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The Food and Drug Administration said it needs to review changes to Novavax’s manufacturing before deciding whether to authorize its Covid-19 vaccine in the U.S.
The FDA’s committee recommended the Novavax vaccine for use in the U.S. on Tuesday.
The FDA is not obligated to follow the committee’s recommendation, though the agency normally does so.

A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands.
Patrick Van Katwijk | Getty Images

The Food and Drug Administration needs to review changes to Novavax’s manufacturing process before it can authorize the biotech company’s Covid-19 vaccine in the U.S., an agency spokesperson said on Wednesday.
The FDA’s committee of independent vaccine experts on Tuesday voted overwhelmingly to recommend Novavax’s vaccine for use in the U.S., after an all-day meeting in which they reviewed data on the shot’s safety and its effectiveness at preventing Covid.

During the pandemic, the FDA has moved quickly to authorize Covid shots after the committee has given its endorsement. Pfizer, Moderna and Johnson & Johnson’s vaccines received FDA authorization the day after the committee recommended their use in the U.S. FDA authorization of Novavax’s vaccine could take longer.
The FDA, in a statement to CNBC, said Novavax informed the agency of changes to its manufacturing process on June 3, days before the committee was scheduled to review its vaccine’s safety and efficacy data.
“FDA will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use,” FDA spokesperson Abby Capobianco told CNBC.
The FDA is not obligated to follow the committee’s recommendation with its authorization, though the agency normally does so. Capobianco said the FDA will take the committee’s recommendation into consideration when deciding about authorizing the Novavax vaccine.
Novavax, in a statement, said it shared updated information with the FDA about improvements to its manufacturing process. The biotech company wouldn’t provide any further specifics.

FDA authorization would allow Novavax to start shipping doses to the U.S. from its manufacturing partner Serum Institute of India. However, the Centers for Disease Control and Prevention would still need to sign off on the vaccine before pharmacies and other health-care providers could start administering the shots.
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 from Operation Warp Speed. However, the small Maryland biotech company struggled to build a manufacturing base from scratch and its clinical data came much later than Pfizer or Moderna, which rolled their shots out at breakneck speed.
Novavax asked the FDA to authorize its two-dose vaccine in late January. Dr. Doran Fink, a senior official at the FDA’s vaccine division, told CDC advisors in April that reviewing Novavax’s application has been “incredibly complex” because it involves clinical and manufacturing data.
While the vaccine still awaits authorization in the U.S., Novavax has started rolling out its shots around the world. The biotech company’s shots have been authorized in more than 40 countries, including Australia, Canada and the European Union. Dr. Peter Marks, who leads the FDA’s vaccine division, said the U.S. has high regulatory standards when it comes to vaccines and does not base its decisions on authorizations in other countries.
“We take manufacturing very seriously,” Marks said told the FDA committee Tuesday. “We don’t benchmark ourselves against other countries when it comes to manufacturing, we consider that we have a very high standard, and it’s why we’re often considered a gold standard for our manufacturing, and particularly in the area of vaccines.”

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Nio lost $281.2 million in the first quarter, wider than the $68.8 million it lost a year ago.
Covid shutdowns hampered Nio’s production in the first five months of 2022.
But two new models set to launch later this year remain on track, the company said.

Nio’s et5 electric sedan is set to begin deliveries in Sept. 2022.

Chinese electric-vehicle maker Nio lost $281.2 million in the first quarter, wider than the $68.8 million it lost a year ago, as it scrambled to keep pace with intense demand amid China’s recent Covid-related shutdowns.
Here are other key numbers from Nio’s first-quarter earnings report.

Revenue: $1.56 billion, up 24% from the first quarter of 2021.
Adjusted loss per share: 13 cents, versus 4 cents in the first quarter of 2021.
Gross margin: 14.6%, versus 19.5% a year earlier and 17.2% in the fourth quarter of 2021.
Cash at quarter-end: $8.4 billion, down slightly from $8.7 billion as of the end of 2021.

