results of a clinical trial suggested that the vaccine from AstraZeneca offered little protection from mild or moderate infections caused by the Beta variant that was circulating in South Africa.

Weeks later, Johnson & Johnson and the government signed a contract for 11 million doses. South Africa ordered another 20 million doses in April. That would be enough to vaccinate about half the country.

South Africa agreed to pay $10 per dose for the 11 million shots, according to the contract. That was the same price that the United Statespaid and slightly more than the $8.50 that the European Commission agreed to pay. The South African contract prohibited the government from banning exports of the vaccine, citing the need for doses to “move freely across national borders.”

introduced export controls this year to conserve scarce supplies. India halted exports produced by the Serum Institute, which was supposed to be a major vaccine supplier to poor countries. In the United States, officials said they didn’t ban exports, but they didn’t need to. The combination of the extensive vaccine production on American soil and the high prices the U.S. government was willing to pay meant that companies made the delivery of shots for Americans a priority.

Other benefits for Johnson & Johnson were embedded in the South African contract.

While such contracts typically protect companies from lawsuits brought by individuals, this one shielded Johnson & Johnson from suits by a wider range of parties, including the government. It also imposed an unusually high burden on potential litigants to show that any injuries caused by the vaccine were the direct result of company representatives engaging in deliberate misconduct or failing to follow manufacturing best practices.

“The upshot is that you have moved almost all of the risk of something being wrong with the vaccine to the government,” said Sam Halabi, a health law expert at Georgetown University who reviewed sections of the South African contract at the request of The Times.

Mr. Halabi said the contract’s terms appeared more favorable to the pharmaceutical company than other Covid vaccine contracts he had seen. South African officials have said Pfizer, too, sought aggressive legal protections.

The contract said Johnson & Johnson would aim to deliver 2.8 million doses to South Africa by the end of June, another 4.1 million doses by the end of September and another 4.1 million doses by the end of December. (The government expects the 20 million additional doses to be delivered by the end of this year, Mr. Maja said.)

The company has so far fallen far short of those goals. As of the end of June, South Africa had received only about 1.5 million of the doses from its order. The small number of doses that have been delivered to the African Union were on schedule.

The difficulties in procuring doses have revealed the limits of fill-and-finish sites, which leave countries dependent on vaccines from places like the European Union or the United States, said Dr. Salim Abdool Karim, who until March was co-chairman of South Africa’s ministerial advisory committee on Covid.

“Ultimately,” he said, “the solution to our problem has to be in making our own vaccines.”

Lynsey Chutel and Choe Sang-Hun contributed reporting.

View Source

>>> Don’t Miss Today’s BEST Amazon Deals! <<<<

100 Million Vaccine Doses Held Up Over Contamination Concerns, Emergent Reveals

WASHINGTON — The chief executive of Emergent BioSolutions, whose Baltimore plant ruined millions of coronavirus vaccine doses, disclosed for the first time on Wednesday that more than 100 million doses of Johnson & Johnson’s vaccine are now on hold as regulators check them for possible contamination.

In more than three hours of testimony before a House subcommittee, the chief executive, Robert G. Kramer, calmly acknowledged unsanitary conditions, including mold and peeling paint, at the Baltimore plant. He conceded that Johnson & Johnson — not Emergent — had discovered contaminated doses, and he fended off aggressive questions from Democrats about his stock sales and hundreds of thousands of dollars in bonuses for top company executives.

Emergent’s Bayview Baltimore plant was forced to halt operations a month ago after contamination spoiled the equivalent of 15 million doses, but Mr. Kramer told lawmakers that he expected the facility to resume production “in a matter of days.” He said he took “very seriously” a report by federal regulators that revealed manufacturing deficiencies and accepted “full responsibility.”

“No one is more disappointed than we are that we had to suspend our 24/7 manufacturing of new vaccine,” Mr. Kramer told the panel, adding, “I apologize for the failure of our controls.”

Federal campaign records show that since 2018, Mr. El-Hibri and his wife have donated more than $150,000 to groups affiliated with Mr. Scalise. The company’s political action committee has given about $1.4 million over the past 10 years to members of both parties.

