Day: July 13, 2022

The U.S. is getting another COVID-19 vaccine choice as the Food and Drug Administration on Wednesday cleared Novavax shots for adults. 

Novavax makes a more traditional type of shot than the three other COVID-19 vaccines available for use in the U.S. — and one that’s already available in Europe and multiple other countries. 

Nearly a quarter of American adults still haven’t gotten their primary vaccinations even this late in the pandemic, and experts expect at least some of them to roll up their sleeves for a more conventional option — a protein-based vaccine. 

The Maryland company also hopes its shots can become a top booster choice in the U.S. and beyond. Tens of millions of Americans still need boosters that experts call critical for the best possible protection as the coronavirus continues to mutate. 

For now, the FDA authorized Novavax’s initial two-dose series for people 18 and older. 

“I encourage anyone who is eligible for, but has not yet received, a COVID-19 vaccine to consider doing so,” FDA Commissioner Dr. Robert Califf said in a statement. 

Before shots begin, the Centers for Disease Control and Prevention must recommend how they should be used, a decision expected next week. 

Novavax CEO Stanley Erck told The Associated Press he expected the U.S. to expand use of the vaccine beyond unvaccinated adults fairly quickly. 

Already, the FDA is evaluating it for those as young as 12, Erck said. Novavax also has submitted data on booster doses, including “mix-and-match” use in people who’d earlier received Pfizer or Moderna vaccinations. 

The Biden administration has bought 3.2 million Novavax doses so far, and Erck said vaccinations should begin later this month. 

Skeptic convinced

Sharon Bentley of Argyle, Texas, is one of the holdouts. Bentley was hesitant about the first COVID-19 vaccines, but then her husband volunteered for a Novavax trial, getting two doses and later a booster. 

Her husband’s positive experience with a more tried-and-true technology “convinced me,” Bentley said, adding that she planned to tell some unvaccinated friends about the option. 

The Novavax vaccine is made of copies of the spike protein that coats the coronavirus, packaged into nanoparticles that to the immune system resemble a virus. Then an immune-boosting ingredient, or adjuvant, that’s made from the bark of a South American tree is added and acts as a red flag to ensure those particles look suspicious enough to spark a strong immune response. 

Protein vaccines have been used for years to prevent hepatitis B, shingles and other diseases. It’s a very different technology than the dominant Pfizer and Moderna COVID-19 vaccines that deliver genetic instructions for the body to produce its own copies of the spike protein. The lesser-used Johnson & Johnson option uses a harmless cold virus to deliver spike-making instructions. 

Like the other vaccines used in the U.S., the Novavax shots have proved highly effective at preventing COVID-19’s most severe outcomes. Typical vaccine reactions were mild, including arm pain and fatigue. But the FDA did warn about the possibility of a rare risk — heart inflammation — that also has been seen with the Pfizer and Moderna vaccines. 

The Novavax vaccine was tested long before the omicron variant struck. But last month, the company released data showing a booster dose promised a strong immune response even against omicron’s newest relatives — preliminary evidence that several of the FDA’s scientific advisers called compelling. 

Still, U.S. regulators are planning for a fall booster campaign using Pfizer and Moderna shots that better target omicron subtypes, and Novavax also has begun testing updated shots. Erck said the company could have updated doses available late in the year. 

European regulators recently cleared the Novavax vaccine to be used as young as age 12, and several countries have authorized booster doses of its original vaccine. 

Earlier manufacturing difficulties held up the vaccine, although Erck said those have been solved, and Novavax can meet global demand. Much of the company’s vaccine, including doses for the U.S., are being produced by the Serum Institute of India, the world’s largest vaccine manufacturer.
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Twitter sued Tesla CEO Elon Musk on Tuesday to force him to complete the $44 billion acquisition of the social media company. 

Musk and Twitter have been bracing for a legal fight since the billionaire said on Friday he was backing off of his April agreement to buy the company. 

