact-checking team has said that these claims are inaccurate. They reached out to numerous government agencies, including some from outside of the United States, to reach this conclusion.

As of July 26, 2022, the Food and Drug Administration had not listed any recalls for the four COVID-19 vaccines authorized in the U.S., according to AFP. Abby Capobianco, an FDA spokesperson, is even quoted in the article confirming this to be the case.

Representatives from the CDC, European Medicines Agency and World Health Organization also communicated to AFP that they did not know of any global efforts to recall vaccines.

Small batches of some vaccines have been recalled in the last two years, AFPs team added, due to specific issues. But no vaccines have been recalled altogether, and vaccination is still being encouraged all over the world.

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Cardiologist's false claims used to promote fake COVID-19 vaccine recall, fact-checking website says - Cardiovascular Business

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Black toddlers and infants in Texas are being vaccinated against COVID-19 much more slowly than their white, Hispanic and Asian counterparts, according to state health data.

On the other end of the spectrum, 43% of the doses that have been administered to babies and kids who became eligible last month have gone to Hispanic children, state numbers show. And young Asian kids have received a share of the total doses that is nearly triple their share of Texans in that age group.

In the first five weeks that COVID-19 vaccines have been available to Texans ages 6 months to 4 years, more than 64,000 of the states 1.8 million newly eligible children have had at least one shot in the Pfizer or Moderna regimen. While this represents only 3.5% of the states youngest eligible age group, thats roughly the same as the national rate for babies and children in that age group.

Disparities are surfacing along racial lines that are similar to those seen in previous age groups, particularly in the early stages of the vaccine rollout highlighting an ongoing and multilayered challenge to health officials as they try to vaccinate a significant portion of young Texans, more than half of whom are children of color.

In all age groups now eligible for the vaccine, some 77% of Asian Texans have been vaccinated, compared with 68% of Hispanics, 55% of whites and 49% of Blacks.

In whiter, more rural areas, where the rate of fully vaccinated people has consistently lagged behind the statewide rate, vaccine hesitancy is often connected to mistrust in the government and health care access is limited for the 1 in 10 Texans who live in those regions.

Hispanic and Black Texans report more issues with access than do white families, particularly when it comes to taking time off work to get a vaccine. Those communities also experience hesitancy commonly stemming from a mistrust in the health care system.

Sharon Cohan, founder and executive director of VaxTogetherAustin, said an additional challenge comes from the federal guidelines that anyone under the age of 3 receive the vaccine only after getting a doctors prescription. Also, only doctors and public health officials are allowed to give the shot to children ages 2 or younger.

Thats a barrier for people who have limited access to doctors or who feel uncomfortable in traditional health care settings, she said.

And it ties the hands of organizations like hers, which usually partners with Walgreens to run clinics and vaccination events at places like schools that most easily can reach lower-income communities and children of color.

We cant just come in with our usual team and vaccinate the kids who are 6 months and up, she said. In an ideal world, every parent and every child has a primary care pediatrician. But thats just not the reality.

According to data from the Texas Department of State Health Services, of the 64,314 doses administered to the youngest age group:

Texas health officials said the state will continue to focus on populations with lower vaccine uptake, including communities of color and rural communities in its outreach efforts, said Douglas Loveday, spokesperson for the Texas Department of State Health Services.

Texas is slightly ahead of the U.S. in terms of percentage of its youngest children vaccinated, although state and local health officials say the number of children vaccinated is lower than they had hoped.

But vaccine uptake, no matter what age and for most races, has always been a battle in parts of Texas for reasons ranging from politics to poverty, geography to governmental mistrust.

Weve been dealing with that this entire pandemic, Cohan said.

Statewide, some 61% of Texans have been fully vaccinated since the shot was first available in December 2020, compared with 79% nationally.

In the Rio Grande Valley, early interest in and access to the vaccine by adult recipients was higher than expected in fact, the entire border region consistently led the state in its vaccination rates. In Hidalgo County, for example, 83% of the population is fully vaccinated.

Thats why Dr. Ivan Melendez, Hidalgo County health authority, is surprised and saddened by a significant drop-off in vaccine uptake by those same residents when it comes to their young children.

Of the 1,000 doses his agency has received that are earmarked for those children, only about 200 have been administered because interest has been so low, he said.

