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UK approves Pfizer-BioNTech coronavirus vaccine, rollout due next week – CNBC

A worker passes a line of freezers holding coronavirus disease (COVID-19) vaccine candidate BNT162b2 at a Pfizer facility in Puurs, Belgium in an undated photograph.

Pfizer | via Reuters

LONDON — The U.K. on Wednesday authorized the PfizerBioNTech vaccine for emergency use, marking another step in the global battle against the pandemic.

The vaccine will now be rolled out in the country next week, with elderly people in care homes and medical workers first in line. The U.K. government is reportedly the first in the world to formally approve the Pfizer-BioNTech shot for widespread use, and it means Britain will be one of the first countries to begin vaccinating its population.

“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s Covid-19 vaccine for use,” the government said Wednesday. “The vaccine will be made available across the U.K. from next week.”

Pfizer’s Chairman and CEO, Albert Bourla, said the authorization was a “historic moment.”

“This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.,” he said.

“With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”

Pfizer and BioNTech announced in July an agreement with the U.K. to supply 30 million doses of its mRNA-based vaccine, formally known as “BNT162b2,” once authorized for emergency use. That agreement was increased to 40 million doses in early October. As a two-dose vaccine, the U.K. will have enough doses to vaccinate around a third of its 66 million population.

BioNTech said Wednesday that the delivery of the 40 million doses will occur throughout 2020 and 2021, with complete delivery fulfilment expected next year.

A spokesman for the U.K.’s Department of Health and Social Care said it would soon be known which parts of the population would be the first to receive the vaccine.

“The Joint Committee on Vaccinations and Immunisations (JCVI) will shortly publish its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable,” he said.

Time is of the essence when it comes to rolling out a vaccination. The U.K. has the third highest number of confirmed cases in Europe, after France and Spain, with over 1.6 million infections, according to data from Johns Hopkins University. It has seen the highest number of deaths due to the coronavirus in Europe, however, with almost 60,000 fatalities.

The number of daily infections has been steadily falling due to a second lockdown, that was lifted on Wednesday and replaced with a tiered system of restrictions, with the severity of the rules dictated by regional infection rates.

COVID-19 vaccine sprint as Pfizer-BioNTech, Moderna seek emergency EU approval – Reuters

FRANKFURT (Reuters) – Moderna and Pfizer-BioNTech are in a tight race to launch their COVID-19 vaccines in Europe after both applied for emergency EU approval on Tuesday, though there was uncertainty over whether a rollout could begin this year.

The applications to the European Medicines Agency (EMA) came a day after Moderna sought emergency use for its shot in the United States and more than a week after Pfizer and BioNTech did the same.

U.S. drugmaker Pfizer and its German development partner BioNTech said their vaccine could be launched in the European Union as early as this month.

“We can start to deliver within a few hours (of an approval),” said Sierk Poetting, head of operations and finance at BioNTech. “We have been stocking up. And everything that is there can really be distributed within a few hours.”

The EMA clouded the timeline, however, when it said it would complete its review for that vaccine by Dec. 29 at the latest, and for Moderna’s shot by Jan. 12. It added its schedule may be subject to change as its evaluation proceeds.

The European Commission, the EU executive body, said it would likely give its final authorization for a vaccine’s rollout days after a recommendation by the EMA.

An effective immunization is seen as the main weapon against the pandemic, which has claimed more than 1.4 million lives and ravaged economies across the globe. Close to 50 potential vaccines are being tested on volunteers worldwide.

FILE PHOTO: Biontech’s logo is seen through a 3D-printed Pfizer logo in this illustration taken November 10, 2020. REUTERS/Dado Ruvic/File Photo

Both U.S. biotech firm Moderna and Pfizer-BioNTech have reported preliminary findings of more than 90% effectiveness – an unexpectedly high rate – in trials of their vaccines, which are both based on new messenger RNA (mRNA) technology.

CUSTOMISED GENETIC CODE

Their work validates that of several biotech experts, who for years have been labouring to prove a once-unorthodox idea: The human body can act as its own vaccine factory.

