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Scientists vs politicians: the reality check for ‘warp speed’ vaccine research

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When Donald Trump launched Operation Warp Speed last week, he borrowed language from Star Trek to describe the drive for a Covid-19 vaccine. “That means big and it means fast,” the US president said, promising an effort “moving on at record, record, record speed”.

His hope that a coronavirus vaccine might be ready “prior to the end of the year” was even quicker than the optimistic — but often repeated — timeline for a vaccine to be ready in 12 to 18 months.

The race for a vaccine appeared to be picking up pace this week when Moderna, a Boston-based biotech company, unveiled early positive results for its potential vaccine in a small trial — and AstraZeneca said it could have the first doses of another vaccine delivered by October if trials are successful.

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The announcements pleased politicians trying to offer hope to citizens desperate to leave lockdowns and investors eager for economic activity to return.

But many scientists feel a duty to dampen the enthusiasm. They say a vaccine could take much longer because little is known about the disease and how bodies will react to attempts at immunisation. In fact, some warn we may never create a vaccine for Covid-19.

President Donald Trump has said that the US drive to find a vaccine is ‘moving on at record, record, record speed’
President Donald Trump has said that the US drive to find a vaccine is ‘moving on at record, record, record speed’ © Stefani Reynolds/CNP/Bloomberg

Soumya Swaminathan, chief scientist for the World Health Organization, believes an optimistic scenario is a vaccine produced in the “tens of millions” next year, which would be mainly distributed to healthcare workers, and far larger volumes in 2022. To inoculate the world and defeat Covid-19 could take four to five years, she says.

We have no “crystal ball” to tell the future, she told the Financial Times. “It depends how the virus behaves: whether it mutates, whether it becomes more or less virulent, more or less transmittable.”

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Peter Hotez, a professor at the Baylor College of Medicine in Houston who is developing a vaccine, says the US president sees vaccines as a “manufacturing problem”, like making enough ventilators or tests.

“Manufacturing is not the hurdle. It’s taking the time to collect enough efficacy and safety data,” he says. “The Operation Warp Speed language coming out of the White House and biotechs and pharma companies [saying] that they will have a vaccine by the fall — or in weeks or days — does so much damage.”

Soumya Swaminathan, chief scientist at the WHO, predicts defeating the virus could take four to five years
Soumya Swaminathan, chief scientist at the WHO, predicts defeating the virus could take four to five years © Salvatore Nolfi/EPA-EFE

Vaccines are usually developed over many years and even decades. A 2013 paper from Dutch scientists says the average vaccine took 10.71 years and had only a 6 per cent success rate from start to finish. Each stage is an experiment: from the small phase one trials happening now to the large phase three trials needed for regulatory approval.

There are good reasons to believe this time will be quicker. The Covid-19 vaccines benefit from groundwork done for the Sars and Mers coronaviruses even if they were never approved, says Walter Orenstein, a professor at the Emory Vaccine Center in Atlanta.

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New technologies are fuelling the hope for a faster process. Analysts from Morgan Stanley estimate that Moderna’s vaccine has a 65 per cent chance of success. They believe that before the end of the year we could see vaccines from Pfizer and their German partner BioNTech, and AstraZeneca and Oxford university.

But advances like the messengerRNA programming used by Moderna, BioNTech and another German company, CureVac, have never been used to create products approved by a regulator. The technique translates a protein from the virus into human cells and shows it to the B cells that secrete antibodies.

The pandemic has pushed governments and companies to pour money into Covid-19 vaccines, even if there has been a lack of global co-operation. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering, says it helps that there are so many horses in this race.

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Peter Hotez, a professor at the Baylor College of Medicine, says the development of a vaccine should not be viewed as a manufacturing problem
Peter Hotez, a professor at the Baylor College of Medicine, says the development of a vaccine should not be viewed as a manufacturing problem © BCM

Proving that a vaccine is safe and effective takes time. Participants need to be exposed to the virus to prove a vaccine works. That probably means recruiting thousands of people across the world to ensure enough live in an area where there is an outbreak, unless vaccine makers opt for the ethically complicated human challenge trials, where participants are deliberately infected.

“I don’t want to be a Debbie Downer but let’s be clear: to get a vaccine by 2021 would be like drawing multiple inside straights in a row, to use a poker analogy,” Dr Bach says.

To fight a war, it helps to know your enemy. Originally considered solely a respiratory disease, Covid-19 has launched surprise attacks from our eyes to our toes. It appears to use different tactics in children, with reports of some suffering from a serious inflammatory condition.

