With national levels of respiratory illness declining and warmer weather on the horizon, COVID-19 may no longer be top of mind. But dont let it slip too far, health experts warn.
COVID is down, but it has not gone away. I would say its continuing to smolder out there, says infectious disease expert William Schaffner, M.D., a professor of medicine at Vanderbilt University School of Medicine in Nashville, Tennessee.
Unlike influenza, which Schaffner says virtually disappears during the summer months, COVID-19 keeps circulating. In fact, federal data shows that historically, COVID-19 cases and hospitalizations spike some during the summer months.
One thing that could fuel another surge this summer: a new variant, one that is better able to escape our immune defenses from vaccines and previous infections. Right now, all eyes in the U.S. are on two variants KP.2 and KP.1.1 from a group known as the FLiRT variants. Together these two variants make up about one-third of infections in the U.S.
No doubt weve seen some strange nicknames for variants throughout the COVID-19 pandemic Arcturus, Pirola and Eris, to name a few. According to an explainer posted by the Infectious Diseases Society of America, FLiRT is an acronym for some of the variants spike protein mutations.
The FLiRT variants, which are still in the omicron family, appear to be highly transmissible, meaning they spread easily. However so far, they do not appear to cause more severe disease, Schaffner says.
The slight caution about the FLiRT variants, Schaffner says, is that from a genetic perspective, they are a little more distant from their parents. That means immunity from previous infections and vaccines may not protect perfectly against an infection with a FLiRT variant, he notes.
The protocol was approved by the ethics committee (EC) of each of the 16 study centers and the Vietnam National EC in Biomedical Research and Ministry of Health. All participants provided informed consent before enrolment, and the study was conducted in accordance with the ethical principles of Good Clinical Practice, the Declaration of Helsinki and International Council for Harmonisation (ICH E6R2), and applicable local regulatory and bioethics requirements. Primary objectives of phase 1, 2, and 3a studies were to assess in comparison with placebo the safety and reactogenicity of two ARCT-154 doses administered four weeks apart, and the immunogenicity four weeks after the second dose. Primary objectives of the phase 3b study were to assess the safety and reactogenicity of two doses of ARCT-154 and their efficacy against COVID-19 disease from 7 (Day 36) to 63 (Day 92) days after the second vaccination. An exploratory assessment of efficacy from Day 1 to Day 92 was done in all participants who had received at least one dose of ARCT-154 in any phase of the study. An independent data and safety monitoring board (DSMB) had full oversight over the study, including assessment of blinded data on safety and confirmed COVID-19 cases, and made recommendations to continue enrolment or the study.
Study designs for individual study phases are illustrated in Fig.1. In phase 1 eligible participants were healthy adults > 18 to <60 years of age; in phases 2/3a/3b eligible participants were adults > 18 years of age. Enrolled volunteers in phases 1/2/3a were randomized 3:1 and those in phase 3b 1:1 to receive ARCT-154 or placebo. Phase 3b included volunteers at increased risk of severe COVID-19 due to their comorbidity status31 or being 60 years old, and randomization included stratification of these at-risk participants. Phase 1 participants were recruited and treated first, parallel enrolment for phases 2 and 3a was only allowed after the DSMB and Vietnam MoH had reviewed all safety data collected up to 7 days after the second vaccination (Day 36) in phase 1. Similarly, enrolment for phase 3b was only approved following review of all safety data collected through Day 7 following the first dose in phases 2 and 3a.
Other than the above age restrictions, eligible participants were male or female adults who could consent to participate, agreed to comply with all required study visits and procedures, and were willing to provide required blood and nasal swab samples. Major exclusion criteria were evidence of an acute infection at the time of enrolment, pregnancy or breastfeeding, previous COVID-19 infection (including a positive result of RT-PCR), close contact with a person known to be infected with SARS-CoV-2 or any known history of anaphylactic reactions to vaccines. Detailed exclusion criteria are shown in Supplementary Table2.
