It’s entirely understandable that the national conversation has turned to a single question: “When can we get back to normal?” The shutdown has caused immeasurable pain in jobs lost, people isolated and worsening inequity. People are ready to get going again.
Unfortunately, although we have the will, we don’t have the way — not yet. Before the United States and other countries can return to business and life as usual, we will need some innovative new tools that help us detect, treat and prevent covid-19.
It begins with testing. We can’t defeat an enemy if we don’t know where it is. To reopen the economy, we need to be testing enough people that we can quickly detect emerging hotspots and intervene early. We don’t want to wait until the hospitals start to fill up and more people die.
Innovation can help us get the numbers up. The current coronavirus tests require that health-care workers perform nasal swabs, which means they have to change their protective gear before every test. But our foundation supported research showing that having patients do the swab themselves produces results that are just as accurate. This self-swab approach is faster and safer, since regulators should be able to approve swabbing at home or in other locations rather than having people risk additional contact.
Another diagnostic test under development would work much like an at-home pregnancy test. You would swab your nose, but instead of sending it into a processing center, you’d put it in a liquid and then pour that liquid onto a strip of paper, which would change color if the virus was present. This test may be available in a few months.
We need one other advance in testing, but it’s social, not technical: consistent standards about who can get tested. If the country doesn’t test the right people — essential workers, people who are symptomatic and those who have been in contact with someone who tested positive — then we’re wasting a precious resource and potentially missing big reserves of the virus. Asymptomatic people who aren’t in one of those three groups should not be tested until there are enough for everyone else.
The second area where we need innovation is contact tracing. Once someone tests positive, public-health officials need to know who else that person might have infected.
For now, the United States can follow Germany’s example: interview everyone who tests positive and use a database to make sure someone follows up with all their contacts. This approach is far from perfect, because it relies on the infected person to report their contacts accurately and requires a lot of staff to follow up with everyone in person. But it would be an improvement over the sporadic way that contact tracing is being done across the United States now.
An even better solution would be the broad, voluntary adoption of digital tools. For example, there are apps that will help you remember where you have been; if you ever test positive, you can review the history or choose to share it with whoever comes to interview you about your contacts. And some people have proposed allowing phones to detect other phones that are near them by using Bluetooth and emitting sounds that humans can’t hear. If someone tested positive, their phone would send a message to the other phones, and their owners could get tested. If most people chose to install this kind of application, it would probably help some.
Naturally, anyone who tests positive will immediately want to know about treatment options. Yet, right now, there is no treatment for covid-19. Hydroxychloroquine, which works by changing the way the human body reacts to a virus, has received a lot of attention. Our foundation is funding a clinical trial that will give an indication whether it works on covid-19 by the end of May, and it appears the benefits will be modest at best.
But several more-promising candidates are on the horizon. One involves drawing blood from patients who have recovered from covid-19, making sure it is free of the coronavirus and other infections, and giving the plasma (and the antibodies it contains) to sick people. Several major companies are working together to see whether this succeeds.
Another type of drug candidate involves identifying the antibodies that are most effective against the novel coronavirus, and then manufacturing them in a lab. If this works, it is not yet clear how many doses could be produced; it depends on how much antibody material is needed per dose. In 2021, manufacturers may be able to make as few as 100,000 treatments or many millions.
If, a year from now, people are going to big public events — such as games or concerts in a stadium — it will be because researchers have discovered an extremely effective treatment that makes everyone feel safe to go out again. Unfortunately, based on the evidence I’ve seen, they’ll likely find a good treatment, but not one that virtually guarantees you’ll recover.
That’s why we need to invest in a fourth area of innovation: making a vaccine. Every additional month that it takes to produce a vaccine is a month in which the economy cannot completely return to normal.
The new approach I’m most excited about is known as an RNA vaccine. (The first covid-19 vaccine to start human trials is an RNA vaccine.) Unlike a flu shot, which contains fragments of the influenza virus so your immune system can learn to attack them, an RNA vaccine gives your body the genetic code needed to produce viral fragments on its own. When the immune system sees these fragments, it learns how to attack them. An RNA vaccine essentially turns your body into its own vaccine manufacturing unit.