Nio’s shares were down about 6% in premarket trading Thursday as investors digested the decline in gross margin.
Rising commodity costs have continued to squeeze margins, CEO William Bin Li said during the company’s earnings call. But he expects Nio’s gross margin to begin to recover in the third quarter as offsetting cost cuts take hold.
Nio said its new factory, the company’s second, has begun pre-production builds of the upcoming ET5 sedan, due in September. The company also confirmed plans to launch a new upscale, five-passenger SUV, the ES7, later this month, with deliveries beginning in August.
Nio delivered 25,768 vehicles in the first quarter, up from 20,060 a year ago. Second-quarter deliveries are on pace to reach between 23,000 and 25,000 vehicles, the company said, suggesting a particularly strong June. Covid-19 shutdowns and supply-chain issues limited Nio’s total deliveries in April and May to just over 12,000.
Demand has remained strong through China’s most recent pandemic disruptions, however. Li said Nio “achieved an all-time high order flow” in May.
This is breaking news. Please check back for updates.

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European lawmakers have voted to ban the sale of new diesel and gasoline cars and vans in the EU from 2035, representing a significant shot in the arm to region’s ambitious green goals.
It takes the EU a step closer to its goal of cutting emissions from new passenger cars and light commercial vehicles by 100% in 2035
MEPs will now negotiate the plans with the bloc’s 27 member states.

Traffic in Paris, France, on May 12, 2020. The European Parliament now supports the European Commission’s goal of a 100% cut in emissions from new passenger cars and vans by 2035.
Ludovic Marin | AFP | Getty Images

European lawmakers have voted to ban the sale of new diesel and gasoline cars and vans in the EU from 2035, representing a significant shot in the arm to the region’s ambitious green goals.
On Wednesday, 339 MEPs in the European Parliament voted in favor of the plans, which had been proposed by the European Commission, the EU’s executive branch. There were 249 votes against the proposal, while 24 MEPs abstained.

It takes the European Union a step closer to its goal of cutting emissions from new passenger cars and light commercial vehicles by 100% in 2035, compared to 2021. By 2030, the target is an emissions reduction of 50% for vans and 55% for cars.
The Commission has previously said passenger cars and vans account for roughly 12% and 2.5% of the EU’s total CO2 emissions. MEPs will now undertake negotiations about the plans with the bloc’s 27 member states.
The U.K., meanwhile, wants to stop the sale of new diesel and gasoline cars and vans by 2030. It will require, from 2035, all new cars and vans to have zero tailpipe emissions. The U.K. left the EU on Jan. 31, 2020.

Read more about electric vehicles from CNBC Pro

Dutch MEP Jan Huitema, who is part of the Renew Europe Group, welcomed the result of Wednesday’s vote. “I am thrilled that the European Parliament has backed an ambitious revision of the targets for 2030 and supported a 100% target for 2035, which is crucial to reach climate neutrality by 2050,” he said.
Others commenting on the news included Alex Keynes, clean vehicles manager at Brussels-based campaign group Transport & Environment. “The deadline means the last fossil fuel cars will be sold by 2035, giving us a fighting chance of averting runaway climate change,” Keynes said.

He also argued that the plans provide the car industry with the certainty it needed to “ramp up production of electric vehicles, which will drive down prices for drivers.”

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For its part, the European Automobile Manufacturers’ Association said it was “concerned that MEPs voted to set in stone a -100% CO2 target for 2035.”
Oliver Zipse, who is the president of the ACEA and CEO of BMW, said his industry was “in the midst of a wide push for electric vehicles, with new models arriving steadily.”
“But given the volatility and uncertainty we are experiencing globally day-by-day, any long-term regulation going beyond this decade is premature at this early stage,” Zipse added. “Instead, a transparent review is needed halfway in order to define post-2030 targets.”
The EU has said it wants to be carbon neutral by 2050. In the medium term, it wants net greenhouse gas emissions to be cut by at least 55% by the year 2030, which the EU calls its “Fit for 55” plan.
The realization of this plan has not been all plain sailing. The news on cars and vans came after MEPs rejected a revision to the EU Emissions Trading System, or ETS.
In a press release on Thursday, the European Parliament said three draft laws in the Fit for 55 package were now “on hold pending political agreement.” More