Both inoculations work by injecting people with customised genetic code that instructs human cells to make key virus proteins to induce an immune response.

Pfizer and BioNTech reported final trial results on Nov. 18 that showed their vaccine candidate, known as BNT162b2, was 95% effective in preventing COVID-19, with no major safety concerns.

Moderna Inc said on Monday that full results from a late-stage study showed its candidate, mRNA-1273, was 94.1% effective, also with no serious safety concerns.

Any clearance in the EU and United States for the vaccines will be “conditional” or for “emergency use”, meaning developers are obliged to continue trials and provide more trial results as they emerge.

The European filings complete so-called rolling reviews, initiated by the EMA on Oct. 6 in the case of Pfizer and on Nov. 16 for Moderna, aimed at speeding up the process by doing a real-time assessment of the data as it lands.

The EMA said on Tuesday it had started a rolling review of Johnson & Johnson’s vaccine candidate after preliminary results showed it triggered production of antibodies and immune cells against the virus. The review will go on until enough evidence ss available for a formal marketing authorisation application, the regulator added.

The British government said here last week that Pfizer and BioNTech had reported the data from their clinical trials to the Medicines and Healthcare products Regulatory Agency (MHRA).

Reporting by Ludwig Burger and Josephine Mason; Additional reporting by Markus Wacket in Berlin; Editing by Pravin Char

Elon Musk Says Tesla Open To Merger With Legacy Automakers But Wont Attempt Hostile Takeover – Benzinga

Tesla Inc (NASDAQ: TSLA) CEO Elon Musk said Monday the electric vehicle maker is open to merging with a legacy carmaker in theory but such a transaction would have to be friendly and not hostile.

What Happened: Musk made the disclosure in an interview with Mathias Doepfner, CEO of the German publishing house Axel Springer SE during a live event, first noticed on CNBC.

“I think we’re definitely not going to launch a hostile takeover,” Musk told Doepfner. “If somebody said, ‘hey, we think it would be a good idea to merge with Tesla,’ we’d certainly have that conversation. But we don’t want it to be a hostile takeover situation.”

The two executives were discussing a purely theoretical scenario.

Why It Matters: As of last month, Tesla’s valuation is greater than all the legacy automakers — including General Motors Company (NYSE: GM), Ford Motor Company (NYSE: F), and Fiat Chrysler Automobiles NV (NYSE: FCAU) — put together.

Musk is reportedly also calling upon employees to take significant cost-cutting measures. The CEO described Tesla’s line of business as a “tough Game of Pennies” in a memo and warned employees that if they do not slash costs “[Tesla] stock will immediately get crushed like a souffle under a sledgehammer!”

Price Action: Tesla shares closed nearly 3% higher at $584.76 on Monday and fell 1.59% to $575.48 in the after-hours session.

Photo by Daniel Oberhaus on Flickr

© 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Walmart scraps shipping minimum for subscription service in move to take on Amazon – CNN

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Lucid Says Its Casa Grande Factory Is Ready For Business – Jalopnik

Illustration for article titled Lucid Says Its Casa Grande Factory Is Ready For Business

Photo: Lucid

When I went to visit Lucid’s Silicon Valley facility in September, I was told that the Casa Grande, Ariz. facility was nearly up and running. I was cautiously optimistic that such a large facility could be built and ready to turn out a brand new from-scratch electric car in under a year, but being that the company broke ground in December of 2019 and even with coronavirus-related delays in construction still managed to get the damn thing to this point in late November of 2020 is a testament to the underpromise and overdeliver lifestyle that Lucid seems to be delivering on at every step.

As opposed to the bold and brash path that Tesla has taken over the last decade, shouting company progress from up high on a Twitter soapbox, Lucid has been speaking softly and carrying a giant fuck-off stick. If the Air doesn’t deliver exactly what they say it delivers, at this point I’ll be a little bit surprised. The company isn’t built on a foundation of braggadocio and that seems a little refreshing from an electric car startup.

