Tag: cohort

Pfizer Says Its Vaccine is 90.7% Effective Against Symptomatic Covid-19 In Children Ages 5 To 11

Bridgette Melo, 5, holds the hand of her father, Jim Melo, during her inoculation of one of two reduced 10 ug doses of the Pfizer BioNtech COVID-19 vaccine during a trial at Duke University in Durham, North Carolina September 28, 2021 in a still image from video. Video taken September 28, 2021. Shawn Rocco/Duke University/Handout via REUTERS NO RESALES. NO ARCHIVES. THIS IMAGE HAS BEEN SUPPLIED BY A THIRD PARTY.

In a new document posted ahead of a key meeting of the US Food and Drug Administration’s vaccine advisers, Pfizer says its vaccine is safe and 90.7% effective against symptomatic Covid-19 in children ages 5 to 11.

In the trial, which included around 2,000 children, there were three Covid-19 cases among the group that received the vaccine and 16 cases in the placebo group. In the trial, twice as many children received the vaccine as the placebo.

Pfizer/BioNTech are seeking FDA emergency use authorization of a two-dose regimen of their 10-microgram dose for children ages 5 to 11. The two doses would be administered three weeks apart. Last month, Pfizer released details of a Phase 2/3 trial that showed its Covid-19 vaccine was safe and generated a “robust” antibody response in children ages 5 to 11. The trial included 2,268 participants ages 5 to 11.

Participants’ immune responses were measured by looking at neutralizing antibody levels in their blood and comparing those levels to a control group of 16- to 25-year-olds who were given a two-dose regimen with the larger 30-microgram dose. Pfizer said the levels compared well with older people who received the larger dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”

The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet October 26 to discuss whether to recommend the vaccine for authorization for those ages 5 to 11.

If authorized, this would be the first Covid-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people ages 12 to 15.

The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268participants who were 5 to 11 years of age and received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose.

This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.

A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year.

Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.

A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.

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Source: Pfizer says its vaccine is 90.7% effective against symptomatic Covid-19 in children ages 5 to 11 – ABC17NEWS

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Other Sources:

Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com

or by calling 1-800-438-1985.

Please click here for full Prescribing Information (16+ years of age). Please click here for Fact Sheet for Vaccination Providers (12+ years of age)

Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection (PDF). Regulation 174 (Report). Medicines and Healthcare products Regulatory Agency (MHRA). 15 December 2020. Archived (PDF) from the original on 16 December 2020. Retrieved 23 April 2021. Burger L (15 March 2020). “BioNTech in China alliance with Fosun over coronavirus vaccine candidate”. Reuters. Archived

People Who Eat More Dairy Fat Have Lower Risk of Heart Disease Study Suggests

An international team of researchers studied the consumption of milk fat in 4,150 60-year-olds in Sweden — a country with one of the world’s highest levels of dairy production and consumption — by measuring blood levels of a particular fatty acid found mostly in dairy products. Experts then followed the cohort for an average of 16 years to observe how many had heart attacks, strokes and other serious circulatory events, and how many of them died.

After statistically adjusting for other known cardiovascular disease risk factors, including age, income, lifestyle, diet, and other diseases, the researchers found that those with high levels of the fatty acid – signs of a high intake of lactic fat – had the lowest risk of cardiovascular disease. , as well as no increased risk of death from any cause.

The team then confirmed these findings in other populations after combining the Swedish results with 17 other studies involving a total of almost 43,000 people from the United States, Denmark and the United Kingdom.

“Although the results may be partly influenced by factors other than milk fat, our study does not suggest any harm of milk fat per se,” said Matti Marklund, senior researcher at the George Institute for Global Health in Sydney and co-author of the paper. declaration.

“We found those with the highest levels actually had the lowest risk of CVD (cardiovascular disease). These conditions are very interesting, but we need further research to better understand the full health impact of milk fats and dairy products,” he said.

Lead author Kathy Trieu, a researcher at the George Institute, said that consumption of some dairy products, especially fermented products, had previously been associated with benefits for the heart.

Dairy products are rich in nutrients

“More and more evidence suggests that the health consequences of dairy products may be more dependent on the type – such as cheese, yoghurt, milk and butter – rather than the fat content, which has raised doubts as to whether avoiding milk fat is generally beneficial to cardiovascular health. She said in the statement.

“Our study suggests that cutting down on milk fat or avoiding dairy altogether may not be the best choice for heart health,” she added.

“It is important to remember that although dairy products can be rich in saturated fat, they are also rich in many other nutrients and can be part of a healthy diet. But other fats such as those found in seafood, nuts and Non-tropical vegetable oils can have greater health benefits than milk fat, “said Trieu.