Mr. El-Hibri expressed contrition on Wednesday. “The cross-contamination incident is unacceptable,” he said, “period.”

Mr. Kramer’s estimate of 100 million doses on hold added 30 million to the number of Johnson & Johnson doses that are effectively quarantined because of regulatory concerns about contamination. Federal officials had previously estimated that the equivalent of about 70 million doses — most of that destined for domestic use — could not be released, pending tests for purity.

confidential audits, previously reported by The Times, that cited repeated violations of manufacturing standards. A top federal manufacturing expert echoed those concerns in a June 2020 report, warning that Emergent lacked trained staff and adequate quality control.

“My teenage son’s room gives your facility a run for its money,” Representative Raja Krishnamoorthi, Democrat of Illinois, told Mr. Kramer.

Mr. Kramer initially testified that contamination of the Johnson & Johnson doses “was identified through our quality control procedures and checks and balances.” But under questioning, he acknowledged that a Johnson & Johnson lab in the Netherlands had picked up the problem. Johnson & Johnson hired Emergent to produce its vaccine and, at the insistence of the Biden administration, is now asserting greater control over the plant.

The federal government awarded Emergent a $628 million contract last year, mostly to reserve space at the Baltimore plant for vaccine production. Among other things, lawmakers are looking into whether the company leveraged its contacts with a top Trump administration official, Dr. Robert Kadlec, to win that contract and whether federal officials ignored known deficiencies in giving Emergent the work.

Mr. El-Hibri told lawmakers that the government and Johnson & Johnson were aware of the risks.

“Everyone went into this with their eyes wide open, that this is a facility that had never manufactured a licensed product before,” he said. While the Baltimore plant was “not in perfect condition — far from it,” he argued that the facility “had the highest level of state of readiness” among the plants the government had to choose from.

the coronavirus leaked from a laboratory in China, the “lies of the Communist Party of China,” mask mandates and the Biden administration’s call for a waiver of an international intellectual property agreement.

“You are a reputable company that has done yeoman’s work to protect this country in biodefense,” exclaimed Representative Mark E. Green, Republican of Tennessee, adding, “So you gave your folks a bonus for their incredible work.”

Emergent is skilled at working Washington. Its board is stocked with former government officials, and Senate lobbying disclosures show that the company has spent an average of $3 million a year on lobbying over the past decade. That is about the same as two pharmaceutical giants, AstraZeneca and Bristol Myers Squibb, whose annual revenues are at least 17 times higher.

Democrats pressed Mr. Kramer and Mr. El-Hibri about their contacts with Dr. Kadlec, who previously consulted for Emergent. Documents show that Emergent agreed to pay him $120,000 annually between 2012 and 2015 for his consulting work, and that he recommended that Emergent be given a “priority rating” so that the contract could be approved speedily. Dr. Kadlec has said he did not negotiate the deal but did sign off on it.

“Did you or any other Emergent executives speak to or socialize with Dr. Kadlec while these contracts were being issued?” Representative Nydia M. Velázquez, Democrat of New York, asked Mr. Kramer.

“Congresswoman,” he replied carefully, “I did not have any conversations with Dr. Kadlec about this.”

A Times investigation found that Emergent has exercised outsize influence over the Strategic National Stockpile, the nation’s emergency medical reserve; in some years, the company’s anthrax vaccine has accounted for as much as half the stockpile’s budget.

The investigation found that some federal officials felt the company was gouging taxpayers — an issue that also came up at Wednesday’s hearing when Representative Carolyn B. Maloney, Democrat of New York, demanded to know how much it cost to make the vaccine and what it sold for. Mr. El-Hibri promised to supply the information later.

Company executives also view their coronavirus work as one of the “prime drivers” of its 2020 revenues, according to a memorandum released on Wednesday by committee staff members. The executives were rewarded for what the company’s board called “exemplary overall 2020 corporate performance including significantly outperforming revenue and earnings targets.”

Mr. Kramer received a $1.2 million cash bonus in 2020, the records show, and also sold about $10 million worth of stock this year, in trades that he said were scheduled in advance and approved by the company. Three of the company’s executive vice presidents received bonuses ranging from $445,000 to $462,000 each.

