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Johnson & Johnson's single-dose COVID-19 vaccine on track for March rollout: exec – CTV News

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Johnson & Johnson is on track to roll out its single-shot coronavirus vaccine in March, and plans to have clear data on how effective it is by the end of this month or early February, the U.S. healthcare company’s chief science officer said.

Dr. Paul Stoffels in an interview on Tuesday also said J&J expects to meet its stated target of delivering 1 billion doses of its vaccine by the end of this year as the company ramps up production.

The New York Times reported earlier on Wednesday that J&J was experiencing manufacturing delays that would reduce the number of doses initially available. Stoffels declined to say how many doses would be ready to go into people’s arms in March, presuming it receives emergency authorization from the U.S. Food and Drug Administration.

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“We are aiming for 1 billion doses in 2021. If it is a single dose, that means 1 billion people. But it will be in a ramp-up throughout the year,” Stoffels said.

Initial launch capacity depends in part on validation of manufacturing plants, he added. The company is scaling up efforts to both produce the active vaccine and the means to package and ship it in large quantities.

Johnson & Johnson’s vaccine is being produced in the United States, Europe, South Africa and India with the help of contract manufacturers in order to build capacity.

“It’s a few weeks too early to be giving final numbers on what we can launch in the first couple months,” he said.

Although J&J’s clinical trial protocols allowed for an early look at the data after 20 people became infected by the novel coronavirus, the company intends to deliver data on at least 154 confirmed cases – the target needed to fully assess the vaccine’s efficacy – when it releases results. That should come in the last week of January or the first week of February, Stoffels said.

The U.S. Food and Drug Administration requires at least two months of safety data on half of the study participants to ensure no unexpected side effects crop up, as well as data on specific populations such as the elderly. The company crossed that two-month threshold earlier this month.

“That point came so close to the final analysis that we decided not to do an interim analysis,” Stoffels said.

A surge in COVID-19 cases in the fall that exceeded J&J’s initial projections allowed the company to reduce the number of study volunteers to 40,000 from the initially planned 60,000 participants. Data can be collected faster when community transmission is widespread during testing.

J&J plans to seek emergency use authorization from the FDA based on the study of the vaccine as a single shot, Stoffels said. If results of ongoing studies suggest people would fare better with a second booster shot, Stoffels said J&J would file separately for a booster dose authorization.

The company is closely monitoring changes or mutations in the virus that might affect the vaccine’s effectiveness.

Scientists are particularly concerned about a highly transmissible variant of the virus first discovered in South Africa that could affect how well vaccines protect against it.

Because part of J&J’s clinical trial is being conducted in South Africa, Stoffels said the company should have data on how its vaccine fares against this new variant.

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Meta shares sink after it reveals spending plans – BBC.com

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Woman looks at phone in front of Facebook image - stock shot.

Shares in US tech giant Meta have sunk in US after-hours trading despite better-than-expected earnings.

The Facebook and Instagram owner said expenses would be higher this year as it spends heavily on artificial intelligence (AI).

Its shares fell more than 15% after it said it expected to spend billions of dollars more than it had previously predicted in 2024.

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Meta has been updating its ad-buying products with AI tools to boost earnings growth.

It has also been introducing more AI features on its social media platforms such as chat assistants.

The firm said it now expected to spend between $35bn and $40bn, (£28bn-32bn) in 2024, up from an earlier prediction of $30-$37bn.

Its shares fell despite it beating expectations on its earnings.

First quarter revenue rose 27% to $36.46bn, while analysts had expected earnings of $36.16bn.

Sophie Lund-Yates, lead equity analyst at Hargreaves Lansdown, said its spending plans were “aggressive”.

She said Meta’s “substantial investment” in AI has helped it get people to spend time on its platforms, so advertisers are willing to spend more money “in a time when digital advertising uncertainty remains rife”.

More than 50 countries are due to have elections this year, she said, “which hugely increases uncertainty” and can spook advertisers.

She added that Meta’s “fortunes are probably also being bolstered by TikTok’s uncertain future in the US”.

Meta’s rival has said it will fight an “unconstitutional” law that could result in TikTok being sold or banned in the US.

President Biden has signed into law a bill which gives the social media platform’s Chinese owner, ByteDance, nine months to sell off the app or it will be blocked in the US.

Ms Lund-Yates said that “looking further ahead, the biggest risk [for Meta] remains regulatory”.

Last year, Meta was fined €1.2bn (£1bn) by Ireland’s data authorities for mishandling people’s data when transferring it between Europe and the US.

And in February of this year, Meta chief executive Mark Zuckerberg faced blistering criticism from US lawmakers and was pushed to apologise to families of victims of child sexual exploitation.

Ms Lund-Yates added that the firm has “more than enough resources to throw at legal challenges, but that doesn’t rule out the risks of ups and downs in market sentiment”.

