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  1. #3931

    Re: covid-19 Virus Updates and Discussion

    Don't know how many of you might have seen this video already. [/URL]Great job using Beauty and the Beast.
    "And for my next fearless prediction..."

  2. #3932

    Re: covid-19 Virus Updates and Discussion

    Quote Originally Posted by Jeff in TX View Post
    Don't know how many of you might have seen this video already. [/URL]Great job using Beauty and the Beast.
    Brilliant.
    Meet again we do, old foe...

  3. #3933
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    Re: covid-19 Virus Updates and Discussion

    I've been remiss in posting these recently due to this proposal due on Thursday. My apologies. Here is the WHO report for October 18, 2020. Lots going on.

    ::

    EPI UPDATE The WHO COVID-19 Dashboard reports 39.94 million cases and 1.11 million deaths as of 8:00am EDT on October 19. The WHO reported a new record high for global weekly incidence for the fifth consecutive week. The global total reached 2.44 million cases—an increase of more than 5% over the previous week. Additionally, the WHO reported 394,510 new cases on Saturday, a new daily record.

    Total Daily Incidence (change in average incidence; change in rank, if applicable)
    1. India: 61,391 new cases per day (-9,570)
    2. USA: 56,007 (+6,765)
    3. France: 23,151 (+6,608; ↑ 1)
    4. Brazil: 20,052 (-5,619; ↓ 1)
    5. United Kingdom: 16,956 (+2,565)
    6. Russia: 14,374 (+2,414; ↑ 1)
    7. Argentina: 13,639 (-35; ↓ 1)
    8. Spain: 10,778* (-15)
    9. Italy: 8,470 (+4,239; new)
    10. Czech Republic: 8,111 (+3,159; new)

    Per Capita Daily Incidence (change in average incidence; change in rank, if applicable)
    1. Andorra: 1,259 daily cases per million population (+176)
    2. Czech Republic: 757 (+295)
    3. Belgium: 620 (+90; ↑ 2)
    4. Netherlands: 448 (+126; ↑ 2)
    5. Armenia: 397 (+207; new)
    6. Montenegro: 397 (+1; ↓ 3)
    7. France: 355 (+101; ↑ 1)
    8. Slovenia: 345 (+196; new)
    9. Liechtenstein**: 322 (+277; new)
    10. Argentina: 302 (-1; ↓ 3)
    *Spain’s average daily incidence is not reported for today; these values correspond to the previous day’s averages.
    **Liechtenstein is a member of the UN, but not the WHO. Liechtenstein’s COVID-19 data is reported by Switzerland.

    Considering the current COVID-19 resurgence in the US, India is unlikely to surpass the US as #1 for cumulative incidence in the near future. India is still reporting more new daily cases than the US; however, India continues its decline, while US daily incidence is increasing again.

    Colombia and Mexico fell out of the top 10 in terms of total daily incidence, and they were replaced by the Czech Republic and Italy. Notably, Italy’s daily incidence doubled over the past week, and the daily incidence increased by more than 60% in the Czech Republic. France’s daily incidence has doubled over the past 2 weeks. The Bahamas, Iceland, and Israel fell out of the top 10 in terms of per capita daily incidence, and they were replaced by Armenia, Liechtenstein, and Slovenia. Belgium, which was not in the top 10 per capita daily incidence two weeks ago, has jumped to #3 globally. Armenia’s daily incidence increased by 108% compared to the previous week, Slovenia’s increased by 132%, and Liechtenstein’s increased by 617%.

    UNITED STATES
    The US CDC reported 8.08 million total cases and 218,511 deaths. The daily COVID-19 incidence continues to increase, now up to 55,323 new cases per day, the highest since August 5. On Saturday (data corresponding to October 16), the CDC reported 70,078 new cases, the highest daily incidence since July 24 and the sixth highest daily total to date. The US COVID-19 mortality continues to hold steady at approximately 700 deaths per day.

    The US surpassed 8 million cumulative cases. From the first case reported in the US on January 22, it took 96 days to reach 1 million cases. From there:
    1 million to 2 million: 44 days
    2 million to 3 million: 27 days
    3 million to 4 million: 15 days
    4 million to 5 million: 17 days
    5 million to 6 million: 22 days
    6 million to 7 million: 25 days
    7 million to 8 million: 21 days

    More than half of all US states have reported more than 100,000 cases, including 10 with more than 200,000 cases:
    >800,000: California, Texas
    >700,000: Florida
    >400,000: New York
    >300,000: Georgia, Illinois
    >200,000: Arizona, New Jersey, North Carolina, Tennessee

    The Johns Hopkins CSSE dashboard reported 8.17 million US cases and 219,811 deaths as of 12:30pm EDT on October 19.

    US HOSPITAL SURGE As much of the US continues to face another resurgence of COVID-19, rural hospitals are struggling to manage the patient demand. The US COVID-19 epidemic, which was largely concentrated in higher-density urban populations early on (eg, New York City, Boston, Detroit), has shifted toward rural populations across the country. In fact, the per capita COVID-19 mortality in small towns and rural areas is now more than double the mortality in large cities. Unlike urban areas, which may have many nearby hospitals to provide care for their large populations, and to distribute increased patient load, hospitals and other healthcare facilities in rural areas are spread further apart, covering much larger geographic areas. In some cases, the nearest hospital may be hundreds of miles away. Additionally, these hospitals tend to be smaller than their urban counterparts, and the associated limitations on resources, including hospital and intensive care unit (ICU) beds, increase the burden of COVID-19 patient surges. As we covered early in the pandemic, a growing number of rural hospitals in the US have closed their doors over the past several years, and restrictions on elective procedures during the height of social distancing measures in the US placed additional economic stress on hospitals and health systems, causing more to close.

    In an effort to decompress patients from overburdened health systems (ie, transfer them to other facilities), Wisconsin established a temporary field hospital at its state fairgrounds. The facility opened last week, and it will initially be able to accommodate up to 50 patients. It is designed to provide care for patients who are recovering from COVID-19 but who are not yet ready to be discharged. More severe patients will remain at traditional hospitals to receive more advanced clinical care. Ultimately, the field hospital could be expanded to handle more than 500 patients, if necessary. Wisconsin currently has more than 1,000 hospitalized COVID-19 patients statewide, its highest total to date.

    SWEDEN SOCIAL DISTANCING Since early in the COVID-19 pandemic, Sweden has largely resisted highly restrictive social distancing and other mitigation measures to limit SARS-CoV-2 transmission. Unlike most other European countries, Sweden placed few restrictions on retail stores, restaurants and bars, or schools. The reluctance to implement widespread social distancing policies has resulted in numerous accusations from the international community that Sweden is pursuing a herd immunity strategy through natural infection—Swedish officials have denied that herd immunity is the goal. In light of increased incidence during Europe’s “second wave,” Swedish officials are reportedly evaluating plans to implement local social distancing restrictions in severely affected areas.

    Dr. Anders Tegnell—Sweden’s leading epidemiologist, who received the brunt of opposition to Sweden’s perceived herd immunity strategy—recently commented that the seroprevalence in the population was not as high as previously believed, which likely factors into Sweden’s evolving mindset. It appears as though the new policies will still largely be recommendations, as opposed to mandates, and they will be implemented locally not at the national level. While these measures are not nationwide mandates, it appears that Sweden’s overall strategy toward containing COVID-19 is moving closer to the model implemented across the rest of Europe. On October 13, Sweden reported 970 new cases, its highest daily total since late June.