Melendez doesnt find the proportionately higher rates among Hispanic children to be particularly encouraging, given the low overall number of takers for a vaccine thats in plenty of supply.

Our community partners are kind of reporting something similar, that were just disappointed in the amount of people that are taking it up in this age group, he said. The physicians and the health department are trying to be really proactive in educating people, but I dont think its a resource issue. I dont think its because we dont have enough air time. Its not that we dont have enough vaccines, because we certainly do.

Melendez, who is also a family practitioner, said hes not seeing the same level of vaccine uptake for the kids as he did for the adults in the early days mainly due to misinformation about the safety and efficacy of the vaccine, and apathy about the pandemic.

Probably the underlying thing is, Ill risk it, but Im not going to let my kids risk it, Melendez said.

Eric Lau contributed to this story.

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In Texas, racial disparities emerge in vaccines for the youngest kids - The Texas Tribune

SINGAPORE and BASEL, Switzerland and SYDNEY, July 29, 2022 /PRNewswire/ --ACM Biolabs, a biotechnology company with operations in Singapore, Switzerland and Australia, focusing on the development of next generation vaccines for infectious diseases, personalized immunotherapy for cancer patients using its proprietary delivery platform (non-lipid, non-viral), today announced that the first subject has been dosed in the firstinhuman Phase 1 trial of its clinical candidate vaccine, ACM-001, a 2ndgeneration adjuvanted SARS-CoV-2 spike protein (beta variant) vaccine with broad protection against variants of concerns, including delta and omicron demonstrated in a variety of preclinical studies (Clinicaltrials.gov identifier NCT05385991).

About the study: The vaccine is evaluated as a booster in a phase 1, dose escalation study comparing intramuscular versus intranasal administration of various doses of antigen and adjuvant in healthy adult volunteers who have previously received 3 doses of approved Covid vaccines.

"The start of this First-in-human trial is an important milestone for ACM Biolabs. Our next generation COVID-19 vaccine ACM-001, a nasal vaccine, can make a significant contribution to block infections and transmission. The current situation of high infection and reinfection rates despite repeated booster vaccinations reinforces the emerging consensus of the scientific community that there is a high need for an intranasal COVID vaccine," said Dr. Madhavan Nallani, Chief Executive Officer of ACM Biolabs. "We are now very much looking forward to see our promising preclinical results translate in this important Phase 1 study within the next months."

The spike-protein component of ACM-001 is modeled after the immune-evasive beta variant. In animal studies the clinical vaccine candidate was safe and generated a protective immune response against the beta-variant and ancestral form of SARS-2. Additionally, it also elicited broadly neutralizing antibodies against other variants, including delta and omicron. Furthermore, the plug-and-play platform would allow for quick adaption for current and future mutations of the SARS-2 virus.

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ACM-001 is utilizing ACM Biolabs' innovative delivery technology, allowing administration not only via the conventional intramuscular route but also the intranasal route. The nose is the entry point for SARS-CoV-2 and the site where the virus initiates replication. Vaccine application to the mucosal surface lining the nasal cavity is deemed highly relevant and disrupts infection and potentially transmission of COVID-19. This effect could also be applicable to other respiratory infectious diseases. ACM Biolabs has published its comprehensive investigation of the significant benefits of intranasal ACM-001 (Lam JH et al., Biorxiv 2022.02.12.480188). Animals that were immunized with ACM-001 and were infected with live virus, had significantly less viral burden in their noses than their unvaccinated counterparts. Moreover, animals that had received ACM-001 through the nose, needed significantly lesser time to clear infection.

ACM Biolabs' researchers described the exact way of how the vaccine component is delivered inside the body. The formulation facilitates uptake of the vaccine by specialized cells of the body's own immune system (Lam JH et al., ACS Nano 2021, 15, 10, 1575415770). These cells are highly efficient activators of T-cells, antibody-producing B-cells as well as the immune system's memory.