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Photo: Lucid

On Tuesday Lucid announced the completion of phase one of its first full-scale manufacturing facility, and it should still be on track to deliver the first customer Air luxury electric sedans in the spring of next year. Further expansion of the site will begin early in 2021 to allow the company to begin production of its SUV, slated for a 2023 delivery date.

In my time at the Silicon Valley location, I saw dozens of beta and prototype Lucid Airs already completed and looking pretty much ready for prime time. In addition to being an actually really beautiful car, it seems to be pretty well put together. Of course, most of these are hand-built prototypes, so time will tell if the production version can stack up to this. Lucid says it is in the process of building a final series of “production-representative” versions of the car to complete testing ahead of full-scale launch.

The plan for this facility, just south of Phoenix, is to cut the red ribbon with an initial capacity of 30,000 annual units. The launch will of course begin with the most expensive and most powerful Lucid Air Dream Edition models, which make 1,080 horsepower and retail at $169,000. It will take a year for Lucid to deliver the Air Pure, which is the least expensive model planned, starting at $69,900.

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Photo: Lucid

Lucid is already looking at two further expansions beyond adding another production line for the SUV. Construction will continue on through 2028, taking the factory from its current 999,000 square feet to over 5 million square feet, says the company. Production will allegedly ramp from the current plan of 30,000 units per year to a whopping 400,000 units per year.

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Photo: Lucid

The Arizona site was selected for a number of reasons – including infrastructure, talent, geographic location, and pre-existing automotive supply chain – but it also offered space for a large footprint and planned expansions, as key areas of the factory were intentionally designed with this in mind. This includes a state-of-the-art, water-based paint shop designed to be future-proof with the necessary footprint and specialized infrastructure so it can be expanded to meet the needs of all future phases of the factory itself. A total of four phases are planned through 2028, taking the square footage of the factory from its current 999,000 square feet to 5.1 million square feet. In its final form, AMP-1’s manufacturing capacity will be up to 400,000 units per year.

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Photo: Lucid

I’ve been promised a visit to this facility as well, hopefully around the time the first production cars roll off the assembly line, and look forward to taking it all in first hand. Of course, I’ll report back with any concrete findings. In the meantime, this looks quite promising for Lucid. I wonder if this means the company’s stock price will shoot up to half a trillion dollars.

More than half of emergency small-business funds went to larger businesses, new data shows – The Washington Post

According to data on the government’s Paycheck Protection Program (PPP), about 600 mostly larger companies, including dozens of national chains, received the maximum amount allowed under the program of $10 million.

Officials from the Treasury Department and the Small Business Administration (SBA) have argued that the program primarily benefited smaller businesses because a vast majority of the loans ― more than 87 percent ― were for less than $150,000, as of August. But the new data shows that more than half of the $522 billion in the same time frame went to bigger businesses, and only 28 percent of the money was distributed in amounts less than $150,000.

The newly released data comes after a federal lawsuit filed by The Washington Post and 10 other news organizations under the Freedom of Information Act challenging the SBA’s refusal to release records on borrowers and loan amounts. A federal judge ordered the release of the data by Tuesday and the agency did not appeal.

Devised as a way to temporarily pay small companies to keep their employees on staff for eight weeks, the Paycheck Protection Program is widely credited with helping millions of businesses make payroll during the early months of the coronavirus pandemic, benefiting tens of millions of employees. A bipartisan group of senators unveiled plans Tuesday for another $908 billion in stimulus, including nearly $300 billion in new funding for the Paycheck Protection Program and other SBA programs.

However, the program’s spring rollout was fraught with confusion over rules for borrowers and an early run on the money by large chains and big banks that caused the first pot of funding to run dry in eight days. The Treasury Department later asked large well-capitalized borrowers to return their funding, though the agency has not disclosed which borrowers have done so.

The data released Tuesday disclosed for the first time the exact dollar figures received by some of the top recipients, showing that a number of restaurant chains received the maximum $10 million, among them the parent companies of Uno Pizzeria & Grill, Legal Sea Foods, Boston Market and Cava Mezze Grill. Law firms, churches and professional staffing services were also among recipients of $10 million loans.