    VATICAN/HOLY SEE When reporting the per capita daily incidence top 10, we typically omit small countries that normally report zero daily cases but occasionally report a minor, temporary spike in incidence in favor of countries that exhibit a trend of elevated incidence. This week, the Vatican/Holy See reported 7 new cases twice, which would put it at #1 globally in terms of per capita incidence, at nearly 2,500 daily cases per million population.

    At least 11 of the 14 new COVID-19 cases are among the Swiss Guard, who provide security for the Pope. Additionally, a man who lives “in the same Vatican residence as Pope Francis” tested positive for SARS-CoV-2. Pope Francis is 83 years old, and he reportedly “had part of one lung removed during an illness when he was a young man,” which could further increase his risk for severe COVID-19 disease. The Pope undergoes regular testing, and there is no indication that he has been directly exposed to any infectious individuals. These are the first cases reported by the Vatican/Holy See since mid-March—and more than doubled the country’s cumulative total—but considering that both reports included multiple cases and that most of the cases were among a small group of individuals, it is worth monitoring for early signs of sustained transmission.

    LITHUANIA ELECTION Lithuania updated its policies regarding COVID-19 isolation and quarantine to provide an exemption that would allow quarantined citizens to vote during the upcoming elections. Under the new policy, individuals who have exposure to known COVID-19 cases but who have not tested positive are permitted to leave quarantine to participate in a limited window of early voting, October 19-22 from 7-8pm only. Voters must be transported to the polling station in their own car, wear a face covering while voting, and then return directly home. Reportedly, 4 polling stations have set up drive-through ballot drop-off. Individuals with active COVID-19 disease are not permitted to participate in early voting, but they can “vote from home,” presumably by mail. According to a report by the Associated Press, Lithuania did not offer an option for quarantined individuals to vote in person during the previous round of the national election.

    WHO SOLIDARITY TRIAL Last week, the WHO published preliminary results from the Solidarity Therapeutics Trial, the world’s largest randomized controlled trial evaluating candidate COVID-19 treatment drugs. Despite high hopes, the findings indicated that remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon—all of which are repurposed drugs—had “little or no effect on…mortality or the in-hospital course of COVID-19 among hospitalized patients.”

    Physicians and researchers have expressed mixed reviews of the trial, however, including criticism of the study design and inconsistency between the Solidarity Trial’s results and other major clinical trials, particularly for remdesivir.

    Notably, Gilead Sciences, the company that produces remdesivir, issued a press release that leveled criticism against the WHO’s findings. In particular, Gilead argued that while the international, multi-center nature of the Solidarity Trial increased availability of the drugs, it also introduced heterogeneity that could call into question the validity of the results. Additionally, Gilead noted that the data had not yet been peer reviewed. Solidarity Trial researchers submitted a manuscript discussing the Solidarity Trial data for peer review, but a preprint version is available here.

    VACCINE ROLLOUT Despite Pfizer’s recent announcement that it would not seek an Emergency Use Authorization (EUA) from the US FDA before late November, US government planning continues for the future rollout of a COVID-19 vaccine. Last Friday marked the deadline for US states to submit preliminary plans to the US CDC regarding future vaccine distribution programs. The CDC released its own guidance for state planning in mid-September. The US Department of Health and Human Services and the Department of Defense also recently announced an agreement with the CVS and Walgreens pharmacy chains to vaccinate residents and staff of nursing homes and long-term care facilities, once a vaccine is available, at zero out-of-pocket cost for recipients. CVS and Walgreens will also manage storage of the vaccine and related supplies as well as reporting vaccination data to local, state, and federal officials. Long-term care facilities will not be mandated to participate in the mass vaccination program, but they can opt in via the CDC’s National Healthcare Safety Network.

    This planning comes at a time when polls show Americans are increasingly hesitant to receive a SARS-CoV-2 vaccine. In fact, a recent poll conducted by STAT News and The Harris Poll found that only 58% of Americans indicated that they would receive a vaccination as soon as it was available. This is down from 69% in August. Among Black Americans, only 43% of individuals stated they would receive a vaccination as soon as it was available—down from 65% in August—further illustrating challenges in encouraging vaccination among racial and ethnic minority communities. Rob Jekielek, Managing Director of The Harris Poll, indicated that Black individuals are more likely to live more than 1 hour away from a primary care physician and more likely to use a hospital emergency department as their point of entry into the healthcare system. T As we have covered previously, racial and ethnic minorities have been demonstrated to be at elevated risk for severe COVID-19 disease and death, so it is critical to engage these communities prior to the availability of a SARS-CoV-2 vaccine in order to increase vaccination coverage among vulnerable individuals.

    Outside of the US, similar preparation work is also being done. UNICEF, Gavi, and the WHO recently partnered to stockpile supplies and equipment needed for future vaccine distribution, such as syringes, safe syringe disposal boxes, and cold chain equipment. Notably, UNICEF announced that it is working to stockpile more than half a billion syringes by the end of 2020.

    DIABETES Emerging reports indicate that COVID-19 patients may develop new-onset diabetes or experience complications to pre-existing diabetes as a result of SARS-CoV-2 infection. Diabetes has already been documented as one of the underlying health conditions that can increase the risk of severe COVID-19 disease and death, but it appears as though the association could work the opposite way as well—with COVID-19 actually causing patients to develop diabetes. Current hypotheses indicate that the complication may be related to SARS-CoV-2 binding to ACE2 receptors, which also play a part in regulating glucose metabolism.

    The onset of type 1 diabetes has been linked in the past to other viral infections, which may cause stress that raises blood sugar levels; however, new-onset diabetes in those circumstances typically only occurs in patients who are already predisposed to developing diabetes. Conversely, new-onset diabetes in COVID-19 patients has been observed in patients that do not have risk factors for diabetes. Further, some hospitals have reported unusually high rates of pediatric diabetes and patients presenting with diabetic ketoacidosis—a complication of diabetes—during the pandemic.

    In order to further research this phenomenon, doctors and researchers from King’s College London and Monash University (Australia) are establishing an international registry of COVID-19-related diabetes cases. More than 300 physicians have already agreed to participate by sharing clinical case data. The US National Institutes of Health is also funding research exploring the link between COVID-19 and new-onset diabetes or high blood glucose.

    GENETICS Previous studies have evaluated genetic risk factors for severe COVID-19, including a potential link between severe outcomes and blood type, but a new study published in the The New England Journal of Medicine may provide further evidence of genetic risk factors for COVID-19. The genomewide association study (GWAS), conducted by the Severe COVID-19 GWAS Group, involved 1,980 severe COVID-19 patients from 7 hospitals in Italy and Spain.