At enrolment volunteers were allocated to ARCT-154 or placebo groups using an interactive response technology (IRT) system which provided a unique identifying study code and the allocated study intervention for each participant. Codes were accessible only to unblinded study personnel who prepared and administered the vaccine/placebo but played no other role in the study. All other study personnel and participants were blinded to study allocation. A nasal swab was collected for SARS-CoV-2 testing by RT-PCR at screening on or within 5 days of Day 1. On Day 1, after a baseline blood draw for testing for SARS-CoV-2 nucleocapsid-specific antibodies and negative urine or blood pregnancy test for females of child-bearing potential, the first assigned vaccine or placebo injection was administered; a second dose was given in the same manner on Day 29. To ensure all participants received immunization against COVID-19 there was as switchover at Day 92 when placebo recipients from all phases were offered ARCT-154 as two doses four weeks apart. Vaccinees from the different phases received either a third dose of ARCT-154 or two doses of placebo. This report only presents data acquired up to Day 92, data from the switchover will be presented separately.
ARCT-154 consists of a replicon based upon Venezuela equine encephalitis virus in which RNA coding for the virus structural proteins has been replaced with RNA coding for the full-length spike (S) glycoprotein of the SARS-CoV-2 D614G variant, encapsulated in lipid nanoparticles. 100g active ingredient, stored in vials at -20C or lower, was dissolved in 10mL sterile saline immediately before use and 0.5mL doses containing 5g were administered by intramuscular injection in the deltoid. Placebo was sterile saline.
After 30minutes monitoring for any immediate reactions, all participants completed electronic or paper study diaries for 7 days starting on the day of each study injection. Diaries solicited local reactions (injection site erythema, pain, induration/swelling, and tenderness) and systemic adverse events (AEs; arthralgia, chills, diarrhea, dizziness, fatigue, headache, myalgia, nausea/vomiting and fever). Unsolicited AEs were recorded up to 28 days after each vaccination. Any adverse event leading to discontinuation or withdrawal from the study, any medically attended adverse event (MAAE) or serious adverse event (SAE) was to be documented for one year of follow-up after the completion of the initial vaccination series. Here we present general safety data including MAAEs, SAES and withdrawals up to six months (Day 210). Participants were contacted through weekly telephone calls to ensure compliance with completing the study diaries, which were collected on Days 8 and 36, 7 days after each vaccination, and at a follow-visit on Day 57. Adverse event data was entered into the case report form, and the causal relationship of events was established by the reporting investigator.
Sera for immunogenicity analyses were collected on Days 1, 29 and 57. The primary immunogenicity objective was the response at Day 57 in all sera available from eligible phase 1/2/3a participants as measured at the Vietnamese National Institute of Hygiene and Epidemiology Laboratory using the SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) kit (GenScript, Piscataway, NJ, USA). This kit is a functional enzyme-linked immunosorbent assay for qualitative or semiquantitative detection of antibodies (Nabs) that block the binding of SARS-CoV-2 to the human ACE2 receptor of host cells. Antibodies were expressed as group geometric mean concentrations (GMC), seroconversion rates (SCR), and geometric mean fold rises (GMFR) from Day 1. Results were expressed in units per mL (U/mL) calibrated with the WHO standard serum.
To confirm observations from the exploratory assay, immunogenicity was also assessed in a validated 293T-ACE2 cell-based microneutralization assay by the Pharmaceutical Product Development Bioanalytical Laboratory (PPD, Richmond, VA, USA). This measured neutralizing antibodies against SARS-CoV-2 in sera from Days 1 and 57 from all phase 1 participants, the first 150 samples from phase 2, and randomly selected samples from the other participants in phase 2, and all available samples from phase 3a.
For efficacy assessments, participants with suspected COVID-19 were evaluated for the presence of potential symptoms and clinical signs of COVID-19 including fever, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting or diarrhea. Any of these symptoms occurring after 3 days post-vaccination triggered COVID-19 diagnostic testing. Where possible, participants visited their respective study clinic where nasal swabs were taken for RT-PCR, with documentation of medical history and medications taken. A protocol-defined COVID-19 case had to have virological confirmation (by RT-PCR) of SARS-CoV-2 and at least one of the symptoms or clinical findings listed above.
Case definitions for evaluations of COVID-19 and severe COVID-19 were based on US FDA recommendations in line with similar clinical trials, which for severe COVID-19 included any of the following: acute pulmonary, cardiac, renal, hepatic, or neurologic dysfunction; shock; death; or admission to an intensive care unit (Supplementary table3). All suspected COVID-19 cases underwent blinded tiered review by an independent Event Adjudication Committee (EAC) composed of clinical experts experienced in the diagnosis, care, and treatment of COVID-19. The EAC reviewed blinded data from each case and concluded on whether the case met the protocol-defined COVID-19 case criteria, and severity according to the US FDA and WHO classifications. Only virologically confirmed, protocol-defined cases adjudicated by the EAC are included in the primary vaccine efficacy (VE).