Didi global ought to be dead. Over the past year the Chinese government has stopped the domestic ride-hailing giant from signing up new users and launched a cyber-security investigation into its operations, days after its $4.4bn initial public offering in New York last June. In a seemingly fatal blow, Didi is being forced to delist from America but blocked from relisting in Hong Kong. That the company has not collapsed is a testament to the strength of its business. Its future survival—and that of other Chinese tech darlings—remains in the gift of the Communist Party.The probe into Didi is expected to wrap up shortly and on June 6th the Wall Street Journal reported that the firm will soon be able to take on new customers. The news propelled Didi’s share price up by 60%. It still faces an investigation in America, where it is alleged to have underplayed regulatory risks in its domestic market, and investors are suing it on similar grounds. But these problems seem piffling next to what it has soldiered through at home.The first sign that the Communist Party’s two-year campaign against big tech would ease came in March from Liu He, a top economics adviser to President Xi Jinping. In May Mr Liu met a handful of tech executives and spoke of supporting the digital economy and balancing the relationship between state and market. The potential resumption of Didi’s business in China is one sign that things are indeed normalising. Some large tech platforms’ first-quarter results were also better than expected. Meituan, a delivery super-app, said on June 6th that revenue grew by 25% year on year in the first three months of 2022. Yet China’s tech companies are returning to a very new normal. Its two mightiest tech titans, Alibaba and Tencent, are growing much more slowly than in the past. Room to expand into new areas beyond their core businesses (e-commerce, and social media and video-gaming, respectively) has all but vanished. Outspoken entrepreneurs such as Jack Ma, Alibaba’s co-founder, are a thing of the past. Tech executives instead parrot official lines about ending their industry’s “reckless expansion” (which has also meant laying off tens of thousands of employees). And the state is taking direct stakes in their firms.Not long ago global investors shuddered at the prospect of state ownership. Now some are coming around to the idea. When Bloomberg reported on May 27th that faw, a state-run carmaker, was planning to buy a large stake in Didi, the ride-hailer’s share price surged by 10%. A big state investor such as faw could help Didi navigate compliance and governance issues, explains Cherry Leung of Bernstein, a broker. State investors have been eyeing the consumer-lending and credit-scoring businesses of Ant Group, Alibaba’s financial affiliate at the heart of the techlash. Once viewed as a drag on profitability, backing from a powerful government group is increasingly seen as a precondition for big tech firms to remain going concerns. It may be the only way for companies that have fallen foul of Mr Xi, and his grand plan for achieving “common prosperity” in China, to stay alive. Investors appear happy to forget about Didi’s death throes now that the firm has been resuscitated. They would be wise to remember that China’s leader has changed his mind before—and could do so again. ■For more expert analysis of the biggest stories in economics, business and markets, sign up to Money Talks, our weekly newsletter. More

The pandemic denied both the pleasures and tribulations of travel. The urge to make up for lost holidays and reunions with friends and families has brought the sort of airport holiday chaos that travellers avoided while covid-19 scuppered their plans. A rush to take advantage of school breaks caused recent misery in Europe. Passengers queued for hours at airports from Mallorca to Manchester, and flights were delayed or cancelled. Americans were furious after nearly 3,000 flights were scrapped in the four days around the Memorial Day weekend in late May. At least the hordes of unsatisfied customers are a sign that air travel is returning to normal. “Pent-up demand for travel is becoming un-pent,” says Andrew Charlton of Aviation Advocacy, a consultancy. The number of seats available on European airlines in the week commencing June 6th was only 9% below the same week in 2019. In North America it was just 5.6% down, according to oag, another consultancy. Japan, which was in effect shut to tourists for two years, said on May 26th that it would start to relax restrictions on visitors. With the exception of China, where severe recent lockdowns set back a strong recovery in domestic flying, the planes are back in the air at close to pre-pandemic levels. Bookings also look encouraging for the summer. Airlines are having to cope with a new uncertainty—a tendency of travellers to buy tickets later, induced by the riskiness of planning too far ahead during the pandemic. Even so, up to September sales for international routes are at 72% of their level in 2019 and those on domestic ones are at 66%, according to iata, an industry body. Capacity is ascending towards pre-covid levels, according to oag (see chart). Willie Walsh, iata’s boss, said in May that the speed of the rebound meant that passenger numbers worldwide would match figures from 2019 by 2023, a year earlier than previously forecast.The pace of the recovery has caught out an industry that has been rebuilding at a steady clip. In particular, traffic has become much more concentrated in peak periods, according to aci Europe, a group representing the region’s airports. Passenger numbers are already exceeding pre-pandemic levels in short spells in some places. Airports, in particular, are struggling to cope with these peaks. Replacing workers laid off during the pandemic is tough amid tight labour markets, especially so because of the extra security checks required to hire airport staff. Swissport, the world’s largest airport-service firm, said in May that it needed to take on 30,000 new workers worldwide by the summer on top of the 45,000 it now employs. Staff shortages have already prevented some airlines from adding even more capacity to meet the surging demand. Continuing disruptions may deter passengers, especially if the novelty of taking a holiday in a faraway place wears off. Even if airlines and airports are able to recruit staff to make the summer months less painful, other problems remain.Foremost is a sky-high oil price. Mr Walsh said recently that surging fuel costs had added 10% to fares already. Michael O’Leary, the irrepressibly bouncy boss of Ryanair, Europe’s biggest carrier, admits only to “cautious grounds for optimism”. A white-hot summer could be followed by a difficult winter. ■For more expert analysis of the biggest stories in economics, business and markets, sign up to Money Talks, our weekly newsletter. More

