Yilian Yuan STAT, Adobe By Yilian Yuan and José Luis Fernández Dec. 17, 2019 Reprints [email protected] How does this work?In the prelaunch phase, investigators can use artificial intelligence and machine learning to identify which patients are more likely to progress to severe disease with greater predictive accuracy than other models. This can help define patient subpopulations that might achieve greater benefits versus risks with an investigational product, which can increase the odds of success downstream.Effective and fast market access is an essential component for a successful launch. Real-world anonymized patient-level data and machine learning models that predict a product’s potential impact on patient outcomes can be incorporated into documentation for a health technology assessment, providing additional insights that can support negotiating optimal pricing and reimbursement rates with payers prior to market launch.Machine learning models can predict physicians’ prescribing potential by examining current prescribing behaviors across all diseases and patient mixes. With superior capabilities to handle the complexity of a vast volume of data, proprietary models can predict if a physician will prescribe a new product over a six- to 12-month time period with 80% accuracy. This capability can help drug makers optimize their promotional efforts and better target doctors during the launch period.These aren’t just theoretical possibilities. We and our colleagues at IQVIA have developed a platform that incorporates anonymized patient longitudinal data, payer and health plan data, and data about health behaviors and characteristics of health care providers across the U.S.Working with one pharmaceutical company, we delivered a 25% lift for the launch of a second-line indication in the cancer treatment market. Once a patient starts the treatment, keeping them on the therapy according to the regimen improves the patients’ outcome. Our algorithm identifies candidate patient profiles to improve patient persistence and compliance which are sent to nurse educators or other patient engagement programs.Artificial intelligence and machine learning can be powerful game changers for the industry. These capabilities can power better decision-making and improve efficiencies within the entire clinical development ecosystem.Yilian Yuan is senior vice president for data science and advanced analytics at IQVIA. José Luis Fernández is the company’s senior vice president for consulting services. Related: At the same time, we recognize that the pharmaceutical industry often wrestles with understanding how to apply these technologies to support their business objectives and how best to deploy them within an already established drug development.advertisement With the growth of big data and exponential advancements in technology, we are seeing more opportunities to apply artificial intelligence and machine learning in decision-making for drug development. Indeed, we believe that AI and ML represent powerful, disruptive tools that will transform the future of drug development, empowering manufacturers with faster and better insights that will improve drug launch success. So, what is the transformational power of AI and ML?Over the past decade, artificial intelligence and machine learning have become woven into our daily lives. In our homes, AI and ML power voice-recognition devices that control lights and thermostats, tell us the weather, schedule appointments, and answer questions. On-demand content providers use AI and ML to suggest new programming based on individuals’ viewing habits. Artificial intelligence and machine learning help Internet search engines target ads based on our browsing history, while they help e-commerce companies provide us with more personalized shopping experiences. Clearly, these technologies have evolved from buzzwords and hype to fundamentally transforming the way we live and work.That same power is beginning to be used in the pharmaceutical industry to arm companies with the kinds of insights needed to improve the success of a drug launch. And companies are gaining access to these insights in less time than with traditional models and methods.From the preclinical phase all the way through clinical development and launch, artificial intelligence and machine learning can help companies navigate the development pathway with greater guidance and understanding. They can provide insights on the right patient sub-population for a specific compound, the prescribers who are most likely to adopt that treatment once approved, and the drug’s potential performance once in the market. This kind of information is especially critical when exploring a therapeutic area in which there are limited or no treatment options available and thus no market data to use as a guide. [email protected] First OpinionArtificial intelligence and machine learning can be the backbones of a drug launch playbook The days of the blockbuster drug might not be over, but they are dwindling. As markets become more crowded, pharmaceutical companies are focusing their drug development strategies on specialized populations, such as individuals with rare diseases or those with genetic subsets of chronic conditions like cancer and diabetes and cardiovascular diseases.Identifying a specific subgroup of patients from a niche population poses challenges for many companies.The integration of artificial intelligence (AI) and machine learning (ML) in a drug development and launch playbook offers new possibilities to find the right subpopulation(s) for product targeting as a way to ensure a successful launch.advertisement About the Authors Reprints Tags Artificial Intelligencedrug developmentHealth IT José Luis Fernández Machine learning for clinical decision-making: pay attention to what you don’t see The FDA needs to set standards for using artificial intelligence in drug development Related:
Adam’s Take @adamfeuerstein The truth about JPM: Less is more Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More GET STARTED Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. What is it? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Adam Feuerstein By Adam Feuerstein Jan. 17, 2020 Reprints Alex Hogan/STAT About the Author Reprints SAN FRANCISCO — Yet another J.P. Morgan Healthcare Conference is done. Was it worth it?All in all, this was a really pleasant week in San Francisco. The weather this year was an A-minus. There was a noticeable drop in attendance. Meeting rooms weren’t jam-packed. Ubers and Lyfts were easy to hail and coffee shops were bustling but not overloaded. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Tags biotechnology What’s included? [email protected]
