Johnson & Johnson’s Covid vaccine was supposed to be one of Africa’s most important weapons against the coronavirus.
The New Jersey-based company agreed to sell enough of its inexpensive single-shot vaccine to eventually inoculate a third of the continent’s residents. And the vaccine would be produced in part by a South African manufacturer, raising hopes that those doses would quickly go to Africans.
That has not happened.
South Africa is still waiting to receive the overwhelming majority of the 31 million vaccine doses it ordered from Johnson & Johnson. It has administered only about two million Johnson & Johnson shots. That is a key reason that fewer than 7 percent of South Africans are fully vaccinated — and that the country was devastated by the Delta variant.
At the same time, Johnson & Johnson has been exporting millions of doses that were bottled and packaged in South Africa for distribution in Europe, according to executives at Johnson & Johnson and the South African manufacturer, Aspen Pharmacare, as well as South African government export records reviewed by The New York Times.
donated by the United States. But about four million of the country’s 60 million residents are fully vaccinated.
That left the population vulnerable when a third wave of cases crested over the country. At times in recent months, scores of Covid-19 patients at Helen Joseph Hospital in Johannesburg were waiting in the emergency department for a bed, and the hospital’s infrastructure struggled to sustain the huge volumes of oxygen being piped into patients’ lungs, said Dr. Jeremy Nel, an infectious-disease doctor there.
“The third wave, in terms of the amount of death we saw, was the most heartbreaking, because it was the most avoidable,” Dr. Nel said. “You see people by the dozens dying, all of whom are eligible for a vaccine and would’ve been among the first to get it.”
a United Nations-backed clearinghouse for vaccines that has fallen behind on deliveries. South Africa was slow to enter negotiations with manufacturers for its own doses. In January, a group of vaccine experts warned that the government’s “lack of foresight” could cause “the greatest man-made failure to protect the population since the AIDS pandemic.”
announced in November. Aspen’s facility in Gqeberha, on South Africa’s southern coast, was the first site in Africa to produce Covid vaccines. (Other companies subsequently announced plans to produce vaccines on the continent.)
Understand the State of Vaccine and Mask Mandates in the U.S.
Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.
Vaccine rules . . . and businesses.Private companies are increasingly mandating coronavirus vaccines for employees, with varying approaches. Such mandates are legally allowed and have been upheld in court challenges.
College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.
Schools. On Aug. 11, California announced that it would require teachers and staff of both public and private schools to be vaccinated or face regular testing, the first state in the nation to do so. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots.
Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.
New York. On Aug. 3, Mayor Bill de Blasio of New York announced that proof of vaccination would be required of workers and customers for indoor dining, gyms, performances and other indoor situations, becoming the first U.S. city to require vaccines for a broad range of activities. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.
At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.
South African officials hailed Aspen’s involvement as indispensable.
Aspen “belongs to us as South Africans, and it is making lifesaving vaccines,” South Africa’s president, Cyril Ramaphosa, said during a visit to Aspen’s plant in March. He said he had pushed Johnson & Johnson to prioritize the doses made there for Africans.
“I want them now,” Mr. Ramaphosa added. “I’ve come to fetch our vaccines.”
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.
ISLAMABAD, Pakistan — The coronavirus was ripping through Pakistan, and Muhammad Nasir Chaudhry was worried. Long lines and tight supplies plagued the government’s free vaccine campaign. Newspapers were filled with reports of well-connected people jumping the line for a free dose.
Then Mr. Chaudhry, a 35-year-old government consultant, discovered he could pay to leapfrog the long lines himself. He registered to take two doses of the Russian-made Sputnik V vaccine for about $80 from a private hospital. That’s a lot of money in a country where the average worker makes about $110 per month, but Mr. Chaudhry was ready to make the commitment.
Critics have assailed such private sales in Pakistan and around the world, saying that they make inoculations available only to the wealthy. But in Pakistan, like elsewhere, tight supplies have stymied those efforts. The private hospitals are out of supplies, and Mr. Chaudhry still hasn’t been vaccinated.