The SBA calculated loan amounts based on monthly payroll figures and capped loans at a maximum of $10 million. Businesses with up to 500 employees were eligible, though that limit was relaxed for restaurant and hotel companies.

Previous disclosures of PPP loan data showed that the program was falling fall short of the Trump administration’s claims of its success. A Post analysis of 4.9 million loans initially released by the SBA contained numerous errors, casting doubt on the administration’s claim that the $517 billion in lending had “supported” 51 million jobs.

Many companies were reported to have “retained” far more workers than they employ. Likewise, in some cases, the agency’s jobs claim for entire industries surpassed the total number of workers in those sectors. For more than 875,000 borrowers, the data showed that zero jobs were supported or no information is listed at all, according to the analysis.

There is also increasing evidence that the program was subject to considerable fraud. Investigators at the Justice Department, FBI, IRS and other agencies have joined forces to identify fraudulent borrowers, and in September the government announced that it had charged 57 people with trying to steal a total of $175 million. The SBA inspector general’s office has received tens of thousands of fraud tips, and federal officials have launched hundreds of investigations.

Additionally, a “blanket approval” allowed Congress, officials and their families to receive PPP funds without a required conflict of interest review. Several members of Congress, including some who helped shape the program’s rules, benefited from funds, according to news reports and financial records.

The Post filed a Freedom of Information Act for complete records about the lending program on April 24. After the SBA failed to respond in the time required by law, The Post and 10 other national news organizations sued for the release of records on the Paycheck Protection Program and a separate smaller loan program, the Economic Injury Disaster Loans program, or EIDL.

In response to the lawsuit, the SBA posted loan-level data of 660,000 business and nonprofit organizations that received at least $150,000 in funding. But despite a disclaimer on the loan application stating that the names of borrowers and amounts of loans would be “automatically released” in response to FOIA requests, the agency argued to the court that it should not have to provide exact loan figures for any of the loans, as well as borrower information for loans under $150,000, an estimated 87 percent of all PPP loans.

The agency claimed that FOIA’s confidential business information and personal privacy exemptions allowed the agency to withhold the records.

Ultimately, Judge James E. Boasberg of the U.S. District Court for the District of Columbia rejected the agency’s arguments and ordered the SBA to “release the names, addresses, and precise loan amounts for all individuals and entities that obtained PPP and EIDL COVID-related loans by December 1, 2020,” noting that while the agency had the right to appeal the ruling “the Court sees no basis for any further delay.”

As the pandemic continued into the summer and fall, some of the employment gains proved temporary. The payroll processor Gusto estimates that small businesses laid off about 232,000 workers nationwide soon after their PPP requirements expired, according an analysis of the records of about 37,000 Gusto clients who received PPP loans.

Losses were sharpest in retail trade, facilities management and other sectors hit hard by the pandemic, said Gusto economist Luke Pardue. “This is a significant head wind to the economy in the fall,” he said.

In rolling out the Paycheck Protection Program, the SBA and the Treasury Department stripped away much of the paperwork that is traditionally required for business loans, something that allowed banks to move quickly but also made the program more vulnerable to abuse. And the federal government promised that PPP loans could be entirely forgiven, making them far more attractive than what most businesses could find without government help.

In addition to traditional mom-and-pop shops, the program was open to a broad array of businesses, representing nearly every corner of the U.S. economy. Loan recipients included independent contractors such as Uber drivers, franchises of international brands, health-care workers, nonprofit organizations, churches, schools, Wall Street investment firms and others.

Some industries successfully lobbied for access to the program after they were initially excluded. The Trump administration removed a restriction on businesses that profit from gambling after the gaming industry argued it should be eligible. Strip clubs and payday lenders argued that their businesses had been hurt by the virus, too, and many of them ended up receiving loans.

In other cases, the SBA sought to claw back funding from loan recipients that were seen as controversial.

Later the SBA sent letters to dozens of Planned Parenthood nonprofits, which offer a range of health-care services including abortions, demanding that they return the funds. Republican lawmakers including Sen. Marco Rubio (R-Fla.), a key architect of the Paycheck Protection Program, argued that the organization’s local affiliates did not qualify because they were too closely associated with Planned Parenthood Federation of America, the national advocacy organization.