Primary safety endpoints were evaluated in the Safety Analysis Set (SAS; all participants who received any study injection) and Reactogenicity Analysis Set (RAS; all participants who received any study injection and provide at least one diary report). Statistical analysis of safety and reactogenicity data was descriptive with frequency and percentage for participants analyzed according to study group.
Primary immunogenicity analysis in the Immunogenicity Analysis Set (IAS) included all participants who received both assigned study injections by the evaluated timepoint with no evidence of prior SARS-CoV-2 infection at Day 1 (i.e., were seronegative for N-antibody) and at least one valid post-vaccination immunogenicity assay result. GMCs were calculated as the mean of log-transformed results and then exponentiating the mean (in order to present the results on the original scale). GMFR was calculated as the mean of the difference after log-transformed results (post baseline minus baseline) and exponentiating the mean. Two-sided 95% CI for GMCs and GMFRs were obtained by taking log-transformation of the antibody results; the 95% CI was calculated based on Students t-distribution for the mean difference, then exponentiating the confidence limits. Seroconversion was defined as 4-fold increase in titer from baseline and its two-sided 95% CI was calculated using the Clopper-Pearson method.
The primary efficacy objective was assessed in the modified Intention to Treat (mITT) set composed of all participants who received both assigned study injections and had no evidence of SARS-CoV-2 infection on Day 1 and up to Day 36, 7 days after the second study injection. The first primary endpoint was defined as the first occurrence of confirmed, protocol-defined COVID-19 with onset between Days 36 and 92 inclusive. For the overall primary efficacy objective of the study, the null hypothesis was that the vaccine efficacy (VE) of ARCT-154 to prevent COVID-19 was 30% (i.e., H0efficacy: VE 0.3). Vaccine efficacy was calculated from 1-hazard ratio, where the hazard ratio (HR) and 95% CI are estimated by Cox proportional hazard regression. The primary efficacy objective would be met if the lower limit of the 95% CI for VE exceeded 30%; a total of 372 COVID-19 cases were needed to provide approximately 90% power to detect a 50% reduction in hazard rate (50% VE). Factors used as covariates in Cox proportional hazard regression included: Risk group: 18 to <60 years and healthy, 18 and <60 years and at risk and 60 years and study site region. If the primary efficacy objective was met, following a hierarchical approach, the null hypothesis that the vaccine efficacy to prevent occurrence of confirmed severe COVID-19 was 0% (i.e., H0efficacy: VEsevere0) was also tested. A secondary efficacy assessment was done in the ITT set, comprising all participants who received at least one study injection, in which the secondary endpoint was the occurrence of confirmed, protocol-defined COVID-19 with onset at any time after the Dose 1 up to Day 92, inclusive.
Further information on research design is available in theNature Portfolio Reporting Summary linked to this article.
The number of children who received their routine vaccinations declined during the pandemic, so public health officials have been focusing on getting kids back up to date. They should also be paying attention to adults as a new, first-of-its-kind report quantifying the economic impact of adult immunizations makes clear.
Researchers at the nonprofit Office of Health Economics, based in London, analyzed four adult vaccine programs for the flu, pneumonia, respiratory syncytial virus (RSV), and shingles across 10 countries including Australia, France, Japan, and the United States. They found that adult vaccination programs paid for themselves many times over, returning up to 19 times the initial investment in societal benefits.
Vaccines are among the most effective public health inventions in human history. Yet despite the clear benefits, the most recent data from The Commonwealth Fund indicates that the 2021 flu vaccination rate for U.S. adults was just 42%. By contrast, in the 2022-2023 school year, 93% of kindergartners received all state-required vaccines.
This shows what a difference a concerted policy effort can make: providers administer childhood vaccines based on a schedule set by the U.S. Centers for Disease Control and Preventions Advisory Committee on Immunization Practices. The schedule for adult vaccines is much more complex.
I know the public health community can do better. During the pandemic, nearly 80% of U.S. adults completed their primary series of Covid-19 shots.