“I am willing to pay double the price for the vaccine, but I don’t want to wait on and on,” Mr. Chaudhry said.
bought up most of the world’s vaccine supplies to protect their own people, leaving millions of doses stockpiled and in some places unused. Less developed countries scramble over what’s left.
To speed up vaccinations, some countries have allowed doses to be sold privately. But those campaigns have been troubled by supply issues and by complaints that they simply reflect the global disparities.
blocked them over fears that counterfeit vaccines would be sold. In the United States, some well-connected companies, like Bloomberg, have secured doses for employees.
can’t find vaccines to buy. Demand has been strong. The government sets a ceiling on prices but has been locked in a dispute with private importers over how much that should be.
In April, in the city of Karachi, long lines formed when two private hospitals began selling the Sputnik V vaccine to walk-ins. Private hospitals in Islamabad, the capital, and Lahore faced a similar rush of people and ran short within days. Hospitals in the major cities have now stopped taking walk-ins, and online registration has also been put on hold.
Sputnik V isn’t the only vaccine that the government allows to be sold privately. A one-dose shot made by CanSino Biologics of China is priced at around $28. Demand has been weaker because of greater public confidence in the Russian vaccine. Still, supplies sold out quickly after the CanSino doses went on sale last month. The government has said another 13.2 million doses will arrive in June.
AGP Limited, a private pharmaceutical company that has imported 50,000 doses of Sputnik, is urging patience.
“Sputnik V received an overwhelming response in Pakistan with thousands of people being vaccinated in just a few days and an even higher number of registrations confirmed in hospitals across Pakistan,” said Umair Mukhtar, a senior official of AGP Limited. He said the company has placed large orders for more.
The government price dispute could delay further expansion. The drug regulatory authority wants Sputnik V to be sold at a lower price. AGP won an interim court order on April 1 to sell the vaccine until a final price is fixed.
For those who can afford the doses, frustration is growing. Junaid Jahangir, an Islamabad-based lawyer, said several of his friends got private inoculations. He registered with a private lab for Sputnik V but got a text message later saying that the vaccination drive was on hold.
Junaid Jahangir, an Islamabad-based lawyer, registered with a private lab for Sputnik V but got a text message later saying that the vaccination drive was on hold.
“I am being denied a fair chance to fight this virus if I end up getting infected,” Mr. Jahangir said. “The demand is there, and I don’t see what could possibly be the reason behind the inefficiency in supply.”
Some of the people who paid for private doses justified their decision by citing media reports that some well-connected people were jumping the line to get free, public doses. In May, at least 18 low-level health care workers were suspended by the authorities in Lahore for vaccinating people out of turn after taking bribes.
Iffat Omar, an actor and talk show host, apologized publicly in April for jumping ahead of the line to get the vaccine. “I am sorry,” she said on Twitter. “I am ashamed. I apologise from the bottom of my heart. I will repent.”
Fiza Batool Gilani, an entrepreneur and the daughter of Yusuf Raza Gilani, the former prime minister, said she knows of several young people who jumped the queue and got the free government vaccine in recent weeks.
“I was myself offered out of turn, free vaccine, but I declined as I wanted to avail the private vaccine,” said Ms. Gilani. Wealthy people should pay for their doses, she said, adding that her family would pay for CanSino shots for its household staff.
Many people, like Tehmina Sadaf, don’t have that option.
Ms. Sadaf, 35, lives along with her husband and a seven-year old son in a working-class neighborhood on the outskirts of Islamabad. Her husband is a cleric at a mosque. She gives Quran lessons to young children. She said the pandemic had negatively impacted the family’s income of around $128 per month. “After paying the house rent and electricity bill, we are not left with much,” she said.
She had her doubts about the public vaccine, “but the price of the private vaccine is very high,” she said. “It should have been lower so that poor people like us can also afford it.”
Zia ur-Rehman contributed reporting from Karachi, Pakistan. Richard C. Paddock and Muktita Suhartono contributed reporting.