    The researchers found that the ABO blood group locus at 9q34.2 and the multigene locus at 3p21.31 were associated with severe COVID-19 outcomes. Consistent with other research, the findings suggest that patients with blood type A had a higher risk of severe outcomes and that patients with blood type O had a lower risk of severe outcomes. An insertion-deletion GA or G variation at locus 3p21.31 was specifically linked to patients requiring mechanical ventilation. Due to limitations in the methodology, the researchers were not able to test and adjust for some potential sources of bias known to be associated with COVID-19, and further study is needed to better characterize the identified relationships. Regardless, the study identified potential areas of focus for future genomic research, and the researchers call for future efforts to further investigate the immunologic synapse between T-cells and antigen-presenting cells.

    https://covid19.who.int/
    Tiz the Dude! Now a winner after his second race!

  4. #3934

    Re: covid-19 Virus Updates and Discussion

    Raise your hand if you have blood type A
    Face it. It's the apocalypse.

  5. #3935

    Re: covid-19 Virus Updates and Discussion

    Trump’s den of dissent: Inside the White House task force as coronavirus surges
    By
    Yasmeen Abutaleb,
    Philip Rucker,
    Josh Dawsey and
    Robert Costa
    Oct. 19, 2020 at 6:00 a.m. EDT

    As summer faded into autumn and the novel coronavirus continued to ravage the nation unabated, Scott Atlas, a neuroradiologist whose commentary on Fox News led President Trump to recruit him to the White House, consolidated his power over the government’s pandemic response.

    Atlas shot down attempts to expand testing. He openly feuded with other doctors on the coronavirus task force and succeeded in largely sidelining them. He advanced fringe theories, such as that social distancing and mask-wearing were meaningless and would not have changed the course of the virus in several hard-hit areas. And he advocated allowing infections to spread naturally among most of the population while protecting the most vulnerable and those in nursing homes until the United States reaches herd immunity, which experts say would cause excess deaths, according to three current and former senior administration officials.

    Atlas also cultivated Trump’s affection with his public assertions that the pandemic is nearly over, despite death and infection counts showing otherwise, and his willingness to tell the public that a vaccine could be developed before the Nov. 3 election, despite clear indications of a slower timetable.

    Atlas’s ascendancy was apparent during a recent Oval Office meeting. After Trump left the room, Atlas startled other aides by walking behind the Resolute Desk and occupying the president’s personal space to keep the meeting going, according to one senior administration official. Atlas called this account “false and laughable.”

    Discord on the coronavirus task force has worsened since the arrival in late summer of Atlas, whom colleagues said they regard as ill-informed, manipulative and at times dishonest. As the White House coronavirus response coordinator, Deborah Birx is tasked with collecting and analyzing infection data and compiling charts detailing upticks and other trends. But Atlas routinely has challenged Birx’s analysis and those of other doctors, including Anthony S. Fauci, Centers for Disease Control and Prevention Director Robert Redfield, and Food and Drug Administration Commissioner Stephen Hahn, with what the other doctors considered junk science, according to three senior administration officials.


    Birx recently confronted the office of Vice President Pence, who chairs the task force, about the acrimony, according to two people familiar with the meeting. Birx, whose profile and influence has eroded considerably since Atlas’s arrival, told Pence’s office that she does not trust Atlas, does not believe he is giving Trump sound advice and wants him removed from the task force, the two people said.

    In one recent encounter, Pence did not take sides between Atlas and Birx, but rather told them to bring data bolstering their perspectives to the task force and to work out their disagreements themselves, according to two senior administration officials.

    The result has been a U.S. response increasingly plagued by distrust, infighting and lethargy, just as experts predict coronavirus cases could surge this winter and deaths could reach 400,000 by year’s end.

    This assessment is based on interviews with 41 administration officials, advisers to the president, public health leaders and other people with knowledge of internal government deliberations, some of whom spoke on the condition of anonymity to provide candid assessments or confidential information.

    Atlas defended his views and conduct in a series of statements sent through a spokesperson and condemned The Washington Post’s reporting as “another story filled with overt lies and distortions to undermine the President and the expert advice he is being given.”

    Atlas said he has always stressed “all appropriate mitigation measures to save lives,” and he responded to accounts of dissent on the task force by saying, “Any policy discussion where data isn’t being challenged isn’t a policy discussion.”

    On the issue of herd immunity, Atlas said, “We emphatically deny that the White House, the President, the Administration, or anyone advising the President has pursued or advocated for a wide-open strategy of achieving herd immunity by letting the infection proceed through the community.”

    The doctor’s denial conflicts with his previous public and private statements, including his recent endorsement of the “Great Barrington Declaration,” which effectively promotes a herd immunity strategy.

    On Saturday, Atlas wrote on Twitter that masks do not work, prompting the social media site to remove the tweet for violating its safety rules for spreading misinformation. Several medical and public health experts flagged the tweet as dangerous misinformation coming from a primary adviser to the president.

    “Masks work? NO,” Atlas wrote in the tweet, followed by other misrepresentations about the science behind masks. He linked to an article from the American Institute for Economic Research — a libertarian think tank behind the Barrington effort — that argued against masks and dismissed the threat of the virus as overblown.


    Trump and many of his advisers have come to believe that the key to a revived economy and a return to normality is a vaccine.

    “They’ve given up on everything else,” said a senior administration official involved in the pandemic response. “It’s too hard of a slog.”

    Infectious-disease and other public health experts said the friction inside the White House has impaired the government’s response.

    “It seems to me this is policy-based evidence-making rather than evidence-based policymaking,” said Marc Lipsitch, director of the Center for Communicable Disease Dynamics at the Harvard T.H. Chan School of Public Health. “In other words, if your goal is to do nothing, then you create a situation in which it looks okay to do nothing [and] you find some experts to make it complicated.”

    These days, the task force is dormant relative to its robust activity earlier in the pandemic. Fauci, Birx, Surgeon General Jerome Adams and other members have confided in others that they are dispirited.

    Birx and Fauci have advocated dramatically increasing the nation’s testing capacity, especially as experts anticipate a devastating increase in cases this winter. They have urged the government to use unspent money Congress allocated for testing — which amounts to $9 billion, according to a Democratic Senate appropriations aide — so that anyone who needs to can get a test with results returned quickly.

    But Atlas, who is opposed to surveillance testing, has repeatedly quashed these proposals. He has argued that young and healthy people do not need to get tested and that testing resources should be allocated to nursing homes and other vulnerable places, such as prisons and meatpacking plants.

    White House spokeswoman Sarah Matthews defended Trump and the administration’s management of the crisis.

    “President Trump has always listened to the advice of his top public health experts, who have diverse areas of expertise,” Matthews said in a statement. “The President always puts the well-being of the American people first as evidenced by the many bold, data-driven decisions he has made to save millions of lives. Because of his strong leadership, our country can safely reopen with adequate PPE, treatments, and vaccines developed in record time.”

    Yet 10 months into a public health crisis that has claimed the lives of more than 219,000 people in the United States — a far higher death toll than any other nation has reported — a consensus has formed within the administration that some measures to mitigate the spread of the virus may not be worth the trouble.


    The president gave voice to this mind-set during an NBC News town hall Thursday night, when he declined to answer whether he supported herd immunity. “The cure cannot be worse than the problem itself,” Trump told host Savannah Guthrie.

    But medical experts disagreed, saying it is dangerous for government leaders to advocate herd immunity or oppose interventions.