Sean Kirk, the executive responsible for overseeing development and manufacturing operations at all of Emergent’s manufacturing sites, received a special bonus of $100,000 last year, in addition to his regular bonus of $320,611, in part for expanding the company’s contract manufacturing capability to address Covid-19, the documents show. Mr. Kirk is now on personal leave.

Emergent officials “appear to have wasted taxpayer dollars while lining their own pockets,” Ms. Maloney charged.

Mr. Krishnamoorthi asked Mr. Kramer if he would consider turning over his bonus to the American taxpayers.

“I will not make that commitment,” Mr. Kramer replied.

“I didn’t think so,” Mr. Krishnamoorthi shot back.

Rebecca R. Ruiz contributed reporting.

View Source

Emergent, Which Ruined Vaccine Doses, Gave Its Top Executives Bonuses

Mr. Kramer received a $1.2 million cash bonus, the records show; the board found that he had “significantly exceeded expectations.” Three of the company’s executive vice presidents received bonuses ranging from $445,000 to $462,000 each.

Sean Kirk, the executive responsible for overseeing development and manufacturing operations at all of Emergent’s manufacturing sites, received a special bonus of $100,000 last year, over and above his regular bonus of $320,611, in recognition of his “exceptional performance in 2020,” and for significantly expanding the company’s contract manufacturing capability to address Covid-19, the documents show.

Mr. El-Hibri, who was praised for leveraging his connections, cashed in stock worth $42 million last year, according to an investigation by The Times.

Over the past two decades, Emergent has grown from a fledgling biotech company into a firm with annual revenues that last year topped $1.5 billion. Much of its success has come from selling products aimed at thwarting a bioterrorist attack, including its anthrax vaccine, to the Strategic National Stockpile, the nation’s emergency medical reserve.

The $628 million contract, awarded by the Trump administration nearly a year ago, was mostly to reserve space at Emergent’s Baltimore plant for vaccine manufacturing. The contract was approved by a former Trump administration official, Dr. Robert Kadlec, who previously consulted for Emergent.

The documents show that Emergent retained Dr. Kadlec to serve as a consultant from 2012 through 2015, agreeing to pay him $120,000 annually over that three-year period. In return, Dr. Kadlec agreed to provide advice on “international biosecurity and biodefense related issues to Emergent BioSolutions,” including outreach to senior government officials in Saudi Arabia and other countries.

Dr. Kadlec has said that while he did not negotiate the contract, he did sign off on it. The documents show he recommended that Emergent be given a “priority rating” so that it could be approved speedily.

Rebecca R. Ruiz contributed reporting.

View Source

Biden Signs Executive Order to Bolster Federal Government’s Cybersecurity

WASHINGTON — As the East Coast suffered from the effects of a ransomware attack on a major petroleum pipeline, President Biden signed an executive order on Wednesday that placed strict new standards on the cybersecurity of any software sold to the federal government.

The move is part of a broad effort to strengthen the United States’ defenses by encouraging private companies to practice better cybersecurity or risk being locked out of federal contracts. But the bigger effect may arise from what could, over time, become akin to a government rating of the security of software products, much the way automobiles get a safety rating or restaurants in New York get a health safety grade.

The order comes amid a wave of new cyberattacks, more sophisticated and far-reaching than ever before. Over the past year, roughly 2,400 ransomware attacks have hit corporate, local and federal offices in extortion plots that lock up victims’ data — or publish it — unless they pay a ransom.

The most urgent fear is an attack on critical infrastructure, a point made clear this week to Americans, who were panic-buying gasoline. A ransomware attack on Colonial Pipeline’s information systems forced the company to shut down a critical pipeline that supplies 45 percent of the East Coast’s gasoline, diesel and jet fuel for several days.

SolarWinds hack, in which Russia’s premier intelligence agency altered the computer code of an American company’s network management software. It gave Russia broad access to 18,000 agencies, organizations and companies, mostly in the United States.

The new order also requires all federal agencies to encrypt data, whether it is in storage or while it is being transmitted — two very different challenges. When China stole 21.5 million files about federal employees and contractors holding security clearances, none of the files were encrypted, meaning they could be easily read. (Chinese hackers, investigators later concluded, encrypted the files themselves — to avoid being detected as they sent the sensitive records back to Beijing.)