Mongolia, a country of grassy hills, vast deserts and endless skies, has a population not much bigger than Chicago’s. The small democratic nation is used to living in the shadow of its powerful neighbors, Russia and China.
But during a pandemic, being a small nation sandwiched between two vaccine makers with global ambitions can have advantages.
At a time when most countries are scrambling for coronavirus vaccines, Mongolia now has enough to fully vaccinate its entire adult population, in large part thanks to deals with both China and Russia. Officials are so confident about the nation’s vaccine riches that they are promising citizens a “Covid-free summer.”
Mongolia’s success in procuring the vaccines in the span of a few months is a big victory for a low-income, developing nation. Many poor countries have been waiting in line for shots, hoping for the best. But Mongolia, using its status as a small geopolitical player between Russia and China, was able to snap up doses at a clip similar to that of much wealthier countries.
deep skepticism over their homegrown vaccines.
Mongolia is a buffer between eastern Russia, which is resource rich and mostly unpopulated, and China, which is crowded and hungry for resources. While Russia and China are often aligned on the global stage, they have a history of conflict and are wary of each others’ interests in Mongolia. Those suspicions can be seen in their vaccine diplomacy.
arrived this week. Mongolia’s most recent agreement with China’s Sinopharm Group, which is state-owned, was made days before the company received emergency authorization from the World Health Organization.
Mongolia was late to the global clamber for Covid-19 vaccines. For nearly a year officials boasted that there were no local cases. Then came an outbreak in November. Two months later, political crisis precipitated by the mishandling of the virus led to the sudden resignation of the prime minister. The prospect of continued coronavirus restrictions threatened to throw the country into further political turmoil.
The new prime minister, Oyun-Erdene Luvsannamsrai, pledged to restart the economy, which had suffered from lockdowns and border closures, particularly in the south, where Mongolian truck drivers ferry coal across the border to China’s steel mills. But these plans were complicated by surging cases, with the daily count going from hundreds a day to thousands.
“We were quite desperate,” said Bolormaa Enkhbat, an economic and development policy adviser to Mr. Luvsannamsrai.
Vero Cell vaccine. Soon after, China donated 300,000 doses of its Sinopharm vaccine to Mongolia, citing a “profound traditional friendship” as motivation.
Opening up more of the border between China and Mongolia was also a part of the vaccine discussions, Chinese and Mongolian officials said in Chinese state media. Mongolia needs China to buy its coal — exports to the country make up nearly a quarter of Mongolia’s annual economic growth. The revenues helped to pad Mongolia’s budget by a quarter last year.
After a month of back and forth, the Mongolian government struck a deal in March with Russia’s Gamaleya Research Institute, too, for one million doses of the Sputnik vaccine. Days later, Mongolia finalized an agreement to buy 330,000 additional doses of the Sinopharm vaccine.
Ulaanbaatar, Mongolia’s capital, 97 percent of the adult population has received a first dose and more than half are fully vaccinated, according to government statistics. Across the country, more than three quarters of Mongolians have already received one shot.
China has shut its border and stopped purchasing Mongolian coal.
Mongolians have also expressed a preference for Russia’s Sputnik vaccine. To get the population to take the Sinopharm shot, the government has offered each citizen 50,000 tugriks — about $18 — to get fully vaccinated. The average monthly salary in 2020 was $460.
The terms and pricing of the Sinopharm and Sputnik deals were not made public, and Mongolia’s foreign ministry declined to comment on pricing. Representatives for the Gamaleya Research Institute and Sinopharm did not respond to requests for comment.
While some global health experts have questioned whether Sinopharm will be able to continue to deliver on its commitments overseas, it has delivered all of the doses Mongolia ordered. China has said it can make as many as five billion doses by the end of the year, though officials have warned that the country is struggling to make enough shots for its citizens.
a third booster shot sooner than expected.
China, for its part, may be playing a long game, said Julian Dierkes, an associate professor at the University of British Columbia who specializes in Mongolian politics. Though many Mongolians may still not trust China, the Mongolian government will remember how it made its vaccines available at a critical moment.