AdvertisementTags: Covid daily totals SOUTHWEST Fla. – Data per the Florida Department of Health as of Thursday, Dec. 3. Additional case data compares to previous update.TOTAL CASES IN FLORIDA: 1,029,030 (+10,870)TOTAL DEATHS IN FLORIDA: 19,112 (+100)TOTAL IN SOUTHWEST FLORIDA: 60,564 (+705)LEE COUNTY – 31,243 (+387) | 596 (+8)COLLIER COUNTY – 18,334 (+202) | 285 (+1)CHARLOTTE COUNTY – 5,293 (+73) | 197 (+0)HENDRY COUNTY – 2,561 (+21) | 45 (+0)DESOTO COUNTY – 2,450 (+18) | 34 (+0)GLADES COUNTY – 683 (+4) | 10 (+0) AdvertisementRecommended ArticlesBrie Larson Reportedly Replacing Robert Downey Jr. As The Face Of The MCURead more81 commentsGal Gadot Reportedly Being Recast As Wonder Woman For The FlashRead more29 commentsDC Young Fly knocks out heckler (video) – Rolling OutRead more6 comments’Mortal Kombat’ Exceeded Expectations Says WarnerMedia ExecutiveRead more2 commentsDo You Remember Bob’s Big Boy?Read more1 commentsKISS Front Man Paul Stanley Reveals This Is The End Of KISS As A Touring Band, For RealRead more1 comments Southwest Florida coronavirus case totals for Wednesday, June 2 June 3, 2021 Southwest Florida coronavirus case totals for Thursday, June 3 June 4, 2021 Southwest Florida coronavirus case totals for Tuesday, June 1 June 2, 2021 May 31, 2021 RELATEDTOPICS Southwest Florida coronavirus case totals for Friday, May 28
Lee County COVID-19 vaccine site moving to North Fort Myers this month June 13, 2021 Mobile pediatric vaccination clinic happening in Cape Coral Friday June 11, 2021 Dr. Anthony Fauci, the long-time director of the National Institute of Allergy and Infectious Diseases, has said vaccines will help put the pandemic behind us. However, since most Americans won’t get vaccinated until next year, people still need to be vigilant with mask wearing and social distancing measures for the next few months. AdvertisementTags: covid-19 vaccine Mobile pediatric clinic provides COVID vaccines for children 12+ June 15, 2021 RELATEDTOPICS AdvertisementRecommended ArticlesBrie Larson Reportedly Replacing Robert Downey Jr. As The Face Of The MCURead more81 commentsGal Gadot Reportedly Being Recast As Wonder Woman For The FlashRead more29 commentsDC Young Fly knocks out heckler (video) – Rolling OutRead more6 comments’Mortal Kombat’ Exceeded Expectations Says WarnerMedia ExecutiveRead more2 commentsDo You Remember Bob’s Big Boy?Read more1 commentsKISS Front Man Paul Stanley Reveals This Is The End Of KISS As A Touring Band, For RealRead more1 comments DOH-Collier bringing COVID-19 vaccines to homebound residents June 17, 2021 Advertisement“It’s been a big week of delivery of vaccines,” Gen. Gustave Perna, chief operating officer of Operation Warp Speed, told reporters Wednesday. “Over 7,800 deliveries by the end of tomorrow, as we are delivering the 7.9 million doses of vaccine that were allocated for this week around the country — really a tremendous feat.”According to Perna, about 15.5 million doses of the vaccine have been allocated and another 4.5 to 5 million will be allotted next week.“We’ll finish those deliveries in the first week of January,” he said. WASHINGTON (CNN) – More than 1 million people have received their first shot of the COVID-19 vaccine. That reported number is low, because many doses administered in recent days haven’t been tabulated yet in the figures from the CDC, the agency said. “With cases of COVID-19 continuing to surge nationwide, this achievement comes at a critical time and will help to protect those on the frontlines — our healthcare providers treating COVID-19 patients — as well as our most vulnerable: elder individuals living in nursing homes and assisted living facilities,” CDC Director Dr. Robert Redfield said.The government has said it plans on distributing 20 million first doses of the Pfizer-BioNTech and Moderna vaccines in the coming weeks. So far, about 9.5 million doses have been distributed.
bloomua/123RF Keywords Mutual fund dealers Toronto-based Monarch Wealth Corp. is launching an end-to-end digital platform for its advisors, which will enable those advisors to fully onboard their clients in an electronic manner. Related news Facebook LinkedIn Twitter Rapport Credit Union partners with Wealthsimple Tessie Sanci Share this article and your comments with peers on social media Industry seeks clarity on MFDA proposal regarding discretionary trading Monarch’s system uses Toronto-based Fundserv Inc.’s “eDOCS” program, a paperless onboarding system that functions across various mobile devices and allows for electronic signatures. “Fundserv’s eDOCS initiative is an integral part of our digital console for advisors,” says Yama Yaqeen, vice president of operations and technology at Monarch, in a statement released Monday. “The eDOCS feature allows advisors to easily and efficiently onboard nominee accounts, reducing paperwork and administration and eliminates ‘not in good order’ errors, which gives advisors more time to add client value.” The eDOCS program is an opportunity for the investment management industry to conduct business efficiently and securely, adds Harry Gundy, director of product management for Fundserv, in a statement. Monarch’s new digital platform provides fee-based account management, model portfolio solutions and automated rebalancing and related trades in addition to a contact management system. It also allows for the electronic delivery of client statements and related regulatory documents through secure email links. “With time freed up to devote to clients, advisors can provide fee transparency and fee based accounts and focus more time on life-stage planning and holistic wealth management with their clients,” the announcement states. Photo copyright: bloomua/123RF Agora partners with Pascal Financial
andreypopov/123RF Keywords Fund companiesCompanies Mackenzie Financial Corp., Ontario Securities Commission Facebook LinkedIn Twitter Mackenzie fined for excessive promotional spending Share this article and your comments with peers on social media The Ontario Securities Commission (OSC) will hold a hearing on Friday, April 6, to consider a settlement with Toronto-based Mackenzie Financial Corp. concerning the firm’s alleged violations of mutual fund sales practices rules.The rules set limits on the sorts of inducements that fund managers can provide to mutual fund dealers and dealing representatives (advisors). OSC to consider settlement with 1832 Related news James Langton According to the OSC’s allegations, Mackenzie violated those rules by:engaging in “excessive spending” on promotional activities and items that it provided to advisors;hosting conferences, and providing non-monetary benefits to advisors, that did not comply with the limits set out in the rules; andfinancing non-educational dealer events.The allegations have not been proven and details of any sanctions will only be revealed if the settlement is approved at the hearing.Securities regulators introduced rules regarding sales practices back in the late 1990’s amid concerns about the conflicts of interest that arose as fund manufacturers competed for distribution.In the past couple of years, some of those concerns have re-emerged, as regulators have focused on conflicts in the retail investments business, and the harm that these conflicts can inflict on investors — leading them to consider policy action, such as banning embedded compensation structures, and raising industry conduct standards.Also readOSC outlines key priorities 1832 to pay $950,000 settlement
