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USA plans massive coronavirus vaccine testing effort to meet year-end deadline


Reuters
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The project will compress what is typically 10 years of vaccine development and testing into a matter of months. — AFP/File


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 in an effort to deliver a safe and effective one by the end of 2020, scientists leading the program told Reuters.

The project will compress what is typically 10 years of vaccine development and testing into a matter of months, testimony to the urgency to halt a pandemic that has infected more than 5 million people, killed over 335,000 and battered economies worldwide.

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 US government has committed billions of dollars to help manufacturers produce doses of vaccines that may never prove successful.

The shortlist

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 US 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 US 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.

  • May 23, 2020
 
. .
May 24, 2020, 20:30 GMT


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United States

Coronavirus Cases:

1,682,322

Deaths:
99,219

Recovered:
451,390


Projections

CLOSED CASES
550,609

Cases which had an outcome:


451,390 (82%)
Recovered / Discharged

99,219 (18%)
Deaths
 
.
Trump take the 100k mark as a badge of honor...psychopath!

It is still about himself
 
. .
Trump released COVID from Fort Derrick bio weapon lab on his own people last year to blame China start war with China. Even Hitler was not as evil as Trump.
Reminiscent of 911, iraq. venezuela, etc....they might be deliberately letting as many as their own people die as a justification for a hot war with china.

US regime do hv a long history of false flags...this is coming from yours truly who used to see them as the good folks.
 
Last edited:
. .
May 25, 2020, 16:28 GMT


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United States

Coronavirus Cases:

1,693,157

Deaths:
99,448

Recovered:
453,245


Projections

CLOSED CASES
552,693

Cases which had an outcome:

453,245 (82%)
Recovered / Discharged

99,448 (18%)
Deaths
 
.
Coronavirus: Americans flock to beaches on Memorial Day weekend


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Missouri, revellers partied on the Lake of the Ozarks, violating social-distancing rules
Americans have flocked to beaches and lakes for Memorial Day weekend, often flouting restrictions imposed to tackle the coronavirus outbreak.

In Florida, state police dispersed an unauthorised gathering of hundreds of people in Daytona Beach on Saturday.

In Missouri, bars at the Lake of the Ozarks were packed with revellers, who violated social-distancing rules.

US coronavirus task force chief Dr Deborah Birx said she was "very concerned" after seeing such scenes.

"We really want to be clear all the time that social distancing is absolutely critical. And if you can't social distance and you're outside, you must wear a mask," Dr Birx said on ABC's This Week on Sunday.

Lyda Krewson, the mayor of St Louis, Missouri, said: "It's irresponsible and dangerous to engage in such high risk behaviour just to have some fun over the extended holiday weekend.

"Now, these folks will be going home to S. Louis and counties across Missouri and the Midwest, raising concerns about the potential of more positive cases, hospitalisations, and tragically, deaths. Deeply disturbing."

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In California, big crowds descended on Newport Beach
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These surfers enjoyed the waves on Los Angeles' Venice Beach

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In New Jersey, some beachgoers braved the cold weather after state beaches were opened - albeit with some restrictions


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New York's Coney Island swimming was not allowed - so people just enjoyed the beach
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In South Carolina, dozens of boats took part in a Make America Great Again parade off Charleston


In Florida's Tampa area, the crowds were so big that authorities closed parking lots because they were full, the Associated Press reports.

In California, big crowds were seen enjoying beaches over the weekend. State officials said most people were covering their faces and keeping their distance on beaches and parks.

On Monday, US Vice-President Mike Pence said that some people "would do well to be reminded about the importance of social distancing and the importance of continuing regular hygiene".

However, he added: "We have every confidence that as restrictions are loosened in the days ahead, the American people are going to step forward and put this country back to work in a safe and responsible way."

Memorial Day - an annual holiday held on the last Monday of May - honours all those who have died serving in the US military. It marks the unofficial start of summer.

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Flags at a memorial in Boston honour military personnel who died while serving in the US Armed Forces

The US has more coronavirus cases than anywhere in the world. It has over 1.6 million known infections and is nearing 100,000 deaths linked to the virus.

All 50 US states have now partially reopened after a two-month shutdown. However, remaining restrictions vary across the country.

Wide discrepancies also remain between states in terms of infection rates and the pace of their economic restart.

Some of the hardest-hit areas, including New York, New Jersey and Washington state are now showing the sharpest declines, while majority of states have reached plateaus.
 
. . .
May 26, 2020, 16:31 GMT


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United States

Coronavirus Cases:

1,713,000

Deaths:
100,021

Recovered:
468,669


Projections

CLOSED CASES
568,690

Cases which had an outcome:

468,669 (82%)
Recovered / Discharged

100,021 (18%)
Deaths
 
. . .
May 26, 2020, 23:35 GMT


tn_us-flag.gif

United States


Coronavirus Cases:

1,725,232

Deaths:
100,539

Recovered:
478,225

Projections

CLOSED CASES
578,764

Cases which had an outcome:

478,225 (83%)
Recovered / Discharged

100,539 (17%)
Deaths
 
.

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