    “We’d be foolish to reenter a situation where we know what to do and we’re not doing it,” said Rochelle Walensky, chief of the division of infectious diseases at Massachusetts General Hospital and a professor of medicine at Harvard Medical School. “This thing can take off. All you need to do is look at what’s happened at 1600 Pennsylvania Avenue over the last two weeks to see that this thing is way faster than we’re giving it credit for.”

    ‘The cure’

    After Trump came home from the hospital this month, he all but promised Americans that they could soon be cured from the coronavirus just as he claimed to have been. In a video taped at the White House on Oct. 5, he vowed, “The vaccines are coming momentarily.”

    Then, at a rally last Tuesday night in Johnstown, Pa., Trump told supporters, “The vaccines are coming soon, the therapeutics and, frankly, the cure. All I know is I took something, whatever the hell it was. I felt good very quickly . . . I felt like Superman.”

    Trump’s miraculous timeline has run headlong into reality, however. On the same day that he declared “the cure” was near, Johnson & Johnson became the second pharmaceutical giant, after AstraZeneca, to halt its vaccine trial. A third trial, a government-run test of a monoclonal antibody manufactured by Eli Lilly & Co., was also paused. Each move was prompted by safety concerns.

    And on Friday, Pfizer said it will not be able to seek an emergency use authorization from the FDA until the third week of November, at the earliest, seemingly making a vaccine before Election Day all but impossible.


    Trump’s notion of a vaccine as a cure-all for the pandemic is similarly miraculous, according to medical experts.

    “The vaccines, although they’re wonderful, are not going to make the virus magically disappear,” said Tom Frieden, a former CDC director who is president of Resolve to Save Lives. “There’s no fairy-tale ending to this pandemic. We’re going to be dealing with it at least through 2021, and it’s likely to have implications for how we do everything from work to school, even with vaccines.”

    Frieden added: “Remember, we have vaccines against the flu, and we still have flu.”


    (...)

    Trump has envisioned a greenlit vaccine as the kind of breakthrough that could persuade voters to see his management of the pandemic as successful and thus upend a race in which virtually all public polls show him trailing Democratic nominee Joe Biden.

    Earlier this fall, Trump called Albert Bourla, the chief executive of Pfizer, and asked whether a vaccine could be ready for distribution by late October, before the election. Pfizer spokeswoman Sharon Castillo said executives have regular communications with administration officials on a wide range of health policy issues but that she could not comment on private conversations.

    On a call in August with Francis Collins, director of the National Institutes of Health, Trump accused the agency of moving too slowly to approve a vaccine or other treatments, including convalescent plasma, according to two officials familiar with the conversation. The NIH, which declined to comment, is a biomedical research agency and does not approve treatments or vaccines.

    (...)

    The relationships between FDA officials and White House staffers have grown more acrimonious since September, when details of stricter FDA vaccine guidance were reported by The Post. Trump and White House Chief of Staff Mark Meadows — who has involved himself in the work of health agencies to a degree other officials consider inappropriate — have repeatedly challenged Hahn over his agency’s proposals and rules, much to the FDA commissioner’s frustration.

    Trump is asserting control over the messaging campaign around a vaccine. His politically minded aides in the White House have taken over the government’s communications effort, as opposed to health or scientific communicators at the relevant agencies.

    For example, White House aides have sought to persuade Moncef Slaoui, head of “Operation Warp Speed,” the government’s initiative to mass-distribute an eventual vaccine, to speak more positively about the vaccine, and sometimes he has pushed back on their talking points, two officials said.

    Trump routinely has told his political advisers that a vaccine would be ready by the time he stands for reelection. And he has plotted with his team on a pre-election promotional campaign to try to convince voters a vaccine is safe, approved and ready for mass distribution — even if none of that is true yet.

    These are some of the ingredients of a public health disaster, experts say.

    “The one thing you can’t do — and it’s what everybody fears, it’s what the pharmaceutical companies fear, it’s what everybody on the inside fears — is that the government would, because of political purposes or because other countries put a vaccine out before us, truncate the normal process you’d accept for a safe and effective vaccine,” said Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, a professor of vaccinology at the University of Pennsylvania and a member of the FDA’s vaccine advisory council.

    (...)

    Trump’s conspiratorial view of the FDA is shaped in part by White House trade adviser Peter Navarro and others in the president’s orbit, both inside and outside the government.

    Saad B. Omer, director of the Yale Institute for Global Health, said the atmosphere of pressure and recrimination, nurtured by the president, is “very concerning.”

    “These are people who have dedicated their lives to working in public health and medicine and research,” he said. “To think that in the biggest public health event of their lives they would sleep an extra hour or slow-walk this for any reason is absurd.”

    He added, “It’s like how an ambulance drives faster than a regular car because it’s an emergency, but even an ambulance driver is not foolhardy. They don’t want to drive over the bridge.”

    ‘A lot of political pressure’

    The distrust in Washington has trickled down to the states, where friction has increased between several governors and the administration over the vaccine process.

    Some governors and officials close to them privately have expressed alarm about Trump and his aides laying the groundwork for a rushed vaccine announcement. The president has delegated much of the state outreach to Pence, who in regular calls with governors has come across as a smooth salesman for Trump’s speedy approach. The vice president has encouraged governors to help build confidence for eventual vaccines among their constituents.

    (...)

    The politicization of the process has damaged public credibility in an eventual vaccine. A Gallup poll released this month found that 50 percent of Americans said they would be willing to take a coronavirus vaccine approved by the FDA “right now at no cost.” That is a sharp decline from 61 percent in August and 66 percent in July.

    During a virtual task force meeting led by Pence on Sept. 21, Washington Gov. Jay Inslee (D) said, “There is a substantial concern,” according to an audio recording of the meeting. “A significant part of that problem is the president’s continued anti-science statements that are contradictory to his medical advisers in so many different ways.”

    Inslee asked Pence directly, “Have you discussed with the president how he’s been eroding public confidence in our efforts, including the vaccine approval? Have you discussed that with him? Have you urged him to stop this behavior?”

    Pence did not directly answer the question. Rather, he replied, “We think you and all the governors on this call have a great responsibility to make sure the public knows while we’re moving rapidly and while there may be differences in opinion about various events, we just don’t want any undermining of confidence in the vaccine.”

    The vice president added, “I can assure you the president will continue to speak clearly about that process.”

    ‘A magic dust’

    Health and Human Services Secretary Alex Azar, a former Eli Lilly president who has close ties to the pharmaceutical industry, has sought to cool Trump’s temper and assure him that the process is sound.

    Also whispering optimism in the tempestuous president’s ear has been Atlas, who is said to be operating with the full confidence of Jared Kushner, Trump’s son-in-law and senior adviser overseeing key aspects of the pandemic response, and Hope Hicks, the president’s counselor and confidante.

    This is in part because Atlas has sought to spin the public with what others deride as “happy talk” that the outbreak is close to over. “Everybody looks for what Atlas is giving them,” one official involved in the response said.

    Offit said, “This administration, like it does with everything, is overselling vaccines. They make it sound like a magic dust they’ll distribute over the country and the disease will go away . . . What could happen is people think, great, I just got my vaccine, I can throw away my mask, I can engage in high-risk activity, and then we’d actually take a step back.”