Facebook LinkedIn Twitter Share this article and your comments with peers on social media The global life insurance business is growing impressively, but mostly in emerging markets, according to a recent report from New York-based consulting firm McKinsey & Co. In order to generate growth in the years ahead, the report suggests, companies will have to make bold moves, such as seeking innovation, engaging in mergers and acquisitions (M&A) and enhancing productivity.The McKinsey report examined the global insurance industry and found that recent top-line growth in global premiums is masking a stark divergence between developed markets and emerging markets. For example, while global premiums increased by 5% in 2017, growth in developed markets, such as the U.S., Canada, Europe and Japan, was between 1% and 2%, compared with 12%-15% in developing Asia and Latin America. Additionally, the report notes, asset managers have taken market share from insurers in the retirement-savings business over the past five years. Merger of B.C. financial services, real estate regulators nears completion kentoh/123RF Keywords InsuranceCompanies Manulife Financial Corp., Sun Life Financial Inc. James Langton GWL reports ‘solid’ Q1 earnings There’s $149 million in B.C.’s lost and found The report states that, in the years ahead, the industry’s winners “will benefit from bold resource allocation to the right markets, customer segments and adjacent sectors, such as asset management, while also driving substantial productivity improvement.”In particular, the firm reports, the insurance industry has not tackled its cost structure as effectively as the global banking business has over the past few years. “Costs have become a greater priority because investment returns have remained fairly muted,” the report states. “Meanwhile, insurers have not substantially altered their customer engagement or distribution strategies even as customer expectations have changed dramatically.”Along with evolving customer expectations, the report notes, financial advisors and captive agents also will increasingly expect firms to provide “a digital interface and automated tools in their interactions with insurance home offices and wholesalers. Successful insurers will focus on improving the partner experience to help elevate the customer experience.”Firms will need to make “bold moves,” the report adds, regarding the ways in which they allocate resources, engage in M&A and invest in their businesses to create long-term value. Two Canadian insurance giants — Manulife Financial Corp. and Sun Life Financial Inc. — rank among the industry’s large, globally diverse firms that have led the way in these sorts of strategic efforts over the past 10 years, the report notes.“Conditions continue to be attractive for M&A,” the report states, “including improved investor confidence, rising rates and areas for potential technology acceleration.”To the extent that the industry’s leading firms have engaged in M&A over the past decade, however, the report says that they have “avoided big-ticket deals in favor of targeted, strategic transactions, including deals to expand into new product lines, go up- or down-market in a given segment, acquire new technological capabilities or diversify into less capital-intensive lines of business, such as asset management.”Looking ahead, the report notes, “companies must pick the right markets,” to find future growth in global markets. “Over the past five years, for example, the still-developing Asia-Pacific region has accounted for almost 70% of global premium growth.”Additionally, the report says, to take advantage of future growth opportunities, insurers will have to strengthen their M&A capabilities, enhance their resource allocation efforts, improve productivity through automation and outsourcing and increase their operational agility. Related news
RelatedPedro Plains Farmers Learn Strategies to Manage Beet Army Worm RelatedPedro Plains Farmers Learn Strategies to Manage Beet Army Worm Advertisements RelatedPedro Plains Farmers Learn Strategies to Manage Beet Army Worm Pedro Plains Farmers Learn Strategies to Manage Beet Army Worm AgricultureJune 9, 2009 FacebookTwitterWhatsAppEmail Farmers in and around Pedro Plains in St. Elizabeth were last week exposed to strategies to manage the beet army worm, which has destroyed 37.5 hectares of escallion in the area.At a farm day hosted by the St. Elizabeth Parish Office of the Rural Agricultural Development Authority (RADA), officials from the Ministry of Agriculture and Fisheries demonstrated and recommended practical ways to protect their fields.These include inspecting fields at least twice per week for the presence of moths, eggs, larvae and pupae and spraying with recommended insecticides at the stage when eggs have just hatched and worms are small in size.Farmers are also encouraged to apply best crop production practices such as crop rotation, proper selection and rotation of insecticides and correct timing of applications, and to recognise the importance of natural enemies and the role of biological control.“We looked at the various strategies that the farmers can implement in addressing the outbreak and minimising any further impact of the pest on their crops,” informed Senior Research Director for Plant Protection in the Ministry, Dr. Lisa Myers.She stated that integrated crop and pest management strategies are critical in the prevention effort.“We are stressing an integrated pest management approach, making sure that they have sufficient knowledge of the pest itself and what are the most susceptible stages that they can attack it with the hope of getting some amount of control,” she added.Dr. Myers stressed that there is no evidence of a link between the outbreak of the pest and fertiliser imported into the island. “And, we must consider that an outbreak happened 15 years ago, and the fertiliser was no way in the picture. Scientifically, too, there is no evidence to suggest that there is a link between any fertiliser and this particular pest,” she emphasised.
