As of May 11, the COVID-19 pandemic will no longer be considered a national or public health emergency in the U.S., the Biden Administration announced on Jan. 30. That’s not only a symbolic move. It also means the government will stop footing the bill for things like COVID-19 tests, vaccines, and treatments, which could bring changes to many of the free programs U.S. residents have come to rely on throughout the pandemic. For example, the end of the public health emergency may mean the end of the federal government’s free at-home test program, through which U.S. residents can periodically order antigen test kits. Medicare and private insurers will also no longer be required to cover free at-home tests each month, though some plans may choose to continue reimbursing some costs, with beneficiaries picking up the rest of the price out-of-pocket. Read More: Why Rapid COVID-19 Test Results Are Getting More Confusing For now, though, these programs are still up and running—so you can stock up on free at-home COVID-19 tests while they’re a sure thing. Each U.S. household can currently get four tests for free from the federal government, and Medicare and private insurance plans reimburse the costs of up to eight at-home tests per insured person per month. Between the two, an insured individual could receive more than two dozen free tests between now and May 11. Those at-home kits expire, however, so your stash won’t last forever. But the U.S. Food and Drug Administration (FDA) has extended the expiration dates for many test kits, so their shelf lives may be longer than the packaging suggests. Current expiration dates are listed here on the FDA’s website. Whether they’re reimbursed or not, at-home tests will remain for sale even after the public-health emergency expires, and labs and pharmacies will also still offer testing services—people may just have to pay for them going forward. It remains to be seen exactly how much lab tests will cost in the future, but some insured people may continue to have no out-of-pocket costs as long as they use in-network providers. from https://ift.tt/9vHEc5q Check out https://takiaisfobia.blogspot.com/
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Almost since the emergence of COVID-19, the U.S. has treated the disease as both a national and public health emergency. That will end on May 11, 2023, the Biden Administration announced Jan. 30. The decision to end these important designations will have wide-ranging impacts on many health measures that Americans have come to take for granted over the past few years, including free vaccines, booster shots, tests, and treatments. Declaring COVID-19 a public health emergency (PHE) in Jan. 2020 allowed the federal government—via a COVID-19 response led by the Department of Health and Human Services (HHS)—to access funds and resources to pay for everything from personal protective equipment such as masks, to tests and vaccines, and respond in other ways to the pandemic. Under the PHE, the government could also modify Medicare and Medicaid reimbursement policies to increase access to treatments and other resources critical to controlling the spread of COVID-19. Two months later, President Trump declared a national emergency surrounding COVID-19, which opened up additional funding for the response, including continued coverage for people under Medicaid and expanded funds for hospitals to care for COVID-19 patients. The declarations allowed “a public health approach to health care during the pandemic,” says Dr. Josh Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health. “They helped a lot of people to get services. Now we’re going back to a health care approach to health care, and that brings all of the weaknesses of our system into play.” Sharfstein notes that when the emergency declarations end, more than just access to COVID-19 services will be affected. The funding made available through the declarations made it possible to continue covering millions of people under Medicaid, even if their eligibility had changed; the Kaiser Family Foundation (KFF) estimates that anywhere from five to 14 million people could lose Medicaid coverage if states deem they are no longer eligible when this provision ends. “The majority of them are expected to be Black and Latino people, so there are concerns that health inequities will worsen,” says Dr. Jose Figueroa, assistant professor of health policy and management at the Harvard T. H. Chan School of Public Health. Here’s what will else change when the national and public health emergencies end in May. COVID-19 vaccinesCOVID-19 vaccines and boosters will continue to be covered for people with private insurance when given by in-network providers, but according to an analysis by KFF, people may have to pay out-of-pocket if they get their shots from providers outside of their covered network. People with Medicare will continue to receive free vaccines, which are covered under Medicare Part B through the CARES Act, a $2.2 trillion economic stimulus bill passed by Congress in 2020. Medicaid beneficiaries will also continue to receive free vaccines. Uninsured people will no longer be able to access free vaccines through state Medicaid programs, which had received expanded federal funding to cover these services for the uninsured. COVID-19 testsCurrently, people with private insurance or Medicare can order up to eight rapid at-home tests a month and get reimbursed for their cost. After the PHE ends, insurers may continue to cover COVID-19 tests, including the over-the-counter at-home kind, but only if they are distributed by a narrower pool of in-network providers. Medicare beneficiaries will also have to start paying for a portion of any tests. Medicaid will continue to pay for COVID-19 tests that are ordered by a doctor, but each state will decide whether to cover at-home tests. Read More: When Should You Use Home COVID-19 Tests? Here’s What Experts Say COVID-19 treatmentsPrivately insured people will continue to receive coverage for COVID-19 treatments, including widely used antiviral therapies like Paxlovid. People with Medicare Part D will be covered for antiviral treatments until the federal supply is depleted. After those doses are gone, beneficiaries will have to pay for a portion of this drug treatment. Medicaid will reimburse only for treatments that are approved by the U.S. Food and Drug Administration (FDA). Whether medications that are under an emergency use authorization from the FDA are covered will vary state by state. Emergency use authorizations (EUAs)The dual emergencies aren’t the only ones in place to respond to COVID-19: The HHS Secretary also granted EUA power to the FDA to streamline availability of new COVID-19 drugs. The end of the dual emergencies does not affect the EUAs that the FDA granted to some COVID-19 vaccines and antiviral drugs like Paxlovid. The emergency declaration behind the EUAs is issued by the HHS Secretary, and remains