“For the last two months it has been busy like the weekend every day,” sighs a sales assistant at a large Zara store on Tauentzienstrasse, a shopping street in the centre of Berlin. On the Tuesday after the long Pentecost weekend about a dozen ladies were queuing for the fitting room, each carrying several items, many of them in hot pink or canary yellow, colours en vogue this season. They don’t seem to be deterred by Zara’s higher garment prices. At least not yet.Shoppers are still “revenge buying” to make up for all the time when shops were closed and socialising banned amid waves of covid-19. After grafting pajama bottoms onto their legs over the past two years, buyers are snapping up office and party wear. On June 8th Inditex, which own Zara, Bershka and Massimo Dutti, among other brands, reported glittery results for its latest quarter. Revenues rose by 36% year on year, to €6.7bn ($7.2bn), surpassing levels before the pandemic. Net profit jumped by 80% year on year. Online sales dipped compared with the same period in 2021, when the internet was the only place to shop for clothes owing to lockdowns in America and Europe. But the decline of 6% was much slower than expected, which suggests that people have got used to buying garb on the internet. In another boost, China is reopening after the latest bout of lockdowns. Only four of Inditex’s Chinese outlets remain closed, down from 67 in the three months to April. h&m, Inditex’s Swedish fast-fashion rival, is expected to report similarly perky results on June 15th.The big question for Óscar García Maceiras, who took over as chief executive of Inditex in November, and his opposite numbers at other fast-fashion firms, is whether the party can last. The short answer is that it probably won’t. But if anyone can keep it going for a bit longer, it is Inditex. As Georgina Johanan of JPMorgan Chase, a bank, notes, the Spanish giant looks best-placed to withstand the combined pressures of war, competition, inflation and, possibly, recession. Start with the problems. Fast-fashion firms had to put a complete halt to their operations in Russia and Ukraine after Vladimir Putin invaded his southern neighbour in February. Inditex, which has more than 500 shops in Russia, derived 8.5% of its operating profit from the country in 2021. This year it has had to make a €216m provision for the estimated cost of the war to its Ukrainian and Russian businesses. Beyond eastern Europe, fashion retailers are being squeezed by competition from Shein, an online-only challenger from China that has sashayed into Western wardrobes in the past few years. And then there is the twin “stagflationary” challenge of higher costs and flagging demand. This is acute for clothes pedlars, since many of their customers have already replenished their closets—and a new pair of trousers is a less urgent need than energy, food and rent, all of which have been getting pricier.No fast-fashion house is immune to these forces. But with the exception of the Russia-Ukraine war, Inditex does look less vulnerable than the others. Shein, whose items sell for an average of $20 or so, poses less of a direct threat to the Spanish company’s mid-market frocks, which go for just under $40 at Zara, according to estimates by Anne Critchlow of Société Générale, a bank. In recent years Inditex has also done a better job than its rivals of unifying its online operations with its more than 6,000 shops around the world, thanks to clever radio-frequency trackers, an in-house digital platform and a group-wide inventory database. Crucially, Inditex enjoys one more advantage over rivals when it comes to inventory, the management of which is particularly important in times of stagflation. The company produces around two-thirds of its items in Europe or in nearby north Africa and Turkey. That allows it to adjust output more quickly in response to demand than firms like h&m, which sources 80% of its clothes from Asia. In a slowdown it pays to be faster in fast fashion. ■For more expert analysis of the biggest stories in economics, business and markets, sign up to Money Talks, our weekly newsletter. More