Press Briefing by White House COVID-19 Response Team and Public Health Officials 18 March The White HouseVia Teleconference1:34 P.M. EDTACTING ADMINISTRATOR SLAVITT: Thank you for joining us today. You can see we have a full house.Just this morning, following the President’s direction, the Department of Health and Human Services issued the order to formally direct states, tribes, and territories to make all adults eligible for COVID vaccines no later than May 1st. Even as we take steps to expand eligibility for vaccines in advance of May 1st, we continue to emphasize to states the importance of prioritizing vaccinations for higher-risk populations.Two areas states can focus on in particular are, first, vaccination programs for congregate settings and homebound populations; and, second, creating priority scheduling pathways and dedicated slots for higher-risk populations.Today, our team is going to highlight aggressive actions we are taking to use diagnostic testing to help defeat the pandemic and allow people to safely return to normal activities. We’ve recently discussed investments in at-home and point-of-care testing, which can contribute significantly to our ability to safely get back to normal life.Today, we’re releasing details about how our testing strategy can be advanced in three additional critical ways.First — first is how we can reduce the disparities in health outcomes by investing more testing resources in underserved communities. We will also discuss how we will get critical therapies to underserved communities.Second, our investments we are making in testing to increase screening and surveillance.And third is how we can strategically invest in testing to ramp up the safety of schools and get them back open.First you will hear from Dr. Nunez-Smith. She will then introduce Carole Johnson, the White House Testing Coordinator. She will introduce Dr. Walensky and then Dr. Fauci.Between all of them, you will hear how various elements of our testing strategy come together. And with that, I’ll turn it over to Dr. Nunez-Smith.DR. NUNEZ-SMITH: Thanks so much, Andy. And good afternoon, everyone. You know, as Andy said, we are continuing to advance robust efforts to ensure equity in our federal COVID-19 response, you know, making sure there is equitable access to all COVID-19 resources — so whether that is access to PPE or masks, access to vaccines; you know, access to testing, as you will hear much more about in today’s briefing; or access to treatments.And today I’m here to provide an important update on how this administration is making COVID-19 treatments more accessible and available for the American people, particularly those in the hardest-hit, highest-risk communities.We are working to improve access to one specific class of therapies, the monoclonal antibodies. And you’ve heard Dr. Fauci discuss the benefits of these therapies previously.You know, there are currently three monoclonal antibodies that have been authorized by the Food and Drug Administration for emergency use, with the most recent authorization coming just in February.You know, the positive impact of these treatments has become pretty clear. For individuals who are diagnosed early with COVID-19 — that’s early testing — and who, you know, although they’re currently doing okay, are really at risk of getting pretty sick, these treatments can make a huge difference in preventing them from developing severe illness from COVID.You know, in fact, Eli Lilly’s newest monoclonal antibody combination therapy has shown the ability to reduce COVID-19-related hospitalizations and deaths by up to 87 percent. So the National Institutes of Health, you know, and the Infectious Disease Society of America — that’s an association of over 12,000 physicians, scientists, and public health experts; they specialize in infectious disease — you know, they both formally recommend the use of this treatment in patients with mild or moderate COVID-19 who are at high risk of progression to severe disease.So these recommendations by the NIH and by IDSA send a really strong signal to patients as well as providers all over the country — you know, a message that these treatments are efficacious. They show enough promise in clinical studies to recommend their broader use during this pandemic to help us save lives. And we are certainly tracking all the latest science and updating clinical recommendations as needed.You know, for all Americans, these treatments for COVID-19 are free, and the cost of administering them is covered by Medicare, Medicaid, and most private insurance companies. And these therapies are already available across the United States. We’ve shipped these treatments to over 5,000 sites across the country, so that’s hospitals, emergency rooms, urgent care settings, physician’s offices, and infusion centers.But there is still work to do to make sure that these treatments are available and accessible to the highest-risk communities, those communities that have faced high burdens of COVID-19 over this past year.So today we’re announcing a new $150 million agreement, signed by the Department of Health and Human Services, specifically to help us make sure that any individual and any community who meets the clinical criteria can have access to these important therapeutics. These funds will help us go beyond those existing 5,000 sites to help get these therapies to folks in other settings as well, giving us the ability to continue to meet people where they are.This new effort is going to speed assistance to hard-hit communities, really increasing the use and administration of the monoclonal antibody therapies, preventing hospitalization and death.You know, this assistance may include additional staffing, infusion center capacity in both traditional and non-traditional healthcare settings, and the equipment necessary to administer this intravenous infusion, as well as being sure we increase awareness among healthcare providers and patients about the treatment options that are available, including where and how to access them.So this is just another example of how we are committed to an equitable COVID-19 response. We’re working absolutely to keep people from getting COVID-19 in the first place. You know, and the vaccines that are currently being administered across the country are key to doing just that.But for those individuals who get COVID-19, we want to make sure that they too have the benefit of the latest in scientific discovery to help them hope and help toward a safe and speedy recovery.So you can learn more about these monoclonal antibodies and how to access them by going to CombatCOVID.HHS.gov.And with that, I’ll turn it over to Carole Johnson, the Testing Coordinator, and the White House COVID-19 Response Team.Carole?MS. JOHNSON: Thank you, Dr. Nunez-Smith. When the President