There are at least five other efforts that look promising. But because no one knows which approach will work, a number of them need to be funded so they can all advance at full speed simultaneously.
Even before there’s a safe, effective vaccine, governments need to work out how to distribute it. The countries that provide the funding, the countries where the trials are run, and the ones that are hardest-hit will all have a good case that they should receive priority. Ideally, there would be global agreement about who should get the vaccine first, but given how many competing interests there are, this is unlikely to happen. Whoever solves this problem equitably will have made a major breakthrough.
World War II was the defining moment of my parents’ generation. Similarly, the coronavirus pandemic — the first in a century — will define this era. But there is one big difference between a world war and a pandemic: All of humanity can work together to learn about the disease and develop the capacity to fight it. With the right tools in hand, and smart implementation, we will eventually be able to declare an end to this pandemic — and turn our attention to how to prevent and contain the next one.
Special To The Washington Post · Bill Gates
{Matzav.com}
Bill Gates back with his vaccination to depopulate the world.
Bill Gates admitted vaccinations are designed so governments can ‘depopulate’ the world.
Fake news
Americans don’t need your comments – just tell them WHAT YOU INVESTED IN CHINA AND HELPED THEM DEVELOP THIS VIRUS……………………………………………….
His solution is simple, Destroy the world economy create massive hunger and civil unrest and reopen the economy when we find a cure, And people always said he is the world’s greatest genius. Wonderful
Did anyone else get the shivers when reading these iines? (If you didn’t I cannot explain it to you.)
For now, the United States can follow Germany’s example: interview everyone who tests positive and use a database to make sure someone follows up with all their contacts. This approach is far from perfect, because it relies on the infected person to report their contacts accurately and requires a lot of staff to follow up with everyone in person
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Please view this about the vaccine. Forewarned is forewarned. Don’t put your head in the sand. (Turn off audio due to kol isha.)
https://childrenshealthdefense.org/news/heres-why-bill-gates-wants-indemnity-are-you-willing-to-take-the-risk/?utm_source=salsa&eType=EmailBlastContent&eId=c94b3721-ea3d-464f-b8cc-68adb387220c
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“Our foundation is funding a clinical trial that will give an indication whether it works on covid-19 by the end of May, and it appears the benefits will be modest at best.”
Maybe someone can tell Gates about this study done years ago:
Chloroquine is a potent inhibitor of SARS coronavirus infection and spread (Virology Journal 2005) https://virologyj.biomedcentral.com/articles/10.1186/1743-422X-2-69
Conclusion
Chloroquine is effective in preventing the spread of SARS CoV in cell culture. Favorable inhibition of virus spread was observed when the cells were either treated with chloroquine prior to or after SARS CoV infection. In addition, the indirect immunofluorescence assay described herein represents a simple and rapid method for screening SARS-CoV antiviral compounds.
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And on the subject of tracing and tracking, Utah launches an app to track people. You can be sure this will be coming to more states across the country soon:
https://www.sltrib.com/news/2020/04/22/utah-launches-an-app/?fbclid=IwAR0Z4IQQ9FkZyaOR6QNJZD2U3LqSvW8kAmEq8WgQXWdgHbTKiSfg9ZF5ck4
Drones being used in CT to check out social distancing:
https://www.cnet.com/news/pandemic-drone-test-flights-will-monitor-social-distancing/
When the CDC mandates this vaccine for all Americans, will you have a sense of security that they have thoroughly studied this vaccine to make sure it is safe and effective?
See what happened with the coronovirus tests:
C.D.C. Labs Were Contaminated, Delaying Coronavirus Testing, Officials Say
Sloppy laboratory practices at the Centers for Disease Control and Prevention caused contamination that rendered the nation’s first coronavirus tests ineffective, federal officials confirmed on Saturday.