"With our preclinical data we achieved not only mucosal immunity but also the same kind of systemic immunogenicity as the currently licensed vaccines", said Pierre Vandepapeliere, M.D., PhD, Chief Medical Officer of ACM Biolabs. "Knowing that the infection and transmission of covid virus pass through the upper respiratory tract, this study will allow confirmation in human that intranasal administration induces stronger and better immune responses at the portal of virus entry than classical intramuscular administration. Utilizing this disruptive vaccine platform, ACM Biolabs has the potential to become a real game-changer in the field of vaccines, thanks to its capacity to be administered intranasally, to carry various types of vaccine antigens like proteins or mRNA, and its thermostability."

ACM-001 vaccine is developed based on the company's proprietary ACM (artificial cell membrane) polymer-based technology. This next generation delivery platform offers flexibility with multiple payloads (proteins to RNA) and can be stored in a refrigerator in contrast to the current LNP-based delivery. ACM is working on a wide range of products beyond infectious disease vaccines including personalized immunotherapy for cancer patients.

For further information please contact:

For Investors:

Dr. Alexander Breidenbach

Chief Development Officer

ACM Biosciences

+41 61 975 85 88

office@acmbiosciences.com

About ACM Biolabs

ACM Biolabs is developing next generation vaccines for infectious diseases, immuno-modulator therapies, and personalized cancer vaccines using its proprietary ACM (Artificial Cell Membranes) polymer-based delivery platform (non-lipid, non-viral). The company's lead program, ACM-001, is an adjuvanted SARS-CoV-2 spike protein (beta variant) vaccine currently in Phase 1.

Founded in Singapore in 2013, ACM Biolabs has established laboratories for research and early manufacturing activities. In 2020 ACM Biosciences, a subsidiary of ACM Biolabs, was established in Basel, Switzerland, to internationalize its development activities. In 2022 ACM Biolabs Pty Ltd was established in Australia to operationalize clinical development. ACM Biosciences leads all clinical and regulatory activities of its pipeline programs. It also coordinates business development discussions with potential partners

For further information, please visit: http://www.acmbiolabs.com

Disclaimer

This press release contains forward-looking statements which are based on current assumptions and forecasts of the ACM Biolabs and ACM Biosciences management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. ACM Biolabs and ACM Biosciences disclaim any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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As part of 'Operation Nasal Vaccine' to counter COVID-19 spread, ACM-001 booster vaccine administered to first subject in phase 1 safety and...

THURSDAY 7/28/2022 1:54 p.m.

(WFRV) The Wisconsin Department of Health Services has reported 1,563,351 total positive coronavirus test results in the state and 13,220 total COVID-19 deaths.

Unable to view the tables below?Click here.

The DHS announced an attempt to verify and ensure statistics are accurate, some numbers may be subject to change. The DHS is combing through current and past data to ensure accuracy.

Wisconsins hospitals are reporting, that the 7-day moving average of COVID-19 patients hospitalized was 507 patients. Of those,52 are in an ICU. ICU patients made up 11.3%of hospitalized COVID-19 patients.

The Wisconsin Department of Health Services reports that 10,003,005 vaccine doses and 2,581,543 booster doses have been administered in Wisconsin as of July 28.

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The Wisconsin Department of Health Services is using a new module to measure COVID-19 activity levels. They are now using the Center for Disease Control and Preventions (CDC) COVID-19 Community Levels. The map is measured by the impact of COVID-19 illness on health and health care systems in the communities.

The Center for Disease Control and Prevention (CDC) reports that 16 counties in Wisconsin are experiencing high COVID-19 community levels. Of those 16, two are in northeast Wisconsin: Brown and Door counties.

Nine counties located in northeast Wisconsin are at medium community risk levels: Green Lake, Fond du Lac, Sheboygan, Winnebago, Kewaunee, Oconto, Marinette, Forest, and Langlade.

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Every other county in Wisconsin is experiencing low COVID-19 community levels.

For more information on how the data is collected, visit theCDCs COVID-19 Community Levels data page.

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Over 10M COVID-19 vaccine doses have been given in the State of Wisconsin - WeAreGreenBay.com

With the Omicron wave of COVID-19 sweeping the country, we previously calculated the number of people who were not up to date with vaccination in vulnerable areas as of June 2, 2022. Specifically, we looked at counties classified by the Centers for Disease Control and Prevention (CDC) has having medium or high COVID-19 community levels, signifying not only that new COVID cases were on the rise but also strains on hospital capacity. Since then, the BA.5 Omicron variant, which appears to be even more contagious and is able to evade prior immunity, has become dominant, driving up cases and hospitalizations even further.