“We could coin a phrase here: ‘The opportunity of smallness,’” he said.
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.
In delivering vaccines, pharmaceutical companies aided by monumental government investments have given humanity a miraculous shot at liberation from the worst pandemic in a century.
But wealthy countries have captured an overwhelming share of the benefit. Only 0.3 percent of the vaccine doses administered globally have been given in the 29 poorest countries, home to about 9 percent of the world’s population.
Vaccine manufacturers assert that a fix is already at hand as they aggressively expand production lines and contract with counterparts around the world to yield billions of additional doses. Each month, 400 million to 500 million doses of the vaccines from Moderna, Pfizer and Johnson & Johnson are now being produced, according to an American official with knowledge of global supply.
But the world is nowhere close to having enough. About 11 billion shots are needed to vaccinate 70 percent of the world’s population, the rough threshold needed for herd immunity, researchers at Duke University estimate. Yet, so far, only a small fraction of that has been produced. While global production is difficult to measure, the analytics firm Airfinity estimates the total so far at 1.7 billion doses.
dangerous new variants emerge, requiring booster shots and reformulated vaccines, demand could dramatically increase, intensifying the imperative for every country to lock up supply for its own people.
The only way around the zero-sum competition for doses is to greatly expand the global supply of vaccines. On that point, nearly everyone agrees.
But what is the fastest way to make that happen? On that question, divisions remain stark, undermining collective efforts to end the pandemic.
Some health experts argue that the only way to avert catastrophe is to force drug giants to relax their grip on their secrets and enlist many more manufacturers in making vaccines. In place of the existing arrangement — in which drug companies set up partnerships on their terms, while setting the prices of their vaccines — world leaders could compel or persuade the industry to cooperate with more companies to yield additional doses at rates affordable to poor countries.
Those advocating such intervention have focused on two primary approaches: waiving patents to allow many more manufacturers to copy existing vaccines, and requiring the pharmaceutical companies to transfer their technology — that is, help other manufacturers learn to replicate their products.
more than 100 countries in asking the W.T.O. to partially set aside vaccine patents.
But the European Union has signaled its intent to oppose waivers and support only voluntary tech transfers, essentially taking the same position as the pharmaceutical industry, whose aggressive lobbying has heavily shaped the rules in its favor.
Some experts warn that revoking intellectual property rules could disrupt the industry, slowing its efforts to deliver vaccines — like reorganizing the fire department amid an inferno.
“We need them to scale up and deliver,” said Simon J. Evenett, an expert on trade and economic development at the University of St. Gallen in Switzerland. “We have this huge production ramp up. Nothing should get in the way to threaten it.”
Others counter that trusting the pharmaceutical industry to provide the world with vaccines helped create the current chasm between vaccine haves and have-nots.
The world should not put poorer countries “in this position of essentially having to go begging, or waiting for donations of small amounts of vaccine,” said Dr. Chris Beyrer, senior scientific liaison to the Covid-19 Prevention Network. “The model of charity is, I think, an unacceptable model.”
halting vaccine exports a month ago. Now, as a wave of death ravages the largely unvaccinated Indian population, the government is drawing fire at home for having let go of doses.
poses universal risks by allowing variants to take hold, forcing the world into an endless cycle of pharmaceutical catch-up.
“It needs to be global leaders functioning as a unit, to say that vaccine is a form of global security,” said Dr. Rebecca Weintraub, a global health expert at Harvard Medical School. She suggested that the G7, the group of leading economies, could lead such a campaign and finance it when the members convene in England next month.
Pfizer expects to sell $26 billion worth of Covid vaccines this year; Moderna forecasts that its sales of Covid vaccines will exceed $19 billion for 2021.
History also challenges industry claims that blanket global patent rights are a requirement for the creation of new medicines. Until the mid-1990s, drug makers could patent their products only in the wealthiest markets, while negotiating licenses that allowed companies in other parts of the world to make generic versions.
Even in that era, drug companies continued to innovate. And they continued to prosper even with the later waivers on H.I.V. drugs.
