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Boeing Faces New Hurdle in Delivering Dreamliners

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Federal air-safety regulators have stripped

Boeing Co.

BA 3.28%

’s authority to inspect and sign off on several newly produced 787 Dreamliners, part of heightened scrutiny of production problems that have halted deliveries of the popular wide-body jets.

The Federal Aviation Administration said its inspectors, rather than the plane maker’s, would perform routine pre-delivery safety checks of four Dreamliners that Boeing has been unable for months to hand over to its airline customers while it grapples with various quality lapses.

The agency has long empowered Boeing to perform the final safety signoffs on the FAA’s behalf, allowing it to issue what are known as airworthiness certificates needed to hand over new jets to airlines. The FAA said it has withheld the same authority on some of the planes in previous years to keep inspectors’ skills current.

Now, the FAA said its move to withhold final-approval authority was part of a broader set of actions directed at Boeing’s 787 production issues. A spokesman said the agency could decide to have its own inspectors sign off on more Dreamliners. “We can extend the retention to other 787 aircraft if we see the need,” he said.

A Boeing spokesman said Wednesday that the company has engaged the FAA throughout its efforts to resume Dreamliner deliveries and would follow the agency’s direction on final approvals as it has in the past. The spokesman said Boeing was “encouraged by the progress our team is making” on restarting the deliveries.

After halting deliveries in October, Boeing has built up an inventory of more than 80 newly produced, undelivered Dreamliners, according to aviation consulting firm Ascend by Cirium. Boeing has said it expects to resume deliveries by the end of March.

The wide-body jets have an excellent safety record and are used frequently on international routes. Boeing learned of the FAA’s move in January and has already factored the FAA signoffs into its expected delivery schedule, a person familiar with Boeing’s planning said.

Among specific aircraft slated for final approvals by agency inspectors are two Dreamliners ordered by

United Airlines Holdings Inc.

United expects to receive the planes in late March or early April, a person familiar with the Chicago-based carrier’s plans said this week.

The Boeing spokesman said the manufacturer would adjust its delivery plans if needed so it can take the time to conduct comprehensive 787 inspections “to ensure each meets our rigorous engineering specifications.”

The suspension of deliveries has cut off a significant source of cash paid by customers as the plane maker navigates the Covid-19 pandemic and weak demand in global air travel. Bernstein analyst

Doug Harned

has estimated the Dreamliner delivery slowdown could cost Boeing as much as $8 billion in cash flow through 2020 and 2021. He expects half of that to be recovered next year as airlines take delivery and pay the rest of the cost.

Boeing said in January that it would likely continue burning cash this year but has adequate liquidity after raising billions of dollars in debt last year. Investor optimism about the broader travel recovery helped lift its shares by 21% last week. The stock gained another 3.3% on Wednesday, valuing Boeing at $149 billion.

While limited in scope, the FAA move on the Dreamliner is similar to a step the agency took after two crashes of Boeing 737 MAX jets killed 346 people in 2018 and 2019.

The FAA stripped Boeing of its authority to perform the pre-delivery safety checks on MAX jets in late 2019. At the time, a faulty flight-control system and production-related missteps with that aircraft were under congressional and regulatory scrutiny. The FAA approved the 737 MAX to resume passenger flights last year.

The Dreamliner lapses are among several quality problems Boeing has faced in recent years in its commercial, defense and space programs.

Many of the 787 quality lapses involve tiny gaps where sections of the jet’s fuselage, or body of the plane, join together. Problems have emerged in other places, too, including the vertical fin and horizontal stabilizer at the tail, according to a March 12 FAA summary of the agency’s regulatory actions viewed by The Wall Street Journal.

Boeing has previously disclosed problems with a factory process used to generate small shims—materials used to fill the small gaps where the aircraft sections are joined together. Such gaps could lead to eventual premature fatigue of certain portions of the aircraft, potentially requiring extensive repairs during routine, long-term maintenance.