Nate Jones contributed to this report.

Singapore issues first regulatory approval for lab-grown meat to Eat Just – CNBC

Josh Tetrick, CEO of Eat Just, had at least one thing to be grateful for this Thanksgiving: Regulators in Singapore had issued the company the world’s first approval for its cultured meats.

The decision paves the way for Eat Just, which is best known for its plant-based egg substitute, to sell its lab-grown chicken as an ingredient in Singapore. And it will also likely draw more competitors to the Southeast Asian country and could prompt other countries to follow Singapore’s lead.

“A new space race for the future of food is underway,” Good Food Institute Executive Director Bruce Friedrich said in a statement.

In the last decade, dozens of start-ups have sought to make cell-cultured meat both tasty and affordable with the end goal of persuading consumers to turn their backs on conventional meat. Similar to the makers of plant-based meat alternatives, start-ups such as Eat Just, Future Meat Technologies and the Bill Gates-backed Memphis Meats argue that their products are healthier for consumers and better for the environment.

“We think that [the way] to really solve the meat problem — which is a health problem, a deforestation problem, a morality problem — is to make animal protein,” Tetrick said in an interview.

Eat Just landed at No. 21 on CNBC’s Disruptor 50 list this year for its efforts to change the food and agriculture industries. The company has raised $300 million and was last valued at $1.2 billion.

Cultured meat is made by putting stem cells from the fat or muscle of an animal into a culture medium that feeds the cells, allowing them to grow. The medium is then put into a bioreactor to support the cells’ growth. Tetrick compared the process to brewing beer, with a very different end product.

Eat Just has been working toward gaining approval from the Singapore Food Agency for about two years. To do so, it had to meet food safety requirements for novel foods and demonstrate a consistent manufacturing process for the cell-cultured chicken. Safety and quality inspections determined that it also met the standards for poultry meat.

The product has a high protein content and a diversified amino acid composition, no antibiotics and very low microbiological content, such as salmonella and E. coli.

Eat Just is going through other regulatory processes to get its cultured meat approved elsewhere in the world, including the United States. What set Singapore apart from the others, according to Tetrick, was its “forward-thinking and rigorous” approach. The Good Food Institute, which advocates for alternative proteins, said that it’s been meeting with Singaporean government officials to discuss cultured meat for more than three years.

But in the U.S., regulatory approval for cultured meat seems much further away. The Food and Drug Administration and the U.S. Department of Agriculture have officially overseen the regulation of cell-based seafood, poultry and beef since 2019. But, like plant-based meat, the products will face opposition from traditional meat producers, such as the U.S. Cattlemen’s Association.

Besides regulatory approval, high production cost is one of the primary barriers to the industry’s success. In 2013, a hamburger from Dutch start-up Mosa Meat cost $280,000 per patty to make. But the costs have come down over the years as scale has increased. Eat Just, for example, is using 1,000-liter bioreactors for its cell-cultured chicken, and Tetrick said the company plans to price it similar to that of premium chicken.

Still, the company is far away from bringing its chicken to every household in Singapore. Tetrick said that the product, which will be sold under its new Good Meat brand, will launch at a single restaurant in the country in the near future.

“We’re going to start out with a single restaurant and then scale out to five, 10, 15 and then eventually into retail,” Tetrick said. “The infrastructure required to do it is primarily the bioreactors, so we’ll eventually be moving to 5,000, 10,000 and 20,000 liters.”

Eat Just has already partnered with local manufacturers in Singapore in preparation for the regulatory approval and eventual sale of its cultured chicken.

The company is also planning to campaign for consumer trust in the product. Tetrick said that will include being transparent about how Eat Just makes cell-cultured meat and reminding consumers about the process of conventional meat production.

As Eat Just scales up, the company aims to keep reducing the price, which should also attract consumers and restaurants to try the product.

“Ultimately, this doesn’t become something until it becomes the cost of something that really matters, until we’re below the cost of conventional chicken,” Tetrick said.

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