Previous efforts to mandate minimum standards on software have failed to get through Congress, notably in a major showdown nine years ago. Small businesses have said the changes are not affordable, and larger ones have opposed an intrusive role of the federal government inside their systems.

But Mr. Biden decided it was more important to move quickly than to try to fight for broader mandates on Capitol Hill. His aides said it was a first step, and industry officials said it was bolder than they expected.

Amit Yoran, the chief executive of Tenable and a former cybersecurity official in the Department of Homeland Security, said the question on everyone’s mind was whether Mr. Biden’s order would stop the next Colonial or SolarWinds attacks.

“No one policy, government initiative or technology can do that,” Mr. Yoran said. “But this is a great start.”

Government officials have complained that Colonial had poor defenses, and while it established a hard shell around its computer networks, it had no way of monitoring an adversary who got inside. The Biden administration hopes the standards set out in the executive order, requiring multifactor authentication and other safeguards, will become widespread and improve security globally.

Senator Mark Warner, Democrat of Virginia and the chairman of the Senate Intelligence Committee, praised the order but said it would need to be followed by congressional action.

Mr. Warner said recent attacks “have highlighted what has become increasingly obvious in recent years: that the United States is simply not prepared to fend off state-sponsored or even criminal hackers intent on compromising our systems for profit or espionage.”

The new order is the first major public part of a multilayered review of defensive, offensive and legal strategies to take on adversaries around the world. This executive order, however, focuses entirely on deepening defenses, in hopes of deterring attackers because they fear they would fail — or run a higher risk of being detected.

The Justice Department is ramping up a new task force to take on ransomware, after the discovery in recent months that such attacks are more than just extortion, they can bring down sectors of the economy.

Mr. Biden announced sanctions against Russia for the SolarWinds hack, and his national security adviser, Jake Sullivan, has said there will also be “unseen” consequences. So far, the United States has not taken similar action against China’s government for its presumed involvement in another attack, exploiting holes in a Microsoft system used by large companies around the world.

The executive order was first drafted in February in response to the SolarWinds intrusion. That attack was especially sophisticated because hackers working for the Russian government managed to change code under development by the company, which unsuspectingly distributed the malware in an update to its software packages. It was discovered during Mr. Biden’s transition and led him to declare he could not trust the integrity of federal computer systems.

The review board created under the executive order will be co-led by the secretary of homeland security and a private-sector official, based on the specific episode it is investigating at the time, in an effort to win over industry executives who fear the investigations could be fodder for lawsuits.

Because it was created by an executive order, not an act of Congress, the new board will not have the same broad powers as a safety board. But officials are still hopeful it will be valuable in learning of vulnerabilities, improving security practices and urging companies to invest more in improving their networks.

Much of the executive order is focused on information sharing and transparency. It aims to speed the time companies that have been victimized by a hack or discover vulnerabilities share that information with the Cybersecurity and Infrastructure Security Agency.

View Source

Baltimore Vaccine Plant’s Troubles Ripple Across Africa, Europe and Canada

WASHINGTON — Quality-control problems at a Baltimore plant manufacturing Covid-19 vaccines have led health officials on three continents to pause the distribution of millions of Johnson & Johnson doses, as the troubles of a politically connected U.S. contractor ripple across the world.

Doses made at the plant owned by Emergent BioSolutions have not been cleared by the Food and Drug Administration for use in the United States, and the Biden administration has repeatedly assured Americans that none of the Johnson & Johnson shots administered domestically were made there.

But millions of doses have been shipped abroad, including to Canada, the European Union and South Africa. Regulators in various countries are now working to ensure that those doses are safe after the disclosure in March that workers at the Baltimore plant accidentally contaminated a batch of Johnson & Johnson’s vaccine with the harmless virus used to manufacture AstraZeneca’s. Both vaccines were produced at the same site. The mistake forced Emergent to throw out up to 15 million Johnson & Johnson doses after tests showed that the batch failed to meet purity requirements.

