US Clears Moderna Vaccine For COVID-19, 2nd Shot In Arsenal

first_imgUSAF / Kasey Zickmund WASHINGTON (AP) — The U.S. added a second COVID-19 vaccine to its arsenal last week, boosting efforts to beat back an outbreak so dire that the nation is regularly recording more than 3,000 deaths a day.Much-needed doses are set to arrive Monday after the Food and Drug Administration authorized an emergency rollout of the vaccine developed by Moderna Inc. and the National Institutes of Health.The move marks the world’s first authorization for Moderna’s shots. The vaccine is very similar to one from Pfizer Inc. and Germany’s BioNTech that’s now being dispensed to millions of health care workers and nursing home residents as the biggest vaccination drive in U.S. history starts to ramp up.The two work “better than we almost dared to hope,” NIH Director Dr. Francis Collins told The Associated Press. “Science is working here, science has done something amazing.” Early results of large, still unfinished studies show both vaccines appear safe and strongly protective although Moderna’s is easier to handle since it doesn’t need to be stored at ultra-frozen temperatures.A second vaccine represents a ray of hope amid despair as the virus continues to spread unabated even before holiday gatherings that are certain to further fuel the outbreak.The scourge has claimed more than 312,000 U.S. lives and killed 1.7 million people worldwide. New cases in the U.S. are running at over 216,000 per day on average. Deaths per day have hit all-time highs, eclipsing 3,600 on Wednesday.California has emerged as one of the most lethal hot spots, with hospitals running out of intensive care beds and ambulances lining up outside emergency rooms in scenes reminiscent of the calamity around New York City last spring. California on Friday reported over 41,000 new cases and 300 more deaths.When New York’s hospitals were in crisis, health care workers from across the country came to help out. This time, “there’s no cavalry coming” because so many hospitals are swamped, said Dr. Marc Futernick, an emergency room physician in Los Angeles.The nation is scrambling to expand vaccinations as rapidly as Moderna and Pfizer can churn out doses. Moderna’s is for people 18 and older, Pfizer’s starts at age 16.It’s just the beginning of “what we hope will be a big push to get this terrible virus behind us, although it will take many more months to get to all Americans,” Collins said.Moderna expects to have between 100 million and 125 million doses available globally in the first three months of 2021, with 85-100 million of those available in the U.S.Even with additional candidates in the pipeline, there won’t be enough for the general population until spring, and shots will be rationed in the meantime. And while health workers are enthusiastically embracing vaccination, authorities worry the public may need more reassurance to ensure more people get in line when it’s their turn.“Frankly if we don’t succeed in getting 80% or so of Americans immunized against COVID-19 by the middle of this 2021 year, we have the risk that this epidemic could go on and on and on,” Collins said.He is especially concerned that accurate information about the shots’ value reaches communities of color, which have been hard-hit by COVID-19 yet also are wary after years of health care disparities and research abuses.To try to help instill confidence, Vice President Mike Pence received the Pfizer-BioNTech shot on live TV Friday, along with Surgeon General Jerome Adams.FDA’s decision could help pave the way for other countries that are considering the Moderna vaccine, the first-ever regulatory clearance for the small Cambridge, Massachusetts, company. European regulators could authorize its use as soon as Jan. 6. Britain, Canada and a few other countries already have cleared the Pfizer-BioNTech shot, with a European Union decision due Monday.“What we want to always remember is one size does not fit all. We want to have options,” said Dr. Paul Duprex of the University of Pittsburgh.Moderna has about 5.9 million doses ready for shipment set to begin over the weekend, according to Operation Warp Speed, the government’s vaccine development program. Injections of health workers and nursing home residents continue next week, before other essential workers and vulnerable groups are allowed to get in line.Both Moderna’s and Pfizer-BioNTech’s shots are so-called mRNA vaccines, made with a groundbreaking new technology. They don’t contain any coronavirus – meaning they cannot cause infection. Instead, they use a piece of genetic code that trains the immune system to recognize the spike protein on the surface of the virus, ready to attack if the real thing comes along.Their development less than a year after the coronavirus first emerged set a speed record, but Collins stressed that shouldn’t worry people. The speed was due to billions in company and government investments paired with years of earlier scientific research, not any cut corners.“The rigor of the analysis of these vaccines is unprecedented,” Collins said. “We’re not done with this but hope is on the way, and the hope comes from this scientific brain trust that has pulled out all the stops.”Experts are hoping the two vaccines together will “break the back of the pandemic” when combined with masks and other precautions, said Dr. Arnold Monto of the University of Michigan, who chaired an advisory committee that publicly debated the shots’ evidence ahead of FDA’s decisions.The FDA’s main messages:Both the new Moderna vaccine and the Pfizer-BioNTech shot require two doses several weeks apart. The second dose must be from the same company as the first.In a study of 30,000 volunteers, the Moderna vaccine was more than 94% effective at preventing symptomatic COVID-19 in people 18 and older. It also strongly protected older adults, who are most vulnerable.The inoculated can’t throw away their masks as it’s not yet clear either vaccine prevents silent, symptomless virus spread. But there was a hint that Moderna’s shot might provide some protection against asymptomatic infection.The Moderna study uncovered no major safety problems. Like with the Pfizer-BioNTech shot, expect sore arms, fever, fatigue and muscle aches, which are signs the immune system is revving up.Both vaccines carry “a remote chance” of causing a severe allergic reaction. Moderna’s study turned up none of these, though a handful were reported in Britain as the Pfizer-BioNTech vaccinations got underway and the FDA is looking into five in the U.S., including a severe reaction in Alaska. The vaccines’ ingredients aren’t identical. Still, after any COVID-19 vaccination, people should stick around for 15 minutes – or 30 minutes if they have a history of severe allergies – so if they do have a reaction, it can be treated immediately.Both vaccines remain experimental, and the government is closely monitoring safety in case rare problems crop up.Additional studies are needed to tell if the vaccine should be used by pregnant women and children. Women who are pregnant or breastfeeding should discuss whether to get the vaccine with their doctor.Associated Press reporter Amy Taxin contributed to this report from Orange County, California. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. Share:Click to share on Facebook (Opens in new window)Click to share on Twitter (Opens in new window)Click to email this to a friend (Opens in new window)last_img read more