“At the time, it rattled a lot of people, like ‘How could you do that? It’s going to destroy the pharmaceutical industry,’” recalled Dr. Anthony S. Fauci, President Biden’s chief medical adviser for the pandemic. “It didn’t destroy them at all. They continue to make billions of dollars.”
Leaders in the wealthiest Western nations have endorsed more equitable distribution of vaccines for this latest scourge. But the imperative to ensure ample supplies for their own nations has won out as the virus killed hundreds of thousands of their own people, devastated economies, and sowed despair.
The drug companies have also promised more support for poorer nations. AstraZeneca’s vaccine has been the primary supply for Covax, and the company says it has sold its doses at a nonprofit price.
stumbled, falling short of production targets. And producing the new class of mRNA vaccines, like those from Pfizer-BioNTech and Moderna, is complicated.
Where pharmaceutical companies have struck deals with partners, the pace of production has frequently disappointed.
“Even with voluntary licensing and technology transfer, it’s not easy to make complex vaccines,” said Dr. Krishna Udayakumar, director of the Duke Global Health Innovation Center.
Much of the global capacity for vaccine manufacturing is already being used to produce other lifesaving inoculations, he added.
But other health experts accuse major pharmaceutical companies of exaggerating the manufacturing challenges to protect their monopoly power, and implying that developing countries lack the acumen to master sophisticated techniques is “an offensive and a racist notion,” said Matthew Kavanagh, director of the Global Health Policy and Politics Initiative at Georgetown University.
With no clear path forward, Ms. Okonjo-Iweala, the W.T.O. director-general, expressed hope that the Indian and South African patent-waiver proposal can be a starting point for dialogue.
“I believe we can come to a pragmatic outcome,” she said. “The disparity is just too much.”
Peter S. Goodman reported from London, Apoorva Mandavilli from New York, Rebecca Robbins from Bellingham, Wash., and Matina Stevis-Gridneff from Brussels. Noah Weiland contributed reporting from New York.
Marie Neige, a call center operator in Seychelles, was eager to be vaccinated. Like the majority of the residents in the tiny island nation, she was offered China’s Sinopharm vaccine in March, and was looking forward to the idea of being fully protected in a few weeks.
On Sunday, she tested positive for the coronavirus.
“I was shocked,” said Ms. Neige, 30, who is isolating at home. She said she has lost her sense of smell and taste and has a slightly sore throat. “The vaccine was supposed to protect us — not from the virus, but the symptoms,” she said. “I was taking precaution after precaution.”
China expected its Sinopharm vaccines to be the linchpin of the country’s vaccine diplomacy program — an easily transported dose that would protect not just Chinese citizens but also much of the developing world. In a bid to win good will, China has donated 13.3 million Sinopharm doses to other countries, according to Bridge Beijing, a consultancy that tracks China’s impact on global health.
Instead, the company, which has made two varieties of coronavirus vaccines, is facing mounting questions about the inoculations. First, there was the lack of transparency with its late-stage trial data. Now, Seychelles, the world’s most vaccinated nation, has had a surge in cases despite much of its population being inoculated with Sinopharm.
has managed to beat back the virus. A study has shown that the Pfizer vaccine that Israel used is 94 percent effective at preventing transmission. On Wednesday, the number of daily new confirmed Covid-19 cases per million people in Seychelles stood at 2,613.38, compared to 5.55 in Israel, according to The World In Data project.
Wavel Ramkalawan, the president of Seychelles, defended the country’s vaccination program, saying that the Sinopharm and AstraZeneca vaccines have “served our population very well.” He pointed out that the Sinopharm vaccine was given to people age 18 to 60, and in this age group over all, 80 percent of the patients who needed to be hospitalized were not vaccinated.
according to the Seychelles News Agency. Sinopharm did not respond to a request for comment.
an article from The Wall Street Journal on Seychelles, a spokeswoman for China’s foreign ministry blamed Western media for trying to discredit Chinese vaccines and “harboring the mentality that ‘everything involving China has to be smeared.’”