Brian Power, associate professor at the Department of Health and Nutrition at the Irish Institute of Technology Sligo, said the study encourages us to “reconsider what we think we know about food and disease.”

“Dairy products need not be avoided,” Power, who was not involved in the investigation, told CNN in an email. “This is largely lost in its translation when we communicate what we know about healthy eating.”

Data suggest correlation rather than causality

Alice Lichtenstein, director and senior researcher at Tufts University’s Cardiovascular Nutrition Laboratory, told CNN that her main concern was that the study results could be interpreted to suggest that all full-fat dairy products reduce the risk of cardiovascular disease, adding: “The majority of data support not consuming full-fat dairy products to reduce CVD risk. “

She said the study data showed that the group with the highest biomarker for dairy intake also had, among other things, a significantly lower BMI, was more physically active, had a lower smoking rate, lower rates of type 2 diabetes and cardiovascular disease, a higher level of education, higher intake of vegetables, fruits and fish and lower intake of processed meat – thus a higher dietary quality – all factors associated with a lower risk of cardiovascular disease.

“They were checked for in the statistical analyzes, but residual confusion can not be ruled out. The reported data is for associations, but associations can not establish causality,” she told CNN in an email, adding that it was also remarkable, that the authors could not identify what type of dairy products their cohort ingested.

By: PLOS Medicine

Source: People who eat more dairy fat have lower risk of heart disease, study suggests | MCUTimes

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5 Ways to Learn New Skills Effectively

Learning a new skill can be one of the most satisfying things you can do to grow. Learning a new skill is not just a financially smart decision, but it is also good for your mental health. When you learn new skills, you feel more powerful. New neural connections are formed in your brain when you learn something new. The best way to change your life is to change your mind. And learning new skills is the best way to change your mind, literally.

When the normal routine of life makes your life dull, having entertainment alone is not enough to recharge yourself. Entertainment can be good for a weekend — but if you do not learn anything new for years, you will start hating your work.

The traditional system of education expects us to finish school and college and then work for the rest of our lives. That strategy might have worked 30 years back as the world was slowly moving towards the information age. It is not going to work anymore. To thrive in this day and age, learning has to become a habit and continuous up-gradation of skills is required to stay relevant and competitive.

One of the biggest challenges in learning after school and college is that the learning journey becomes lonely. If you are trying to learn from a book or an online course with a set of video tutorials, your learning can become quite stressful. Students learn best when they are energetic and happy. And the only way to feel energetic and happy during your learning journey is to be part of a community that has the same learning goals as yours.

1. Sign up for a cohort-based online course

Many online courses nowadays are cohort-based, and cohort-based online courses usually have a community around them. Being part of a community can impact your learning journey in very subtle ways that are not obvious. Remember, you are the average of the five people around you.

If you are part of a learning community where you see other students have similar goals such as yours and if you see that they are making progress with their professional journey, you are highly likely to grow along with them. You will have a positive pressure to achieve results.

Related: Why Remote Learning is an Avenue That is Worth Exploring

2. Sign up for a mastermind program

After the completion of the online course, you can think about becoming part of a mastermind community where the learning journey continues beyond the course duration. A mastermind community is usually led by a mentor, and you will have the best of the best students as part of the community.

Mastermind community memberships usually come at a premium, but it is worth the premium because the ideas that you get from the community for your career and business will be well worth the price.

3. Start blogging about what you’ve learned

To make sure that you do not forget what you learn, take notes and write about what you have learned in your blog. Writing organizes your thought process and it is one of the best ways to remember.

If you write in a public blog, you can also build your brand at the same time and may even start having some subscribers who want to copy your notes. A lot of digital mentors have built their following because they started taking their notes in public.

Related: 4 Tips for Finding Your Profitable Blogging Niche

4. Implement your learning

You also have to make sure that you implement what you learn. Implementation is very important because when you implement your leaningsconcepts

perspectives

onlinecourses

and get results, you are going to have validated learning. Validating what you have learned will make sure that the concepts you are trying to learn will go from information to understanding.

Once you understand something new, you will feel powerful and your perspective will expand. Once your perspective has expanded to new horizons, you will never be able to get back to your original state of thinking.

Also, implementing what you have learned gives you a project in hand. You get hired for what you can do, not what you know. Online course certificates usually prove that the student knows something, but not that they can do something. When you do a project, the project proves that you can do something. And who knows — the project can become a side hustle and may even become a business someday.

5. Become a digital mentor and teach

And finally, start teaching what you have learned to your followers. If you are already blogging and blogging about what you know, you will have an audience. Create a smaller mastermind group where you are the mentor and help your students. This will mostly happen online. You are effectively becoming a digital mentor for your students. Teaching is one of the best ways to learn, because it forces you to simplify the concepts you already have in your mind.