In its summary, the agency said it would hold on to its Dreamliner approval authority “until it is confirmed all shimming issues are resolved and airplanes conform to the FAA-approved design.”

Write to Andrew Tangel at Andrew.Tangel@wsj.com

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Business

AstraZeneca Covid-19 Vaccine Effective Against U.K. Variant in Trial

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LONDON—A Covid-19 vaccine developed by the University of Oxford and

AstraZeneca

PLC is effective against a variant of coronavirus that is spreading rapidly in the U.S. and around the world, according to a new study, a reassuring sign for governments banking on mass vaccination to bring the pandemic to an end.

The preliminary findings, published in a study online Friday that hasn’t yet been formally reviewed by other scientists, follow similarly positive results from other manufacturers.

Preliminary studies from

Pfizer Inc.

and

Moderna Inc.

found their Covid-19 shots continued to offer protection against new virus variants that have contributed to a fresh surge in cases in the U.K., Europe, South Africa and elsewhere.

Vaccine makers are nevertheless readying new shots that zero in on the new variants more precisely, underlining how mutations in the virus risk morphing the year-old pandemic into a long-running cat-and-mouse game between scientists and a shifting enemy. The virus behind Covid-19 has so far been linked to almost 2.3 million deaths worldwide and more than 100 million cases.

The study published Friday looked at the AstraZeneca vaccine’s effectiveness against a new variant of coronavirus first identified in the U.K. last year.

As new coronavirus variants sweep across the world, scientists are racing to understand how dangerous they could be. WSJ explains. Illustration: Alex Kuzoian/WSJ

The variant has now displaced older strains to become the dominant version of the coronavirus in Britain and is spreading in many other countries, including the U.S., where public-health officials have said it could become the dominant version of the virus.

Preliminary estimates suggest the variant from the U.K. is 50%–70% more transmissible than earlier versions of the virus. U.K. scientists said recently that early data suggested it could also be deadlier.

Researchers examined blood samples from around 256 participants in an ongoing clinical trial of the vaccine in the U.K. who tested positive for Covid-19.

Genetic sequencing allowed them to identify which participants were infected with the new variant and which had an older version. A little under a third had the new variant.

By testing antibody levels and other markers of immune system activity against the virus, the researchers found the vaccine triggered an effective immune response against the new variant in 75% of cases that showed symptoms of infection, and in around two-thirds of cases if those that didn’t show symptoms were also included.

The U.K. Coronavirus Variant

The small-scale study showed the vaccine works slightly better against older, more established versions of the virus. For those with the older strain, the vaccine was effective in 84% of symptomatic cases and 81% of all cases.

The researchers reported sharply differing antibody responses among the two groups, saying certain types of antibodies induced by the vaccine were up to nine times less effective at neutralizing the new variant than the old. Overall protection was similar, however, suggesting other parts of the immune system are playing a key role.

Andrew Pollard,

director of the Oxford Vaccine Group at the University of Oxford, said it isn’t entirely clear which biological mechanisms are most important. It might be infection-fighting T-cells or other types of antibodies, he said.

“We don’t know the answer,” he said.

Almost 120 million doses of vaccine have been administered worldwide, according to figures compiled by the University of Oxford’s Our World in Data project. Roll-outs have been patchy, with some countries such as Israel and the U.K. moving rapidly to inoculate their most at-risk citizens and others, including in Europe, lagging behind due to supply and other issues. The U.S. has so far given at least one dose of vaccine to 35 million people, around 10% of its population.

Vaccine makers say the technology behind Covid-19 vaccines should allow them to swiftly retool their production lines to produce shots targeted more precisely at new and emerging variants.

Some studies have suggested a variant first identified in South Africa might be less susceptible to existing vaccines than the U.K. variant. Companies including Moderna, Pfizer and its partner

BioNTech

SE,

Johnson & Johnson

and

Novavax Inc.

are designing new vaccines to specifically target the South African variant.

