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Biden vaccination goal stands despite plant contamination, White House says

InternationalApr 05. 2021

By The Washington Post · Amy Goldstein, Jon Swaine, Christopher Rowland

WASHINGTON – The Biden administration said Sunday that the country will have sufficient coronavirus vaccine supply to meet the president’s goal of enabling every adult in the United States to get immunized by the end of May, despite the contamination of millions of doses at a troubled Baltimore manufacturing facility.

A senior administration official, who spoke on the condition of anonymity to discuss the sensitive matter, said health officials had negotiated for more than a week for an arrangement, announced late Saturday, under which Johnson & Johnson would take over responsibility for manufacturing at the plant. Johnson & Johnson developed one of the two coronavirus vaccines being made at the Baltimore facility where the cross-contamination occurred.

Federal officials were working over the weekend to pin down another U.S. site where the other vaccine produced in the facility – developed by AstraZeneca – could be manufactured and have identified potential locations.

Meanwhile, the company that owns the plant, Emergent BioSolutions, may be allowed to retain some of its employees in making the Johnson & Johnson vaccine, as long as it relinquishes all control of the manufacturing and quality inspections, the official said. Emergent Biosolutions is a major government contractor.

The developments followed the news that a batch amounting to 15 million doses of Johnson & Johnson’s vaccine was spoiled at the Emergent plant after being contaminated with ingredients for AstraZeneca’s vaccine.

The error was caught, and no contaminated vaccine left the plant, according to the companies involved. No doses had shipped, because the plant has not yet been certified by the Food and Drug Administration as a manufacturer of coronavirus vaccine.

When President Joe Biden took office in January, his administration inherited a scarcity of the two vaccines that the FDA had by then authorized for emergency use against the novel coronavirus, which can cause the illness covid-19. Those vaccines were developed by Pfizer-BioNTech and Moderna. Johnson & Johnson’s was authorized in late February.

The president and his aides have prioritized increasing vaccine supplies. A month ago, Biden pledged that stepped-up vaccine manufacturing would lead to enough doses for every adult who wanted one by the end of May.

On Sunday, the senior official said that, no matter what happens with the Baltimore plant or the manufacturing of AstraZeneca vaccine, which is not authorized for U.S. use, “there is enough vaccine for all adult Americans who want it by May 31.”

Federal rules specify that “live vector” vaccines should not be made at the same facility, but the official said it had been ambiguous whether the rule applies to the type of vaccines developed by Johnson & Johnson and by AstraZeneca, or whether two vaccines could be made in separate areas of a plant. “They proved they can’t,” the official said.

That official and two other administration officials who also spoke on the condition of anonymity to discuss the sensitive situation said that, in deciding which vaccine should continue at the Emergent facility, the Department of Health and Human Services chose to keep Johnson & Johnson because those shots could be used in the United States if the FDA certifies the plant for that use.

According to the officials, the Biden administration negotiated a path out of the plant’s contamination troubles without explicitly invoking the Defense Production Act, a 1950s-era law that has been used to accelerate vaccine-making material and other coronavirus-fighting supplies.

Johnson & Johnson said in a statement Saturday that it “is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company specialists already at Emergent.”

The company said it expects to deliver 100 million doses of its single-shot vaccine to the U.S. government by the end of May.

Emergent spokeswoman Nina DeLorenzo said the company intends to stop making the AstraZeneca vaccine in the next few days.

AstraZeneca said in a statement that it is working with the federal government “to support agreed-upon plans for the development, production and full delivery of the vaccine.”

AstraZeneca did not say how much its departure from the Emergent plant could set back its manufacturing timeline in the United States. It has taken other manufacturers six months or more to ramp up new supply of coronavirus vaccine lines.

Unrelated to the contamination by Emergent employees, AstraZeneca already has been beset by problems with clinical trials, controversy over reporting of its data, and concerns in Europe about blood clots showing up as a rare side effect. In May 2020, the company predicted that it would begin delivering the first of 300 million doses of its vaccine for the United States in the fall, but it did not meet that promise, nor has the FDA authorized it for emergency use.

For Emergent to spoil raw vaccine substance amounting to 15 million doses suggests a breakdown in quality control at early stages of manufacturing that should have been caught in subsequent steps, said John Avellanet, an FDA compliance expert who is managing director at Cerulean Associates, a pharmaceutical consulting firm.

If contamination had been detected earlier in the process, he said, it probably would have affected far less product. Johnson & Johnson had said last year that Emergent would be making vaccine in single-use, 1,000-liter bioreactor bags. The magnitude of this incident indicates that more than one bag’s product was probably affected, Avellanet said, adding that it was highly unusual for so much vaccine substance to be ruined in one incident.

“This kind of thing just does not happen,” Avallenet said.