The original Rorschach test involves showing a series of ten inkblots to someone, and asking them what images they see. Although the test’s psychological validity is debatable, no one can dispute its wild success as a metaphor: a single object can mean very different things to different people. In business a prime example of Rorschachiness is the corporate jet. Depending on your perspective, it can signal untrammelled greed, rational decision-making, post-pandemic work habits or the fight against climate change. Those who see excess regard the company jet as the worst in a pile of gold-plated perks for overpaid executives. While minions reacquaint themselves with airport queues and the curse of six hours next to the chatty stranger in 24a, bosses skip the lines and travel in luxury. It is difficult to remain grounded in these circumstances. ey, a global accounting firm, reportedly calls its plane “ey One”; on touchdown, auditors doubtless fantasise about radioing that “the eygle has landed”. If jets were used only for work trips, that would be bad enough. But more than half of the ceos of a 500-strong group of companies monitored by Equilar, an analytics outfit, made use of their firm’s jet for personal purposes in 2020. This view equates the company plane with entitlement and waste. The bosses of America’s big carmakers were excoriated for using their jets to travel to Washington, dc, to ask for a bail-out during the financial crisis in 2008. Disquiet about his use of Credit Suisse’s private jet was one reason why António Horta-Osório resigned as chairman of the Swiss bank earlier in the year. When Jeff Immelt, a former chief executive of ge, travelled on the firm’s private plane, a second one would sometimes follow him around the world as backup. Mr Immelt’s successor, John Flannery, made a point of putting ge’s jets up for sale when he took over in 2017. A research study from 2012 found that cost-conscious private-equity firms reduced corporate-jet fleets at firms they had acquired. If the corporate-jet inkblot spells excess to some, to others it represents hard-headed pragmatism. The personal safety of top executives is one consideration: private aircraft are a big part of Meta’s outsized spending ($27m in 2021) on the security of Mark Zuckerberg, its chief executive. So is privacy: it is really hard to finalise a secret takeover when there is a stranger spilling pretzels on you. (Both of these arguments are slightly weakened by the scraping of air-traffic data that lets people track specific aircraft; a paper published last year described a machine-learning algorithm designed to predict where a corporate jet is going to land while it is still in the air.) Above all, chief executives are busy people. If boards would rather they spent more time working and less time watching someone repack their suitcase at the security gates, that’s their call. And because private jets can land on more airfields than commercial airliners can, they are often the only way for executives to travel directly from headquarters to factories and subsidiaries in less accessible locations. A paper published in 2018 by academics at Boston College and Drexel University found that business-related flights of this kind improved firms’ operational performance. Some look at corporate jets and primarily see an enemy in the fight against climate change. Because of the small number of passengers on board, private planes emit much more carbon per passenger mile than commercial flights do. Elon Musk, a clean-tech tycoon who is fast becoming a Rorschach test in his own right, was pilloried recently when his jet took a nine-minute flight from San Jose to San Francisco. Mr Musk is also an outspoken critic of remote work, which is another thing that private jets bring to mind. The argument for using them rests heavily on the importance of in-person communication, something that has become a lot more contentious in the post-pandemic workplace. The point of the Rorschach test is that it has no single right answer. Corporate jets look unjustifiable to some and sensible to others. They can improve productivity or be a sign of an out-of-control ceo; the paper from 2018 found that planes made more flights to resorts when a firm’s boss had been in place for longer and when it had dual-class shares. They raise questions of fairness among critics and spell efficiency to defenders. They have become a useful shortcut for testing someone’s gut instincts on management, as well as for beating the queues. Read more from Bartleby, our columnist on management and work:Do not bring your whole self to work (Jun 2nd)The power of small gestures (May 28th)Making brainstorming better (May 21st) More

The original Rorschach test involves showing a series of ten inkblots to someone, and asking them what images they see. Although the test’s psychological validity is debatable, no one can dispute its wild success as a metaphor: a single object can mean very different things to different people. In business a prime example of Rorschachiness is the corporate jet. Depending on your perspective, it can signal untrammelled greed, rational decision-making, post-pandemic work habits or the fight against climate change. Listen to this story. Enjoy more audio and podcasts on More