Now, less than two months later, the share of the population living in medium or high community level counties and the number of people in those counties who are not up to date on vaccination have grown significantly; in addition, most who are not up to date are now living in counties with high community levels. We provide an update here, as of July 21, 2022.

Most Americans are not up to date with their COVID-19 vaccines. As of July 21, 2022, 227.8 million Americans (70%) were unvaccinated, had not completed their primary series, or had not gotten a booster dose. In each state, at least half the population is not up to date on COVID-19 vaccines. In Alabama, North Carolina, and Virginia, over 80% of people are not yet up to date on COVID-19 vaccines.

In just a short time, with the spread of the latest COVID-19 Omicron variant, the number of people in the U.S. who are particularly vulnerable to the impacts of COVID-19, because they are not up to date on vaccination and live in vulnerable counties, has grown considerably, rising from 120 million in early June to 198 million now. Moreover, an even greater share of people now live in counties with high community levels. The most vulnerable among them those who remain unvaccinated and live in counties with high community levels has grown from 14 million to 50.4 million.

CDC recommends that all people mask indoors in areas that have high COVID-19 community levels, and that people living in medium-level counties mask based on their personal risk, but most jurisdictions and facilities do not require masking. These updated data illustrate how quickly the current wave is spreading and increasing risk across the country. These data underscore the significant vulnerability to COVID-19 illness that still exists at this time, more than a year since vaccines became widely available in the U.S. to most people. As such, they point to the importance of other public health measures, such as masking and testing, in addition to vaccination, in many parts of the country.

COVID-19 Vaccinations: County-level data on COVID-19 vaccinations were sourced from the CDC COVID-19 Vaccinations in the United States, County using data reported as July 20, 2022. Only data from the 50 states and District of Columbia were included (data from territories were excluded as territories are not included in the COVID-19 community level dataset). Counties lacking any vaccination data were also excluded from this analysis. In some cases, the residence county is unknown, and therefore these vaccination data cannot be attributed to a specific county. However, for states where only one COVID-19 community level was possible as of July 20, 2022, namely, the District of Columbia (Medium), Maine (Low), and Rhode Island (Low), vaccination data with unknown county information but attributed to these states were coded as the corresponding COVID-19 community level. Other vaccination data without county information and not attributed to these states were excluded from the analysis (accounting for about 13 million people). For this reason, we are potentially overestimating the number of people not up to date on vaccination. We define up to date on COVID-19 vaccination as people who have completed a primary series and received a booster (except for children under age 5 who are considered to be up to date with primary series COVID-19 vaccination). We calculate the number not up to date on COVID-19 vaccination as population in each county minus people who received primary series and booster. We calculate the number of unvaccinated people as the difference between the county population and the number of people who have received at least a first dose of a COVID-19 vaccine. In a few counties where the population estimate exceeds the number of people who have received a first dose of the COVID-19 vaccine, the number of unvaccinated individuals is assumed to be 0. We calculate people who are partially vaccinated as the difference between the number of people who completed a primary series and those who received at least one dose. We calculate the number of people that have completed a primary series but not received a booster as the difference between the number of people who have completed a primary series and the number of people who have received a booster dose. Although the CDC now recommends that all immunocompromised individuals and people over the age of 50 receive a second booster dose, there are currently no county-level data available on the number of booster doses received. Therefore, we are unable to capture how many individuals are fully up to date on COVID-19 vaccines. Furthermore, children under 5 years of age have recently become eligible to receive COVID-19 vaccination. Children in this age group that have received a first dose are considered to be partially vaccinated.

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Update: The Number of People Not Up to Date on Vaccination in Counties with Elevated COVID-19 Community Levels is Growing - Kaiser Family Foundation

A medical worker administers a dose of the "Cominarty" Pfizer-BioNTech coronavirus disease (COVID-19) vaccine to a patient at a vaccination center in Ancenis-Saint-Gereon, France, November 17, 2021. REUTERS/Stephane Mahe/File Photo/File Photo

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July 28 (Reuters) - The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

Reinfections, severe outcomes may be more common with BA.5

Compared with the earlier Omicron BA.2 subvariant, currently dominant Omicron BA.5 is linked with higher odds of causing a second SARS-COV-2 infection regardless of vaccination status, a study from Portugal suggests.