Two simple (but not easy) strategies for data mastery

first_imgNearly every industry’s front-runners are pursuing data mastery. Today, many consumers are surprised to learn the enhanced experiences they encounter are data-driven. Pretty soon, they’ll expect it.For this reason alone, it’s imperative credit unions become the kind of data-centric organizations that can meet consumer demand for personalized, intuitive and predictive financial services.What can you do from the C-suite, as a board member or as a senior leader to cultivate a data-centric culture in your credit union? Focus on two simple (but not easy) strategies – Top-down leadership, bottom-up engagement.Top-Down Leadership There is no substitute for a CEO with a vision. When he or she is on a personal mission to instill a culture of data-driven insights and fact-based decision-making, the chances of success are exponentially greater. That said, C-suite vision alone does not necessarily equal top-down leadership. Gaining alignment among the executive leadership team is crucial.The Economist Intelligence Unit looked at senior management alignment around a data-centric culture and financial performance. It found companies with senior managers who were aligned around the importance of a data-driven strategy financially outperformed their counterparts.Senior management team members have many years of experience, and their intuition has served them well over the course of their careers. It’s a big part of why they are helping guide the organization. The day will come when the data presented to them will run counter to that intuition. These leaders must commit to trusting the data, even when it points the credit union in new directions.Of course, senior managers must also be sure to avoid grasping at those few data points that may re-enforce “The way we’ve always done it around here.” When it comes to leading a successful, data-driven financial institution, leaders must remember: outliers are just that.Bottom-Up Engagement There are three components to nurturing bottom-up engagement when it comes to success with data:Making data availableTraining staff on data analysisFocusing on critical business issuesMaking Data AvailableData should be available to every staff member in your credit union. Now, that does not mean all data must be available to every staff member. When determining which data to supply to which employees, ask yourself: Does this data allow staff to perform their assignments to the best of their abilities? Does this data help staff understand how their contributions are advancing the organization?The second of these questions is particularly important, and that’s because putting data on display is a terrific way to inspire staff engagement. Post graphs on the breakroom bulletin board; display data over strategically placed monitors throughout your branches or in all-staff presentations. The manner in which data is displayed isn’t as important as displaying it, pointing to it often and declaring, “This is how we are managing our business.”Training Staff on Data AnalysisThink about the last time you were presented with data you couldn’t easily interpret. That brings us to the second component of building bottom-up engagement – training.Everyone who uses data to make decisions can benefit from training. Do not assume staff members know how to read the data necessary for their success. Train, re-train and re-train again, from sessions on how to read graphs and interpret tables to learning new analytics tools and techniques. Enroll everyone from frontline staff to board members and IT executives in your training programs. Raising the level of data literacy throughout your organization will raise the effectiveness of the organization at the same time.Focusing on Critical Business IssuesOnce these issues are identified, frame them in terms of consumer-focused outcomes. This approach holds two advantages.First, it will help avoid the trap of attempting to capture, store and analyze ever-increasing volumes, varieties and velocities of data. Second, focusing on the few critical business issues in terms of consumer-focused outcomes means using only the data that’s relevant – usually data you already have.The process for implementing this discipline looks like this:Define the issue in terms of specific desired outcomes. Do this from the consumer’s perspective, identifying only that data which must be measured to inform the outcomes.Identify the steps needed to collect, store, analyze and visualize the data.Integrate these steps into the service or process you’re using to deliver the desired consumer outcome.Begin to collect data and measure outcomes.Integrate the learnings into the refined product or service.Following this disciplined approach to data-driven strategies will help you avoid those “Oh, isn’t this interesting!” moments that can shift focus away from your credit union’s most critical business issues.From a data analytics perspective, the credit union industry may very well be further behind than it was last year. Yet, we’re not as far behind this year as we will be next year, and the year after that if we don’t take the steps necessary to shift the culture.Credit union leaders have been asking themselves what they can do to cultivate a data-centric culture in their organization. By setting their sights on top-down leadership and bottom-up engagement, these executives, managers and directors will lead their credit unions on courses to success within the big data revolution.Eric Schurr is chief strategy officer for TMG Financial Services, a top-70 credit card agent issuer and credit card portfolio advisor. He is focused on emerging lending and financial products, as well as industry innovation that will trigger the development of competitive solutions for TMG Financial Services’ credit union and community bank partners. In addition to contributing to industry publications, Eric blogs for a consumer audience at He can be reached at [email protected] 41SHARESShareShareSharePrintMailGooglePinterestDiggRedditStumbleuponDeliciousBufferTumblr,Eric Schurr Eric Schurr is chief strategy officer for TMG Financial Services, a top-70 credit card agent issuer and credit card portfolio advisor. He is focused on emerging lending and financial products, … Web: Detailslast_img read more