    Most controversially, Atlas has pushed a baseless theory inside the task force that the U.S. population is close to herd immunity — the point at which enough people become immune to a disease either by becoming infected or getting vaccinated that its spread slows — despite a scientific consensus that the United States is nowhere close.

    Given the transmissibility of the coronavirus, experts estimate about 60 to 70 percent of the population would need to become infected to reach herd immunity, a course that they warn would probably result in hundreds of thousands of excess deaths. A recent CDC study, about which Redfield testified to the Senate, showed about 9 percent of people in the United States had antibodies against the virus.

    But Atlas publicly contradicted Redfield last month, telling reporters that more of the population was protected against the virus because of so-called T-cell immunity, in which people with exposure to previous coronaviruses — such as the common cold — have T cells that also protect them against covid-19, the disease caused by the novel coronavirus.

    No credible scientific study has proved this theory, and Atlas’s advocacy of it dismayed other task force officials.

    At a task force meeting late last month, Atlas stated that there was herd immunity in much of the country because of a combination of high infection rates in cities such as New York and Miami and T-cell immunity, according to two senior administration officials. He said that only 40 to 50 percent of people need to be infected to reach the threshold. And he argued that because of this immunity, all restrictions should be lifted, schools should be opened and only the most vulnerable populations, such as nursing home residents, should be sheltered.

    This resulted in a fierce debate with Birx and Fauci, who demanded Atlas show them the data that backed up his assertions, one of the officials said.

    “It is not the case there’s extra immunity around in T cells,” Lipsitch said. “The vast, vast majority of infectious-disease epidemiologists in this country don’t believe several of the key points these people are arguing for and don’t believe it because the evidence isn’t there and points in the other direction.”

    Regardless, Trump has used Atlas to back up his own rejection of medical expertise. At Thursday’s NBC News town hall, a Florida voter asked the president whether after contracting covid-19 he now believed in the importance of mask-wearing.

    Trump equivocated.

    “I’ve heard many different stories on masks,” he said.

    When Guthrie challenged him by noting that all of his health officials were united in advocating masks, Trump countered by invoking Atlas.

    “Scott Adkins,” Trump said, mispronouncing the doctor’s name. “If you look at Scott, Dr. Scott, he’s from — great guy — from Stanford, he will tell you.”

    “He’s not an infectious-disease expert,” Guthrie said.

    “Oh, I don’t know,” Trump replied. “Look, he’s an expert. He’s one of the experts of the world.”


    https://www.washingtonpost.com/polit...38d_story.html
    “No matter how cynical I get, I just can't keep up.” – Lily Tomlin.




  6. #3936

    Re: covid-19 Virus Updates and Discussion

    Texas passenger died of coronavirus while waiting for plane to take off, officials say
    BY MADDIE CAPRON
    OCTOBER 19, 2020 07:48 PM, UPDATED OCTOBER 19, 2020 08:08 PM

    A Texas woman in her 30s died from COVID-19 while sitting on an airplane waiting to take off, Dallas County officials said.

    The woman died in July while on a flight from Arizona to Texas, NBC DFW and other media outlets reported.

    She lived in Garland, a suburb in Dallas County.

    The woman’s case was confirmed as a COVID-19 death, Dallas County official Lauren Trimble told BuzzFeed News.

    “We don’t know a whole lot,” Dallas County Judge Clay Jenkins told WFAA. “We may not know if she was aware she was sick. Contact took place in Arizona.”

    She had underlying health conditions that made her high-risk, Jenkins said.

    “[This is a] reminder that there is no age restriction in COVID,” Jenkins told WFAA.

    The woman, who the county did not identify for privacy reasons, had trouble breathing and was given oxygen, NBC DFW reported. It is not clear on which airline the woman was traveling.

    Dallas County has reported nearly 90,000 cases of COVID-19 and 1,085 deaths, according to the county.

    More than 203,000 people have died from COVID-19 in the U.S., according to the Centers for Disease Control and Prevention. Of those deaths, about 1,588 people have been between the ages of 25 and 34 years old, the CDC reported.

    Travel has plummeted during the coronavirus pandemic, with the number of people traveling through U.S. airports dropping below 100,000 in April, McClatchy News reported.

    On Sunday, however, more than 1 million people were traveling on airplanes for the first time since March, the Transportation Security Administration said.

    “That weekly volume also represents the highest weekly volume for TSA since the start of the COVID-19 pandemic,” TSA said in the news release.

    https://www.star-telegram.com/news/c...246570138.html
    “No matter how cynical I get, I just can't keep up.” – Lily Tomlin.




  7. #3937

    Re: covid-19 Virus Updates and Discussion

    Personal extended family COVID update:
    My cousin's daughter-in-law's family: Her uncle seems to be doing OK. Her grandmother had a fever, but it was not COVID. Her brother had COVID with no symptoms. No one else has appeared to have contracted COVID. My sister and I, both seem to have avoided contracting it.
    So, everybody appears to be fine now.
    My Suicide Draw Pool avatar

  8. #3938

    Re: covid-19 Virus Updates and Discussion

    Good to hear that, Dave. Let's hope you (and your family) are naturally immune to it.
    Last edited by ponchi101; Today at 07:53 AM.
    Face it. It's the apocalypse.

  9. #3939

    Re: covid-19 Virus Updates and Discussion

    Great news Dave.
    “No matter how cynical I get, I just can't keep up.” – Lily Tomlin.




  10. #3940

    Re: covid-19 Virus Updates and Discussion

    One of the whining cries from the administration (regarding C19) is: Who could have thought of this?
    I started reading The Coming Plague. From the preface:
    "The world needs - now - a global early warning system capable of detecting and responding to new emerging infectious disease threats to health. There is no clearer warning than AIDS. Laurie Garrett has spelled it out clearly for us. Now we ignore it at our peril".
    Jonathan M. Mann (it lists multiple titles, which include "Director, International AIDS Center").

    I didn't know the book came out in 1994. So, yes, who could have thought of this?

    S.C.I.E.N.C.E. Science not only thought of it, it told us.
    (maybe at the 1/6 mark and even if the rest were to be trash, highly recommended)
    Face it. It's the apocalypse.

  11. #3941
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    Re: covid-19 Virus Updates and Discussion

    Situation Report for October 22, 2020. My apologies for missing some recent ones again. My proposal was due yesterday.

    ::

    SYSTEMIC RACISM & COVID-19 The Johns Hopkins Center for Health Security’s journal, Health Security, issued a call for papers for an upcoming Special Feature on systemic racism in the context of the COVID-19 pandemic (scheduled for May/June 2021). The COVID-19 pandemic’s impacts on health, economies, and social structures have disproportionately impacted racially marginalized populations. Racial and ethnic minority communities are experiencing elevated COVID-19 morbidity and mortality, stemming in part from ineffective response efforts and longstanding barriers to accessing healthcare and public health programs and services. Evidence-based and peer-reviewed research is urgently needed to examine the root causes and impacts of systemic and pervasive racial and ethnic inequities in the context of COVID-19 as well as how systemic racism manifests in the practice of health security, including in preparedness for, response to, and recovery from COVID-19. The journal is actively encouraging submissions from women, underrepresented minority scholars in health security, and scholars with disabilities. Additional information is available here.

    EPI UPDATE The WHO COVID-19 Dashboard reports 41.57 million cases and 1.13 million deaths as of 9:30am EDT on October 23.