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Oil Firms Doubtful Trans Mountain Pipeline Will Start Full Service by May 1st

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Pipeline

Oil companies planning to ship crude on the expanded Trans Mountain pipeline in Canada are concerned that the project may not begin full service on May 1 but they would be nevertheless obligated to pay tolls from that date.

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In a letter to the Canada Energy Regulator (CER), Suncor Energy and other shippers including BP and Marathon Petroleum have expressed doubts that Trans Mountain will start full service on May 1, as previously communicated, Reuters reports.

Trans Mountain Corporation, the government-owned entity that completed the pipeline construction, told Reuters in an email that line fill on the expanded pipeline would be completed in early May.

After a series of delays, cost overruns, and legal challenges, the expanded Trans Mountain oil pipeline will open for business on May 1, the company said early this month.

“The Commencement Date for commercial operation of the expanded system will be May 1, 2024. Trans Mountain anticipates providing service for all contracted volumes in the month of May,” Trans Mountain Corporation said in early April.

The expanded pipeline will triple the capacity of the original pipeline to 890,000 barrels per day (bpd) from 300,000 bpd to carry crude from Alberta’s oil sands to British Columbia on the Pacific Coast.  

The Federal Government of Canada bought the Trans Mountain Pipeline Expansion (TMX) from Kinder Morgan back in 2018, together with related pipeline and terminal assets. That cost the federal government $3.3 billion (C$4.5 billion) at the time. Since then, the costs for the expansion of the pipeline have quadrupled to nearly $23 billion (C$30.9 billion).

The expansion project has faced continuous delays over the years. In one of the latest roadblocks in December, the Canadian regulator denied a variance request from the project developer to move a small section of the pipeline due to challenging drilling conditions.

The company asked the regulator to reconsider its decision, and received on January 12 a conditional approval, avoiding what could have been another two-year delay to start-up.

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Tesla profits cut in half as demand falls

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Tesla profits slump by more than a half

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Tesla has announced its profits fell sharply in the first three months of the year to $1.13bn (£910m), compared with $2.51bn in 2023.

It caps a difficult period for the electric vehicle (EV) maker, which – faced with falling sales – has announced thousands of job cuts.

Boss Elon Musk remains bullish about its prospects, telling investors the launch of new models would be brought forward.

Its share price has risen but analysts say it continues to face significant challenges, including from lower-cost rivals.

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The company has suffered from falling demand and competition from cheaper Chinese imports which has led its stock price to collapse by 43% over 2024.

Figures for the first quarter of 2024 revealed revenues of $21.3bn, down on analysts’ predictions of just over $22bn.

But the decision by Tesla to bring forward the launch of new models from the second half of 2025 boosted its shares by nearly 12.5% in after-hours trading.

It did not reveal pricing details for the new vehicles.

However Mr Musk made clear he also grander ambitions, touting Tesla’s AI credentials and plans for self-driving vehicles – even going as far as to say considering it to be just a car company was the “wrong framework.”

“If somebody doesn’t believe Tesla is going to solve autonomy I think they should not be an investor,” he said.

Such sentiments have been questioned by analysts though, with Deutsche Bank saying driverless cars face “technological, regulatory and operational challenges.”

Some investors have called for the company to instead focus on releasing a lower price, mass-market EV.

However, Tesla has already been on a charm offensive, trying to win over new customers by dropping its prices in a series of markets in the face of falling sales.

It also said its situation was not unique.

“Global EV sales continue to be under pressure as many carmakers prioritize hybrids over EVs,” it said.

Despite plans to bring forward new models originally planned for next year the firm is cutting its workforce.

Tesla said it would lose 3,332 jobs in California and 2,688 positions in Texas, starting mid-June.

The cuts in Texas represent 12% of Tesla’s total workforce of almost 23,000 in the area where its gigafactory and headquarters are located.

However, Mr Musk sought to downplay the move.

“Tesla has now created over 30,000 manufacturing jobs in California!” he said in a post on his social media platform X, formerly Twitter, on Tuesday.

Another 285 jobs will be lost in New York.

Tesla’s total workforce stood at more than 140,000 late last year, up from around 100,000 at the end of 2021, according to the company’s filings with US regulators.

Musk’s salary

The car firm is also facing other issues, with a struggle over Mr Musk’s compensation still raging on.

On Wednesday, Tesla asked shareholders to vote for a proposal to accept Mr Musk’s compensation package – once valued at $56bn – which had been rejected by a Delaware judge.

The judge found Tesla’s directors had breached their fiduciary duty to the firm by awarding Mr Musk the pay-out.

Due to the fall in Tesla’s stock value, the compensation package is now estimated to be around $10bn less – but still greater than the GDP of many countries.

In addition, Tesla wants its shareholders to agree to the firm being moved from Delaware to Texas – which Mr Musk called for after the judge rejected his payday.

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