Archive for ‘clinical trials’

31/05/2020

Spotlight: Washington faces blast at home, abroad for “terminating” ties with WHO

BEIJING, May 31 (Xinhua) — The U.S. government has been slammed at home and abroad after announcing on Friday “terminating” its relationship with the World Health Organization (WHO).

U.S. health experts and lawmakers have expressed concern over the decision announced by President Donald Trump amid the COVID-19 outbreak.

Patrice Harris, president of the American Medical Association, described Trump’s move as a “senseless” action with “significant, harmful repercussions.”

“COVID-19 affects us all and does not respect borders; defeating it requires the entire world working together,” Harris was quoted by CNN as saying, urging Trump to reverse the course.

Lawrence Gostin, a professor of global health law and director of the O’Neill Institute for National and Global Health Law at Georgetown University, described the move as “foolish and arrogant” in his Twitter account.

“Trump’s action is an enormous disruption and distraction during an unprecedented health crisis,” said Gostin, also the director of the WHO collaborating center on national and global health law. “The President has made us less safe.”

Democratic Senator Joe Manchin of West Virginia said that “the United States cannot eliminate this virus on its own and to withdraw from the World Health Organization — the world’s leading public health body — is nothing short of reckless,” according to a CNN report.

Even within the Republican party, some Republicans also expressed their disagreement. Senate Health Committee Chairman Lamar Alexander reportedly said he disagreed with Trump’s decision, because, without U.S. funding, clinical trials to develop a COVID-19 vaccine might be hampered.

In addition, the European Union (EU) has urged the United States to reconsider its termination of ties with the WHO, warning that Trump’s move would erode global efforts to curb the spread of the virus.

“The WHO needs to continue being able to lead the international response to pandemics, current and future. For this, the participation and support of all is required and very much needed. In the face of this global threat, now is the time for enhanced cooperation and common solutions. Actions that weaken international results must be avoided,” Ursula von der Leyen, president of the European Commission, and Josep Borrell, the EU High Representative for Foreign Affairs and Security Policy, said in the statement on Saturday.

“In this context, we urge the U.S. to reconsider its announced decision,” the statement said.

German Health Minister Jens Spahn tweeted that Trump’s move was “a disappointing backlash for International Health.”

“The EU must take a leading role and engage more financially,” Spahn said, noting that this would be one of Germany’s priorities when it becomes the bloc’s rotating presidency on July 1.

British Prime Minister Boris Johnson’s spokesperson said earlier that Britain “has no plans to stop funding the WHO, which has an important role to play in leading the global health response.”

“Coronavirus is a global challenge and it is essential that countries work together to tackle this shared threat,” the spokesperson was quoted by The Guardian as saying.

Irish Minister for Health Simon Harris on Friday described Trump’s move as an “awful decision.”

“A global pandemic requires the world working together … We should unite in our fight against it (COVID-19) & not fight each other,” Harris tweeted.

Russian Foreign Ministry spokesperson Maria Zakharova told TASS news agency that Washington “dealt a blow” to the international framework for cooperation in healthcare at the moment when the world needed to join forces.

Source: Xinhua

29/04/2020

Coronavirus: Oxford vaccine effective in monkeys, heading for mass production in India

  • Six animals inoculated with vaccine candidate then exposed to virus did not catch Covid-19 after 28 days
  • Up to 60 million doses could be produced by Serum Institute of India this year
Microbiologist Elisa Granato gets an injection on Thursday as part of the first human trials in Britain for a potential coronavirus vaccine. Photo: University of Oxford via AP
Microbiologist Elisa Granato gets an injection on Thursday as part of the first human trials in Britain for a potential coronavirus vaccine. Photo: University of Oxford via AP

A leading candidate for a Covid-19 vaccine has shown promising results in animal trials, and is expected to see mass production in India within months.

The Serum Institute of India, the world’s largest maker of vaccines by volume, said on Tuesday that it plans this year to produce up to 60 million doses of a potential vaccine developed by the University of Oxford, which is under clinical trial in Britain.

While the vaccine candidate, called “ChAdOx1 nCoV-19”, is yet to be proven to work against Covid-19, Serum decided to start manufacturing it as it had shown success in animal trials and had progressed to tests on humans, Serum Chief Executive Adar Poonawalla said.

Six rhesus macaque monkeys were inoculated with the vaccine candidate at the National Institutes of Health’s Rocky Mountain Laboratory in Montana last month, according to The New York Times.

Covid-19 vaccine trial starts in Oxford, but remdesivir treatment reportedly flops in China tests
The subjects were exposed afterwards to large quantities of the novel coronavirus, but all six remained healthy after more than 28 days, the newspaper reported, citing researcher Vincent Munster, who conducted the test.

More than 3 million people have been reported to be infected globally and over 210,000 have died from Covid-19, the respiratory disease caused by the coronavirus.

“They are a bunch of very qualified, great scientists [at Oxford] … That’s why we said we will go with this and that’s why we are confident,” Poonawalla told Reuters in a phone interview.

“Being a private limited company, not accountable to public investors or bankers, I can take a little risk and sideline some of the other commercial products and projects that I had planned in my existing facility,” Poonawalla said.

Bill Gates hopes his virus vaccine ‘manufacturing within a year’

27 Apr 2020

As many as 100 potential Covid-19 candidate vaccines are now under development by biotech and research teams around the world, and at least five of these are in preliminary testing in people in what are known as phase one clinical trials.

Poonawalla said he hoped trials of the Oxford vaccine, due to finish in about September, would be successful. Oxford scientists said last week the main focus of initial tests was to ascertain not only whether the vaccine worked but that it induced good immune responses and no unacceptable side effects.

Serum, owned by the Indian billionaire Cyrus Poonawalla, plans to make the vaccine at its two manufacturing plants in the western city of Pune, aiming to produce up to 400 million doses next year if all goes well, Poonawalla said.

“A majority of the vaccine, at least initially, would have to go to our countrymen before it goes abroad,” he said, adding that Serum would leave it to the Indian government to decide which countries would get how much of the vaccine and when.

Rhesus macaque monkeys are often used in animal testing because of their similarity to humans. Photo: AFP
Rhesus macaque monkeys are often used in animal testing because of their similarity to humans. Photo: AFP
Serum envisages a price of 1,000 rupees (US$14.70) per vaccine, but governments would give it to people without charge, he said.

He said Prime Minister Narendra Modi’s office was “very closely” involved in the vaccine production and the company is hoping the government will help foot the cost of making it.

Over roughly the next five months, Serum will spend some 300 million to 400 million rupees (US$4.4 million to US$5.9 million) on making around 3-5 million doses per month, he said. “[The government] are very happy to share some risk and fund something with us, but we haven’t really pencilled anything down yet,” Poonawalla said.

Coronavirus: clinical trial begins on third vaccine candidate in China

22 Apr 2020

Serum has also partnered with the US biotech firm Codagenix and Austria’s Themis on two other Covid-19 vaccine candidates and plans to announce a fourth alliance in a couple of weeks, he said.

Serum’s board last week also agreed to invest roughly 6 billion rupees (US$8.8 billion) on making a new manufacturing unit to solely produce coronavirus vaccines, Poonawalla said.

Source: SCMP

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