Moderna announced early results from its phase one trial on Monday, showing its vaccine had elicited immune responses at least as robust as those found in recovered patients.

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Information graphic explaining how vaccines work

But some scientists questioned how the trial defined an average patient response. Dr Hotez says the release came days after a study showing that recovered patients only had a low level of antibodies. Umer Raffat, a biotech analyst at Evercore, says it will be important to know when the convalescent antibody level was tested — because it tends to fade over time. If it is tested later, it might not be such a promising comparison.

There are big questions about how long an immune response protects patients for. Most scientists think having had the disease confers some immunity — but we don’t know how long it lasts. Immunity to Sars only lasted a couple of years.

So far, the virus behind Covid-19 has not mutated significantly, so it shifts shape less rapidly than the flu. But we have only been following the virus for months, so there is a risk that it will still mutate. Most vaccine makers are focusing on the ‘spike’ protein, which it uses to invade cells. They try to teach the body to recognise this protein and produce antibodies. If the spike changes, many of the potential immunisations would miss their target.

Former US president Gerald Ford receives a swine flu shot in 1976
Former US president Gerald Ford receives a swine flu shot in 1976 © Bettmann Archive/Getty

Early trials are done in healthy, younger populations: Moderna’s first results were from people aged 18 to 55. But it is people over 65 who have suffered the most from Covid-19 and whose immune systems tend to be less responsive. The US National Institute of Allergy and Infectious Diseases is adding an older age group to the trial.

Howard Koh, a former US assistant secretary at the health department, says: “One issue that often comes up is whether older people are able to generate a response that makes it an effective vaccine.”

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Mr Trump is not the first president to see a vaccine as a way of neutralising the political risk carried by a virus. In 1976, Gerald Ford rushed out a vaccine for what he feared would be a massive outbreak of swine flu, having his photo taken getting the shot at the White House. But the vaccine had a serious side effect: hundreds of people developed Guillain-Barré syndrome, where the body is paralysed by the immune system attacking the nerves.

Covid-19 has proven to be the pandemic that the 1976 swine flu never became. But easing requirements for approval could put vaccines on the market before we discover all the side-effects. In the US, the loosening of regulations during the pandemic has already led to battles over safety and accuracy. Government agencies and doctors have disputed whether it is safe to treat patients with hydroxychloroquine, an antimalarial drug being used by Mr Trump that has cardiac and psychiatric side effects, and the Food and Drug Administration has warned about the inaccuracy of many antibody tests.

Boston-based biotech company Moderna unveiled early positive results for its potential vaccine in a small trial of patients aged 18 to 55
Boston-based biotech company Moderna unveiled early positive results for its potential vaccine in a small trial of patients aged 18 to 55 © Gretchen Ertl/FT

Scientists have still not ruled out the grim prospect that a vaccine could make the disease worse. In some conditions including dengue fever, and the common childhood respiratory infection RSV, vaccines have actually enhanced the disease. In the first attempts at making a Sars vaccine, there was some immune enhancement in animal testing. So far, there is no evidence that this is a problem for Covid-19 — but the early trials are on tens, rather than hundreds or thousands of people.

Dr Swaminathan says this “antibody dependent enhancement” is why the vaccines need to be tested very carefully. “Sometimes antibodies can actually make things worse.”

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If a vaccine proves safe, there will still be questions about its effectiveness. Paul Stoffels, chief scientific officer at Johnson & Johnson, says one of the biggest questions is whether it will stop infection or just the disease — or even, like the flu shot, only prevent the most severe symptoms of the disease.

“It would be good if it protects against both,” he says. “If you can prevent infection, it prevents spread going forward in the community.”

Vaccines for all may be far off, with initial doses likely to be given to healthcare workers
Vaccines for all may be far off, with initial doses likely to be given to healthcare workers © Patrick Semansky/AP

Before a vaccine is produced, developments in treatments — such as antivirals and antibodies — may help improve outcomes for Covid-19 patients. A vaccine that is only 60 or 70 per cent effective could still be approved by the regulator and have a significant impact on the spread of the disease, says Stéphane Bancel, Moderna chief executive.

He is “cautiously optimistic” he will see efficacy in the large and final phase three trial — but does not know if it will be 70 or 95 per cent. “Even if it was 70 per cent effective it would reduce tremendously the problem, which is that the virus is so contagious,” he says.

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Political leaders will declare victory if a vaccine maker manages to move safely at speeds more suited to science fiction. However, the mass inoculation that could speed up the return to normal life is further away. The first vaccines will probably be given to healthcare workers who will be studied closely, as if they were still part of a trial.