announced his national strategy to fight COVID, he outlined a comprehensive plan to scale and expand testing in order to safely reopen schools and society.Today, thanks to the American Rescue Plan, we’re turning that plan into action. We know that school districts want to reopen, but up to this point, many lack the resources to set up COVID screening programs for students, teachers, and staff to help keep COVID out of our schools.Today, that all changes. Earlier today, the Department of Education announced the state funding allocations for the $122 billion in the American Rescue Plan to help schools invest in mitigation strategies like PPE, additional space, more teachers, and extending their critical learning and enrichment programs.And today, the Department of Health and Human Services announced plans to distribute $10 billion to support COVID-19 testing in schools across our country. With this funding for testing, every state in America will have access to millions of dollars to set up screening testing programs to add a layer of protection for schools, teachers, and students. This funding can be used to test teachers and staff, students and others with symptoms of COVID, those who may have been exposed, and to establish sustained regular screening testing programs across the school system.We recognize that establishing a COVID testing program is new for many schools, and that’s why CDC will work with state and local health departments to support technical assistance to help schools and states in standing up and implementing these programs.With this critical funding from the American Rescue Plan, we hope more schools will reopen across the country and more kids will be back in the classroom soon.We know that testing works. We know that it works to identify cases and slow the spread of COVID. And we look forward to working with schools to implement this exciting new program.Finally, I want to note that this work builds on additional actions the administration has already taken to scale up testing nationwide, like establishing regional coordinating centers to help accelerate testing and make the process easier, increasing domestic manufacturing of testing supplies, and rapidly increasing genomic sequencing.The American Rescue Plan, which was signed into law last week, will invest nearly $50 billion over all in testing. We believe it was important — we believe it is important to get the first $100 billion out to states for school reopening as quickly as possible.So with that, I’ll turn it over to Dr. Walensky who will share additional testing news for today. Thank you, Dr. Walensky.DR. WALENSKY: Thank you, Carole. And good afternoon. I’m glad to be back with you today. Let’s start first with an overview of the data.Cases continue to hover around 50- to 55,000 cases per day, and the most recent seven-day average is 53,000 cases per day. Hospital admissions continue to fall, with the most recent seven-day average just over 4,700 admissions per day. We continue to see declines in the number of deaths from COVID-19, averaging slightly more than 1,100 deaths per day over the last seven days.Today, I want to spend a little time discussing COVID-19 testing and why this remains a critical component of our comprehensive approach to ending this epidemic.Reliable and widely available testing is a crucial part of our efforts to stop the spread of COVID-19. But several factors can make testing strategy decisions complex, including the different kinds of tests available, the changing dynamics of the pandemic in communities, and the increasing proliferation of new variants that are more transmissible.Having clear, evidence-based recommendations to help state and local public health departments and the medical community make informed decisions about COVID-19 testing is paramount to an overall national testing strategy.Today, CDC is releasing a suite of five updated guidance documents on COVID-19 testing, building on the latest science, available testing options, and what we have learned about testing during this pandemic.Our testing overview guidance describes the available tests that are used to detect COVID-19, how to choose a test, and the reasons for using them. They also explain the impact of vaccination on testing.Importantly, until now, limited test capacity has resulted in our use of tests for largely diagnostic purposes when someone presents with symptoms or has been exposed. Only in selected places have we capitalized on the benefits of how testing can be used as a screening intervention, with frequent tests to identify asymptomatic disease and prevent clusters before they start.Testing can also be used as a surveillance tool to monitor the burden of disease in communities. Our newly released set of guidances offers a comprehensive approach to testing and helps to prevent the spread of COVID-19 through the rapid identification and isolation of people who are infected, including those who do not know they are infected because they do not have symptoms.The updated overview also provides new information about how health equity — about health equity issues related to testing. To end this pandemic, everyone must have equal access to affordable and timely testing, with fast turnaround time for results, to identify infections and reduce community spread.In addition to the overview guidance, we are also releasing four complementary guidance documents that focus on testing in specific settings, including correctional and detention facilities, non-healthcare workplaces, institutions of higher education, and homeless shelters and encampments.Each of these companion documents — guidance documents provide tailored recommendations that take into account the unique circumstances and risks for COVID-19 spread in the different settings.Today’s updated guidance is intended to help public health officials, medical providers, school and justice system administrators, and others make decisions about setting up testing programs in their communities.All five guidance documents are now posted on our website at CDC.gov. And while guidance is critical to informing decisions making for — decision making for COVID-19 testing, it’s equally important that testing programs and communities are supported with resources to do the work. This requires much-needed and long-overdue resources.So I’m proud to share that CDC is announcing new funding for $2.25 billion in grants to public health departments — on average, $20 million per grant to more than 100 health departments — to address COVID-19 health disparities and advance health equity among people who are at high risk and underserved, including racial and ethnic minority groups and people living in rural areas.A large component of this funding will focus on strategies to improve testing and contact tracing, along