Related: How VR Will Accelerate Talent Learning and Development

Deepak Kanakaraju

By: Deepak Kanakaraju / Entrepreneur Leadership Network Contributor

Source: 5 Ways to Learn New Skills Effectively

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What Does It Mean to Be a Manager Today?

A year into the pandemic, the implications of how Covid-19 has changed how people will work from now on are becoming clear. Many employees will be working in a hybrid world with more choices about where, when, and how much they work. For midsize companies specifically, Gartner analysis shows that 46% of the workforce is projected to be working hybrid in the near future.

To better understand the impact of Covid-19 on the future of work, we surveyed 3,049 knowledge workers and their managers across onsite, remote, and hybrid work contexts, as well as 75 HR leaders, including 20 leaders from midsize companies. Except where indicated, our findings come from these 2021 surveys.

Managers used to be selected and promoted largely based on their ability to manage and evaluate the performance of employees who could carry out a particular set of tasks. Within the last five years, HR executives started to hire and develop managers who were poised to be great coaches and teachers. But the assumption that coaching should be the primary function of management has been tested since the pandemic began. Three disruptive, transformative trends are challenging traditional definitions of the manager role:

Understanding Midsize Businesses

Normalization of remote work. As both employees and managers have become more distributed, their relationships to one another have also become more asynchronous. Gartner estimates that in more than 70% of manager-employee relationships, either the manager or the employee will be working remotely at least some of the time. This means that employees and their managers will be less likely to be working on the same things at the same time. Managers will have dramatically less visibility into the realities of their employees’ day-to-day and will begin to focus more on their outputs and less on the processes used to produce them.

Acceleration in use of technology to manage employees. More than one in four companies have invested in new technology to monitor their remote employees during the pandemic. Companies have been buying scheduling software, AI-enabled expense-report auditing tools, and even technologies to replace manager feedback using AI. While companies have been focused on how technology can automate employee tasks, it can just as effectively replace the tasks of managers. At the extreme, by 2024, new technologies have the potential to replace as much as 69% of the tasks historically done by managers, such as assigning work and nudging productivity.

Employees’ changing expectations. As companies have expanded the support they offer to their employees in areas like mental health and child care during the pandemic, the relationships between employees and their managers have started to shift to be more emotional and supportive. Knowledge workers now expect their managers to be part of their support system to help them improve their life experience, rather than just their employee experience.

When managerial tasks are replaced by technology, managers aren’t needed to manage workflows. When interactions become primarily virtual, managers can no longer rely on what they see to manage performance, and when relationships become more emotional, they can no longer limit the relationship to the sphere of work. These three trends have culminated in a new era of management where it’s less important to see what employees are doing and more important to understand how they feel.

Radical flexibility requires empathetic managers

To be successful in this new environment, managers must lead with empathy. In a 2021 Gartner survey of 4,787 global employees assessing the evolving role of management, only 47% of managers are prepared for this future role. The most effective managers of the future will be those who build fundamentally different relationships with their employees.

Empathy is nothing new. It’s a common term in the philosophy of good leadership, but it has yet to be a top management priority. The empathic manager is someone who can contextualize performance and behavior — who transcends simply understanding the facts of work and proactively asks questions and seeks information to place themselves in their direct reports’ contexts.

Empathy requires developing high levels of trust and care and a culture of acceptance within teams. This is a lot to ask of any individual: that they ask questions that produce vulnerable answers without compromising trust, diagnose the root cause of an employee’s behavior without making assumptions, and demonstrate the social-emotional intelligence necessary to imagine another’s feelings.

Empathy isn’t easy, but it’s worth it. In fact, in that same survey, 85% of HR leaders at midsize companies agreed that it’s more important now for managers to demonstrate empathy than it was before the pandemic. Further Gartner analysis shows that managers who display high levels of empathy have three times the impact on their employees’ performance than those who display low levels of empathy. Employees at organizations with high levels of empathy-based management are more than twice as likely to agree that their work environment is inclusive.

Creating a new workforce of empathic managers is especially difficult for midsize companies. While larger companies can earmark billions of dollars for learning and development for massive workforce transformation, smaller companies are more fiscally constrained and don’t have the same resources. Midsize companies also often don’t have the scale to create a managerial class within their workforce — they need managers to be both managers and doers.

Midsize companies need to find solutions to develop more empathic managers without massive investments and continue to have those managers work rather than just manage. This will require organizations and their HR functions to develop their managers’ skills, awaken their mindsets to manage in new ways, and create the capacity across the organization to enable this shift. Here’s how to adopt a holistic strategy that invests in all three of those strategies.