E.U. officials, as well as those in Canada and South Africa, said there was no evidence that any of the doses they had received were tainted. But the problems identified in Baltimore have slowed their vaccination efforts while they perform additional quality assessments as a precaution.

said they would “not allow the release of any product until we feel confident that it meets our expectations for quality.” The plant is still finishing batches of vaccine that were already in process.

previously acknowledged that it had allowed doses of AstraZeneca’s Covid-19 vaccine made at the same Emergent plant to be sent to Canada and Mexico but said it had not attested to their quality, instead leaving that assessment to the company and authorities in both countries. Unlike the Johnson & Johnson vaccine, the AstraZeneca vaccine is not approved for use in the United States.

The Times reported last month that Emergent had discarded five lots of AstraZeneca vaccine — each the equivalent of two million to three million doses — between October and January because of contamination or suspected contamination at the same Bayview plant in Baltimore.

The European Union’s drug regulator, the European Medicines Agency, said in a statement to The Times that one batch of vaccine manufactured at the Emergent facility “is being used” after “a thorough testing of the batch and a review of the controls in place at the manufacturing site.” There is no indication of any problems with those doses.

That batch was distributed for use in the European Union only after meeting “the rigorous quality standards of our company and the European Medicines Agency,” Johnson & Johnson said in a statement.

Two more batches, amounting to about 2.5 million doses, are on hold as regulators in Europe and the United States investigate the cause of the contamination at the Emergent plant and ensure that problems have been fixed, the E.M.A. said.

“When the investigations conclude, E.M.A. may decide on actions to prevent future contamination of batches,” the statement said.

Batches of vaccine made at Emergent are not released for bottling until they have passed required safety tests, including one designed to identify “adventitious agents” such as a virus used in the manufacture of another product. People familiar with Emergent’s processes said the tests were much the same whether the vaccine was destined for domestic or foreign use.

one of the lowest vaccination rates of any country, and the Johnson & Johnson vaccine is particularly important to the nation’s plans. Many developing countries are relying on AstraZeneca’s vaccine, but South Africa stopped using it in February after a trial indicated that it was less effective against the dominant coronavirus variant then circulating in the country.

Under its contract with Johnson & Johnson, Emergent manufactured the active ingredient for the vaccine in bulk, and the substance was then sent to other facilities for final processing and packaging. One of the sites performing these final manufacturing stages is a plant run by the South African company Aspen Pharmacare. Johnson & Johnson announced in March that the site would support the company’s pledge to provide vaccine to countries throughout Africa.

The Canadian regulatory authority, Health Canada, said in a statement that officials were working with Johnson & Johnson and the F.D.A. to perform further assessments of vaccine manufactured at the Emergent facility and that the doses “will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy.”

The newly disclosed delays underscore the global impact of the problems at the Baltimore factory operated by Emergent, a government contractor known for its aggressive lobbying and political connections.

As The Times previously reported, the federal government last year banked on Emergent to be the main domestic manufacturer for both the Johnson & Johnson and AstraZeneca vaccines even as evidence of serious quality problems mounted.

announced “significant revenue growth and corresponding profitability” for the first quarter of this year and projected record revenues for 2021, driven largely by the company’s Covid-19 vaccine manufacturing deals.

Emergent built a profitable business largely by cornering the market for biodefense products, a Times investigation found. Throughout most of the last decade, sales of the company’s anthrax vaccines accounted for nearly half of the annual budget of the nation’s emergency medical reserve, the Strategic National Stockpile, leaving the federal government with less money to buy supplies needed in a pandemic.

Emergent has repeatedly touted its influence in Washington in presentations to investors. Six of its 10 board members have previously served in government, and since 2010, the company has spent an average of $3 million a year on lobbying — far outspending similarly sized biotech firms, and roughly matching the outlays of some larger pharmaceutical companies.

Matina Stevis-Gridneff contributed reporting from Brussels and Ian Austen from Ottawa.

View Source

Shake-Up at Covid Vaccine Manufacturer That Tossed Millions of Doses

The Baltimore plant is one of two federally designated sites that were supposed to be ready to manufacture vaccines or therapeutics in a public health emergency. In June 2020, the Trump administration awarded Emergent a $628 million contract, mostly to reserve space in Baltimore to produce coronavirus vaccines.