The changes in vaccine production at the plant were first reported Saturday by The New York Times.

The Washington Post reported last week that an FDA investigator flagged problems at the Baltimore facility six weeks before the Trump administration announced a $628 million deal with Emergent as part of Operation Warp Speed, the government’s program at the time to develop and produce vaccines to fight the novel coronavirus.

Emergent secured deals totaling more than $740 million with Johnson & Johnson and AstraZeneca to produce vaccines for both companies at the Baltimore site.

The Post reported last year that Emergent had benefited from billions of dollars in federal contracts as health officials directed public spending toward the threat of bioterrorism attacks at the expense of some preparations for a pandemic.

Emergent’s Warp Speed deal was made as part of a long-standing contract between the company and the agency within the Department of Health and Human Services responsible for preparing for public health threats.

At the time of the award, that agency was led by Assistant Secretary Robert Kadlec. The Post previously reported that before joining the Trump administration, Kadlec was paid as a consultant to Emergent and formed a start-up company with Emergent’s chairman. Kadlec did not mention either role in a questionnaire about his career that he completed for the Senate when it considered his nomination by Trump in 2017. Kadlec and Emergent previously told The Post that Kadlec’s past work for Emergent had no bearing on the firm’s government contracts.

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Australia sets national record for virus vaccinations in a day

InternationalApr 05. 2021

By Syndication Washington Post, Bloomberg · Thuy Ong

Australia says it has given nearly 80,000 people a virus vaccination to set a new single-day high, boosted by strong stockpiles.

A record 79,283 people received an initial dose on Thursday, the latest day that such data is available, Health Minister Greg Hunt told a press briefing on Sunday.

“The supply at this stage is looking strong,” he said. “Given the great and enormous global competition, the fact we have this domestic supply is fundamental.”

Australia has nearly eliminated local transmissions by closing its international border to non-residents, but occasional cases have leaked into the community from quarantine hotels where returned overseas travelers must isolate for 14 days. States have imposed several snap lockdowns in recent months to contain clusters.

Australia has met its principal targets for vaccination start dates, Hunt added, and wants to see everyone who wants a shot getting an initial dose by the end of October. More than 841,000 vaccinations have been completed across Australia as of Saturday evening, he added.

The government is behind on its vaccine rollout plans, Mark Butler of the opposition Australian Labor Party said Sunday. Prime Minister Scott Morrison had promised 4 million doses would be given by the end of March, Butler said.

Australian authorities said on Saturday they were working with the European Union and the U.K. to investigate the first local case of an unusual clotting in a patient after receiving the AstraZeneca Plc vaccine.

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Phone numbers, personal information for 533 million Facebook users exposed online, report says

InternationalApr 05. 2021

By The Washington Post · Hannah Knowles

Personal information on more than 500 million Facebook users – previously leaked and now made more widely available – was shared online Saturday, according to the news site Insider, worrying experts who said the compromised data could make people more vulnerable to fraud.

Insider said it reviewed a sample of the leaked phone numbers, birth dates, biographical details and more and found that some data matched known Facebook users’ records. The Washington Post has not independently verified the information. Facebook said the leak involved “old” data stemming from a problem resolved in 2019, but the news still sparked renewed scrutiny of a social media giant previously dogged by high-profile concerns about data privacy.

“Bad actors will certainly use the information for social engineering, scamming, hacking and marketing,” tweeted Alon Gal, the co-founder of an Israeli cybercrime intelligence company called Hudson Rock, who flagged the release of the Facebook data Saturday. Social engineering involves getting access to people’s confidential information by gaining their trust rather than overcoming technical barriers – for example, by impersonating a tech support person.

“I have yet to see Facebook acknowledging this absolute negligence of your data,” Gal tweeted. Gal said the compromised data also included Facebook IDs, full names, locations, some email addresses, relationship statuses and other details.

Facebook did not immediately respond to questions Saturday evening, but company spokeswoman Liz Bourgeois tweeted Saturday that the leak detailed by Insider involved “old data that was previously reported on in 2019.”

“We found and fixed this issue in August 2019,” Bourgeouis wrote.

Insider said a Facebook spokesperson told the news organization that the data was scraped through a now-fixed vulnerability.

The breach affected more than 533 million users spanning 106 countries, according to Insider, and includes more than 32 million records for users in the United States.

Gal told The Washington Post that the leaked database was previously sold for tens of thousands of dollars and then circulated, selling for lower prices until it finally was offered at no charge.

Early this year, Gal said, someone built a bot that gave people access to the database for a fee – a development that made the trove of data “much more worrisome,” Gal tweeted at the time. Motherboard reported in January on that peddling of access in a “low-level cybercriminal forum.”

On Saturday a user posted on a forum offering the data free.

