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FDA authorizes emergency use for Novavax Covid-19 vaccine for ages 12 to 17

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A box of the Novavax Covid-19 vaccine arranged at a pharmacy in Schwenksville, Pennsylvania, US, on Monday, Aug. 1, 2022.

Bloomberg | Bloomberg | Getty Images

Biotechnology company Novavax announced on Friday that its Covid-19 vaccine has been authorized for emergency use by the U.S Food and Drug Administration for adolescents between the ages of 12 and 17.

In July, Novavax’s two-dose Covid-19 vaccine for adults ages 18 and over got its emergency approval from the FDA.

Having more vaccine options for adults and children will “hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of Covid-19 with the start of fall and the back-to-school season,” Stanley C. Erck, president and CEO of Novavax, said in a statement.

Novavax was one of the original participants in the U.S. government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the small Maryland biotech company struggled to quickly get manufacturing in place and its clinical trial data read out much later than rivals Pfizer or Moderna.

Dr. Peter Marks, a senior FDA official, has said that Novavax’s vaccine would potentially appeal to unvaccinated people who would prefer a shot that is not based on the messenger RNA technology used by Pfizer and Moderna.

How Novavax is different

The Novavax shot is based on more conventional protein technology used for decades in hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA-approved vaccines to use mRNA.

Pfizer and Moderna’s vaccines use mRNA, a molecule encoded with genetic instructions, to tell human cells to produce copies of a virus particle called the spike protein. The immune system responds to these copies of the spike, which prepares the human body to attack the actual virus.

Novavax makes copies of the virus spike outside human cells. The genetic code for the spike is put into an insect virus that infects moth cells, which produce copies that are then purified and extracted during the manufacturing process. The finished spike copies are injected into the human body, inducing an immune response against Covid.

The Novavax vaccine also uses an additional ingredient called an adjuvant, which is extracted and purified from the bark of a tree in South America, to induce a broader immune response. The shots consist of 5 micrograms of the spike copy and 50 micrograms of the adjuvant.

Effectiveness and safety

Two doses of the Novavax vaccine were 90% effective at preventing illness from Covid across the board and 100% effective at preventing severe illness, according to clinical trial data from the U.S. and Mexico. However, the trial was conducted from December 2020 through September 2021, months before the omicron variant became dominant.

Novavax did not present any data on the shot’s effectiveness against the variant at the FDA committee meeting in June. However, the vaccine will likely have lower effectiveness against omicron as is the case with Pfizer and Moderna’s shots. Omicron is so distinct from the original strain of Covid that the antibodies produced by the vaccines have trouble recognizing and attacking the variant.

Novavax published data in December showing that a third shot boosted the immune response to levels comparable to the first two doses which had 90% effectiveness against illness. The company plans to ask the FDA to authorize a third dose of its vaccine.

FDA authorization of Novavax’s vaccines comes as the U.S. is preparing to update Covid shots to target the omicron BA.4 and BA.5 variants to increase protection against the virus. Novavax’s vaccine, like all the other shots, is based on the original version of the virus that first emerged in Wuhan, China. The effectiveness of Covid vaccines against mild illness has slipped substantially as the virus has evolved, though they still generally protect against severe disease.

Novavax presented data at an FDA committee meeting in late June demonstrating that a third dose of its vaccine produced a strong immune response against omicron and its subvariants. Committee members were impressed by the company’s data on omicron.

The Novavax vaccine also appears to carry a risk of heart inflammation for younger men, known as myocarditis and pericarditis, similar to Pfizer and Moderna’s shots. Myocarditis is an inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the heart.

FDA officials flagged four cases of myocarditis and pericarditis from Novavax’s clinical trial in young men ages 16 to 28. People who develop heart inflammation as a side effect of Covid vaccines are usually hospitalized for several days as a precaution but then recover.

The FDA has issued a fact sheet for health-care providers warning that clinical trial data indicates there is an increased risk of myocarditis with the Novavax vaccine. People who experience chest pain, shortness of breath and feelings of a fluttering or pounding heart should immediately seek medical attention, according to the FDA.

In the case of the mRNA shots, the CDC has found that the risk of myocarditis is higher from Covid infection than vaccination. Myocarditis is usually caused by viral infections.



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Ford CEO says 65% of U.S. dealers agree to sell EVs

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Ford F-150 Lightning trucks manufactured at the Rouge Electric Vehicle Center in Dearborn Michigan.

Courtesy: Ford Motor Co.

DETROIT – About 65% of Ford Motor’s dealers have agreed to sell electric vehicles as the company invests billions to expand production and sales of the battery-powered cars and trucks, CEO Jim Farley said Monday.

About 1,920 of Ford’s nearly 3,000 dealers in the U.S. agreed to sell EVs, according to Farley. He said roughly 80% of those dealers opted for the higher level of investment for EVs.

Ford offered its dealers the option to become “EV-certified” under one of two programs — with expected investments of $500,000 or $1.2 million. Dealers in the higher tier, which carries upfront costs of $900,000, receive “elite” certification and be allocated more EVs.

Ford, unlike crosstown rival General Motors, is allowing dealers to opt out of selling EVs and continue to sell the company’s cars. GM has offered buyouts to Buick and Cadillac dealers that don’t want to invest to sell EVs.