in effect until the Secretary decides to terminate it. If the emergency EUA declaration ends, then any medications authorized under it may no longer be available. The drugs would have to receive full FDA approval in order to make it to market again. In a statement, the FDA says that if that occurs, it would allow enough time for the transition to ensure that approvals of the drugs are forthcoming. TelehealthMost Medicare coverage of telehealth services that were expanded and allowed during the pandemic will end when the PHE concludes reports KFF. The only exceptions are permanent changes for beneficiaries seeking mental health and substance use help. For these services, providers from another state can treat patients in different states, and audio-only services are also permanently covered. For Medicaid recipients, services and coverage will vary state by state. Hospital careThe 20% increase in Medicare reimbursements that hospitals received for COVID-19 patients will end with the expiration of the PHE. This may indirectly affect patients hospitalized for COVID-19, who may see higher costs reflected in their medical bills. With people having to pay for COVID-19-related health services, the virus could find new opportunities to spread, and potentially even morph into more disease-causing variants. “It means there will be less testing in this country, and likely less treatment because not everyone can afford it,” says Figueroa. “Will this change the trajectory of the pandemic? It’s something we are going to have to watch.” from https://ift.tt/W0sUpoD Check out https://takiaisfobia.blogspot.com/ When it comes to avoiding COVID-19 in the U.S., it’s increasingly everyone for themselves. The Biden Administration announced it will end pandemic emergency declarations in May 2023, which will affect the availability of free tests, treatments, and vaccines. But even now, nobody has fewer tools to protect themselves than immunocompromised people. On Jan. 26, the U.S. Food and Drug Administration (FDA) revoked emergency-use authorization for Evusheld, a therapy first authorized in December 2021. Evusheld was meant to be used preventatively as an alternative to COVID-19 vaccines for people have a medical reason not to get the shots, or who are immunocompromised and do not mount strong immune responses after being vaccinated. But the therapy—a monoclonal antibody, or a lab-made protein meant to mimic the immune system’s natural response to the virus—has waned in efficacy as the virus has mutated. The FDA pulled Evusheld’s authorization after concluding that it isn’t effective against the newer circulating variants. It could be re-authorized if it’s shown to be effective against future variants. But for now, one of the only COVID-19-prevention tools meant for the roughly 3% of Americans who are immunocompromised—albeit one that was never widely used—is off the table. “Immunocompromised Americans are screwed,” says Matthew Cortland, a senior fellow at the progressive think tank Data for Progress whose work focuses on disability, and who is immunocompromised. AstraZeneca, the pharmaceutical company that makes Evusheld, is currently testing a new version of the therapy that is meant to work across viral strains, but there’s no way to know yet if it works or when or if it will be available to patients, says Erin McCreary, director of infectious diseases improvement and clinical research innovation at the University of Pittsburgh Medical Center. Evusheld’s demise is “devastating to these patients,” McCreary says. “It made them more comfortable doing daily tasks and going out into the world to run errands and going out to dinner with their friends.” Read More: It Isn’t Just Long COVID. Post-Viral Illnesses Are More Common Than You Think Now, many people who are not well-protected by vaccines are in a dangerous and isolating situation—especially because the arsenal of effective COVID-19 treatments is shrinking for everyone as the virus evolves. In recent months, the FDA also pulled authorization for monoclonal antibodies that were used as treatments. Antiviral drugs including Paxlovid and remdesivir are still available, and research suggests that antivirals can help prevent hospitalization and severe disease among immunocompromised people. But “it’s really sad” to see the array of treatment options get smaller, McCreary says. Following the Evusheld decision, the U.S. Centers for Disease Control and Prevention (CDC) recommended that immunocompromised people abide by old guidance: staying up-to-date on vaccines, masking, social distancing, and seeking out well-ventilated or outdoor areas. But to some people, those tips are a poor replacement for effective preventive therapies. “Basically they have nothing to offer,” says Dr. Eric Topol, founder of the Scripps Research Translational Institute. “They should be honest and say there’s a hole in supporting people who are immunocompromised now.” Topol and his colleagues recently launched a study that provides immunocompromised people with access to at-home tests, telemedicine services, and antiviral drugs if they test positive. In addition to gathering data about disease outcomes among immunocompromised people, Topol hopes the program will help prevent serious cases. Still, he’s disheartened that the federal government hasn’t undertaken similar efforts and isn’t pushing harder for the development of new monoclonal antibodies that work against newer strains. Without that push, he says, pharmaceutical companies have little incentive to do the work themselves. Cortland called the CDC’s guidance “pathetic” and an “abject failure,” arguing that it does little to protect immunocompromised people in a country without adequate systemic COVID-19 mitigation measures. (CDC representatives did not respond to TIME’s comment request before publication.) Now that most mask mandates are gone, less than half of American adults had worn a mask in the three months leading up to January 2023, according to Harris Poll data collected for TIME. While wearing a high-quality mask does help reduce the risk of infection for the wearer, it’s not as protective as if everyone in a space were wearing one. There are also aren’t enforceable ventilation requirements in most public spaces. There is some hope on the horizon, Cortland says. The Occupational Health and Safety Administration is working on permanent COVID-19 safety standards for health-care facilities. And some drug makers are testing new therapies that may benefit immunocompromised patients. In addition to the potential updated version of Evusheld, a small number of new monoclonal antibody treatments are in development, as is a vaccine that may better protect people who don’t respond to the currently available ones. But for the moment, immunocompromised people are essentially on their own. “Immunocompromised Americans have been forgotten and ignored,” Cortland says. “We have been left behind.” from