With that public health emergency in the rearview mirror, the U.S. has slipped into complacency, and demand for vaccines across the life course is falling. Fewer than half of adults received updated Covid-19 and flu shots last year. New vaccines offer adults protection against RSV and shingles, but most Americans eligible for these shots arent getting them: Nearly two in three people age 65 and older havent received the shingles vaccine, which the CDC recommends that people aged 50 and older get. Only 23% of people 65 and older have gotten the RSV shot, which is encouraged for every adult aged 60 and over.
Severe cases of flu, pneumonia, RSV, and even shingles can be deadly. Vaccines can prevent many of these deaths. A study by the Brown School of Public Health found that if Covid-19 vaccinations had stayed at their peak rate, the United States could have averted more than 300,000 deaths between January 2021 and April 2022.
Vaccines also offer protection against conditions beyond the ones for which theyre designed, because they reduce the risk of other health issues like heart attacks and certain cancers. A study cited in the Office of Health Economics report found that getting a flu shot can lower the risk of stroke and subsequent hospitalization among elderly people by as much as 16%.
As the U.S. population ages, the importance of boosting adult vaccination rates will only grow. Without a campaign to increase adult vaccination, experts estimate that rates of vaccine-preventable illnesses will rise over the next 30 years. That wont just lead to more human suffering. It will also impose staggering costs on major world economies.
How can the U.S. increase vaccination rates for adults? The process begins with encouraging doctors, biopharmaceutical companies, and government leaders to work together to build awareness of recommended vaccines and their impact and remove barriers to access. Studies show that when physicians and community leaders recommend vaccination, it has a positive impact on increasing rates.
During the pandemic, a focus on community-based organizing helped ensure that vaccination rates for Covid-19 were high. The CDCs Covid-19 Vaccine Equity Community Education and Outreach Initiative, for example, provided federal funding to trusted community organizations during the pandemic. The outreach conducted by these organizations helped increase vaccine uptake in communities disproportionately impacted by the pandemic. Its why one of the policy priorities of BIO, the organization I work for, is to continue the CDC-funded, community-based outreach approach and transition the focus to routine vaccinations.
Every American, regardless of their insurance status, should have equitable access to all recommended vaccines with no out-of-pocket costs.
The federal government can guarantee that uninsured adults have access to routine vaccines with zero cost sharing, just like insured patients. And when insured patients try to get vaccinated, they shouldnt run into surprise charges from their insurance company. High vaccine coverage in adults would more than pay for itself by preventing healthy adults from getting sick and incurring taxpayer-funded healthcare expenses in the future.
Lawmakers at every level of government should also ensure that different types of medical providers including physician assistants and pharmacists can administer vaccines to adults, no matter what state they work in. Some states still impose restrictions on the ability of non-physician providers to administer vaccines, despite a lack of evidence that more relaxed policies pose any health risk to patients. This measure would prove especially valuable for underserved communities.
The public health community knows what works and knows how to get things done. Investing in life-course immunization will pay for itself in health and prosperity.
Phyllis Arthur is the senior vice president of infectious disease and emerging science policy at the Biotechnology Innovation Organization (BIO).
Federal Court Rules University of Colorado Vaccine Policies Motivated by Religious Animus
Last week the United States Court of Appeals for the Tenth Circuit reversed a lower court decision, issuing a 55-page ruling holding that the University of Colorado Anschutz School of Medicines policies refusing religious exemptions to its COVID-19 vaccination mandate were motivated by religious animus and unconstitutional under the First Amendments Religion Clauses.
The original mandate had been rejected by some university staff and students after a vaccine was developed in response to the global COVID-19 pandemic. The court case was mounted by the conservative Thomas More Society, a not-for-profit law firm based in Chicago. In an appeal filed in March 2022, the firm represented 17 faculty and students who asserted that the university refused to accommodate their sincerely and deeply held religious objections that prevented them from taking the vaccine.
The University of Colorado Anschutz Medical Campus on the academic health sciences campus in Aurora, Colorado, houses the University of Colorados six health sciences-related schools and colleges. In September 2021, the university enacted and enforced a policy that all students, employees, and other individuals who currently or may in the future access any CU Anschutz facility or participate in any CU Anschutz program or otherwise interact with members of the Anschutz community regardless of location must become fully vaccinated against COVID-19 with a vaccine that has been approved by the World Health Organization.
COVID-19 vaccines. Photo by Daniel Schludi for unsplash
In addition to finding religious animus, the Court found that the vaccine mandates of the Universitys Anschutz Medical Campus granted exemptions for some religions, but not others, because of differences in their religious doctrines and granted secular exemptions on more favorable terms than religious exemptions, all of which was illegal.