Dealers who decided not to invest in EVs may do so when Ford reopens the certification process in 2027.

“We think that the EV adoption in the U.S. will take time, so we wanted to give dealers a chance to come back,” Farley said during an Automotive News conference.

Ford’s plans to sell EVs have been a point of contention since the company split off its all-electric vehicle business earlier this year into a separate division known as Model e. Farley said the automaker and its dealers needed to lower costs, increase profits and deliver better, more consistent customer sales experiences.

Farley on Monday also reiterated that a direct-sales model is estimated to be thousands of dollars cheaper for the automaker than the auto industry’s traditional franchised system.

Wall Street analysts have largely viewed direct-to-consumer sales as a benefit to optimize profit. However, there have been growing pains for Tesla, which uses the sales model, when it comes to servicing its vehicles.

Ford’s current lineup of all-electric vehicles includes the Ford F-150 Lightning pickup, Mustang Mach-E crossover and e-Transit van. The automaker is expected to release a litany of other EVs globally under a plan to invest tens of billion of dollars in the technologies by 2026.



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Tim Draper predicts bitcoin will reach $250,000 despite FTX collapse

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Tim Draper, founder of Draper Associates, onstage at the Web Summit 2022 tech conference.

Ben McShane | Sportsfile via Getty Images

Venture capitalist Tim Draper thinks bitcoin will hit $250,000 a coin by the middle of 2023, even after a bruising year for the cryptocurrency marked by industry failures and sinking prices.

Draper previously predicted that bitcoin would top $250,000 by the end of 2022, but in early November, at the Web Summit tech conference in Lisbon, he said it would take until June 2023 for this to materialize.

He reaffirmed this position Saturday when asked how he felt about his price call following the collapse of FTX.

“I have extended my prediction by six months. $250k is still my number,” Draper told CNBC via email.

Bitcoin would need to rally nearly 1,400% from its current price of around $17,000 for Draper’s prediction to come true. The cryptocurrency has plunged over 60% since the start of the year.

Digital currencies are in the doldrums as tighter monetary policy from the Fed and a chain reaction of bankruptcies at major industry firms including Terra, Celsius and FTX have put intense pressure on prices.

FTX’s demise has also worsened an already severe liquidity crisis in the industry. Crypto exchange Gemini and lender Genesis are among the firms said to be impacted by the fallout from FTX’s insolvency.

Last week, veteran investor Mark Mobius told CNBC that bitcoin could crash to $10,000 next year, a more than 40% plunge from current prices. The co-founder of Mobius Capital Partners correctly called the drop to $20,000 this year.

Nevertheless, Draper is convinced that bitcoin, the world’s largest cryptocurrency, is set to rise in the new year.

“I expect a flight to quality and decentralized crypto like bitcoin, and for some of the weaker coins to become relics,” he told CNBC.

What is DeFi, and could it upend finance as we know it?

Draper, the founder of Draper Associates, is one of Silicon Valley’s best-known investors. He made successful bets on tech companies including Tesla, Skype and Baidu.

In 2014, Draper purchased 29,656 bitcoins confiscated by U.S. Marshals from the Silk Road dark web marketplace for $18.7 million. That year, he predicted the price of bitcoin would go to $10,000 in three years. Bitcoin went on to climb close to $20,000 in 2017.

Some of Draper’s other bets have soured, however. He invested in Theranos, a health startup that falsely claimed it was able to detect diseases with a few drops of blood. Elizabeth Holmes, Theranos’ founder, has been sentenced to 11 years in prison for fraud.

‘The dam is about to break’

Draper’s rationale for bitcoin’s breakout next year is that there remains a massive untapped demographic for bitcoin: women.

“My assumption is that, since women control 80% of retail spending and only 1 in 7 bitcoin wallets are currently held by women, the dam is about to break,” Draper said.

Crypto has long had a gender disparity problem. According to a survey conducted for CNBC and Acorns by Momentive, twice as many men as women invest in digital assets (16% of men vs. 7% of women).

“Retailers will save roughly 2% on every purchase made in bitcoin vs dollars,” Draper added. “Once retailers realize that that 2% can double their profits, bitcoin will be ubiquitous.”

Payment middlemen such as Visa and Mastercard currently charge fees as high as 2% each time credit cardholders use their card to pay for something. Bitcoin offers a way for people to bypass the middlemen.

However, using the digital coin for everyday spending is tough, since its price is very volatile and the coin is not widely accepted as currency.

“When people can buy their food, clothing and shelter all in bitcoin, they will have no use for centralized banking fiat dollars,” Draper said.

“Management of fiat is centralized and erratic. When a politician decides to spend $10 trillion, your dollars become worth about 82 cents. Then the Fed needs to raise rates to make up for the spend, and those arbitrary centralized decisions create an inconsistent economy,” he added. Fiat currencies derive their worth from their issuing government, unlike cryptocurrencies.

Meanwhile, the next so-called bitcoin halving — which cuts the bitcoin rewards to bitcoin miners — in 2024 will also boost the cryptocurrency, according to Draper, as it chokes the supply over time. The total number of bitcoins that will ever be mined is capped at 21 million.



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Three pharmaceutical stocks were top performers last week

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