https://ift.tt/s3Gi5Al Check out https://takiaisfobia.blogspot.com/ WASHINGTON — President Joe Biden informed Congress on Monday that he will end the twin national emergencies for addressing COVID-19 on May 11, as most of the world has returned closer to normalcy nearly three years after they were first declared. The move to end the national emergency and public health emergency declarations would formally restructure the federal coronavirus response to treat the virus as an endemic threat to public health that can be managed through agencies’ normal authorities. It comes as lawmakers have already ended elements of the emergencies that kept millions of Americans insured during the pandemic. Combined with the drawdown of most federal COVID-19 relief money, it would also shift the development of vaccines and treatments away from the direct management of the federal government. Biden’s announcement comes in a statement opposing resolutions being brought to the floor this week by House Republicans to bring the emergency to an immediate end. House Republicans are also gearing up to launch investigations on the federal government’s response to COVID-19. Then-President Donald Trump’s Health and Human Services Secretary Alex Azar first declared a public health emergency on Jan. 31, 2020, and Trump later declared the COVID-19 pandemic a national emergenc y that March. The emergencies have been repeatedly extended by Biden since he took office in January 2021, and are set to expire in the coming months. The White House said Biden plans to extend them both briefly to end on May 11. “An abrupt end to the emergency declarations would create wide-ranging chaos and uncertainty throughout the health care system — for states, for hospitals and doctors’ offices, and, most importantly, for tens of millions of Americans,” the Office of Management and Budget wrote in a Statement of Administration Policy. More than 1.1 million people in the U.S. have died from COVID-19 since 2020, according to the Centers for Disease Control and Prevention, including about 3,700 last week. Congress has already blunted the reach of the public health emergency that had the most direct impact on Americans, as political calls to end the declaration intensified. Lawmakers have refused for months to fulfill the Biden administration’s request for billions more dollars to extend free COVID vaccines and testing. And the $1.7 trillion spending package passed last year and signed into law by Biden put an end to a rule that barred states from kicking people off Medicaid, a move that is expected to see millions of people lose their coverage after April 1. “In some respects, the Biden administration is catching up to what a lot of people in the country have been experiencing,” said Larry Levitt, the executive vice president for health policy at Kaiser Family Foundation. “That said, hundreds of people a day are still dying from COVID.” Still, some things will change for Americans once the emergency expires, Levitt pointed out. The costs of COVID-19 vaccines are also expected to skyrocket once the government stops buying them, with Pfizer saying it will charge as much as $130 per dose. Only 15% of Americans have received the recommended, updated booster that has been offered since last fall. People with private insurance could have some out-of-pocket costs for vaccines, especially if they go to an out-of-network provider, Levitt said. Free at-home COVID tests will also come to an end. And hospitals will not get extra payments for treating COVID patients. Legislators did extend for another two years telehealth flexibilities that were introduced as COVID-19 hit, leading health care systems around the country to regularly deliver care by smartphone or computer. The Biden administration had previously considered ending the emergency last year, but held off amid concerns about a potential “winter surge” in cases and to provide adequate time for providers, insurers and patients to prepare for its end. Officials said the administration would use the next three months to transition the response to conventional methods, warning that an immediate end to the emergency authorities “would sow confusion and chaos into this critical wind-down.” “To be clear, continuation of these emergency declarations until May 11 does not impose any restriction at all on individual conduct with regard to COVID-19,” the administration said. “They do not impose mask mandates or vaccine mandates. They do not restrict school or business operations. They do not require the use of any medicines or tests in response to cases of COVID-19.” Case counts have trended downward after a slight bump over the winter holidays, and are significantly below levels seen over the last two winters — though the number of tests performed for the virus and reported to public health officials has sharply decreased. On Monday, the World Health Organization said the coronavirus remains a global health emergency, even as a key advisory panel for the group found the pandemic may be nearing an “inflexion point” where higher levels of immunity can lower virus-related deaths. China, for example, reported an unprecedented surge in December after lifting most of its COVID-19 restrictions. Moments before the White House’s announcement, Rep. Tom Cole, R-Okla., accused the president of unnecessarily extending the public health emergency to take action on issues like forgiving some federal student loan debts. “The country has largely returned to normal,” Cole said Monday, introducing a Republican-backed bill calling for an end to the health emergency. “Everyday Americans have returned to work and to school with no restrictions on their activities. It is time that the government acknowledges this reality: the pandemic is over.” The House was scheduled to vote Tuesday on legislation that would terminate the public health emergency. The bill’s author, Rep. Brett Guthrie, R-Ky., said he still hopes the House will proceed with a vote. He said he was surprised by the White House move, but thinks the legislation may have played a role in prompting the administration to act. “I think we should go forward,” he said late Monday as lawmakers returned to the Capitol. “If for some reason they don’t do it on May the 11th, the vehicle is still there for Congress to take back its authority.” from https://ift.tt/O2HZC86 Check out https://takiaisfobia.blogspot.com/ Check the COVID-19 Data Tracker from the U.S. Centers for Disease Control and Prevention (CDC), and you’ll get a rundown of the latest case numbers, hospitalizations, and deaths. Those categories might seem straightforward, but the data, say many experts, are telling us a lot less than we think they are. That’s because it’s getting increasingly difficult to parse who is hospitalized or dies from COVID-19, and who is hospitalized or dies from another reason but with COVID-19. Across the U.S., “COVID-19 hospitalizations” represent all kinds of patients: those who need hospital-level care for severe cases of COVID-19; those with risk factors like heart disease or kidney issues who got infected, then had a heart attack, stroke, or kidney failure and needed to be hospitalized; and those who were admitted for one health condition but tested positive for COVID-19 at some point during their stay or several weeks afterward. COVID-19 plays a role of varying importance in all of these hospitalizations. “The situation is murky because we don’t know if COVID-19 is to blame for their worsening chronic health, or whether they developed a COVID-19 opportunistic infection that is [having] more of a bystander effect,” says Dr. Susan Cheng, professor of cardiology and director of public health research at Cedars-Sinai. “It’s hard to parse these things out except in the most extremely obvious cases.” Among public health experts, there’s a simmering debate over what U.S. COVID-19 numbers really reflect. In a widely discussed and controversial column, George Washington University professor Dr. Leana Wen recently argued in the Washington Post that deaths reported due to COVID-19 are likely overcounted, as some of them might have been more attributable to other causes but were listed as COVID-19 deaths because the individual also tested positive. In Los Angeles County, academic and public health researchers reported last year that in the county’s public hospital, 67% of people testing positive for COVID-19 were not hospitalized because of their infections. Others disagree: since COVID-19 often exacerbates health events and conditions, the numbers, they say, may be undercounting the impact of COVID-19 on deaths. “I don’t think we are overcounting COVID-19 deaths,” says Dr. Carlos del Rio, professor of medicine at Emory University and president of the Infectious Diseases Society of America. He notes that most of the deaths are occurring among older people who are more vulnerable to the worst effects of COVID-19. “I think the data suggest that we are still seeing a fair number of deaths [from COVID-19], and they are occurring in people with high risk for complications,” he says. Even in the third year of the pandemic, getting the numbers right matters. Being able to accurately identify who is still getting gravely sick from COVID-19 could help public-health officials better target those who would benefit most from booster doses and antiviral treatments. As the country’s health officials move toward simplifying COVID-19 immunizations, knowing who is experiencing severe COVID-19 could also tailor immunization recommendations, such as increasing the number of doses, for the most vulnerable so they can avoid the more serious symptoms of disease. Such detailed hospitalization and death data would also help health officials to learn a lot more about how COVID-19 is interacting with other common health issues. Why the numbers are such a messThe CDC’s data come from hospitals or state health departments, which are required to report daily admissions of patients who have COVID-19 and deaths of patients with COVID-19. In some states, hospitals report COVID-19 hospitalizations directly to the CDC, while in others, state health departments collect the data and provide it to the federal government. (The CDC did not respond to requests for comment on how it presents COVID-19 hospitalization and death data.) But what hospitals consider a COVID-19 admission often differs. “Right now, the health care system is still struggling to keep up,” says Cheng. “We’re doing the best we can with the knowledge we have to code [cases and deaths] as appropriately as possible. But we’re not even close to the ideal state of being able to talk about what that means in practice about [getting consistency in] how we are coding these things.” Some groups recognize this problem and have standardized how they classify COVID-19 hospitalizations and deaths. For example, in King County, Wash., which includes Seattle, the health department reviews every COVID-19 hospitalization record to “understand whether people are coming in primarily because of a COVID-19-related condition or if COVID-19 is incidental to something else,” says Dr. Jeff Duchin, health officer for public health in Seattle and King County. By their standards, COVID-19 hospitalizations include people who are admitted and have positive COVID-19 tests either within 14 days prior to their hospitalization, or up to 21 days following their discharge. His department also reviews every COVID-19 death, and Duchin says there’s an 80% concordance between the reviewers’ determination of whether COVID-19 contributed to the death and what the medical records suggest. “We are trying to reflect the true burden of disease from COVID-19 on the health care system as best we can,” he says. But even though hospitals and health departments in one Washington county are all on the same page, comparing hospitalizations in Seattle to those in another city using the CDC’s COVID-19 Data Tracker won’t necessarily mean you’re comparing the same thing. Hospitals also use different criteria for determining when a patient who tests positive for COVID-19 is no longer a COVID-19 patient. Some states consider people who test positive at any time during their hospital stay a COVID-19 case, even if they test negative eventually, while others, including New York, no longer log patients as COVID-19 cases if they test negative. Others stop counting people as COVID-19 patients once their symptoms go away, or after two weeks pass following a positive test if regular testing isn’t performed. The same discrepancies muddle the information on deaths. Hospitals rely on death certificates, which doctors fill out when patients pass away, to determine causes of death. But doctors don’t have a national set of criteria for determining whether COVID-19 caused a particular patient’s death. At Emory, Del Rio says doctors there use the intensity of treatment for a patient’s COVID-19 infection as a guide for determining what role the virus played in the person’s deteriorating health and ultimate death. “If a patient who is positive for COVID-19 is treated with steroids and then passes away, we say COVID-19 contributed to their death,” he says. “If a person with COVID-19 is not treated with a steroid, we do not say COVID-19 contributed to their death.” Even the way states report COVID-19 deaths to the CDC is subject to interpretation. Doctors have the option of listing primary and secondary causes of death; in Florida and New York, for example, if a doctor records COVID-19 as either the primary or secondary cause of death, the state reports that as a COVID-19 death. The need for better dataThe Council of State and Territorial Epidemiologists is currently devising a new definition for what should be coded as a COVID-19 death, versus what should be considered a death with COVID-19, which could help doctors in hospitals to make more consistent determinations of