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From late April through early June, researchers there studied 15,396 adults infected with the BA.2 variant and 12,306 infected with BA.5. Vaccines and boosters were equally effective against both sublineages, according to a report posted on Monday on medRxiv ahead of peer review. However, 10% of BA.5 cases were reinfections, compared to 5.6% of BA.2 cases, which suggests a reduction in protection conferred by previous infection against BA.5 compared to BA.2, the researchers said. Moreover, the vaccines appeared to be less effective in reducing the risk of severe outcomes for BA.5 compared with BA.2.

"Among those infected with BA.5, booster vaccination was associated with 77% and 88% reduction in risk of COVID-19 hospitalization and death, respectively, while higher risk reduction was found for BA.2 cases, with 93% and 94%, respectively," the researchers wrote. While "COVID-19 booster vaccination still offers substantial protection against severe outcomes following BA.5 infection," they said, their findings provide "evidence to adjust public health measures during the BA.5 surge."

Virus spike protein damages heart muscle cells

The spike protein on its surface that the coronavirus uses to break into heart muscle cells also triggers a damaging attack from the immune system, according to new research.

The SARS-CoV-2 spike protein interacts with other proteins in cardiac myocytes to cause inflammation, researchers said on Wednesday in a presentation at the American Heart Association's Basic Cardiovascular Sciences Scientific Sessions 2022. In experiments with mice hearts, comparing the effects of SARS-CoV2 spike proteins and spike proteins from a different, relatively harmless coronavirus, the researchers found that only the SARS-CoV-2 spike protein caused heart dysfunction, enlargement, and inflammation. Further, they found, in infected heart muscle cells only the SARS-CoV-2 spike interacted with so-called TLR4 proteins (Toll-like receptor-4) that recognize invaders and trigger inflammatory responses. In a deceased patient with COVID-19 inflammation, the researchers found the SARS-CoV-2 spike protein and TLR4 protein in both heart muscle cells and other cell types. Both were absent in a biopsy of a healthy human heart.

"That means once the heart is infected with SARS-CoV-2, it will activate the TLR4 signaling," Zhiqiang Lin of the Masonic Medical Research Institute in Utica, New York said in a statement. "We provided direct evidence that spike protein is toxic to the heart muscle cells and narrowed down the underlying mechanism as spike protein directly inflames the heart muscle cells," he told Reuters. "More work is being done in my lab to test whether and how spike protein kills heart muscle cells."

Omicron-targeted antibody combo nears human trials

A new monoclonal antibody combination can prevent and treat Omicron infections in monkeys, researchers reported on Monday in Nature Microbiology.

The antibodies, called P2G3 and P5C3, recognize specific regions of the spike protein the SARS-CoV-2 virus uses to enter cells. "P5C3 alone can block all SARS-CoV-2 variants that had dominated the pandemic up to Omicron BA.2," said Dr. Didier Trono of the Swiss Institute of Technology in Lausanne. "P2G3 then comes to the rescue as it not only can neutralize all previous SARS-CoV-2 variants of concern, but it can also block BA.4 and BA.5," he said. "P2G3 is even effective against some BA.2 or BA.4/BA.5 mutants capable of escaping (Eli Lilly's (LLY.N)) bebtelovimab, the only antibody approved for the clinics still displaying activity against the currently dominant BA.4/BA.5 subvariants."

In lab experiments, mutations that might make SARS-CoV-2 variants resistant to P2G3 did not allow escape from P5C3, and P5C3 escape mutants were still blocked by P2G3, Trono said. "In essence, the two antibodies cover for each other, one filling in for the lapses of the other and vice versa."

Aerium Therapeutics plans to start testing the combination in humans next month, said Trono, who is among the company's founders. If larger trials eventually confirm its effectiveness, the P5C3/P2G3 combination will be given by injection every three-to-six months to people who are immunocompromised and do not have a strong response to COVID-19 vaccines, the company has said.

Click for a Reuters Global COVID-19 Tracker and for a Reuters COVID-19 Vaccination Tracker.

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Reporting Nancy Lapid; Editing by Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

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Reinfection, severe outcome more common with BA.5 variant; virus spike protein toxic to heart cells - Reuters