Two of the three C.D.C. laboratories in Atlanta that created the coronavirus test kits violated their own manufacturing standards, resulting in the agency sending tests that did not work to nearly all of the 100 state and local public health labs, according to the Food and Drug Administration.
Early on, the F.D.A., which oversees laboratory tests, sent Dr. Timothy Stenzel, chief of in vitro diagnostics and radiological health, to the C.D.C. labs to assess the problem, several officials said. He found an astonishing lack of expertise in commercial manufacturing and learned that nobody was in charge of the entire process, they said.
Problems ranged from researchers entering and exiting the coronavirus laboratories without changing their coats, to test ingredients being assembled in the same room where researchers were working on positive coronavirus samples, officials said. Those practices made the tests sent to public health labs unusable because they were contaminated with the coronavirus, and produced some inconclusive results.
In a statement on Saturday, a spokeswoman for the F.D.A., Stephanie Caccomo, said, “C.D.C. did not manufacture its test consistent with its own protocol.”
Read more at:
https://www.nytimes.com/2020/04/18/health/cdc-coronavirus-lab-contamination-testing.html?smid=fb-share&fbclid=IwAR3r_-k9pot5PLmQn6evXTLkhKrK_i-Oq-MXmP7qEWxJ1ICp8Io1TIWfOUg
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Do you have faith in the CDC?
No sane person has faith in the CDC.
רבות מחשבות בלב איש ועצת ה היא תקום
Maybe the FDA will protect us? Maybe not…
https://www.ncbi.nlm.nih.gov/pubmed/25664866
JAMA Intern Med. 2015 Apr;175(4):567-77. doi: 10.1001/jamainternmed.2014.7774.
Research misconduct identified by the US Food and Drug Administration: out of sight, out of mind, out of the peer-reviewed literature.
RESULTS:
Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems: falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate recordkeeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%). Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.
CONCLUSIONS AND RELEVANCE:
When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.
https://jamanetwork.com/journals/jama/fullarticle/2765251?guestAccessKey=48bdb891-777d-41e5-8dac-5e99c331f633&utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jama&utm_content=olf&utm_term=042320
Viewpoint
April 23, 2020
Increasing Access to FDA Inspection Reports on Irregularities and Misconduct in Clinical Trials
Rafael Dal-Ré, MD, PhD, MPH1; Aaron S. Kesselheim, MD, JD, MPH2; Florence T. Bourgeois, MD, MPH3,4
Transparency related to clinical trial protocols and data has become the expected standard over the past 2 decades, with broad support from patients, the scientific community, and regulatory agencies. Requirements for trial disclosures are codified in US statute and, since 2017, regulation requires timely submission of trial results to ClinicalTrials.gov. However, meaningful clinical trial transparency extends beyond prospective registration and reporting results. The public, for example, must know whether trials were conducted according to international standards for research integrity and must have access to reports investigating departures from good clinical practice guidelines.
Transparency around clinical trial conduct is especially relevant for trials supporting approvals for new products, including drugs and devices. The US Food and Drug Administration (FDA) inspects clinical trial sites that involve FDA-regulated products to ensure the safety of study participants and the quality and integrity of the data. These inspections occasionally reveal objectionable practices, such as failure to obtain informed consent, falsification of data, or violations in adverse event reporting. If research misconduct is identified, the FDA may reject the affected data from the product’s safety and efficacy evaluations and also omit these data from the product labeling.
Despite their importance, FDA inspection reports are not proactively disclosed. A common reason is that these reports may contain confidential commercial information. In certain cases, information regarding the FDA’s findings and actions can be found in publicly available review documents and letters to investigators. Still, most reports are extensively redacted to remove information on the investigational product and details of the clinical trial, making it difficult to link the FDA inspections to specific drugs or published trial reports.1 As a result, the frequency with which research irregularities are uncovered is not known. The FDA compiles an annual report with aggregate data on a list of standardized inspection citations, indicating that more than 200 violations related to clinical trial conduct are observed in most years.2 However, the database is not comprehensive, and certain trial irregularities identified during inspections, such as flawed trial procedures that do not necessarily violate federal regulations, are not reported.
