September 23, 2022
2 min read
London, United Kingdom (UK)- The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a COVID-19 vaccine made by Moderna that targets both the original strain and the Omicron variant.
It is now up to the Joint Committee on Vaccination and Immunization (JCVI) to decide whether it will, as expected, be used in the planned autumn booster programme, expected to begin in September.
The booster dose, known as Spikevax bivalent Original/Omicron, contains 25 micrograms of Omicron vaccine and 25 micrograms of the original COVID-19 vaccine.
“I am pleased to announce the approval of the Moderna bivalent booster vaccine, which was found in the clinical trial to provide a strong immune response against the Omicron BA.1 variant as well as the original 2020 strain.
The first generation of COVID-19 vaccines being used in the UK continues to provide important protection against the disease and save lives. What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve.
We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this will include the vaccine approved today,” said Dr. June Raine, chief executive of the MHRA.
In addition, Stephane Bancel, the CEO at Moderna, described the vaccine as a next-generation COVID-19 vaccine which will play an important role in protecting people in the UK from COVID-19 over the upcoming winter.
“We are delighted with the MHRA’s authorization of Spikevax Bivalent Original/Omicron, our next generation COVID-19 vaccine.
This represents the first authorization of an Omicron-containing bivalent vaccine, further highlighting the dedication and leadership of the UK public health authorities in helping to end the COVID-19 pandemic. This bivalent vaccine has an important role to play in protecting people in the UK from COVID-19 as we enter the winter months,” said Bancel.
Prof. Sir. Munir Pirmohamed, the chair of the Commission on Human Medicines, which independently reviewed the vaccine data, said the commission agreed with the MHRA’s decision.
“The Commission on Human Medicines and its COVID-19 Vaccines Expert Working Group has independently reviewed the data on safety, quality and effectiveness and agrees with the MHRA’s decision. The virus, Sars-CoV-2, is continually evolving in order to evade the immunity provided by vaccines.
This novel bivalent vaccine represents the next step in the development of vaccines to combat the virus, with its ability to lead to a broader immune response than the original vaccine,” said Prof. Pirmohamed.
September 23, 2022
2 min read
One author reports receiving speaker and consultant fees from Bayer and Janssen for work unrelated to this study. Walli-Attaei and the other authors report no relevant financial disclosures.
The magnitude of associations with major CVD for most risk factors are similar in women and men, despite sex differences in risk factor levels, according to an analysis of the PURE study.
In a comprehensive overview of the prevalence of metabolic, behavioral and psychosocial risk factors for CVD in women and men globally, researchers also found that diet was more strongly associated with CVD in women than in men. However, high concentrations of non-HDL and related lipids and symptoms of depression were more strongly associated with risk for CVD in men than in women. Patterns remained consistent across countries regardless of income level.
“Existing studies, mostly from high-income countries, have reported that hypertension, diabetes, and smoking are more strongly associated with cardiovascular disease in women than in men,” Marjan Walli-Attaei, PhD, a research fellow at the Population Health Research Institute of McMaster University and Hamilton Health Sciences, and colleagues wrote in The Lancet. “Such findings would imply that women would benefit to a greater extent in reducing cardiovascular disease risk from control of these risk factors than would men. However, the burden of cardiovascular disease is greatest in low-income and middle-income countries, for which prospective data on the association of risk factors with cardiovascular disease are sparse, with a paucity of analysis by sex.”
Walli-Attaei and colleagues analyzed data from 155,724 adults aged 35 to 70 years at baseline without a history of CVD enrolled in the PURE study, which included participants from 21 high-, middle- and low-income countries, and followed them for approximately 10 years (58% women; mean baseline age, 50 years). Researchers recorded information on participants’ metabolic, behavioral and psychosocial risk factors; all participants had at least one follow-up visit. The primary outcome was a composite of major CV events, defined as CV death, MI, stroke and HF. Researchers reported the prevalence of each risk factor in women and men, HRs and population-attributable fractions associated with major CVD.
As of the data cutoff of Sept. 13, 2021, researchers observed 4,280 major CVD events in women (age-standardized incidence rate, 5 events per 1,000 person-years) and 4,911 in men (age-standardized incidence rate, 8.2 per 1,000 person-years).
Compared with men, women presented with a more favorable CV risk profile, especially at younger ages. HRs for metabolic risk factors were similar in women and men, except for non-HDL, for which high non-HDL was associated with an HR for major CVD of 1.11 in women (95% CI, 1.01-1.21) and 1.28 in men (95% CI, 1.19-1.39; P for interaction = .0037), with a consistent pattern for higher risk among men than women with other lipid markers.
Researchers also observed that maintaining a diet with a PURE score of 4 or lower (score range, 0-8) was more strongly associated with major CVD in women than in men, with HRs of 1.17 (95% CI, 1.08-1.26) and 1.07 (95% CI, 0.99-1.15; P for interaction = .0065), respectively.
In contrast, symptoms of depression were more strongly associated with CVD in men than in women, with the HRs for symptoms of depression being higher in men than in women (P for interaction = .0002). “The HRs of other behavioral and psychosocial risk factors, as well as grip strength and household air pollution, were similar among women and men,” the researchers wrote.
The total population-attributable fractions associated with behavioral and psychosocial risk factors were greater in men than in women (15.7% vs. 8.4%) mostly due to the larger contribution of smoking to population-attributable fractions in men (10.7%) vs. women (1.3%).
“Our results emphasize the importance of a similar strategy for the prevention of cardiovascular disease in both sexes,” the researchers wrote. “However, the increased risk of cardiovascular disease in men might be substantially attenuated with better reductions in tobacco use and lipid concentrations.”