    The US surpassed India in terms of daily incidence, resuming the #1 position globally with approximately 60,000 new cases per day. This means that the US is again increasing its lead over #2 India in terms of cumulative COVID-19 incidence.

    The current COVID-19 resurgence in Europe and the US have been well covered globally, as well as India’s epidemic and the high-profile success of countries like New Zealand. Today, we briefly discuss global trends in COVID-19 incidence, with a specific focus on parts of the world that are receiving less attention recently.
    Notably, Central and South America, which were major global hotspots several months ago, are largely reporting decreasing COVID-19 incidence, as is the nearby Caribbean region. While there are some exceptions, many countries in Sub-Saharan Africa are reporting decreasing incidence as well. Additionally, daily incidence is decreasing in most of the Eastern Mediterranean region, which includes numerous countries that previously reported among the highest per capita incidence in the world. This trend continues across much of South and Southeast Asia as well, including India, which has reported a decrease of 40% over the past 5 weeks.

    These trends can also be observed on a continental level, with incidence decreasing in South America and Asia (driven principally by India), increasing moderately in North America, and increasing more sharply in Europe (nearly doubling over the past 2 weeks). Incidence in Oceania is increasing sharply as well, but Oceania has generally reported very low incidence over the course of the pandemic, so even minor absolute increases result in large relative changes. Similarly, incidence in Africa appears to be increasing at approximately the same rate as North America, but this is a result of a much smaller absolute change due to Africa’s generally low incidence, particularly on a per capita basis.

    UNITED STATES
    The US CDC reported 8.31 million total cases and 221,438 deaths. The daily COVID-19 incidence continues to increase, now up to 59,699 new cases per day, the highest since August 3. Following the previous peak (66,960 new cases per day on July 24), the US daily incidence fell by 48% to its most recent low (34,371 new cases per day on September 12). Since that time, however, the US has climbed more than 75% of the way back to its highest peak, and still increasing steadily.

    The US COVID-19 mortality increased for the third consecutive day, up from approximately 700 deaths per day to 773—a 10% increase and the highest average since September 19. It is still too early to determine if this is the beginning of a longer-term trend.

    More than half of all US states have reported more than 100,000 cases, including 10 with more than 200,000 cases:
    >800,000: California, Texas
    >700,000: Florida
    >400,000: New York
    >300,000: Georgia, Illinois
    >200,000: Arizona, New Jersey, North Carolina, Tennessee

    Wisconsin is averaging more than 3,500 new cases per day over the past week, so we expect it to surpass 200,000 cumulative cases in the next several days.

    The Johns Hopkins CSSE dashboard reported 8.43 million US cases and 223,289 deaths as of 12:30pm EDT on October 21.

    LOMBARDY, ITALY Early in the COVID-19 pandemic, Italy’s Lombardy region was one of the most severely affected parts of the world. According to Italy’s Ministry of Health, the region has reported more than 143,000 total cases, including more than 17,000 deaths. The initial patient surge overwhelmed Lombardy’s health system, and approximately 12,000 healthcare workers were infected. In order to better understand the impacts and drivers of the epidemic, the Regional Council of Lombardy created a “COVID-19 investigative commission.” The commission will “analyse the sequence of events and the specific choices that led to so many infections and deaths” with the aim of learning and sharing lessons and providing “accountability [for] the Italian people.” The commission will assess a variety of data and include input from technical experts in order to characterize the COVID-19 epidemiology, response, and effects on the region. A member of the commission indicated that this effort is the first of its kind in Europe, and possibly globally.

    IRELAND Ireland is implementing one of the most restrictive sets of social distancing measures in Europe in response to its “second wave” of COVID-19. This week, Ireland entered Phase 5 “lockdown,” the highest level in Ireland, which includes restrictions on social gatherings (indoors and outdoors), including weddings and funerals; religious services; retail businesses, restaurants, cafes, and pubs; essential services; sporting events and outdoor activities; and travel, hotels, and public transportation. Notably, schools and childcare services will remain open in Phase 5. Households are permitted to form a “support bubble” with one other household, under specific circumstances. The Irish government is also increasing financial assistance for unemployed individuals under Phase 5. The Phase 5 restrictions are currently scheduled to last at least 6 weeks. In early October, when Ireland was at Phase 2, senior medical experts in Ireland reportedly called on the government to move immediately to Phase 5, arguing that this was the only option to contain transmission while keeping schools open; however, Ireland moved one step to Phase 3, which still permitted many aspects of social and economic activity to continue. Ireland has reported nearly 55,000 cases and more than 1,800 deaths, and its daily incidence has increased by a factor of 11 since early September, setting new records there.

    KENYA Following efforts by the Kenyan government to ease social and economic restrictions, Kenya is reporting a second surge in COVID-19 incidence. The policy changes included shifting the start of a nationwide curfew to a later hour in order to support bars and restaurants and a partial reopening of public schools. Kenyan President Uhuru Kenyatta announced the changes during a national address in late September, in which he discussed the challenges Kenya endured over the early stage of the pandemic and called for continued vigilance by Kenyans to contain the virus. The restrictions implemented in response to Kenya’s “first wave” of transmission enabled the country to largely bring its epidemic under control; however, Kenya has seen a steady increase in COVID-19 activity since mid-to-late September. Since its low of 118 new cases per day on September 21, Kenya’s daily incidence has increased by a factor of 5. It has nearly returned to the height of its first peak and is still increasing rapidly.

    KYRGYZSTAN The government’s response to COVID-19 has added fuel to protests in Kyrgyzstan that started in opposition to disputed results of the country’s parliamentary election. In addition to concerns about the validity of the election results, protestors expressed frustration with the lack of government support during the national “lockdown.” According to a report by Reuters, some protestors indicated that citizens were largely left to “fend for themselves,” which has contributed to growing anger and opposition toward government leadership. Kyrgyzstan relies on external travel with China and Russia to support the national economy, and many have argued that the government did not do enough to support their citizens financially following the border closure and travel restrictions. COVID-19 daily incidence has been increasing in Kyrgyzstan since its low in mid-September, increasing from approximately 57 new cases per day to more than 500 over that time.

    WHO REFORM The German government and the EU reportedly drafted a document calling for reforms that aim to increase transparency by the WHO. The WHO has received criticism over the course of the COVID-19 pandemic, including for a perceived shortage of information shared publicly in the pandemic’s early stages. US President Donald Trump has repeatedly cited a lack of transparency, with a particular focus on China, as one of the primary reasons for his decision to withdraw the US from the WHO. According to a report by Reuters, the document is part of an ongoing EU effort to improve WHO’s capabilities. The report also indicates that the EU proposal aims to reduce the impact of “political influence” on WHO activities and reporting as well as increase funding and address the WHO’s lack of legal authority to take and compel action around health issues. The proposal is still in draft form and, to our knowledge, has not yet been published publicly.