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Do you get the feeling that maybe those “pro-choice” vaccine advocates knew what they were talking about when they said that you cannot trust the FDA, CDC, clinical trials, etc that promote the mantra “vaccines are safe and effective” ??
Maybe the W.H.O. will make sure that our coronavirus vaccine will be safe and effective before we are forced into getting it? Maybe not…
Look at what was said behind closed doors!!
From the W.H.O. Global Vaccine Safety Summit, December 2-3, 2019 (leading world authorities on vaccine science and safety)
https://www.youtube.com/watch?v=sPSpyEi01VI&list=PL9JldIf7HUZTqPbAlsZ6xjnQ_OZP2nQc6&index=1
Dr. Soumya Swaminathan, Chief Scientist, W.H.O. Pediatrician
“I think we cannot overemphasize the fact that we really don’t have very good safety monitoring systems in many countries.”
Professor Heidi Larson, PhD, Director, Vaccine Confidence Project
“We have a very wobbly health professional frontline that is starting to question vaccine and the safety of vaccines….In medical school, you are lucky if you have a half day on vaccines….We have a lot of ambiguity in the safety field….There’s a lot of safety science that’s needed….You can’t repurpose the same old science to make it sound better if you don’t have the science that’s relevant to the new problem. We need much more investment in safety science.”
Dr. David Kaslow, PhD, PATH
“One of the things we really need to invest in are better biomarkers, better mechanistic understanding of how these things work so we can better understand adverse events as they come up.”
Dr. Bassey Okposen, a doctor from Nigeria, asked if there is a possibility of different vaccine antigens, preservatives, adjuvants, etc., from different vaccine companies cross-reacting with each other and causing problems for children getting multiple vaccines at one time, and whether safety studies have been done on these possible cross-reactions.
(Partial) answer from Dr. Robert Chen, Scientific Director, Brighton Collaboration
“…We’re really only in the beginning of the era of large data sets, where hopefully you can start to harmonize the data bases from multiple studies and there’s actually an initiative underway to try to get more national vaccine safety data bases linked together so we can start to answer these types of questions that you just raised….”
Dr. Martin Howell Friede, PhD, Coordinator, Initiative for Vaccine Research, W.H.O.
“When we add an adjuvant, it’s because it is essential. We do not add adjuvants to vaccines because we want to do so. But when we add them, it adds to the complexity. I give courses every year on how do you develop vaccines, how do you make vaccines, and the first lesson is, while you are making your vaccine, if you can avoid using an adjuvant, please do so. Lesson two is, if you are going to use an adjuvant, use one that has a history of safety, and lesson three is, if you’re not going to do that, think very carefully.”
Dr. David Kaslow, PhD, PATH
“Coming down the pike, maybe relatively quickly, is a new target population for us in vaccines…women who are pregnant…. Part of the problem is that we don’t have a strong enough pharmacoepidemiologic baseline in the targeted populations that we are studying to be able to say, is this an expected adverse event due to pregnancy or is this related to the vaccines?”
Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene and Tropical Medicine
“It seems to me they [adjuvants] multiply the reactogenicity in many instances and therefore it seems to be that it is not unexpected if they multiply the incidence of adverse reactions that are associated with the antigen but may not have been detected through lack of statistical power in the original studies. Now I wonder if this thinking is correct, and if it is, if it has some implications for how we do pharmacovigilance.”
(Partial) response from Dr. Martin Howell Friede
“As we add adjuvants, especially some of the more recent ones…we do see increased local reactogenicity. The primary concern though usually is systemic adverse events rather than local adverse events, and we tend to get in the phase two and the phase three studies quite good data on local reactogenicity…but this is not the major health concern. The major health concern which we are seeing are accusations of long-term effects.”