Babak Javid,

associate professor of infectious diseases at the University of California, San Francisco, said small differences in how vaccines perform against new variants compared with established versions isn’t a major concern provided those vaccinated are protected against severe illness and hospitalization. That will be critical to determining when countries relax lockdowns and other public health restrictions, he said.

Write to Jason Douglas at jason.douglas@wsj.com

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World

Russian Covid-19 Vaccine Was Highly Effective in Trial, Study Finds, Boosting Moscow’s Rollout Ambitions

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MOSCOW—Russia’s homegrown Sputnik V vaccine showed high levels of efficacy and safety in a peer-reviewed study released Tuesday, a potential boost for the Kremlin’s aim to promote the Covid-19 shot abroad and curb the pandemic at home.

The findings, from a preliminary analysis of a large-scale clinical trial published in the British medical journal the Lancet, demonstrated that the two-shot vaccine was 91.6% effective against symptomatic Covid-19 and offered complete protection against severe cases. There were no serious side effects, the paper said. The vaccine was also found to be similarly safe and effective in elderly people.

The study could be a significant milestone for Moscow in the global vaccination race, potentially offering President

Vladimir Putin’s

government geopolitical clout in the developing world and the chance to tap into the lucrative global vaccine market. Russia—the world’s fourth worst-hit country with nearly four million cases—has also banked on Sputnik V to avoid new costly lockdowns as authorities plan to vaccinate 60% of the domestic population by the end of the year.

The shot, which was approved by Russian authorities in August before undergoing large-scale clinical trials, has stirred questions in light of its fast-tracked development and lack of published trial data. So far, Sputnik V has been administered to more than two million people world-wide, including in Argentina, Serbia and Algeria, according to Russian authorities.

The Sputnik V Vaccine

Type: Two-dose viral vector vaccine

Efficacy: 91.6% (91.8% among people older than 60 years)

Price: Less than $10 a shot

Storage and transportation temperature: 36º-46ºF

Approved for use in: Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Guinea, Tunisia and Armenia

Administered in: Russia, Argentina, Bolivia, Belarus, Serbia, Algeria, Kazakhstan

Sources: The Lancet, Russian Direct Investment Fund

Tuesday’s results could help clear doubts surrounding the Russian shot.

“The development of the Sputnik V vaccine has been criticized for unseemly haste, corner cutting, and an absence of transparency,” virology professors Ian Jones at the U.K.’s University of Reading and Polly Roy at the London School of Hygiene & Tropical Medicine wrote in the Lancet. “But the outcome reported here is clear and the scientific principle of vaccination demonstrated, which means another vaccine can now join the fight to reduce the incidence of Covid-19.”

Alexander Gintsburg,

the head of the vaccine’s developer, the Moscow-based Gamaleya Institute, said that the data demonstrates Sputnik V’s safety and high efficacy against the virus.

This “is a great success in the global battle against the Covid-19 pandemic,” he said.

Sputnik V’s efficacy rate compares to vaccines developed by

Moderna Inc.

and

Pfizer Inc.

and its German partner

BioNTech SE,

which are around 95% effective.

The Lancet study didn’t address the shot’s usefulness against new variants of the virus, amid some early evidence suggesting strains may prove resistant to current vaccines. Russian officials said on Tuesday that they are continuously testing Sputnik V against new variants and they expect the shot to achieve the same level of efficacy. They also expect it to provide long-term immunity of as long as two years, based on early experimental evidence.

The results published on Tuesday were based on an interim analysis of a Phase 3 trial of nearly 20,000 participants, three-quarters of whom received the vaccine while the rest received a placebo. The analysis was based on a total of 78 confirmed Covid-19 cases, 62 of which were identified in the placebo group and 16 in the vaccine group. The clinical trial, totaling 40,000 volunteers, is ongoing.

Researchers found that the Covid-19 vaccine didn’t produce serious adverse reactions, the Lancet paper said. Most side effects included flulike symptoms, pain at the injection site and headaches.

Among the elderly, the vaccine was well tolerated and demonstrated an efficacy of 91.8%, based on a group of 2,144 volunteers older than 60, the paper said.

