Friday, April 10, 2020

Gates should look at researchers working w BCG









Melinda Gates: This is not a once-in-a-century pandemic. 'We will absolutely have more of these' & if we do not we stll have all the work done at Pine Bluff & elsewhere ready to go


How a 100-year-old vaccine for tuberculosis could help fight the novel coronavirus

(CNN)As researchers scramble to find new drugs and vaccines for Covid-19, a vaccine that is more than a century old has piqued researchers' interests. The Bacillus Calmette-Guerin vaccine -- which was first developed to fight off tuberculosis -- is being studied in clinical trials around the world as a way to fight the novel coronavirus.
Tuberculosis and Covid-19 infection are two very different diseases -- TB is caused by a type of bacteria while Covid-19 is caused by a virus, for starters. But the BCG vaccine might help people build immune responses to things other than TB, causing "off-target effects," according to Dr. Denise Faustman, director of immunobiology at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School.
"In other words, in clinical trial format, people started picking up positive benefit from getting the vaccine that had nothing to do with tuberculosis," she said. Faustman has studied how the BCG vaccine affects people with Type 1 diabetes for many years. She is interested in how its off-target effects change the immune system in beneficial ways for people with autoimmune diseases such as Type 1 diabetes.
    Though the exact mechanism for these off-target effects of the BCG vaccine isn't clear, it's believed that the vaccine can cause a nonspecific boost of the immune response. 
    There is currently no vaccine or treatments approved by the US Food and Drug Administration for the novel coronavirus. While hopeful that the BCG vaccine will prove to be effective against Covid-19 -- as with any of the treatments and vaccines under development -- Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine, admits the concept is a bit unconventional.
    "I think BCG vaccine is a bit of the equivalent of a Hail Mary pass," said Schaffner. "it's such an outside-the-box concept that one would like to be optimistic, but we'll have to wait and see."
    Several countries around the world are beginning human clinical trials to evaluate the BCG vaccine's efficacy, such as Australia and the Netherlands.
    Faustman and her colleagues are preparing for trials in Boston, which are currently under a multistep review process. Once approved, she and her team members hope to enroll about 4,000 health care workers into the trial.
    The vaccine has been available for more than 100 years and has proved to be relatively safe, Faustman said.
    "BCG is heralded by the World Health Organization as the safest vaccine ever developed in the world," she said. "Greater than 3 billion people have gotten it."
    While several countries, including the United States, do not regularly administer the BCG vaccine, it is still used widely in developing countries. 
    Researchers have attempted to look at whether these countries with regular BCG vaccine administration have lower rates of Covid-19-related mortality. One study by researchers in New York found an association between universal BCG vaccination policies in countries and reduced morbidity and mortality for Covid-19. The study has not been peer-reviewed or published in a medical journal.
    But why has China had high morbidity and mortality with Covid-19 despite a universal BCG policy since the 1950s? The study said China had a weakened policy during the Cultural Revolution in the 1960s and '70s, which might have created "a pool of potential hosts that would be affected by and spread COVID-19."
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    Also, China has not had as steep of a rise in its curve compared to some other countries without universal policies, such as Italy, Spain and the US, said Faustman. She also added that different strains of the BCG vaccine might have different rates of efficacy.
    One of the main limitations of the study is that it compares data from different countries, which have different timelines for Covid-19 and different abilities to test.
      "It was a 30,000 foot comparison of the occurrence of Covid-19 infections in countries that were intensely using BCG vaccine, and those that were not," Vanderbilt's Schaffner said. "We shouldn't draw any conclusions from that because ... the countries are very different. And so there may be many other reasons that determine how frequently Covid has occurred in those countries.
      "The study provides further encouragement for more specific investigations, such as the clinical trials that are going to take place."


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      • Business Insider spoke with Melinda Gates about COVID-19, the prospect and timeline of making an effective vaccine, and how the world will be permanently changed by the coronavirus.
      • Gates said it would likely take about 18 months for a vaccine to become widely available, and that it should first go to healthcare workers to help them keep others safe.
      • She said this pandemic was not a once-in-a-century situation, like the Spanish flu. Because the world is now a global community, we're likely to see other pandemics in our lifetimes, Gates said.
      • Even after things get back to normal "our psyches are going to permanently changed ... I hope we change to realize that we're a global community."
      • Read the full interview below.
      Melinda Gates is the cochair of the Bill & Melinda Gates Foundation, which has donated more than $45 billion to tackle some of the world's toughest problems, including vaccination research and combating pandemics, from coronavirus to Ebola.
      Gates and her husband have long been concerned about a pandemic and have warned that we need to be more prepared at a global level.
      In a wide-ranging interview with Gates on Thursday afternoon, she gave her thoughts on the coronavirus pandemic, the inequality of it all, and how the world can go back to semi-normal. The highlights:
      • The world needs a vaccine delivered at mass scale to go back to "normal." A realistic timeline is about 18 months, the same time it took to create an Ebola vaccine.
      • It is possible we won't be able to find an effective vaccine for coronavirus, although Gates thinks that is highly unlikely.
      • The idea of herd immunity solving coronavirus is far-fetched. Gates said that would require more than half the population to get coronavirus (which isn't anywhere close to happening) and a lot of death along the way.
      • To effectively roll out a vaccine, Gates believes you need to first give it to health workers, then to high-risk groups, then distribute it equitably to different countries and communities. The vaccine also has to cost very little with a fund to cover it for everyone. What the US is doing right now, pitting states against each other for supplies and allowing wealthy individuals to access tests first, would be disastrous for a vaccine rollout.
      • To prepare for the second wave of coronavirus this fall, or even a next pandemic, we need mass testing from the get-go, voluntary data sharing from people so that we can trace who has been tested and where they have been, and vaccine stockpiles so you can distribute those as soon as you see signs of an outbreak.
      • Gates said there would "absolutely" be more pandemics in our lifetime. Coronavirus is not a once-in-a-century occurrence like the Spanish flu.



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