The Post messaged the user on the app Telegram and did not immediately hear back.

Facebook – the world’s most popular social media site, with well over 2 billion users – has drawn rebukes before for its handling of people’s data. In 2019, the Federal Trade Commission fined the company $5 billion, alleging that it misled users about how third parties such as advertisers were accessing their personal information. Facebook did not have to admit guilt, but its settlement with the government included what was the largest privacy violation fine in American history.

The FTC began investigating after reports that Cambridge Analytica, a firm that worked with the campaign of former president Donald Trump, had improperly accessed names, “likes” and other information for millions of users without their knowledge.

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Johnson & Johnson says it will take full control of its coronavirus vaccine production at Baltimore plant

InternationalApr 05. 2021

By The Washington Post · Jon Swaine

Johnson & Johnson will take full control of the production of its coronavirus vaccine at a troubled plant in Baltimore where millions of doses worth of drugs were contaminated, the company said late Saturday.

Production at the plant of the vaccine developed by AstraZeneca will be relocated with help from the Biden administration following the mix-up, according to AstraZeneca and a seniorfederal health official.

The developments followed the news that a batch amounting to 15 million doses of Johnson & Johnson’s vaccine was spoiled at the plant after being contaminated with ingredients for AstraZeneca’s vaccine.

The error was caught and no contaminated drugs made it out of the plant, according to the companies involved.

The plant is operated by Emergent BioSolutions, a major government contractor. The senior health official said the administration had determined that only one vaccine should be made at the facility.

Johnson & Johnson said in a statement that it was “assuming full responsibility” of production of its vaccine at the plant and that it was sending additional staff to Baltimore to oversee production.

“Specifically, the company is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company specialists already at Emergent,” the statement said.

AstraZeneca said in a statement that it was working with the government to find an alternative location for production of its vaccine, which has not yet been authorized by U.S. authorities.

“AstraZeneca and the U.S. government continue to work closely together to support agreed upon plans for the development, production and full delivery of the vaccine,” the statement said.

Johnson & Johnson said that it still expected to deliver 100 million doses of its single-shot vaccine to the U.S. government by the end of May. President Biden has pledged that all American adults will be eligible for vaccination by that time.

Emergent spokeswoman Nina DeLorenzo confirmed Saturday that the company had been notified that production of the AstraZeneca vaccine would be relocated and that Emergent intended to stop making the vaccine in the next few days.

“We are welcoming additional Johnson & Johnson personnel on-site at Bayview for their technical expertise and support,” DeLorenzo said.

The changes in vaccine production at the plant were first reported Saturday by the New York Times.

Emergent’s coronavirus vaccine production line has not yet been certified by the Food and Drug Administration. Until it is certified, vaccines made there cannot be distributed to consumers. Drugs made at the Baltimore plant have been set aside while the FDA reviews the Emergent plant.

The Washington Post reported on Thursday that an FDA investigator flagged problems at the Baltimore facility six weeks before the Trump administration announced a $628 million deal with Emergent as part of Operation Warp Speed, the government’s program to rapidly produce vaccines to fight the novel coronavirus.

Emergent secured deals totaling more than $740 million with Johnson & Johnson and AstraZeneca to produce vaccines for both companies at the Baltimore site.

The Post reported last year that Emergent had benefited from billions of dollars in federal contracts as health officials directed public spending toward the threat of bioterrorism attacks at the expense of some preparations for a pandemic.

Emergent’s Warp Speed deal was made as part of a long-standing contract between the company and the office in the Department for Health and Human Services responsible for preparing for public health threats.

At the time of the award, that office was led by Assistant Secretary Robert Kadlec. The Post previously reported that before joining the Trump administration, Kadlec was paid as a consultant to Emergent and formed a startup company with Emergent’s chairman. Kadlec did not mention either role in a questionnaire about his career that he completed for the Senate when it considered his nomination by Donald Trump in 2017. Kadlec and Emergent previously told The Post that Kadlec’s past work for Emergent had no bearing on the firm’s government contracts.

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How the Ever Given was freed from the Suez Canal

InternationalApr 04. 2021

By Atthar Mirza, Júlia Ledur, Ruby Mellen
The Washington Post

The crisis in the Suez Canal last month turned the world’s attention on a single challenge few had ever considered: how to refloat a 200,000-ton mass of steel, as long as the Empire State Building is high.

Digging, tugging and pulling, it turned out, freed the ship. The days-long, round-the-clock effort to move the massive vessel involved sucking sand and mud from underneath its hull, as tugboats pushed and pulled the ship in confluence with a swelling tide.

Here’s how it happened.

The Ever Given container ship became stuck at an angle in the Suez Canal during a sandstorm on March 23, blocking for six days a vital waterway through which about 15 percent of all shipping passes.