The court also reaffirmed the First Amendment principle that the government may not test the sincerity of employees religious beliefs by judging the legitimacy of those doctrines. The Court also held that the Universitys mandates violated clearly established constitutional rights.
The University of Colorado ran roughshod over staff and students of faith during COVID, and the Court of Appeals has now declared plainly what weve fought to establish for almost three years: the University acted with religious animus and flagrantly violated the fundamental religious liberties of these brave healthcare providers and students, said Thomas More Society Executive Vice President & Head of Litigation Peter Breen.
These medical providers were hailed as heroes, as they served bravely on the front lines through the worst of the pandemic, but when their religious principles conflicted with the beliefs of the University of Colorado bureaucrats, these heroes were callously tossed aside. he added.
With this ruling in favor of our clients, the Court of Appeals has made clear that people of faith are not second-class citizens, he added. They are deserving of full respect and the protection of the United States Constitution in their free exercise of religion. By unlawfully and intrusively probing our staff and students religious beliefs, the university rendered value judgments that not only reeked of religious bigotry but violated our clients constitutional rights, as well as basic decency.
The Court of Appeals decision highlighted specific instances of what it referenced as religious discrimination, including the following:
. . . the Administration decided that it is morally acceptable for Roman Catholics to take vaccines against COVID-19, and that any Roman Catholic objections to the COVID-19 vaccine are personal beliefs, not religious beliefs. Id. at 116263. As a result, the Administration would not grant exemptions to Roman Catholic applicants under the September 1 Policy. (Slip Opinion, p. 5.)
. . . the Administration refused to approve any exemptions for Buddhist applicants under the September 1 Policy. Nor would the Administration approve any exemptions for members of the Roman Catholic Church or the Eastern Orthodox Church. At the same time, the Administration admitted it would approve applications from practitioners of select, favored religions, such as Christian Scientists. (Slip Opinion, p. 30.)
a government policy that grants an exemption for medical reasons but denies the same exemption for religious reasons is not generally applicable, as it devalues religious reasons . . . by judging them to be of lesser import than nonreligious reasons. The September 24 Policy on its face makes a value judgment in favor of secular motivations because it has a lower bar for denying religious exemptions.
Under its September 1, 2021 policy, the university declared that it would only accept requests for religious exemptions from those whose religions taught that all vaccines are forbidden. In addition, those seeking exemptions were required to justify their religious beliefs under questioning. Under its September 24, 2021 policy, the University entirely excluded students from religious exemptions and provided for medical exemptions on more generous terms than religious exemptions.
Read the May 7, 2024 decision by the United States Court of Appeals for the Tenth Circuit in Jane Does 1-11 and John Does 1, 3-7 v. The Board of Regents of the University of Colorado, et. al. here [https://uploads-ssl.webflow.com/63d954d4e4ad424df7819d46/663bd07a66d645d57f832e4a_010111045465.pdf].
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A study by the University of Cambridge, UK, and Fudan University, China, has found that a single dose of the measles jab is up to 2.6 times more likely to be completely ineffective in children born by C-section, compared to those born naturally.
Failure of the vaccine means that the childs immune system does not produce antibodies to fight against measles infection, so they remain susceptible to the disease.
A second measles jab was found to induce a robust immunity against measles in C-section children.
Measles is a highly infectious disease, and even low vaccine failure rates can significantly increase the risk of an outbreak.
A potential reason for this effect is linked to the development of the infants gut microbiome the vast collection of microbes that naturally live inside the gut. Other studies have shown that vaginal birth transfers a greater variety of microbes from mother to baby, which can boost the immune system.
Weve discovered that the way were born - either by C-section or natural birth - has long-term consequences on our immunity to diseases as we grow up, said Professor Henrik Salje in the University of Cambridges Department of Genetics, joint senior author of the report.
He added: We know that a lot of children don't end up having their second measles jab, which is dangerous for them as individuals and for the wider population.
Infants born by C-section are the ones we really want to be following up to make sure they get their second measles jab, because their first jab is much more likely to fail.
The results are published today in the journal Nature Microbiology.
At least 95% of the population needs to be fully vaccinated to keep measles under control but the UK is well below this, despite the Measles, Mumps and Rubella (MMR) vaccine being available through the NHS Routine Childhood Immunisation Programme.
