U.S. Plans Massive Coronavirus Vaccine . Trials May Be Conducted Abroad, Including In Africa

loyola llothta

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To get the quickest answer, vaccines will be tested in healthcare workers and communities where the virus is still spreading to show whether they reduced new cases of COVID-19.

Washington, D.C, which has not reached the peak of its outbreak, is one likely test site. Trials may be conducted abroad, including in Africa, where the virus has just started to spread, Collins said.




  • The United States plans a massive testing effort involving more than 100,000 volunteers and a half dozen or so of the most promising vaccine candidates
  • The project will compress what is typically 10 years of vaccine development and testing into a matter of months
  • To get there, leading vaccine makers have agreed to share data and lend the use of their clinical trial networks to competitors should their own candidate fail, the scientists said.
  • Candidates that demonstrate safety in small early studies will be tested in huge trials of 20,000 to 30,000 subjects for each vaccine, slated to start in July.
  • Between 100,000 and 150,000 people may be enrolled in the studies, said Dr. Larry Corey, a vaccine expert at Fred Hutchinson Cancer Center in Seattle, who is helping design the trials.
  • If you don’t see a safety problem, you just keep going,” Dr. Francis Collins, director of the National Institutes of Health (NIH), told Reuters.
  • The vaccine effort is part of a public-private partnership called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) announced last month.
  • The effort fits into the research and development arm of “Operation Warp Speed,” the White House program announced last week to accelerate coronavirus vaccine development.
  • Vaccines, which are intended for use in healthy people, are typically tested in successive steps, starting with trials in animals.
  • Human testing begins with a small safety trial in healthy volunteers, followed by a larger study to find the right dose and get an early read on efficacy.
  • The final stage consists of large-scale testing in thousands of people. Only then would a vaccine developer commit to manufacturing millions of doses.
  • In the era of coronavirus, many of those steps will overlap, particularly the mid-stage and late-stage trials, Collins and Corey said.
  • The approach has its risks, as certain safety issues may only appear in large-scale trials.
  • Americans are concerned about the speed of the vaccine effort, a Reuters/Ipsos poll showed.
  • A highly effective vaccine could be tested in as little as six months if there is a big difference in benefit between the vaccine and placebo groups, Corey said.
  • For a modestly effective vaccine, trials could take nine to 12 months.
  • The U.S. government has committed billions of dollars to help manufacturers produce doses of vaccines that may never prove successful.
  • To get the quickest answer, vaccines will be tested in healthcare workers and communities where the virus is still spreading to show whether they reduced new cases of COVID-19.
  • Washington, D.C, which has not reached the peak of its outbreak, is one likely test site.
  • Trials may be conducted abroad, including in Africa, where the virus has just started to spread, Collins said.
  • The government plans to tap its own trial networks, including the Department of Veterans Affairs’ 100 healthcare facilities, for potential study volunteers, while drugmakers will recruit from their clinical research networks.
  • A Moderna Inc vaccine, developed in partnership with the NIH, will be the first to the enter large-scale testing in July, and may be joined by a vaccine from Britain’s Oxford University and AstraZeneca Plc, Collins said.
  • The U.S. government said on Thursday it would spend $1.2 billion to secure 300 million doses of the Oxford vaccine.
  • “What we might try to do is run those two side by side, but with a control arm” that would also include 10,000 healthy individuals who got a dummy vaccine, Collins said.
  • Moderna’s candidate is already proceeding to mid-stage human trials.
  • Vaccines by Johnson & Johnson, Sanofi and Merck & Co are a month or two behind the frontrunners and “may get added over the course of the summer” following early-stage human trials, Collins said.
  • Merck has not made any specific announcements on its vaccine program and declined to comment.
  • Collins would not name other candidates on the U.S. shortlist of 14, but said they will need to finish early safety testing by this summer to make it into the bigger trials.
  • Trials will need to assess if the vaccines cause disease enhancement - a potentially dangerous side effect in which the vaccine makes the disease worse in some individuals instead of preventing it.
  • Disease enhancement has been seen in animal studies of vaccines developed to fight a close cousin of the virus that causes COVID-19.
  • “If there is enhancement, that’s a big stop sign for everything,” said Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases at NIH.
  • “If all the cards fall into the right place and all the stars are aligned, you definitely could get a vaccine by December or January,” Fauci said.
 
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loyola llothta

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those African leaders better stand up for their people and tell them to GTFO :mjpls:
I read the article again and saw this coded language. Seem like they will target the black community in the US as well

  • To get the quickest answer, vaccines will be tested in healthcare workers and communities where the virus is still spreading to show whether they reduced new cases of COVID-19.
 

Arinam

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its 100% gonna happy. shytt...A lot of African countries allowed China to come in and buy everything. Their governments are more corrupt than any other government
 

Arinam

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I read the article again and saw this coded language. Seem like they will target the black community in the US as well

The last time I went to get my flu shot they had different cases with vials in it with different color labels around the vials. Before she gave me the shot she scanned it into the computer...now I understand different flu vaccines maybe for kids but wtf was everything else
 

sportscribe

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Speeding in Africa?


Should test that ish in middle America
Africa has the lowest incidence out of any continent in the world.

They say the virus "has just started to spread" in Africa, which is false. In many respects it has been contained in some countries.

They keep running this narrative that somehow because the virus devastated the Western world, it should do the same to Africa with "inferior health services", disregarding African countries have very young urban populations that are up and moving, and not glued to their TVs and laptops all day and also have very clean diets (in most countries). The older African populations are in sparse rural areas.

They need to quit with the BS. The virus has not hit the continent the way they'd hoped. Melinda Gates had the nerve to be on television saying that there will soon be bodies lying on the streets across Africa. It's what they want, so they can make billions dictacting health policies and selling these vaccines that they themselves are sponsoring. They will fail miserably.
 
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