Using satellite imagery and vessel data, The Post reconstructed the operation that released the ship

The canal narrows below the shoreline, which meant the ship was much more stuck than it appeared to be in photos. Riprap, or loosely placed stones, lines the banks, which made it even harder to dislodge the ship.

A fleet of tugboats, dredgers and salvage crews worked for several days to refloat the ship. On Monday morning, they managed to free the stern, the back of the vessel, the most visible sign of progress since the blockage.

After a morning boost from a high tide reaching nearly seven feet, a new attempt to release the Ever Given began Monday afternoon.

The Ever Given was fully dislodged on Monday at 3:05 p.m. local time.

The Ever Given got stuck the morning of March 23, amid poor visibility and high winds in one of the narrower parts of the 120-mile canal. Egyptian officials have launched an investigation into the details of the crash.

“When you’re traveling on a boat and you hit something, there’s a tremendous sense of loss,” said Gregory Tylawsky, a licensed shipmaster and founder of the Maritime Expert Group.

Early in the crisis, experts were unsure how they would be able to move the ship. “It is not really possible to pull it loose,” said Peter Berdowski, the CEO of Dutch dredging company Boskalis, which helped with the week’s efforts.

The vessel, he said, was like “an enormous beached whale.”

The canal is dug in sand and mud, meaning a boat hitting the edge would get “stuck in the sand rather than [getting] repelled by a hard wall,” said Ragui Assaad, a professor at the University of Minnesota and research fellow at the Economic Research Forum in Cairo.

There is little room for error. “As a pilot, you cannot deviate from that center line,” Tylawsky said.

Within hours of the blockage, tugboats were on the scene, followed by dredgers, working through the week to free the Japanese-owned, Taiwanese-operated ship.

– – –

Each hour the Ever Given remained stuck on a muddy bank of the Suez Canal meant worse disruptions to international commerce. A substantial share of all shipping passes through the waterway. In the face of delays, the prices of oil and coffee began to rise, and livestock faced starvation aboard some of the hundreds vessels left waiting indefinitely.

With a ship that size already caught in the canal’s bank, there wouldn’t be much for the operators to do.

“It’d be controlled chaos onboard,” said Gary Cordes, a retired shipmaster and senior adviser at the Maritime Expert Group, who said he transited the canal nine times between the 1960s and 1980s. He said it would fall on those familiar with the landscape to come up with a plan to free the ship.

Authorities worked day and night, dredging and using tugboats to dig and pull the ship away from the banks. Salvagers dredged underneath and around the hull, pumping sediment from the bottom of the canal.

The dredgers on scene were heavy-duty. The 10th of Ramadan came to help, as did the Dutch-made Mashhour, owned and operated by the Suez Canal Authority, which was touted by the Transportation Research Board in 1996 as the “world’s largest and most powerful stationary cutter suction dredger,” capable of sucking up “abrasive sand with gravel, compacted sand, sticky clay and rocks.”

Often more than 10 tugboats were also leading the effort, pushing and pulling the ship in an effort to dislodge it from the bank.

Loaders excavated the eastern embankment at the ship’s bow. Over the weekend, those efforts removed nearly 1 million cubic feet of mud and water, officials said.

In an added effort to refloat the ship, some 9,000 tons of the Ever Given’s ballast water – used to stabilize the ship – were released to help lighten the vessel, officials said.

– – –

While efforts throughout the week proved unsuccessful, the weekend bore promises of shifting tides. A full moon on Sunday night meant unusually high waters that could help refloat the ship. And more help was on the way: two big and powerful tugboats, the Dutch-flagged Alp Guard and the Italian-flagged Carlo Magno.

Through Sunday night into Monday afternoon, teams worked tirelessly to get enough of the sand and mud out from under the boat that it would rejoin the canal’s waters, staving off a catastrophe for global trade.

On Monday afternoon around 3 p.m., the Ever Given broke free, its leviathan haul slowly creeping north to the Great Bitter Lake.

“I think they did a spectacular job,” said Cordes, acknowledging he initially thought the effort would maybe take “a couple of weeks.”

The mood on the scene in the Suez Canal was ebullient, as workers cheered and vessels honked. But the ripples of the Ever Given’s release were felt around the globe.

“To do that is one thing but to do it in front of the world, with the world watching, it was massive,” Tylawsky said.

– – –

About this report: Sources: VesselFinder, Suez Canal Authority, Leth Agencies. Satellite image 2021 Maxar Technologies. The 3-D models of the Suez Canal were built based on measurements from the engineering department of the Suez Canal Authority. The positions of the Ever Given container ship and the tugboats are based on satellite imagery by Maxar, Airbus Space and Planet Labs Inc., as well as location data from VesselFinder. The dredger position is an approximation based on satellite images of the scene.