Develop empathy skills through vulnerable conversation practice

Asking managers to lead with empathy can be intimidating. Many managers understand empathy conceptually but aren’t sure how to use it as a management tool: Are these questions too personal? How do I create a trusting relationship with my direct reports? Is caring acceptable at work? How do I talk about social justice?

It goes against deeply ingrained assumptions that we should keep work and life separate. Managers need opportunities to practice — and, crucially, room to make mistakes — in order to learn to lead with empathy. Unfortunately, only 52% of 31 learning and development leaders polled in May 2020 report that they’re increasing their focus on soft skills.

To build empathy, Zillow creates cohorts of managers across the organization who engage in rotating one-on-one conversations with their peers to troubleshoot current managerial challenges. These conversations offer frequent, psychologically safe opportunities to engage in vulnerable conversations focused on how managers can commit to specific actions to care for themselves, as well as support the well-being of their team.

Managers are able to practice their empathy with their peers, asking specific questions to understand their challenges and articulating their own circumstances in response to probes. Importantly, these types of conversations offer managers the opportunity to fail — and in a safe space — which is an opportunity rarely given to figures of authority. They also help managers feel less isolated by practicing empathy with peers, who are less likely to pass judgment.

Empower a new manager mindset by creating a network of support

According to our 2021 survey of 4,787 global employees, 75% of HR leaders from midsize companies agree that managers’ roles have expanded, yet roles and teams are not structured to support well-being.

Goodway Group, a fully remote company since 2007, knows that the best business results and purpose for work happens within teams and that distributed teams face greater challenges with communication and shared visibility. Goodway created a dedicated role, the team success partner, whose responsibilities include fostering trust and psychological safety and supporting team health. Managers work with team success partners to respond to the unique challenges distributed employees are facing; this includes facilitating remote psychologically safe remote conversations and supporting new team member assimilation.

Managers’ motivation to be empathic increases when they have a support system that makes it clear that the burden isn’t theirs alone and when organizations invest in roles designed to support them.

Create manager capacity for empathy by optimizing reporting lines

Managers are already overburdened by the demands of the evolving work environment, and actions that drive empathy are time consuming. While 70% of midsize HR leaders agree managers are overwhelmed by their responsibilities, only 16% of midsize organizations have redefined the manager role to reduce the number of responsibilities on their plate.

Recognizing the pressure on managers to maintain team connectedness in a remote environment, leaders at Urgently, a digital roadside assistance company, rebalanced their managers’ workloads. When managers have a team size they can handle, they’re able to dedicate time to fostering deeper connections and responding with empathy. Moving to a hybrid environment creates complexity; one key part of the solution is to help managers prioritize their workload to focus on fewer, higher-impact relationships with individuals and teams.

Organizations that equip managers to be empathic by holistically addressing the three common barriers — skill, mindset, and capacity — will achieve outsized returns on performance in the post-Covid-19 world.

By:Brian Kropp, Alexia Cambon, and Sara Clark

Source: What Does It Mean to Be a Manager Today?

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Critics:

In the field of management, strategic management involves the formulation and implementation of the major goals and initiatives taken by an organization‘s managers on behalf of stakeholders, based on consideration of resources and an assessment of the internal and external environments in which the organization operates. Strategic management provides overall direction to an enterprise and involves specifying the organization’s objectives, developing policies and plans to achieve those objectives, and then allocating resources to implement the plans.

Academics and practicing managers have developed numerous models and frameworks to assist in strategic decision-making in the context of complex environments and competitive dynamics. Strategic management is not static in nature; the models often include a feedback loop to monitor execution and to inform the next round of planning.

Michael Porter identifies three principles underlying strategy:

  • creating a “unique and valuable [market] position“
  • making trade-offs by choosing “what not to do”
  • creating “fit” by aligning company activities with one another to support the chosen strategy

Corporate strategy involves answering a key question from a portfolio perspective: “What business should we be in?” Business strategy involves answering the question: “How shall we compete in this business?”

Management theory and practice often make a distinction between strategic management and operational management, with operational management concerned primarily with improving efficiency and controlling costs within the boundaries set by the organization’s strategy.

Interorganizational relationships allow independent organizations to get access to resources or to enter new markets. Interorganizational relationships represent a critical lever of competitive advantage.[40]

The field of strategic management has paid much attention to the different forms of relationships between organizations ranging from strategic alliances to buyer-supplier relationships, joint ventures, networks, R&D consortia, licensing, and franchising.

On the one hand, scholars drawing on organizational economics (e.g., transaction costs theory) have argued that firms use interorganizational relationships when they are the most efficient form comparatively to other forms of organization such as operating on its own or using the market. On the other hand, scholars drawing on organizational theory (e.g., resource dependence theory) suggest that firms tend to partner with others when such relationships allow them to improve their status, power, reputation, or legitimacy.

See also

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