An increasing number of women around the world are choosing to give birth by caesarean section: in the UK a third of all births are by C-section, in Brazil and Turkey over half of all children are born this way.
With a C-section birth, children arent exposed to the mothers microbiome in the same way as with a vaginal birth. We think this means they take longer to catch up in developing their gut microbiome, and with it, the ability of the immune system to be primed by vaccines against diseases including measles, said Salje.
To get their results, the researchers used data from previous studies of over 1,500 children in Hunan, China, which included blood samples taken every few weeks from birth to the age of 12. This allowed them to see how levels of measles antibodies in the blood change over the first few years of life, including following vaccination.
They found that 12% of children born via caesarean section had no immune response to their first measles vaccination, as compared to 5% of children born by vaginal delivery. This means that many of the children born by C-section did still mount an immune response following their first vaccination.
Two doses of the measles jab are needed for the body to mount a long-lasting immune response and protect against measles. According to the World Health Organisation, in 2022 only 83% of the world's children had received one dose of measles vaccine by their first birthday the lowest since 2008.
Salje said: Vaccine hesitancy is really problematic, and measles is top of the list of diseases were worried about because its so infectious.
Measles is one of the worlds most contagious diseases, spread by coughs and sneezes. It starts with cold-like symptoms and a rash, and can lead to serious complications including blindness, seizures, and death.
Before the measles vaccine was introduced in 1963, there were major measles epidemics every few years causing an estimated 2.6 million deaths each year.
The research was funded by the National Natural Science Foundation of China.
Reference
Wang, W. et al: Dynamics of measles immunity from birth and following vaccination. Nature Microbiology, 13 May 2024. DOI: 10.1038/s41564-024-01694-x
Pentagon Compensated Zero Civilian Victims in 2022 Despite Evidence That the U.S. Killed a Mom and Child in Somalia
The 22-year-old woman and her child were civilian casualties of a U.S. drone strike, but the Pentagon won't return the family's messages.
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The judge said only workers with no access to patients or colleagues made case for vaccine exemption
Published May 14, 2024 Last updated 18hours ago 4 minute read
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A nurse-practitioner who lost her job after refusing the COVID-19 vaccine on religious grounds was among 15 health-care workers who failed to have B.C. public health orders dismissed on constitutional and other grounds.
A B.C. Supreme Court ruled on three similar petitions to have two orders issued in 2023 by B.C.s provincial health officer thrown out, according to the reasons for judgment released Monday.
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The orders, issued in October 2023, extended a previous order requiring COVID vaccinations by workers in health-care settings and long-term care homes.
The health-care workers sought to dismiss the orders, arguing their continuation was an unreasonable exercise of the powers of the health officer, Dr. Bonnie Henry.
They argued the orders caused ongoing hardship and harm to workers who had lost their jobs and to the health-care system from the loss of personnel. About 1,800 health-care workers were fired for refusing to get vaccinated.
The petitions challenged the reasonableness of the orders on four grounds.
That, by late 2023, COVID was no longer an immediate and significant risk to public health and the health officers emergency powers no longer applied.
That there was no medical evidence that unvaccinated health-care workers posed a greater risk to vulnerable patients than vaccinated workers.
That it was unconstitutional to force the workers to choose between their fundamental and personal beliefs about vaccination and keeping their jobs, because it infringed on rights to freedom of conscience and religion in Canadas Charter of Rights and Freedoms.
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They also argued that it was unreasonable to apply the order to those who worked remotely or held administrative positions, given their lack of contact with vulnerable patients and front-line workers.
Justice Simon Coval dismissed the first three grounds. He agreed with the fourth one, ordering the issue be returned to the public health officer to tweak her health order.
And while he found the orders did violate Charter guarantees of conscience and religion, he ruled that infringement was reasonable because the health officer did not exceed what was necessary to balance the protection of vulnerable patients, residents and clients from serious illness and death and the safety of the public.
Peternella Hoogerbrug, the Christian nurse practitioner, was fired in May 2022 for refusing the vaccine for religious reasons.
She told court her faith is an integral and deeply held root part of her life and identity and her church, the Reformed Congregation in North America, opposes vaccination because it interferes with the providence of God and the church teaches placing ones trust in the vaccine, rather than God, can lead to idolatry, Coval wrote in his judgment.