with funding to support continued implementation and prevention strategies for COVID-19. These funds will provide much-needed funding to states, cities, counties, and rural locations.I’m so excited to report that this funding represents CDC’s largest investment to date to support communities that are affected by COVID-19-related health disparities, especially those in high-risk and underserved groups.This is truly a historic investment for CDC and an important step forward to help hard-hit communities turn the corner on this pandemic.Thank you. And I’ll now turn it over to Dr. Fauci.DR. FAUCI: Thank you very much, Dr. Walensky. I’m just going to change topics somewhat, just for the next minute or two, to give you an update in the context of vaccines and what we are learning in the longer range as we go from the EUAs.This slide is a familiar slide that I’ve shown a couple of times at these briefings. Just to summarize, we have three vaccines that have been proven to be highly efficacious. Namely, within the context of the clinical trial, they work. Now the question is: What happens when you get out into the real world?Next slide.We refer to this as the difference between efficacy and effectiveness. Efficacy is what you show in a clinical trial. Effectiveness means what happens when you use that in the real world.And what we are seeing is that, in fact, these types of vaccines that I just mentioned are working. Let me give you just a couple of quick examples among several.This is a study from Israel, in which 600,000 newly vaccinated people with the Pfizer-BNT vaccine were matched against 600,000 controls. Look at the right-hand part of the slide: Seven or more days after the second dose, the effectiveness of this vaccine in the community was well within the range of the efficacy of the trial — 92 to 94 percent.Next slide.This is a slide from the UK in which regular asymptomatic testing was done among healthcare providers who did the same kind of routine testing that many of us do. It was shown that in an arena and a context in which there was a variant, B117, predominated — in England — again, you had a very high degree of effectiveness seven days after the second dose, as shown here, with 85 percent.Next slide.Back to the United States, in the Mayo Clinic: In this study of individuals who went un- — who underwent routine pre-procedural testing — coming into the hospital for a sigmoidoscope, a colonoscopy, dental procedures, or what have you — they were tested, and it was found that after adjustment for confounding factors, there was an 80 percent reduction in the risk of a positive screening test in people who received two doses of an mRNA vaccine.And then, finally, on this last slide, in Israel and in Spain: The study in Spain showed that viral load is a proxy for infectivity. And then, in a study in Israel, they found out, when there were breakthrough infections either among vaccinated individuals or those who are not vaccinated, when you look at the viral load in the nasopharynx, it was decreased fourfold for those who actually were within 12 to 28 days of the first dose of vaccine.Bottom line: The vaccines work in the real world. Not only are they efficacious, but they are effective.Now back to you, Andy.ACTING ADMINISTRATOR SLAVITT: Thank you. All right, why don’t we take questions?MODERATOR: All right. First question we will go to Shannon Pettypiece with NBC.Q On the school testing, there’s been concern from schools that they are not able to use the rapid tests for asymptomatic students unless they get one of these CLIA waivers. And they say there’s been a big issue with them being able to use the rapid test. So does this guidelines that you’re putting out today, is that going to open the door for schools to use the rapid tests more easily in asymptomatic students?ACTING ADMINISTRATOR SLAVITT: Let me ask Carole to take that.MS. JOHNSON: Yeah, so I will say that the CDC is putting out guidance today, but there’s more work to do. We’re putting these resources out to help schools plan, but we continue to work on the policy background here. And there continues to be work to do.We have seen some states do some creative work around CLIA waivers, and we have seen some work from the Department of Health and Human Services to make it easier to access CLIA waivers. And we’re going to continue to work on that issue.I will also point out that, just yesterday, the FDA made a policy announcement about making it easier for tests to get authorization for asymptomatic screening use. So, again, much more work to do, but we are continuing to move forward on the policy environment here to support screening testing.ACTING ADMINISTRATOR SLAVITT: Dr. Walensky, is there anything you want to add to that question? Nothing?DR. WALENSKY: Nothing to add. Thank you.ACTING ADMINISTRATOR SLAVITT: Okay. Next question.MODERATOR: Next we’ll go to Sheryl Stolberg with the New York Times.Q Thank you for taking my question. I’m wondering what metrics you’re going to apply to measure the effects of the spending on testing and the other mitigation measures. How much will this hasten the end of the pandemic or bring about the reopening of schools and the economy? How quickly will that happen, and how will you measure it?ACTING ADMINISTRATOR SLAVITT: That’s a — it’s a broad question, so I would invite anyone to take that. Carole, is that something you want to start with?MS. JOHNSON: Yeah, let me just start by saying that what we — our goal, from the front end, was that — we have heard from folks who work directly with school districts about schools that are anxious to have the resources to be able to do testing to support their reopening. So, as part of our broader goal to — the President’s broader goal to safely reopen schools, we want to make sure there are resources available to do that. And we are continuing to track school reopenings with our colleagues at the Department of Education.But our main message here is that we want schools to have the resources so that they can add this layer of mitigation that the CDC guidance on school reopening has pointed out can be an added protective factor. We know schools want — there are many schools that want that. We know there are schools that have tried to do it and have struggled to have the resources to do it. And so we want the resources out there, and we want to attract school reopenings.ACTING ADMINISTRATOR SLAVITT: Anybody want to add to that?DR. WALENSKY: Maybe I’ll just add that there a lot of metrics that people are using. We’re looking at wastewater for disease burden in communities. We’re looking at hospitalization rates. We’re looking at clusters and outbreaks in these schools that implement these screening strategies. So I think there are a lot of metrics that we can impose. Of course, there are a lot of