In Washington, Emergent is known for its aggressive lobbying and government connections spanning both Democratic and Republican administrations. The company’s board is stocked with former federal officials, and its ranks of lobbyists include former members of Congress.

“We’ve been at this for 22 years as a company,” Mr. Kramer said on Thursday’s call, adding that the firm’s relationships with government agencies, including the Biomedical Advanced Research and Development Agency, known as BARDA, which issued the $628 million contract, “remain intact and strong.”

In June 2020, shortly after the Trump administration awarded the contract to Emergent, a top official from Operation Warp Speed, the government’s fast-track vaccine initiative, warned that the company lacked enough trained staff and had a record of problems with quality control.

A copy of the official’s assessment, obtained by The Times, cited “key risks” in relying on Emergent to handle the production of vaccines developed by both Johnson & Johnson and AstraZeneca at the same plant in Baltimore.

Cross-contamination is a “well-known risk” when making two vaccines using live viruses, Mr. Kramer said on Thursday, but the decision to produce both in Baltimore was the government’s. There were layers of safeguards in place, he said, though Emergent believes that they “did not function as anticipated” and that the AstraZeneca virus probably contaminated the Johnson & Johnson batch.

“It’s easy to go back and second-guess these decisions that were made in the early stages of the pandemic,” he said. “At the time, no one knew how fast we can get into a clinically viable vaccine, and which candidates would be most successful.”

View Source

Blue Origin Challenges NASA Over SpaceX Moon Lander Deal

Mr. Smith said Blue Origin would put in bids on a future competition. But he added, “The idea that we’re going to be able to restore competition with something that right now is completely undefined and completely unfunded doesn’t make a lot of sense to us.”

When Bill Nelson, a former senator from Florida whom President Biden has nominated to be the next administrator for NASA, testified at a confirmation hearing last week, Senator Maria Cantwell, Democrat of Washington and chairwoman of the Senate Committee on Commerce, Science and Transportation, asked him to commit to providing Congress with a plan for how NASA would ensure commercial competition in the moon lander program.

“I do,” Mr. Nelson said. “Competition is always good.”

Mr. Smith said that with similar programs in the past, like the space station missions, NASA had hired more than one company even though it lacked certainty on future budgets.

The Blue Origin-led bid, at $6.0 billion, was more than double the price of SpaceX’s. But Mr. Smith said NASA had gone back to SpaceX and negotiated the price of its proposal, even though it did not have similar discussions with the other two teams.

“We didn’t get a chance to revise and that’s fundamentally unfair,” Mr. Smith said.

Less than $9 billion would have paid for two landers, and that is comparable to the $8.3 billion cost of the commercial crew program that now provides transportation to the space station, the protest argued.

“NASA is getting some great, great value from these proposals,” Mr. Smith said.

NASA’s evaluations of the bids gave ratings of “acceptable” on the technical aspects of Blue Origin’s and SpaceX’s proposals. Dynetics’s rating was lower, at “marginal.” SpaceX’s management was regarded as “outstanding,” while Blue Origin and its partners were judged, “very good,” as was Dynetics.

Mr. Smith said NASA misjudged aspects of its proposal, like the communications system and redundancy in guidance and navigation, as weaknesses. He also said it downplayed the risks in SpaceX’s design like the need to refuel Starship in orbit, which has never been tried before.

View Source

The Covid-19 Plasma Boom Is Over. What Did We Learn From It?

Scott Cohen was on a ventilator struggling for his life with Covid-19 last April when his brothers pleaded with Plainview Hospital on Long Island to infuse him with the blood plasma of a recovered patient.

The experimental treatment was hard to get but was gaining attention at a time when doctors had little else. After an online petition drew 18,000 signatures, the hospital gave Mr. Cohen, a retired Nassau County medic, an infusion of the pale yellow stuff that some called “liquid gold.”

In those terrifying early months of the pandemic, the idea that antibody-rich plasma could save lives took on a life of its own before there was evidence that it worked. The Trump administration, buoyed by proponents at elite medical institutions, seized on plasma as a good-news story at a time when there weren’t many others. It awarded more than $800 million to entities involved in its collection and administration, and put Dr. Anthony S. Fauci’s face on billboards promoting the treatment.