Like other Covid-19 vaccines, including ones developed by

Johnson & Johnson

and

AstraZeneca

PLC and Oxford University, Sputnik V uses a so-called viral vector approach. It introduces a genetically altered form of a harmless virus, known as the adenovirus, to serve as a vehicle—or vector—for a fragment of genetic material from the coronavirus.

As wealthier countries buy up supplies of Western drugmakers’ Covid-19 vaccines that are still in development, China and Russia are offering their fast-tracked shots to poorer nations. Here’s what they’re hoping to get in return. Illustration: Ksenia Shaikhutdinova

Each of the vaccine’s two shots is based on a different adenovirus vector, which Russian scientists say achieves a stronger immune response. Sputnik V has simpler logistics requirements compared with some of its peers, with a storage and transportation temperature of between 36 and 46 degrees Fahrenheit. The Pfizer vaccine must be kept at minus 94 degrees Fahrenheit before thawing.

With Sputnik V—a reference to the satellite the Soviet Union launched into orbit ahead of the U.S. in the Cold War space race—Russia could gain clout with some countries, analysts say, as well as participate in a global coronavirus vaccine market estimated by Russian officials at $100 billion annually.

Competing on price, Russia is selling the vaccine at less than $10 a dose, lower than Pfizer and Moderna, and is targeting up to 30% market share among Covid-19 shots in the countries buying Sputnik, according to Russian officials.

AstraZeneca has said that it would test whether a combination of its Covid-19 vaccine, which has shown to be between 62% and 90% effective depending on dosage, and Sputnik V can boost efficacy. Clinical trials for a combined shot are expected to start soon in Azerbaijan, the United Arab Emirates and other countries.

Some 15 countries outside Russia have already authorized Sputnik V, and Moscow has received orders or expressions of interest for 2.4 billion doses, including from Brazil, Mexico and India. In a bid to accelerate the global rollout, Russia will also offer a one-dose vaccine, dubbed Sputnik Light, which Russian authorities say would be between 73% and 85% effective.

To produce its vaccine, Russia relies on a global supply chain, including manufacturing hubs in Brazil, South Korea, India and China. Russia has also mounted an aggressive public-relations campaign abroad, including posting weekly video updates in English and maintaining a Twitter account for Sputnik V.

Sputnik V hasn’t been approved by Western health authorities or received authorization from the World Health Organization, which many developing countries rely on for vetting vaccines. Russia is in talks with the European Medicines Agency about approving the shot in the European Union and has applied for WHO authorization.

In Iran, health-care professionals and lawmakers criticized the government’s announcement that it would import Sputnik V, saying that the vaccine had not been approved by international bodies and that the purchase was politically motivated. Government officials said on Tuesday that Tehran would buy up to 1.5 million doses, with the first batch arriving as early as Saturday.

The domestic rollout has also faced challenges, including production delays and a skeptical populace.

Authorities have recently said that manufacturing is now being ramped up following initial equipment problems. They now expect to produce 11 million doses this month, up from seven million in January.

Around 46% of Russians said they would get a vaccine in a January survey by British polling firm Ipsos MORI, up 5 percentage points compared with December. Still, Russians were among the most reluctant to get inoculated globally, compared with 55% in France, 63% in the U.S. and 86% in the U.K.

Russia doesn’t publish daily vaccination rates, but regional data shows that at least 1.3 million Russians have received a dose so far.

Irina Levashova, a kindergarten teacher in Romodanovo, a small town some 400 miles southeast of Moscow, received her second shot last month along with her husband.

“I have many acquaintances who have been ill or even died from this disease, so I wanted to protect myself and my family,” Ms. Levashova, 58, said, adding that she didn’t experience any major side effects. “As soon as they started talking about vaccinations, I immediately told myself that me and my family would do it.”

—Valentina Ochirova contributed to this article

Write to Georgi Kantchev at georgi.kantchev@wsj.com

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