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, says we must remember there is still a chance we do not get a vaccine at all. It is not a “slam dunk”, he says.

He is concerned that people are not taking other public health measures to stop the spread because of the “optimism and enthusiasm” about a vaccine.

“People will just assume it’s like a Hollywood movie and at the very last minute, someone will swoop in their helicopter with a new vaccine that was only made a day ago. And the whole world is saved,” Mr Osterholm says. “It’s human behaviour. When you’re faced with such a serious challenge, you want any good news you can get.”

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(Note: This is a Article Automatically Generated Through Syndication, Here is The Original Source

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Ontario Sunshine List 2024 Reveals Why People Can’t Afford To Buy A Home

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Ontario’s Sunshine List Reveals Why People Can’t Afford To Buy A Home

Ontario Sunshine List is released every year and it reveals the salaries of public sector workers who take home a salary in excess of $100,000. This year the list features 300,570 names which is 30,000 higher than last year of public sector employees with salaries over $100,000. The Ontario Sunshine list also features five employees working at the Ontario Power Generation who are among the top 10 earners with the province’s highest salary nearing $2 million.

Ontario had passed the Public Sector Salary Disclosure Act in 1996 under the Mike Harris government and the stated aim of the act was to make the government more transparent and accountable. The $100,000 limit was a big deal then.

However the $100,000 in 1996 in relative terms in 2024 will be equivalent to $180,564.97. If you remove 300,570 people on this year’s Ontario Sunshine List for that salary threshold there you drop 279,781 names. In other words there will be many people who will not be able to own a house without help from family or an inheritance.

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In a nutshell it means that employees who take home a six figure salary package will still feel the pinch of Canada’s affordability crisis. The soaring inflation and rising cost of living a $100,000 salary doesn’t guarantee financial security in many parts of the country.

Also, to maintain the $100,000 threshold today, the province should have adjusted it to $55,381.73 in 1996. Ontario has fixed a threshold of $100,000, while the threshold varies in other provinces. Alberta, for example, has set a threshold of $125,888 for government employees and $150,219 for people in public sector bodies.

Not much information is available for the federal government, but a Canadian Taxpayers Federation access-to-information request revealed that 110,593 employees in the federal public service earned $100,000 or more in 2023.

There are a couple of options for Ontario and other governments with non-indexing disclosure requirements. Resetting the threshold to a number that makes more sense today and then continuing to index the threshold going forward seems feasible.

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We also don’t need to reveal the names of all individuals. The government could report aggregated salary ranges by job title rather than disclosing specific names below a second, lower threshold. This would maintain government accountability and transparency by still disclosing who the highest earners are.

As it stands, we have a list that publishes the names and salaries of potentially hundreds of thousands of people who could not afford to buy a house. This doesn’t seem aligned with the original intent of the disclosure act.

Some features of the Ontario Sunshine List 2024 are as follows:

  • The highest paid employee took a pay check of $1.9M
  • Public sector employees were paid salaries in excess of $100K
  • The Ontario Sunset list top position is held by Kenneth Hartwick, CEO of the electricity Crown Corporation with a salary of $1.93 million followed by chief strategy officer Dominique Miniere $1.2 million and chief projects officer Michael Martelli drawing $1 million as salary.
  • Public sector workers were paid counting in Bill 124 compensation
  • 2024 budget revealed that Ontario deficit will triple
  • CEOs of the Hospital for Sick Children and the University Health Network figured in the top 10 list and each drew a salary of $850,000 each while CEO of the provincial transit agency, Metrolinx drew a salary of $838,097.
  • 17 professors or associate professors at the University of Toronto drew a salary in excess of $500,000

Caroline Mulroney, president of the Treasury Board, stated in a release,

“The largest year-over-year increases were in the hospitals, municipalities, and services, and post-secondary sectors, which together represented approximately 80 percent of the growth of the list.”

Also Read: Hims & Hers CEO Andrew Dudum Says Wants to Hire Student Protesters Backlash Underway

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Hims & Hers CEO Andrew Dudum Says Wants to Hire Student Protesters Backlash Underway

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Hims & Hers CEO Andrew Dudum Says Wants Hire Student Protesters Backlash Underway

Andrew Dudum, CEO and founder of Telemedicine Company Hims & Hers is facing flak on the social media after his reported statement that he wants to hire students and protestors who are taking part in the protest in support of Palestinians in Universities across the US.

A number of tech sector founders has also condemned his statements.