A coalition of companies and nonprofit groups, including the Mayo Clinic, Red Cross and Microsoft, mobilized to urge donations from people who had recovered from Covid-19, enlisting celebrities like Samuel L. Jackson and Dwayne Johnson, the actor known as the Rock. Volunteers, some dressed in superhero capes, showed up to blood banks in droves.

took a long time to measure its effectiveness. Eventually, studies did emerge to suggest that under the right conditions, plasma might help. But enough evidence has now accumulated to show that the country’s broad, costly plasma campaign had little effect, especially in people whose disease was advanced enough to land them in the hospital.

N.I.H. recently halted an outpatient trial of plasma because of a lack of benefit.

Doctors have used the antibodies of recovered patients as treatments for more than a century, for diseases including diphtheria, the 1918 flu and Ebola.

So when patients began falling ill with the new coronavirus last year, doctors around the world turned to the old standby.

In the United States, two hospitals — Mount Sinai in New York City and Houston Methodist in Texas — administered the first plasma units to Covid-19 patients within hours of each other on March 28.

Dr. Nicole M. Bouvier, an infectious-disease doctor who helped set up Mount Sinai’s plasma program, said the hospital had tried the experimental treatment because blood transfusions carry a relatively low risk of harm. With a new virus spreading quickly, and no approved treatments, “nature is a much better manufacturer than we are,” she said.

As Mount Sinai prepared to infuse patients with plasma, Diana Berrent, a photographer, was recovering from Covid-19 at her home in Port Washington, N.Y. Friends began sending her Mount Sinai’s call for donors.

thousands of Orthodox Jewish people were getting tested for coronavirus antibodies and showing up to donate. Coordinating it all was exhausting.

“April,” Mr. Lebovits recalled with a laugh, “was like 20 decades.”

Two developments that month further accelerated plasma’s use. With the help of $66 million in federal funding, the F.D.A. tapped the Mayo Clinic to run an expanded access program for hospitals across the country. And the government agreed to cover the administrative costs of collecting plasma, signing deals with the American Red Cross and America’s Blood Centers.

news releases announcing those deals got none of the flashy media attention that the billion-dollar contracts for Covid-19 vaccines did when they arrived later in the summer. And the government did not disclose how much it would be investing.

American Red Cross and America’s Blood Centers since last April.

“The convalescent plasma program was intended to meet an urgent need for a potential therapy early in the pandemic,” a health department spokeswoman said in a statement. “When these contracts began, treatments weren’t available for hospitalized Covid-19 patients.”

As spring turned to summer, the Trump administration seized on plasma — as it had with the unproven drug hydroxychloroquine — as a promising solution. In July, the administration announced an $8 million advertising campaign “imploring Americans to donate their plasma and help save lives.” The blitz included promotional radio spots and billboards featuring Dr. Fauci and Dr. Hahn, the F.D.A. commissioner.

provided access to its advertising agency, which created the look and feel for the Fight Is In Us campaign, which included video testimonials from celebrities.

although he later corrected his remarks following criticism from the scientific community.

the Infectious Diseases Society of America recommended that plasma not be used in hospitalized patients outside of a clinical trial. (On Wednesday, the society restricted its advice further, saying plasma should not be used at all in hospitalized patients.) In January, a highly anticipated trial in Britain was halted early because there was not strong evidence of a benefit in hospitalized patients.

narrowed the authorization for plasma so that it applied only to people who were early in the course of their disease or who couldn’t make their own antibodies.

Dr. Marks, the F.D.A. regulator, said that in retrospect, scientists had been too slow to adapt to those recommendations. They had known from previous disease outbreaks that plasma treatment is likely to work best when given early, and when it contained high levels of antibodies, he said.

“Somehow we didn’t really take that as seriously as perhaps we should have,” he said. “If there was a lesson in this, it’s that history actually can teach you something.”

pandemic exceptionalism” — had drained valuable time and attention from discovering other treatments.

“Pandemic exceptionalism is something we learned from prior emergencies that leads to serious unintended consequences,” she said, referring to the ways countries leaned on inadequate studies during the Ebola outbreak. With plasma, she said, “the agency forgot lessons from past emergencies.”