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Hoggerbrug was devastated by losing her job to adherence to her faith and that providing health-care services has been a core aspect of her identity, according to the judgment. She hasnt been able to find a job as a nurse practitioner because of her lack of vaccination, it said.
York Hsiang, a vascular surgeon at Vancouver General, and David Morgan, a psychiatrist from Prince George, also lost their jobs because of their vaccine refusal.
Hsiang said he chose not to get the vaccine based on his own medically informed risk-benefit analysis and strong belief it should be his choice. He stopped performing surgery and retired in 2021 rather than face being fired.
Morgan, who assessed and treated youth in the criminal justice system, was fired in December 2021 for not getting the jab, and now works in private practice and as an assistant University of B.C. professor, the judgment said.
Hilary Vandergugten, a nurse who was a clinical coordinator at Langley Memorial Hospital, where she worked for 27 years, was fired in 2022, which affected her financially and emotionally. In her affidavit, she said she was working part-time doing COVID tests in the film industry.
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Other petitioners described severe consequences from losing their jobs for refusing the vaccine as they were terminated for just cause and were ineligible for severance or employment insurance benefits, and lost pension and insurance plans along with their jobs, the judgment said.
They had trouble replacing their jobs and some considered moving from B.C., Covals judgment said.
Coval wrote that Henrys job during a pandemic is to prevent and manage outbreaks, reduce risk of infection, serious illnesses and premature deaths, and protect the health-care system, and in October 2023 she issued the two orders, which had no expiry date.
Coval wrote that the petitioners argued that by October 2023 the continuation of the vaccination order was being used as a quasi-permanent precautionary measure for a virus which, by that time, the PHO herself described as no more serious than a cold.
But he said the 2023 orders are reasonable because health-care workers are in a special situation given the crucial role they play in the system and their near-constant, close contact with the most vulnerable patients, who generally speaking have no choice but to be treated by them.
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PUTRAJAYA: Data on the AstraZeneca vaccines adverse events following immunisation (AEFI) will be released this week, says Deputy Health Minister Datuk Lukanisman Awang Sauni.
Insights about the data, he said, as well as AstraZenecas clarification would be revealed by Health Minister Datuk Seri Dr Dzulkefly Ahmad.
The government has the data and we will announce it as it is important to the public.
We will explain the data concerning adverse side effects, the issues and also the clarification from AstraZeneca, he said after attending the International Nurses Day celebration here yesterday.
Lukanisman said Health director-general Datuk Dr Muhammad Radzi Abu Hassan would also address issues about the adverse events, along with the number of those affected.
Earlier this month, Dzulkefly sought clarification from AstraZeneca about the adverse events after the pharmaceutical company admitted in court documents that the vaccine could cause, in very rare cases, thrombosis with thrombocytopenia syndrome (TTS).
This syndrome is when the individuals have blood clots together with a low platelet count.
AstraZeneca had recently withdrawn its Covid-19 vaccines worldwide.
Dzulkefly had asked the pharmaceutical company to submit a thorough and transparent explanation not only to Malaysia but to the whole world.
Meanwhile, Lukanisman said the Health Ministrys facilities are prepared to treat those experiencing adverse events from the vaccine.
Checks with the National Pharmaceutical Regulatory Agency found that the last AEFI summary report on all vaccinations was on Nov 30 last year.
The report said it received 26 serious adverse effects reports out of a million doses.
Thus far in Malaysia, no data on the total number of TTS cases caused by the AstraZeneca vaccine has been reported, while Indonesia said that no TTS cases associated with the vaccine were reported.
Separately, Lukanisman said the national nursing workforce numbers 139,000, with 75,000 of these nurses under the Health Ministry while the rest were in the private sector.
When asked about hiring foreign nurses, Lukanisman said such nurses had been hired since last year, and the hiring window was expected to last till October this year.
The recruitment process is very stringent because we dont want to hire unqualified nurses, he said.
The ministrys nursing director, Devi K. Saravana Muthu, said that so far, 101 foreign nurses had been employed in the private sector.
These nurses are coming from India, Sri Lanka, the Philippines and Indonesia. They will be undergoing stringent screening, she said.
In a recent study published in Nature Aging, researchers conducted a randomized clinical trial (RCT) to investigate whether a health education intervention offered to Chinese college students will increase severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) booster vaccinations among their grandparents.