FRIDAY, Sept. 23, 2022 (HealthDay News) — An increased risk of blood clots persists for close to a year after a COVID-19 infection, a large study shows.
The health records of 48 million unvaccinated adults in the United Kingdom suggest that the pandemic’s first wave in 2020 may have led to an additional 10,500 cases of heart attack, stroke and other blood clot complications such as deep vein thrombosis, in England and Wales alone.
The risk of blood clots continues for at least 49 weeks after infection, the study found.
“We have shown that even people who were not hospitalized faced a higher risk of blood clots in the first wave,” said study co-leader Angela Wood, associate director of the British Heart Foundation Data Science Centre.
“While the risk to individuals remains small, the effect on the public’s health could be substantial and strategies to prevent vascular events will be important as we continue through the pandemic,” Wood said in a news release from Health Data Research UK, which sponsors the center.
Researchers found that the risks did lessen over time.
Heart attacks and strokes are mainly caused by blood clots blocking arteries.
The risk of clots in veins was 33 times greater in the week after COVID diagnosis, dropping to eight times greater after four weeks. Conditions caused by these clots include deep vein thrombosis and pulmonary embolism, which can be fatal.
By 26 to 49 weeks after a COVID diagnosis, the risk dropped to 1.3 times more likely for clots in arteries and 1.8 times more likely for clots in veins, the study showed.
While people who were not hospitalized had a lower risk, it was not zero, the study found.
Overall, individual risk remains low, the authors said. Men over 80 years of age are at highest risk.
“We are reassured that the risk drops quite quickly — particularly for heart attacks and strokes — but the finding that it remains elevated for some time highlights the longer-term effects of COVID-19 that we are only beginning to understand,” said study co-leader Jonathan Sterne, director of the NIHR Bristol Biomedical Research Center and of Health Data Research UK South West.
The authors said steps such as giving high-risk patients blood pressure-lowering medication could help reduce cases of serious clots.
Researchers are now studying newer data to understand how vaccination and the impact of new COVID variants may affect blood clotting risks.
The findings were recently published in the journal Circulation.
The U.S. Centers for Disease Control and Prevention has more on blood clots.
SOURCE: Health Data Research UK, news release, Sept. 20, 2022
OTTAWA — An expert told a special joint committee of the House of Commons and Senate that people with mental disorders can suffer for decades, and their distress is equally as valid as someone suffering physical pain.
People suffering solely from mental disorders are due to become eligible for assisted dying in March, and Dr. Justine Dembo, a psychiatrist and medical assistance in dying assessor, also cautioned the committee about perpetuating stigma about mental illness.
Mental health advocates warn it is harder to predict the outcomes and treatments of mental illnesses, and a wish to die is often a symptom, but an expert panel earlier this year said existing eligibility criteria and safeguards in medically assisted dying legislation would be adequate.
Both arguments were made today by a handful of witnesses appearing before the committee, which is deliberating what policies to recommend to lawmakers ahead of the March deadline.
Ellen Cohen, a coordinator advocate for the National Mental Health Inclusion Network, told committee members Canada needs laws to help patients, not hurt them.
“I don’t believe there were any safeguards recommended,” she said.
She resigned from the federal government’s expert panel on MAID and mental illness in December 2021. She said there was no space to identify how vulnerable people could be protected.
The panel released its report May 13, concluding that existing eligibility criteria and safeguards would be adequate “so long as those are interpreted appropriately to take into consideration the specificity of mental disorders.”
Dembo, who was one of the expert panel members, said following those guidelines for people with mental disorders “would ensure an extremely comprehensive, thorough and cautious approach.”
She told the committee people with mental disorders can suffer for decades.
“To say someone with mental illness just shouldn’t be eligible, with that big of a blanket statement, where people don’t even get the chance to be assessed as individuals unique in their circumstances, to me is very stigmatizing,” she said.
While the interim report released earlier this year stops short of making recommendations of its own, it concludes by urging the government to take steps to implement the recommendations of the expert panel “in a timely matter.”
A final report from the committee, complete with recommendations that address other areas including access for mature minors, advance requests, the state of palliative care and the protection of people with disabilities, is due on Oct. 17.
Cohen called the timeline for the legislation to be expanded by March unrealistic.
“I’d like to see this government push this deadline back,” she said.
But Dembo disagreed, telling MPs and senators that assessors are already gaining experience following the existing guidelines.
“Whether or not March 2023 is a realistic deadline depends on how committed and efficient various provincial bodies and local bodies can be in implementing guidelines based on the panel report. I’m hoping they can do that,” she said.
The committee’s review was mandated in the MAID legislation that required that a parliamentary review be initiated five years after the law came into effect in 2016. The committee began its work in 2021 before it was dissolved ahead of the federal election last fall.
The panel and the committee use the terminology “mental disorders,” rather than “mental illness,” stating in their reports that there is no standard definition for the latter and its use could cause confusion.
Conservative MPs on the committee offered a dissenting interim report earlier this year, saying it would be “problematic” to simply endorse the panel’s recommendations.
The MPs argued there are “far too many unanswered questions” on the subject, and nothing precludes the committee from revisiting whether assisted dying should be offered to this category of people at all.
“Legislation of this nature needs to be guided by science, and not ideology,” the Conservatives wrote in May, warning that an outcome that could “facilitate the deaths of Canadians who could have gotten better” would be completely unacceptable.
This report by The Canadian Press was first published Sept. 23, 2022
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