While scant evidence shows that plasma will help curb the pandemic, a dedicated clutch of researchers at prominent medical institutions continue to focus on the narrow circumstances in which it might work.

Dr. Arturo Casadevall, an immunologist at Johns Hopkins University, said many of the trials had not succeeded because they tested plasma on very sick patients. “If they’re treated early, the results of the trials are all consistent,” he said.

found that giving plasma early to older people reduced the progression of Covid-19. And an analysis of the Mayo Clinic program found that patients who were given plasma with a high concentration of antibodies fared better than those who did not receive the treatment. Still, in March, the N.I.H. halted a trial of plasma in people who were not yet severely ill with Covid-19 because the agency said it was unlikely to help.

With most of the medical community acknowledging plasma’s limited benefit, even the Fight Is In Us has begun to shift its focus. For months, a “clinical research” page about convalescent plasma was dominated by favorable studies and news releases, omitting major articles concluding that plasma showed little benefit.

the website has been redesigned to more broadly promote not only plasma, but also testing, vaccines and other treatments like monoclonal antibodies, which are synthesized in a lab and thought to be a more potent version of plasma. Its clinical research page also includes more negative studies about plasma.

Nevertheless, the Fight Is In Us is still running Facebook ads, paid for by the federal government, telling Covid-19 survivors that “There’s a hero inside you” and “Keep up the fight.” The ads urge them to donate their plasma, even though most blood banks have stopped collecting it.

Two of plasma’s early boosters, Mr. Lebovits and Ms. Berrent, have also turned their attention to monoclonal antibodies. As he had done with plasma last spring, Mr. Lebovits helped increase acceptance of monoclonals in the Orthodox Jewish community, setting up an informational hotline, running ads in Orthodox newspapers, and creating rapid testing sites that doubled as infusion centers. Coordinating with federal officials, Mr. Lebovits has since shared his strategies with leaders in the Hispanic community in El Paso and San Diego.

And Ms. Berrent has been working with a division of the insurer UnitedHealth to match the right patients — people with underlying health conditions or who are over 65 — to that treatment.

“I’m a believer in plasma for a lot of substantive reasons, but if word came back tomorrow that jelly beans worked better, we’d be promoting jelly beans,” she said. “We are here to save lives.”’

View Source

U.S. Bet on Covid Vaccine Manufacturer Even as Problems Mounted

Because of the pandemic, most of the auditors drew their conclusions from documents and video tours, during which Emergent workers controlled the camera angles, one former company official said.

Johnson & Johnson’s auditors said monitoring reports for bacteria or other contaminants were filed four to six months late. AstraZeneca’s said that Emergent repeatedly loosened monitoring criteria so it appeared to meet them, resorting to measures like “historical averages.” But even then it failed the tests, the report said.

In another audit, BARDA officials documented similar concerns, classifying some of them, including the risks of microbiological contamination, as “critical.” That designation is reserved for the most serious problems that pose an immediate and significant risk.

Emergent’s own internal audit in July also said the flow of workers and materials through the plant was not adequately controlled “to prevent mix-ups or contamination.”

The reports echoed quality-control shortcomings documented in an April inspection by the F.D.A., reported earlier by The Associated Press, that concluded the facility was “not ready for commercial operations.”

Multiple audits underscore how poorly the company was prepared for the huge workload it accepted.

The Covid-19 projects required significantly more testing to ensure materials remained stable, but Emergent had just one employee coordinating it all, the BARDA audit found. Emergent acknowledged at the time that its testing system was “not ideal” and pledged to train at least one more Emergent worker and hire a third. BARDA did not respond to requests for comment on its audit or any of the others, beyond saying that it had “worked with Emergent to resolve the issues” raised during the F.D.A. inspection.

Another internal investigation in August found that Emergent approved four raw materials used to produce AstraZeneca’s vaccine without first fully testing them. That type of shortcut, called a conditional release of material, occurred on average twice a week in October, internal logs show. The measure was deemed necessary because the company was working with shortened production times, testing backlogs and the needs of Operation Warp Speed, the Trump administration’s crash vaccine development program. And while a manager “knowingly deviated” from standards, the report said, the batches of vaccine would be not released without quality and safety tests.

View Source