    GERMANY Following a recent surge to more than 10,000 new cases per day, Germany issued travel warnings for nearby European countries, including popular tourist destinations such as Austria, Italy, and Switzerland. Returning travelers from these countries must self-quarantine for 10 days; however, if the individual tests negative after the fifth day, they can end their quarantine period early. The new travel policies take effect on October 24, and they are an expansion of previously issued warnings corresponding for more than 10 European countries, based on the Robert Koch Institute's list of high-risk areas. Countries across Europe are facing a severe resurgence of COVID-19, worse than the “first wave” in many countries. While the new measures may impact tourism to affected regions or countries, other tourist regions such as Spain’s Canary Islands have recently been removed from the Robert Koch Institute’s list of high-risk areas.

    Additionally, German Health Minister Jens Spahn recently tested positive for SARS-CoV-2. While Minister Spahn is in isolation and reportedly exhibiting “cold-like symptoms,” no other members of Chancellor Angela Merkel’s cabinet will be subjected to quarantine, despite having contact with Minister Spahn earlier in the week. The extent of the contact between Minister Spahn and other cabinet members is unclear; however, government officials indicated that quarantine is not warranted, based on Germany’s public health guidelines.

    US CDC UPDATES “CLOSE CONTACT” DEFINITION The US CDC published updated guidance regarding the definition of “close contact” for COVID-19. The new iteration of the guidance indicates that even brief contact with infectious individuals could result in transmission. Both the previous version and the newest iteration define close contact as being within 6 feet of an infectious individual for 15 minutes, but the new version notes that the time is cumulative over a 24-hour period. This could include being within 6 feet of an infectious individual for 3 separate periods of 5 minutes each, whereas the previous version was generally understood as referring to a single, prolonged exposure period. The CDC guidance continues to emphasize that it is difficult to concretely define what qualifies as close contact and that the guidance is an “operational definition for contact investigation.”

    The change was reported motivated by a case study recently published in the US CDC’s MMWR. The study documents suspected SARS-CoV-2 transmission over the course of multiple short exposure periods. The event occurred at a correctional facility in Vermont (US), and a correctional officer was infected after “multiple brief encounters with six incarcerated...persons” who were awaiting the results of SARS-CoV-2 tests after their arrival at the facility. All 6 individuals ultimately received positive test results. Review of video surveillance showed that the correctional officer was not within 6 feet of any of the individuals for a 15-minute period, and therefore, he was not identified as a close contact. The officer was not included in contact tracing efforts, and he was permitted to continue working. He later developed COVID-19 symptoms and tested positive for SARS-CoV-2. Further evaluation of the surveillance video found that the correctional officer was within 6 feet of the infected incarcerated individuals at least 22 times, totaling approximately 17 minutes over the course of an 8-hour shift. This example illustrates that SARS-CoV-2 transmission can occur over much shorter periods of contact than suggested by previous CDC guidance.

    REMDESIVIR APPROVED The US FDA announced that it approved remdesivir as treatment for COVID-19, the first drug to obtain full regulatory approval (as opposed to an Emergency Use Authorization [EUA]). According to the official announcement, the approval applies to hospitalized COVID-19 patients aged 12 or older and weighing at least 88 pounds (40 kg). Remdesivir’s EUA remains in effect for hospitalized pediatric patients under the age of 12 and weighing at least 7.7 pounds (3.5 kg) and for hospitalized patients aged 12 and older and weighing 7.7-88 pounds (3.5-40kg). The FDA’s decision was based on the findings from 3 randomized controlled trials that demonstrated a statistically significant effect in terms of speeding recovery among hospitalized COVID-19 patients. However, the trials did not identify an improvement in the odds of recovery/reduction in mortality.

    VACCINE CLINICAL TRIALS Moderna Therapeutics completed enrollment of the Phase 3 clinical trial for its candidate SARS-CoV-2 vaccine. The trial enrolled 30,000 participants, including more than 12,000 Americans who are over the age of 65 or have high-risk health conditions. Approximately 42% of the total trial population is at elevated risk for severe COVID-19 disease and death, including those with a myriad of underlying health conditions: diabetes (36%), severe obesity (25%), severe cardiac disease (19%), and chronic lung disease (18%). Additionally, 37% of enrollees are racial or ethnic minorities. Notably, 10% of all enrollees are Black, 20% are Hispanic or Latinx, and 4% are Asian. Black enrollment in the study is slightly lower than the proportion of Black individuals in the overall US population, but the diversity of the participants has been viewed positively, particularly considering that Moderna faced challenges enrolling participants from certain racial and ethnic minority groups.

    It was widely reported this week that a participant enrolled in the Phase 3 clinical trial for the AstraZeneca/Oxford candidate vaccine trial died, raising concerns about the safety of the vaccine and the clinical trial timeline. The participant was a 28-year-old physician in Brazil who treated COVID-19 patients. However, according to multiple reports, the patient was a member of the control group, and did not receive the candidate SARS-CoV-2 vaccine. Rather, the participant received an approved meningitis vaccine. Because the death was not attributable to an adverse event associated with the candidate vaccine, the trial can continue. Focus has remained centered on developments in the AstraZeneca clinical trials around the world, particularly after the trials in the UK and other countries were paused after a participant was diagnosed with transverse myelitis. The trial has since resumed in the UK and other countries, but not in the US.

    https://covid19.who.int/
    Tiz the Dude! Now a winner after his second race!

  12. #3942

    Re: covid-19 Virus Updates and Discussion

    The Trump administration quietly closed a vaccine safety office last year, hampering efforts to track the long-term safety of a coronavirus vaccine.
    Friday, October 23, 2020 3:39 PM EST

    By Carl Zimmer
    Oct. 23, 2020, 3:35 p.m. ET

    As the first coronavirus vaccines arrive in the coming year, government researchers will face a monumental challenge: monitoring the health of hundreds of millions of Americans to ensure the vaccines don’t cause harm.

    Purely by chance, thousands of vaccinated people will have heart attacks, strokes and other illnesses shortly after the injections. Sorting out whether the vaccines had anything to do with their ailments will be a thorny problem, requiring a vast, coordinated effort by state and federal agencies, hospitals, drug makers and insurers to discern patterns in a flood of data. Findings will need to be clearly communicated to a distrustful public swamped with disinformation.

    For now, Operation Warp Speed, created by the Trump administration to spearhead development of coronavirus vaccines and treatments, is focused on getting vaccines through clinical trials in record time and manufacturing them quickly.

    The next job will be to monitor the safety of vaccines once they’re in widespread use. But the administration last year quietly disbanded the office with the expertise for exactly this job. Its elimination has left that long-term safety effort for coronavirus vaccines fragmented among federal agencies, with no central leadership, experts say.

    “We’re behind the eight ball,” said Daniel Salmon, who served as the director of vaccine safety in that office from 2007 to 2012, overseeing coordination during the H1N1 flu pandemic in 2009. ”We don’t even know who’s in charge.”


    An H.H.S. spokeswoman declined to answer detailed questions about why the vaccine office, set up in 1987, was closed or how the health agencies were planning to track the safety of vaccines once they are injected into millions of people. In a brief statement, she said that Operation Warp Speed was working closely with the Centers for Disease Control and Prevention “to synchronize the IT systems” involved in monitoring vaccine safety data.

    Scientists at the C.D.C. and the Food and Drug Administration have decades of experience tracking the long-term safety of vaccines. They’ve created powerful computer programs that can analyze large databases.

    “It’s like satellites looking at the weather,” said Dr. Bruce Gellin, the president of the Sabin Vaccine Institute, who headed the National Vaccine Program Office from 2002 to 2017.