moving parts. Not only are we ramping up testing, we’re also ramping up vaccination.ACTING ADMINISTRATOR SLAVITT: I would just add, as a reminder for everyone, that since the President’s call for schools to be open, we have issued a set of guidelines from the CDC to help with a roadmap to do that, prioritize vaccinations for teachers, and now this commitment around testing.So the question, I think, for the administration and for the schools in the country is not whether they can be open, but how. And I think with this roadmap, with this testing resources, with these vaccinations, there is a clear path there.Next question.MODERATOR: Next we’ll go to April Ryan with TheGrio.Q Thank you. I want to get back to the issue of children and vaccinations. What is the current research showing right now as it relates to vaccinating school-aged children? And I ask that because I’m hearing from doctors that there is a concern about the possible change in the genetic profile by two of the vaccinations versus the Johnson & Johnson. If you can give me a comment on all of that — all of the above. Thank you.ACTING ADMINISTRATOR SLAVITT: Dr. Fauci.DR. FAUCI: Yeah. Thank you, Andy. Thank you for that question, April. Right now, there are a couple of studies from multiple companies looking at vaccines in children. Just to let everybody know where we are: The vaccine studies that are done right now are looking at both safety and immunogenicity; it’s not looking for vaccine efficacy signals, because you would need tens of thousands of people in those trials. We’re trying to do bridging studies to show comparable immunogenicity at the same time of looking at safety.We will know answers to that for high school-level individuals by the time we get to the fall. And when you do an age de-escalation in younger children — we just started a study with Moderna, literally this past week, in which we’re going to do age de-escalation from 12 to 9, 9 years to 6 years, 6 years to 2 years, and 6 months to 2 years. We’re going to be looking at multiple aspects of safety.There is really no biological reason at all to indicate or even predict that you would even see any modification of the genetic profile when you’re dealing with an mRNA, which has no way of integrating into the genome of a cell. So it is a question, April, that gets asked frequently, but there’s no biological mechanism why we can see how that would happen. We’re going to be looking at all aspects of safety, but I really don’t predict you’re going to see anything in that — in that space.ACTING ADMINISTRATOR SLAVITT: Next question.MODERATOR: Next we’ll go to David Lim at Politico.Q Hi, thanks for taking my question. I wanted to ask about the testing announcement today, specifically supply of tests and what types of tests school districts will have access to, and if CDC is setting up a mechanism for purchasing those tests for distribution. Because it seems that there are still relative limitations, considering the number of students that are in K-through-12 schools.ACTING ADMINISTRATOR SLAVITT: All right, why don’t we start with Carole.MS. JOHNSON: Yeah. Thanks, David. We are obviously closely monitoring supply, and expect that some of the efforts to onshore supply will start to dovetail with the increases associated with this screening testing. We hope that the President’s commitment to testing, with a nearly $50 billion investment in the American Rescue Plan, is a strong signal to all about our commitment to testing and the importance of continuing to ramp up and expand testing.Every — we are using those resources to not only expand testing but to address critical supply issues as we announced earlier last month that we were going to invest critical resources in raw materials and other issues that have presented shortage issues in the past.The awards from CDC — I should let Dr. Walensky add anything that she would like — but these will be awards to state health departments for the purposes of helping to — help schools stand up testing programs. Many schools have — some schools have testing programs, and so the intent is not to disrupt the relationships that they have. Others need help in connecting to programs. And the federal government is continuing to work to build up the Federal Supply Schedule, to ensure that people have easy access to affordable testing.DR. WALENSKY: And maybe I’ll just add that we’re excited because it’s not just to the state health departments, but this goes to the local health departments; it goes to rural and urban health departments so that we can really facilitate not just the testing, but the contact tracing and other prevention/ interventions; the technical support that these local health departments will need to implement this testing.ACTING ADMINISTRATOR SLAVITT: Thank you. Next question.MODERATOR: Next we’ll go to Shira Stein at Bloomberg.Q Hi. Thanks. You used to break down all of the vaccines that we’re getting by various streams — so one by states, tribes, and territories; then by pharmacies; and then — now we’re seeing community health centers. Can you break down how many vaccines, specifically for the 22 million total doses the White House Press Secretary announced for next week? So –basically, so we can better understand where all the vaccines are going.ACTING ADMINISTRATOR SLAVITT: Let me give you a rough — this is not a precise answer but I’ll give you a rough approximation: Somewhere in order of a third of vaccination — of vaccines are going to retail pharmacies; something in the order of half are going to the healthcare systems — the healthcare providers, hospitals, et cetera; then a large piece, after that, going — most of the rest to big community vaccination centers; and then an increasing share to community health centers, mobile vans, et cetera.Now, the reason that that can’t be precise is some of their — there’s some overlap in that states are each distributing their vaccinations into a variety of those channels. And so, you know, you can’t really — you can’t really give a complete picture because we’re sending vaccines directly to, say, community health centers and so are states. But that — the numbers are certainly rough in there.But, Dr. Walensky, anything you want to add or change about that?DR. WALENSKY: No, that’s exactly — you know, the — if the states are distributing to the federal — to pharmacies, but there’s also getting federal supply, it makes it harder to tease apart. But that’s about — that’s exactly what I would have said.ACTING ADMINISTRATOR SLAVITT: Okay. Next question.MODERATOR: Last question will go to Ricardo Alonso-Zaldivar at AP.Q Hi, thank you for taking my question. Can you hear me?ACTING ADMINISTRATOR SLAVITT: We can.Q Okay, thank you. Yeah. My question is for Dr. Walensky. And I was just wondering, with the new guidance today, could