COVID-19 mortality. That would potentially help to nationally standardize how deaths from the coronavirus should be recorded. But even if every state health department and hospital counted COVID-19 deaths and hospitalizations the same way, the data would still be woefully incomplete. Very little testing for the virus is now being done—even at hospitals, since studies show that routine testing, including of people without any symptoms, does not necessarily reduce viral spread among health care workers and patients. Based on the growing evidence, at the end of 2022, the Society for Healthcare Epidemiology of America, a professional organization of public health and infection control providers recommended against routine screening of newly admitted hospital patients, leaning instead toward testing only people who had COVID-19 symptoms. Many states, including Maryland and Florida, follow these guidelines. That policy means that cases are going unrecorded. If all patients were tested, “then we could definitely know, for example, if we saw X% increase in admissions due to heart issues…and a comparable increase in positive COVID-19 cases,” says Beth Blauer, data lead for the Johns Hopkins Coronavirus Resource Center. For many patients dying of things like heart disease, “their condition may have likely been accelerated by COVID-19, but we don’t know because they aren’t being tested.” The issue highlights a deeper problem—one that preceded the pandemic—about how health information in the U.S. is collected. U.S. health data have notoriously lacked detailed demographic information on race, ethnicity, age, and other health conditions for patients who are hospitalized and die in the health care system. It’s a failing that CDC director Dr. Rochelle Walensky acknowledged in numerous press briefings early in the pandemic, when it wasn’t clear how COVID-19 was affecting the health of different racial and ethnic groups. “The data is terrible, and it deeply lags,” says Blauer. “There is no real-time understanding; we’re always looking at data that is one or two years back.” Why real time COVID-19 data are important even nowAs population-wide immunity to SARS-CoV-2 increases through infections and vaccinations, it’s becoming more important to know who benefits most from booster doses—which may require rethinking the current boosters-for-all approach. Now, says Dr. Paul Offit, director of the vaccine education center and professor of pediatrics at the Children’s Hospital of Philadelphia, it’s time to get smarter about targeting boosters to those who need them the most. To do that, public-health officials need to know who is getting severely ill from COVID-19 infections and getting hospitalized, and who is dying from the disease. That would help doctors to focus on making sure those groups of people are vaccinated, boosted, and given access to antiviral medications that can mitigate symptoms. Depending on what better data find, it could also mean pulling back on boosters for those who aren’t receiving dramatically increased protection because their immune systems are relatively healthy, Offit says. “By chasing every variant and boosting everyone, we are on some level acting like the boy who cried wolf, and risking that when there is a wolf”—a strain of COVID-19 resistant to our current immune protection—”people won’t listen [and get boosted when they really need to],” says Offit. Up-to-date data would also help us better nail down exactly who is at highest risk from COVID-19, and how to treat them. Cheng’s group has revealed an intriguing connection between hypertension and COVID-19 infections; after the first Omicron wave in late 2021 and early 2022, she and her team analyzed patients who were hospitalized for COVID-19, and found that after controlling for other factors, hypertension was enough to land some people in the hospital with more serious COVID-19 complications. It’s known that SARS-CoV-2 infects cells by using a receptor that is also involved in regulating blood pressure, ACE2, and that could explain why people with genetic differences that put them at increased risk of high blood pressure might also be at higher risk of more severe cases of COVID-19. Other studies have explore what role blood pressure medications can have in changing how infectious SARS-CoV-2 might be. But understanding these interactions will only be possible if more robust data on people who require hospital care are collected. “We are still at the tip of the iceberg,” says Cheng about the understanding of how COVID-19 is affecting other health conditions. “We have never seen anything like this virus before, so we’d love to understand how this virus is different from all of the other viruses we have seen in our lifetime,” says Cheng. “That way we can be better prepared to counsel, treat, and manage patients as we move forward living with COVID-19.” from https://ift.tt/SjKxDgV Check out https://takiaisfobia.blogspot.com/ When will the COVID-19 pandemic end in the U.S.? Is it over when the president says so, by scientific consensus, or when the public thinks so? Historians of pandemics think it’s mainly the latter. Although blunting the epidemic curve is a major measurement, the perception of when we can “return to normal” resides largely in the subjective individual human domain. But can we come up with a measurable definition to help track progress and serve as the basis for public policy and awareness of the pandemic’s endpoint? That seems an exercise that is vital in this moment of pandemic confusion. Here’s my proposed definition: the country will not fully emerge from the COVID-19 pandemic until most people in our diverse nation accept the risk and consequences of exposure to a ubiquitous SARS-CoV-2, the virus that causes COVID-19. The signal of the pandemic-phase end is not the disappearance of the virus, the attenuation of acute COVID-19 disease, the interruption of transmission, the solving of long-COVID, diminishing emerging variants, or the pronouncements of political or public health leadership; it is instead when the mass of Americans move from avoiding to accepting exposure and its consequences. In practice this requires a societal paradigm-shift. In our culture this transition is often viewed through a distorting political prism. Instead a sharper understanding can be gained through an agnostic evaluation of the evidence and science. Today, this strongly supports a new paradigm of “living with the virus” through accepting exposure for most Americans. But a recent national poll demonstrates a strikingly divided public, not ready to make peace with the virus: while nearly half say that they have returned to their pre-COVID life, one-third still believe this is more than a year away or never. Since the Omicron strain achieved predominance in early 2022, and now with over 500 sub-strains in circulation, the risk-benefit balance has progressively tilted in favor of planning for and accepting exposure of most non-high risk Americans. In this schema, people age 65 and higher, immunocompromised or frail with chronic disease constitute “high risk” for serious disease. The remaining significant majority of the population is “non-high risk.” There are four seismic changes in both the virus and its human host that dictate this reset: 1) Decreased virulence in non-high risk peopleOmicron on average is one-tenth the severity of the prior Delta variant. Infection fatality rates for COVID are now lower than that for the seasonal flu for non-high risk people. CDC respiratory virus surveillance data indicates that in the 18-64 age group, ER visit and hospitalization rates for COVID-19 and the flu have been comparable throughout this winter. 