Study:Influence of grandchildren on COVID-19 vaccination uptake among older adults in China: a parallel-group, cluster-randomized controlled trial. Image Credit:fizkes/Shutterstock.com
Coronavirus disease 2019 (COVID-19) has had a significant impact on older individuals, making them the highest risk group for hospitalization, ICU admission, and mortality. Vaccination is successful, although the Omicron variety has decreased, necessitating booster dosage recommendations.
Despite free vaccinations and public health advice, vaccine reluctance is widespread in China, particularly among elders. New measures are required to alleviate hesitation and promote booster vaccination.
Researchers link family members' recommendations to higher vaccination rates, and college-aged grandchildren may encourage vaccination among family members.
In the present study, researchers evaluated the effectiveness of providing SARS-CoV-2 booster vaccinations among grandparents aged 60 years using an educational intervention provided to their 16-year-old grandchildren in China.
The researchers recruited volunteers between September 1 and September 22, 2022. The RCT included college students in mainland China aged 1635, with at least one eligible living grandparent aged 60yearswho completed the first COVID-19 immunization series but did not receive a booster dose and were willing to persuade their grandparents to obtain booster vaccinations.
The researchers eliminated children whose grandparents had received a SARS-CoV-2 vaccine booster between the baseline evaluation and randomization.
The primary endpoint was the SARS-CoV-2 vaccine booster uptake rate among grandparents. Secondary study outcomes were grandparents' attitudes and intentions to receive the booster dosage.
The researchers randomized 202 college attendees in a 1:1 ratio to receive the health educational intervention online with 14 daily SMS reminders (188 grandparents) or the control group comprising 187 grandparents. The students reported their grandparents' vaccine booster status at study initiation and after three weeks.
The health education campaign, built using the knowledge, attitude, and practice (KAP) paradigm, addressed the epidemiology, policy, effectiveness, safety profile, indications, contraindications, and precautions for COVID-19 vaccinations among older individuals in China.
The program was provided to participants via interactive web pages, with questions to gauge their comprehension and interest.
The primary analyses were per-protocol (PP) and intention-to-treat (ITT), with models with robust standard errors.
The team conducted subgroup analyses to evaluate the interventions impacts stratified by the grandparents' age, gender, domicile, education, past cohabitation with grandchildren, and comorbidities, and sensitivity analyses using generalized estimating equations (GEE).
The intervention group grandparents were more likely to receive the vaccine booster than controls [intervention, 31% (45/147); control, 17% (26/154); risk ratio (RR) of 2.0].
In the per-protocol analysis, grandparents' attitudes toward receiving the booster dosage increased significantly among the intervention recipients grandparents (from 4.9 to 5.3, change = 0.4), and a slight rise was detected among those of the control group (from 5.0 to 5.1, change = 0.1).
The intervention group grandparents showed more statistically significant alterations in attitude ratings from baseline to follow-up than those of the controls. Grandparents from the intervention group showed a statistically significant increase in their intention to receive the booster vaccination (from 5.0to 5.4, change = 0.4).
The control group grandparents only showed a minor increase (from 5.1to 5.2, change = 0.1). Intention rating changes were also considerably higher among intervention group grandparents compared to those of controls.
The ITT analysis results were identical to those of the PP analysis, and sensitivity analyses produced results that were compatible with the PP and ITT analyses.
In a subgroup analysis by GEE modeling, the educational intervention program was more effective for grandparents 60 to 69 years old.
The intervention proved more successful for grandparents suffering from chronic conditions when applying GEE modeling to the per-protocol analysis. The effects of chronic diseases were not significant in the ITT analysis, as by robust standard error modeling.
The study findings showed that an educational intervention aimed at college students improved SARS-CoV-2 booster vaccine uptake among grandparents in China, particularly those aged between 60 and 69 years.
The findings indicate that governments may combat vaccine reluctance by mobilizing young individuals, particularly college students with better health literacy, to persuade older family members to receive the COVID-19 vaccine.
College students may use intergenerational connections to convince grandparents to approve vaccination, citing familial duties, similar values, strong personal relationships, and emotional connections.
The social control function of family members discourages risky behaviors. Further research with larger sample sizes and longer follow-ups is needed to validate the study findings.
Future studies could determine the effectiveness of fewer frequent reminders and investigate characteristics that increase or reduce the effectiveness of intergenerational messaging tactics.