Dudum had posted on X,

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“If you’re currently protesting against the genocide of the Palestinian people and for your university’s divestment from Israel, keep going. It’s working. There are plenty of companies and CEOs eager to hire you, regardless of university discipline.”

He also posted a link to a page showing open positions at Hims & Hers.

X users have expressed their disapproval and have even called for a boycott Hims & Hers, and others said they are selling their stock in the company.

Cofounder of Palantir Technologies as well as the managing partner of early stage venture capital firm 8VC Joe Lonsdale responded on X and said

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“Real moral courage doesn’t involve joining a mindless mob, chanting anti   U.S. and other woke pablum, following instructions not to debate or discuss your positions at all yet being indignantly righteous, while large numbers in the mob chant for violence and block Jewish students.”

While Hims & Hers spokesperson said Dudum were not available for comments, old posts by Dudum have been unearthed which puts in context his actions. Days before the horrific attack by Hamas’ terrorist against Israel on October 7, Dudum had posted –

 “In pursuit for peace: Our leaders need to embrace nuance.”

Dudum further explained that he is a Palestinian American and had roots in and family in the West Bank and Gaza and said Hims & Hers’ values are based on a respect for human dignity and life.

Dudum wrote

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“It is upon those values that I believe all leaders and CEOs should use their platform today to call for an immediate cease   fire. To actively recognize Israel’s right to defense and also recognize the means and manner in which they are responding violates international law. I ask us to find nuance, and share our voice today to help save innocent lives.”

Deadly protests have hit U.S. college campuses through last month and protest encampments have sprung across more than 40 colleges nationwide.

Police crackdown is on and there have been more than 1,900 arrests or detainments following a wave of activism at universities across the country.

Hims & Hers is a Telemedicine Company that links consumers with licensed healthcare professionals, enabling access to high-quality care for conditions related to sexual health, mental health, and more. It also offers its own range of products and is in a partnership with Los Angeles-based Hustle & Co. on media relations.

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Also Read: Brazil Dam Collapse Amid Heavy Rainfall and Flood; Watch Video Here

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More Trouble For Microsoft, OpenAI: Eight US Newspaper Publishers File Lawsuit For Copyright Infringement

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More Trouble For Microsoft, OpenAI: Eight US Newspaper Publishers File Lawsuit For Copyright Infringement

Trouble for Microsoft and OpenAI over copyright infringement is not coming to an end, as they face several lawsuits for violating copyrights.

On Tuesday, eight US newspaper publishers sued Microsoft for illegally reusing articles in AI products.

The 98-page long lawsuit further accused the tech companies of attributing erroneous information to the publishers.

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The eight newspapers that have filed the lawsuits include the New York Daily News and the Chicago Tribune.

They allege that OpenAI’s ChatGPT used their copyrighted articles to perfect its language models without permission.

The lawsuit was filed in a New York federal court on Tuesday. The publishers claim that OpenAI’s large language models, GPT-2 and GPT-3, were perfected using datasets containing text from their newspapers.

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The language models are designed to produce text based on human inputs and reproduce copies of the publishers’ works. Microsoft has been indicted for using newspapers for its Bing search index but seldom provided links to the original articles. Four months ago, The New York Times also filed a lawsuit against OpenAI, accusing the tech giant of using data from its past content. It also asked for consent for usage, criticizing the use of full article excerpts in chatbot responses.

The latest lawsuit filed by the eight news outlets also demanded consent and fair value for using their content to perfect the AI language models. The lawsuit alleged that the AI tools literally regurgitate their content without directing users to the content source.

The lawsuit filings stated, “This lawsuit arises from defendants purloining millions of the publishers’ copyrighted articles without permission and without payment to fuel the commercialization of their generative artificial intelligence products, including ChatGPT and (Microsoft’s) Copilot.”

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The eight newspapers that instituted the lawsuits are as follows:

  • The New York Daily News and The Chicago Tribune, both owned by Alden Global Capital
  • The Orlando Sentinel
  • The Sun Sentinel
  • The San Jose Mercury News
  • The Denver Post
  • The Orange County Register
  • The St. Paul Pioneer Press

OpenAI’s Response

OpenAI did not directly respond to the accusations but stated that it takes great care to support the news and media outlets. It also stated it is in continuous partnerships and conversations with various news outlets around the world to explore new opportunities, discuss problems, and seek out solutions.

Microsoft also stated that OpenAI has entered into fruitful partnerships with a number of publishers, which includes The Financial Times, The Associated Press, Spanish conglomerate Prisa Media, and Germany’s Axel Springer.

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