    But monitoring hundreds of millions of Americans who may get different coronavirus vaccines from a variety of drug makers by summer is like tracking a major storm beyond anything researchers have dealt with before.

    The closest parallel was in the spring of 2009, when a new strain of H1N1 influenza emerged, and researchers raced to make a vaccine. From October 2009 to January 2010, it was administered to over 82 million people in the United States.

    As the vaccine was developed, Dr. Gellin and other federal officials and scientists organized a system to monitor the population for severe side effects and to promptly share results with the public. Eleven years later, it looks like the lessons of 2009 are being forgotten, experts say.

    “We got all these different agencies together, we created governance around it, we created a regular monitoring plan, as well as a public communication plan,” said Dr. Jesse Goodman, the F.D.A.’s chief scientist during the H1N1 pandemic. “I think that something very much like that is even more needed now. And, you know, we haven’t yet seen that emerge.”

    In the 1970s, the U.S. government set up large-scale programs to monitor vaccine safety. There was a system for parents to report symptoms their children experienced after getting a vaccine. It may get 50,000 reports from parents, doctors, hospitals and vaccine makers in a typical year. But the tool has limits: People may not report symptoms that should be investigated, or may see a connection to a vaccination where none exists.

    “People are vaccinated one day, and the next day they have some bad medical event, and then they scratch their head and say, ‘Well, you know, I was fine until this happened,’” Dr. Gellin said

    In 1990, the C.D.C. set up a new way to track vaccines that didn’t depend on people coming forward. The agency worked with health care organizations to get updates on people’s medical conditions. That system now covers 12 million people. Researchers can use it to look for clusters of symptoms that arise in people who get the same vaccine.

    When the H1N1 flu hit in 2009, Dr. Salmon recognized that these methods didn’t track enough people to quickly pick up rare symptoms. He reached out to researchers at Harvard to build a new system, which came to be known as PRISM. Ten states supplied vaccination records, and five health insurance companies shared anonymous information about 38 million members. PRISM then connected the two databases to track insurance claims in the wake of vaccination. “That really gave us a ton of data,” Dr. Salmon said.

    The researchers could come up with a background rate of a host of medical conditions. If the H1N1 vaccine was linked to cases that matched the background rate, they could dismiss the symptoms as ordinary. Only if they rose above the background rate would they be considered unusual and warrant a closer look.

    Scientists from various federal agencies gathered every two weeks to share data and look for worrying clusters of symptoms. Every month, outside experts reviewed the evidence and released public reports. “Vaccine programs are contingent on trust,” Dr. Gellin said, “and transparency is a huge element of that.”

    The vast majority of reports turned out to have nothing to do with the new vaccines. Just a handful of medical conditions required an intensive review. The researchers noticed that some vaccinated people developed a facial weakness called Bell’s palsy, for example, but within two weeks they ruled out vaccines as the cause.

    In the following years, as emerging viruses caused outbreaks of Ebola, MERS and other diseases, experts called for more preparations for the next pandemic. In 2016, President Barack Obama set up a global health security office at the National Security Council. But in 2018, the Trump administration disbanded that office, saying it was streamlining bureaucratic bloat.

    The next year, the National Vaccine Program Office met a similar fate. Alex M. Azar II, the secretary of health and human services, said in a letter to Senator Patty Murray, the ranking member of a health subcommittee, noting that the merger, as part of a broader department reorganization, would “increase operational efficiencies by eliminating program redundancies and decreasing program costs.”

    Dr. Nicole Lurie, who was assistant secretary for preparedness and response at H.H.S. during the 2009 pandemic, said the loss of the vaccine safety office was especially costly once the coronavirus pandemic hit. “The coordinated leadership for stuff like this would likely come from the National Vaccine Program Office,” she said.

    Dr. Lurie, now an adviser at the Coalition for Epidemic Preparedness Innovation, has been waiting along with other researchers, month after month, for coordinated leadership to emerge from the federal government on long-term vaccine safety. “There are a whole bunch of people who were really concerned about this,” she said.

    An F.D.A. official who declined to be identified said that in the absence of the National Vaccine Program Office, F.D.A. and C.D.C. staff members were relying on relationships they had built across the agencies, meeting regularly to discuss their separate projects.

    That leaderless effort concerns Dr. Lurie. “There’s no sort of active coordination to bring all the information together,” she said.


    On Thursday, an expert from the C.D.C. and another from the F.D.A. gave presentations about monitoring systems at a meeting of the F.D.A.’s vaccine advisory committee. One system will use smartphone apps to stay in touch with health and other essential workers after their vaccinations. Another will look at a database of electronic health records and insurance claims, and yet another will use Centers for Medicare & Medicaid data to track people over 65.

    Although each system may reveal important clues, they have limits that worry outside experts. Dr. Steven Black, the co-director of the Global Vaccine Data Network, observed that the Medicare system only registers billing information, resulting in a time lag. “The patient has to get into the hospital, leave the hospital and a bill needs to be sent,” he said.

    The other systems can provide safety information much faster, but they’re small compared with the PRISM system, which now covers about 60 million people. The F.D.A. still uses PRISM for drug safety research, but not for vaccines. Dr. Salmon is baffled that the agency hasn’t tapped into it again. “Why would you not use that?” he asked. (An agency spokeswoman said it might use PRISM in the future should the need arise.)

    The F.D.A. official said the agencies were still building lists of symptoms they plan to track closely. The C.D.C.’s list includes conditions like strokes and seizures. But it is also including entirely new conditions the coronavirus causes, like Multisystem Inflammatory Syndrome, which affects many organs at once.

    The agencies are searching the scientific literature to estimate the background rates of these outcomes. But Dr. Salmon warned that lockdowns and other disruptions have made some conditions more common and others less so. Comparing the health of vaccinated people with that of people from before the pandemic may set off false alarms.

    Dr. Salmon and other researchers are concerned that no overarching plan for communicating findings to the public has emerged. The F.D.A. official said the agency would post its updates on its website. A C.D.C. committee will get safety data from the agencies and discuss the results at public meetings.

    But that may fall short of what’s needed to foster public confidence. A poll conducted earlier this month by Stat and The Harris Poll found that 58 percent of Americans said they would get vaccinated as soon as a vaccine was available, down from 69 percent in August.

    The explosion of disinformation on social media will make clear communication vital. “I think that preparing for Russian disinformation campaigns should be part of preparing for the rollout of a Covid vaccine,” said Steven Wilson, a political scientist at Brandeis University.

    Dr. Grace Lee, a professor at the Stanford University School of Medicine and a member of the C.D.C. committee, agreed that such preparations were urgent, but said they were beyond the committee’s scope: “A national communication strategy and plan is much needed.”

    https://www.nytimes.com/2020/10/23/h...4c512afbcd939d
    “No matter how cynical I get, I just can't keep up.” – Lily Tomlin.




  13. #3943

    Re: covid-19 Virus Updates and Discussion

    Operation Warp Speed ends on November 4th.
    If Tiny wins, he will not care at all about COVID. It will be proven that it mattered little politically.
    If he loses, he will only try to stay, and if he is taken off the WH, it will be Biden's problem.
    Face it. It's the apocalypse.

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