Twitter’s lawsuit opens with a sharply worded accusation: “Musk refuses to honor his obligations to Twitter and its stockholders because the deal he signed no longer serves his personal interests.” 

“Having mounted a public spectacle to put Twitter in play and having proposed and then signed a seller-friendly merger agreement, Musk apparently believes that he — unlike every other party subject to Delaware contract law — is free to change his mind, trash the company, disrupt its operations, destroy stockholder value, and walk away,” the suit says. 

Twitter filed its lawsuit in the Delaware Court of Chancery, which frequently handles business disputes among the many corporations, including Twitter, that are incorporated there. 

As part of the April deal, Musk and Twitter had agreed to pay each other a $1 billion breakup fee if either was responsible for the deal falling through. The company could have pushed Musk to pay the hefty fee but is going further than that, trying to force him to complete the full $44 billion purchase approved by the company’s board. 

“Oh the irony lol,” Musk tweeted after Twitter filed the lawsuit, without explanation. 

‘Strong and compelling’ case

The arguments and evidence laid out by Twitter are “very strong and compelling” and likely to get a receptive ear in the Delaware court, which doesn’t look kindly on sophisticated buyers backing off of deals, said Brian Quinn, a law professor at Boston College. 

“They make a very strong argument that this is just buyer’s remorse,” Quinn said. “You have to eat your mistakes in the Delaware Chancery Court. That’s going to work very favorably for Twitter.” 

Musk alleged Friday that Twitter has failed to provide enough information about the number of fake accounts on its service. Twitter said last month that it was making available to Musk a “fire hose” of raw data on hundreds of millions of daily tweets. 

The company has said for years in regulatory filings that it believes about 5% of the accounts on the platform are fake. Musk is also alleging that Twitter broke the acquisition agreement when it fired two top managers and laid off a third of its talent-acquisition team. 

Twitter’s suit repeatedly emphasizes Musk’s contemplation of starting a Twitter competitor, an alternative option he sometimes aired publicly and sometimes privately to Twitter’s executives and board members. While the company has said it cooperated in providing the spam bot data he requested, the lawsuit suggests there was concern that disclosing too much “highly sensitive information” could expose Twitter to competitive harm if shared. 

The biggest surprise for Quinn was how much evidence Twitter has — for instance, communications with Musk about whether to retain or lay off employees, as well as the billionaire’s own public tweets — to reject his arguments for backing out. 

“They are marshaling many of Musk’s own tweets to hoist him on his own petard,” he said. 

Tesla stock drops

When Musk offered to buy the company and take it private in mid-April, the board initially tried to block him by deploying a financial maneuver that would have made the acquisition prohibitively expensive. 

By April 25, though, Twitter had reconsidered the offer, concluding that selling the company to Musk for $54.20 a share was in the best interest of shareholders. In a joint press release, Musk pledged to “unlock” the social media company’s potential by loosening restrictions on speech and rooting out fake accounts. 

But his confidence didn’t last long. Tesla’s stock — Musk’s primary source of wealth — plummeted amid a broader stock market selloff in May, and Musk soon seemed less enthusiastic about owning Twitter. 

Twitter’s suit calls Musk’s tactics “a model of hypocrisy,” noting that he had emphasized plans to take Twitter private in order to rid it of spam accounts. Once the market declined, however, Twitter noted that “Musk shifted his narrative, suddenly demanding ‘verification’ that spam was not a serious problem on Twitter’s platform and claiming a burning need to conduct ‘diligence’ he had expressly forsworn.” 

Similarly, the company charges that Musk operated in bad faith, accusing him of requesting company information in order to accuse Twitter of providing “misrepresentations” about its business to regulators and investors. 

Twitter’s lawsuit alleges that the company “has suffered and will continue to suffer irreparable harm” as a result of Musk’s contractual breaches that “cast a pall over Twitter and its business.” 

 
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