2) Serious disease heavily concentrated in high-risk peopleIt’s in the high-risk population where society’s attention and resources must be focused—where the disease toll is concentrated and where protection from exposure through both public policy and personal action will have by far the greatest impact. These are the people who must not be left behind as the nation adapts to an indefinite endemic future. People age 65 and older represent 17 percent of the population but are now responsible for 92% of national COVID-19 deaths. Those aged 75 and over are 6.8% of the population and suffer 68% of COVID-19 deaths. The 1.15 million nursing home residents face by far the highest risk. They have experienced 15% of the 1.1 million national deaths to date, and comprise only 0.35% of the population. The age-specific risk of severe disease is exponentially lower in age cohorts under 65 and decreases progressively through younger age groups. The risk of serious COVID disease for the non-high risk majority is comparable to other familiar communicable diseases such as the flu, as well as traumatic causes such as motor vehicle accidents over which they have little control. 3) Inability to control exposure and transmissionThe currently circulating Omicron sub-variants are the fastest spreading viruses in human history. An estimated 98 percent of Americans have been infected at least once and many multiple times. Currently an estimated 11 million Americans are newly-infected each week. Each infected index case may expose dozens of contacts. This natural experiment has generated a high level of population immunity, that even when supplemented by public health measures, has not been sufficient to consistently reduce the effective reproductive number (Rt) to below 1 in most U.S. states. An Rt<1, where each index case infects fewer than one other person, is the level necessary to decrease transmission toward eventual control and elimination. Currently 41 states exceed this critical threshold. This demonstrates that in practice, reliance on exposure-avoidance to deliver a sustained decrease in infection burden is a futile national strategy. 4) Highly protective population immunity against serious diseaseWith the endemic-phase transmission characteristics of Omicron, the infection swirling the globe will continue into the indefinite future. Population immunity will wax and wane dynamically as it finds its own equilibrium of protection. Given the limited durability of protection against infection of hybrid immunity (vaccination and natural infection), we are unlikely to reach classical herd immunity thresholds that drive elimination. However, the current levels of hybrid immunity are highly protective against severe disease. This protection is currently estimated to be 89 percent. The already intrinsically lower virulence of the current Omicron sub-variants is additionally reduced through extensive population immunity. The reality of this paradigm-shift is reflected in the study design of a recent randomized trial to evaluate the efficacy of oral antiviral treatments. None of 822 enrolled high-risk patients with symptomatic COVID progressed to severe disease or death. Absent hospitalization or death, “time to sustained clinical recovery” had to serve as the study’s end-point. Future COVID-19 vaccine or drug trials in the U.S. may face difficulty using severe disease endpoints because these events are now too rare even in high risk patients. This was unthinkable in earlier stages of the pandemic. After three years of the imposition, followed by gradual easing, of lockdowns, quarantine, isolation, testing, vaccination and masking, how does the holdout one-third of the country move from the current obsolete but ingrained “avoid exposure” paradigm to an endemic “accept exposure” reality? This not only has significant medical, public and mental health implications; it will also accelerate a return to a fully-functioning and dynamic society. There are three segments of society—policymakers, experts (scientists, biomedical and public health practitioners), and the media—that form an ecosystem that has played a major interactive role in shaping our current pandemic paradigm. This ecosystem is also the one that could help catalyze and speed a frame-shift. The U.S. COVID ecosystem is largely playing catch-up with the public rather than leading this transformation. Separately and together it forms powerful networks to enable those with an understandable difficulty of letting go of three years of ingrained avoidance behaviors to cling to their practices. This collective force still leaves some people suggestible to health alarms fearful, anxious, and confused about how to protect themselves and others in a time of rapid societal transformation. The U.S. is now at a major pandemic crossroad. “Follow the science” has been a central policy guidepost in the pandemic. Science and public health knowledge and expertise is the conduit to both sound policy and public education through media channels. New courageous “accept exposure” policies, public education and behavior change strategies are needed to capture the benefits of the new paradigm. This could be a major step in bridging our national COVID divide. from https://ift.tt/gSQKhP9 Check out https://takiaisfobia.blogspot.com/ Americans aren’t exercising enough. Less than a third of U.S. adults meet suggested benchmarks for aerobic and muscle-building activities set out by health officials, according to a new study released on Thursday. The U.S. Department of Health and Human Services recommends healthy adults spend at least 150 minutes per week—roughly 20 minutes a day—doing moderate-intensity aerobic exercise and at least two days per week doing muscle-strengthening activities. Only 28% of people in the U.S. are actually following those guidelines, according to the study published by the Centers for Disease Control and Prevention that analyzed more than 30,000 responses from its 2020 National Health Interview Survey. The research from institutions across the country noted that activity could have been dented during the height of the COVID pandemic. Read More: 9 Ways to Squeeze In More Steps Every Day People living