you please review, underline for us what is the value added from this new guidance when compared to the previous layers of CDC guidance that we’ve had?DR. WALENSKY: Thank you for that question. So, this new guidance actually is really quite extensive compared to prior. It’s an expansion of the description of the kind of tests; how might one choose a test; the addition of the intended use of each of the individual tests; the addition of health equity as how we would use these tests in — to ensure that we have equitable distribution, that there’s a rapid turnaround time in all of these settings; the expanded availability of screening tests and how one might consider using diagnostic tests, as well as screening tests; and then, some discussion about how we would interpret these tests in the context of vaccinated individuals; and then, of course, a menu of guidance on specific settings and how you would use the test, both from a diagnostic standpoint, but as well as from a screening and surveillance standpoint.ACTING ADMINISTRATOR SLAVITT: We’ll close with one of the comments that President Biden made the other day, which is that “help is here.” It’s not even 60 days into the administration, and I would just summarize that your government is acting with urgency — acting even as people are being asked to maintain wearing masks.The government is moving as quickly as possible, acting with speed of moving checks into the American — to the American public — near 100 million already; speed of vaccinations — near 100 million since January 20th; the speed of testing dollars moving out into the field, as Carole Johnson said today, with over $10 billion getting out the door quickly; and the speed of action on all of the areas needed to support the public from the most recent legislation that was passed.So I want to thank everybody at the government and who is part of this effort for the great speed with which we’re asked — we’re acting on behalf of the public.With that, thank you, and we will be here again on Friday.2:05 P.M. EDTTo view the COVID Press Briefing slides, visit https://www.whitehouse.gov/wp-content/uploads/2021/03/COVID-Press-Briefing_17March2021_for-transcript.pdf /Public Release. This material comes from the originating organization and may be of a point-in-time nature, edited for clarity, style and length. View in full here. Why?Well, unlike many news organisations, we have no sponsors, no corporate or ideological interests. We don’t put up a paywall – we believe in free access to information of public interest. Media ownership in Australia is one of the most concentrated in the world (Learn more). Since the trend of consolidation is and has historically been upward, fewer and fewer individuals or organizations control increasing shares of the mass media in our country. According to independent assessment, about 98% of the media sector is held by three conglomerates. This tendency is not only totally unacceptable, but also to a degree frightening). Learn more hereWe endeavour to provide the community with real-time access to true unfiltered news firsthand from primary sources. It is a bumpy road with all sorties of difficulties. We can only achieve this goal together. Our website is open to any citizen journalists and organizations who want to contribute, publish high-quality insights or send media releases to improve public access to impartial information. You and we have the right to know, learn, read, hear what and how we deem appropriate.Your support is greatly appreciated. All donations are kept completely private and confidential.Thank you in advance!Tags:america, CDC, COVID-19 Response, Department of Health, EU, Europe, FDA, Government, Human Services, Israel, Mayo Clinic, New York, NIH, Spain, UK, United States, White House
Premier cannot justify job cuts by conning Tasmanians Tasmanian LaborPremier misleads Tasmanians on lower energy pricesTries to justify job cuts with non-existent household savingsThe Government must intervene in HydroPremier Peter Gutwein cannot justify his Government’s clear plan to privatise Hydro and undertake mass sackings by trying to con Tasmanians with lower energy prices.Shadow Minister for Energy David O’Byrne said last Tuesday Peter Gutwein attempted to justify sacking 50 Hydro workers by saying it would lower prices.“Last week Peter Gutwein’s statement on energy prices being lowered by the mass sackings is at odds with the Hydro CEO,” Mr O’Byrne said.“Six days prior to the Premier’s statement, the Government’s hand-picked CEO of Hydro, Evangelista Albertini said the proposed organisational changes will not impact energy security or electricity prices which is completely different to what the Premier has said.“Peter Gutwein is trying to con Tasmanians into thinking they will get cheaper energy prices, when that is clearly not true.“Peter Gutwein is also misleading Tasmanians by claiming his Government is not privatising the Hydro when he has refused to rule out the sale of wholly owned subsidiaries Momentum and Entura.“The Premier must intervene to say no to privatisation and to save Hydro jobs.“He cannot continue to mislead Tasmanians with lower electricity prices when in reality people are losing their jobs.”David O’Byrne MP Shadow Minister for Energy /Public Release. This material comes from the originating organization and may be of a point-in-time nature, edited for clarity, style and length. View in full here. Why?Well, unlike many news organisations, we have no sponsors, no corporate or ideological interests. We don’t put up a paywall – we believe in free access to information of public interest. Media ownership in Australia is one of the most concentrated in the world (Learn more). Since the trend of consolidation is and has historically been upward, fewer and fewer individuals or organizations control increasing shares of the mass media in our country. According to independent assessment, about 98% of the media sector is held by three conglomerates. This tendency is not only totally unacceptable, but also to a degree frightening). Learn more hereWe endeavour to provide the community with real-time access to true unfiltered news firsthand from primary sources. It is a bumpy road with all sorties of difficulties. We can only achieve this goal together. Our website is open to any citizen journalists and organizations who want to contribute, publish high-quality insights or send media releases to improve public access to impartial information. You and we have the right to know, learn, read, hear what and how we deem appropriate.Your support is greatly appreciated. All donations are kept completely private and confidential.Thank you in advance!Tags:electricity, energy, energy security, Government, Impact, job cuts, jobs, Minister, Premier, security, Tasmania, Tasmanian Labor, Tassie