in rural areas were even less likely to get enough exercise: Only 16% of people outside cities met benchmarks for aerobic and muscle-strengthening activities, compared with 28% in large metropolitan cities areas. Regional differences emerged as well. People living in the South were less physically active than those in other regions, while people in the West were most active. Major improvements at the local, state and national level are needed to promote healthy exercise, the authors said, such as sprucing up physical spaces in cities and rural areas to make them more inviting to activity, and encouraging philanthropic investments in research. from https://ift.tt/A5SfrNl Check out https://takiaisfobia.blogspot.com/ WASHINGTON — The U.S. is moving to further ease restrictions on blood donations from gay and bisexual men and other groups that typically face higher risks of HIV. The Food and Drug Administration on Friday announced draft guidelines that would do away with the current three-month abstinence requirement for donations from men who have sex with men. Instead, all potential donors would be screened with a new questionnaire that evaluates their individual risks for HIV based on sexual behavior, recent partners, and other factors. If finalized, many gay and bisexual men in monogamous relationships would be able to donate blood for the first time in decades. It’s the latest move by the FDA to broaden donor eligibility, with the potential to boost donations. “We feel confident that the safety of the blood supply will be maintained,” FDA’s Dr. Peter Marks told reporters. Gay rights groups have long opposed blanket restrictions on who can give blood, saying they discriminate against the LGBTQ community. Medical societies including the American Medical Association have also said such exclusions are unnecessary given advances in technology to test blood for infectious diseases. “Current and former blood donation policies made unfounded assumptions about gay and bisexual men and really entangled individuals’ identity with their likelihood of having HIV,” said Sarah Warbelow of the Human Rights Campaign, an LGBTQ advocacy group. The U.S. and many other countries started blocking blood donations from gay and bisexual men during the early 1980’s AIDS epidemic, aiming to prevent the spread of HIV through the blood supply. In 2015, the FDA dropped the lifetime ban and replaced it with a one-year abstinence requirement. Then in 2020, the agency shortened the abstinence period to three months, after donations plummeted during the COVID-19 pandemic. Regulators said there has been no negative impact on the blood supply as a results of those changes. The FDA sets requirements and procedures for blood banks throughout the U.S. All potential donors answer questions about their sexual history, injectable drug use and any recent tattoos or piercing, among other factors that can contribute to the spread of blood-borne infections. Donated blood is then tested for HIV, hepatitis C, syphilis, and other infectious diseases. Under the new proposal, men who have sex with men will be asked if they have had new or multiple partners in the last three months. Those who answer affirmatively to either question and also report having anal sex would be barred from donating until a later date. The policy would also apply to women who have sex with gay or bisexual men. Anyone who has ever tested positive for HIV would continue to be ineligible to donate blood. Those taking pills to prevent HIV would also still be barred, until three months after their last dose. The FDA noted that the medication, known as PrEP, can delay the detection of the virus in screening tests. Marks said the agency is willing to consider further easing restrictions “but we have to have the science to do that.” FDA regulators will take public comments on the proposal for 60 days before beginning to finalize the guidelines. The proposed policy mirrors those used in Canada and the U.K. The FDA based its latest proposal, in part, on a recent study of 1,600 gay and bisexual men. The FDA-funded research compared the effectiveness of a detailed, personalized questionnaire on sexual behavior to the current time-based abstinence rules. It will take several months for blood banks to make the changes, according to Cliff Numark, an executive with Vitalant, a blood center that participated in the study. The changes will require new questionnaires, training for staff and updating computer software. The Red Cross said it supports the FDA changes but added that it’s too early to know if they will result in more blood donations. Lukas Pietrzak of Washington D.C., said he eagerly volunteered for the FDA study. He credits emergency blood transfusions with saving his father’s life after a cycling accident in 1991. Pietrzak donated blood in high school but became ineligible after becoming sexually active as a gay man. “Until I fully came out to my friends, I had to skirt around why I never went to blood drives with them,” says Pietrzak, 26, who now works for the federal government. When there are calls for blood donations “now we’re able to be part of that,” Pietrzak said. from https://ift.tt/emzLoJt Check out https://takiaisfobia.blogspot.com/ AstraZeneca Plc’s COVID antibody drug is no longer authorized for use in the U.S., regulators said Thursday, as it’s unlikely to work against strains of the virus that are now dominant across the country. Astra’s drug, called Evusheld, was authorized in December 2021 to prevent COVID infection in high-risk people, but has been rendered less effective by the virus’ mutations. At this point, fewer than 10% of the variants currently circulating in the U.S. appear to be responsive to Astra’s treatment, the U.S. Food and Drug Administration said in a statement. In the meantime, Astra said in a statement that it’s testing a next-generation long-acting antibody to prevent COVID in immune-compromised people, and aims to make the drug available in the second half of 2023, pending regulatory approval. In early lab studies, the next-gen antibody was effective against all COVID variants tested, the company said, including those that have thwarted other drugs. “About 2% of the global population is considered at increased risk of an inadequate response to COVID-19 vaccination and could benefit from monoclonal antibodies for COVID-19 protection,” the company said. Earlier this month, the agency warned Evusheld was unlikely to work against the rapidly spreading XBB.1.5 variant, which has grown to account for almost half of the country’s COVID cases, but the drug remained on the market until now. This hasn’t just been a problem for Astra’s antibody. A U.S. National Institutes of Health panel had recommended against using any monoclonal antibodies to treat or prevent COVID in high-risk people because of the drugs’ waning effectiveness. Evusheld was the last antibody left on the market after the FDA revoked other drugs’ authorizations due to variants. COVID antibody drugs made by Eli Lilly & Co., Regeneron Pharmaceuticals Inc. and a partnership between GSK Plc and Vir Biotechnology Inc. have all been pulled from the market as well. from https://ift.tt/FhnlXIT Check out https://takiaisfobia.blogspot.com/ In a unanimous decision, all 21 voting members of the U.S. Food and Drug Administration’s (FDA) vaccine committee recommended that the U.S. start using the same COVID-19 virus strain in all of the COVID-19 vaccines, including primary and booster doses. That means the bivalent booster dose, which targets both the original SARS-CoV-2 strain and the Omicron BA.4/5 strains, would soon become the only type used for all primary shots and boosters. The decision reflects a turning point in the pandemic. Until now, vaccine makers have tried to keep up with constantly evolving variants, but they’ve always been a few steps behind. The variants targeted in the bivalent booster, for instance—which the FDA only authorized in September—have since been eclipsed by the newer Omicron variants BQ.1.1, XBB.1, and XBB.1.5. Standardizing all vaccines to target the same strains—then evaluating whether they should be updated on a regular cadence, an approach the committee seemed enthusiastic about—would make variant-chasing a thing of the past. The committee heard data from FDA scientists, scientists at the U.S. Centers for Disease Control and Prevention (CDC), and vaccine makers. The research they presented all suggests that the bivalent booster generates stronger (albeit not dramatically higher) levels of antibodies against even the latest virus variants. The data included early looks at how the bivalent booster protected against the latest variants BQ.1.1, XBB.1, and SBB.1.5. Moderna and Pfizer-BioNTech showed that the bivalent boosters still provided some protection against these new variants, in the form of antibodies that were several fold higher than levels generated by the original vaccine when used as a booster. Antibodies are the first line of immune defense, and are primarily focused on blocking the virus from infecting cells. Citing previously reported data, Moderna showed that its bivalent booster generated levels of antibodies to neutralize the BQ.1.1 and XBB.1 that were several times higher than those produced by the original vaccine, while Pfizer-BioNTech referenced a recently published study in the New England Journal of Medicine showing responses of a similar magnitude. This data, plus the appeal of a simpler immunization regimen, persuaded the panel. “Simpler is better, and we saw evidence today that closer is better,” said committee member Dr. Michael Nelson, professor of medicine at University of Virginia, referring to the fact that the BA.4/5 in the bivalent vaccine is a closer match to the currently circulating Omicron variants than the virus in the original vaccine. “I’m hoping that the momentum for simplification, along with the efficacy and safety data, spurs additional vaccination and acceptance of these vaccines in all age groups.” Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital and member of the committee, agreed. “As we turn the corner from the pandemic to endemic phase, today’s vote marks a big practical win for the American people,” he said. “It’s going to really simplify things and benefit public health.” Lingering questionsThe experts noted that there are still gaps in what health officials know about how the bivalent vaccine is providing immunity. Data presented at the meeting showed that the additional benefit in protecting against infection is still short-lived, while the protection from the original vaccines in keeping people from getting severely ill appears to be more durable. At future meetings, the committee will consider whether to continue including the original SARS-CoV-2 virus in future immunizations, in so-called multivalent shots, or whether vaccines should contain multiple new variants that better match whatever new forms the virus might take. The committee discussed, but was not tasked to resolve, other issues. The most notable were about whether to move to an annual COVID-19 booster schedule and conduct yearly reviews each June to better match vaccines to whatever version of the coronavirus will likely be circulating the following winter. (The U.S. takes this approach with influenza shots.) The committee members were in favor of these strategies and will make more concrete decisions about them at a meeting in June. Those decisions also require coordination with global health bodies, including the World Health Organization (WHO), to sync immunization strategies to ensure that vaccines are targeting the viruses that are causing the most health issues. Novavax, which makes a COVID-19 vaccine authorized for use as both primary immunization and a booster in the U.S., also presented data at the meeting. Its shot uses a different technology based on a recombinant form of the spike protein on the SARS-CoV-2 virus, along with an adjuvant to wake up the immune system. Novavax reported that its vaccine generated similar protection as that of the mRNA bivalent boosters. Based on that data, the company argued that because its technology targets more conserved portions of the viral spike protein, it could generate broader protection that might include even future variants of SARS-CoV-2. However, Novavax added that it would take about six months to update its vaccine with any new variant targets, while the mRNA manufacturers estimated that it would take roughly half that time to update theirs. The experts also raised questions about some cases of stroke that CDC scientists are continuing to investigate to determine if the bivalent vaccine raises risk of these events. “The evidence is not sufficient to conclude a safety problem with respect to stroke,” said Dr. Tom Shimabukuro, deputy director of the H1N1 vaccine task force in the immunization safety office at the CDC. “The CDC recommendations are that everyone who is eligible should get a bivalent booster. We’ll continue to do more work on this, through more formal epidemiological investigations, and make the information available as it becomes known to us.” Next stepsToday’s vote to make all COVID-19 vaccines the same bivalent formulation did not specify a date by which this should happen. But the FDA will now take the committee’s advice under consideration as it formulates a revised vaccination plan for COVID-19, including whether to move to a yearly or more regular immunization schedule, and which strains to include. “I’m curious about the next stage of discussions involving choosing the [virus] strain,” said Dr. Steven Pergam, medical director of infection prevention at the Seattle Cancer Care Alliance and a member of the committee. “That’s where the rubber meets the road.” from https://ift.tt/jbavB2x Check out https://takiaisfobia.blogspot.com/ |
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