In a news conference, Kate O’Brien, director of immunizations at the World Health Organization, said the agency is evaluating the surge of infections in Seychelles and called the situation “complicated.” Last week, the global health group approved the Sinopharm vaccine for emergency use, raising hopes of an end to a global supply crunch.
She said that “some of the cases that are being reported are occurring either soon after a single dose or soon after a second dose or between the first and second doses.”
According to Ms. O’Brien, the W.H.O. is looking into the strains that are currently circulating in the country, when the cases occurred relative to when somebody received doses and the severity of each case. “Only by doing that kind of evaluation can we make an assessment of whether or not these are vaccine failures,” she said.
But some scientists say it is increasingly clear that the Sinopharm vaccine does not offer a clear path toward herd immunity, particularly when considering the multiple variants appearing around the world.
Governments using the Sinopharm vaccine “have to assume a significant failure rate and have to plan accordingly,” said John Moore, a vaccine expert at Cornell University. “You have to alert the public that you will still have a decent chance of getting infected.”
Many in Seychelles say the government has not been forthcoming.
“My question is: Why did they push everyone to take it?” said Diana Lucas, a 27-year-old waitress who tested positiveon May 10. She said she received her second dose of the Sinopharm vaccine on Feb. 10.
Emmanuelle Hoareau, 22, a government lawyer, tested positiveon May 6 after getting the second dose of the Sinopharm vaccine in March. “It doesn’t make sense,” she said. She said the government had failed to give the public enough information about the vaccines.
“They are not explaining to the people about the real situation,” she said. “It’s a big deal — a lot of people are getting infected.”
Ms. Hoareau’s mother, Jacqueline Pillay, is a nurse in a private clinic in Victoria, the capital. She said she believes there is a new variant in Seychelles because of an influx of foreigners who have arrived in recent months. The tourism-dependent country opened its borders on March 25 to most travelers without any quarantine.
“People are very scared now,” said Ms. Pillay, 58. “When you give people the right information, then people would not speculate.”
Health officials have recently appeared on television to encourage those who have only taken the first dose of the Sinopharm vaccine to return for the second shot. But Ms. Pillay said she is frustrated that the public health commissioner has not addressed why the vaccines don’t appear to be working as well as they should.
“I think a lot of people aren’t coming back,” said Ms. Pillay.
Marietta Labrosse, Elsie Chen and Claire Fu contributed research.
NEW DELHI — Adar Poonawalla made big promises. The 40-year-old chief of the world’s largest vaccine maker pledged to take a leading role in the global effort to inoculate the poor against Covid-19. His India-based empire signed deals worth hundreds of millions of dollars to make and export doses to suffering countries.
Those promises have fallen apart. India, engulfed in a coronavirus second wave, is laying claim to his vaccines. Other countries and aid groups are now racing to find scarce doses elsewhere.
At home, politicians and the public have castigated Mr. Poonawalla and his company, the Serum Institute of India, for raising prices mid-pandemic. Serum has suffered production problems that have kept it from expanding output at a time when India needs every dose. He has come under criticism for departing to London amid the crisis, though he said it was only a quick trip. He told a British newspaper he had received threats from politicians and some of India’s “most powerful men,” demanding that he supply them with vaccines. When he returns to India, he will travel with government-assigned armed guards.
In an interview with The New York Times, Mr. Poonawalla defended his company and its ambitions. He had no choice but to hand over vaccines to the government, he said. He cited a lack of raw materials, which he has partially blamed on the United States. Making vaccines, he said, is a painstaking process that requires investment and major risks. He said he would return to India when he had finished his business in London. He shrugged off his earlier comments about threats, saying they were “nothing we can’t handle.”
backed waiving intellectual property protections for vaccines, which could make it easier for Indian factories to make them. Still, that won’t help India’s current crisis, which as of Friday had claimed more than 230,000 lives — a figure that likely represents a vast undercount.
a horse breeder turned vaccine billionaire. Before the crisis, he was extolled in the Indian media as an example of a new class of young, worldly entrepreneurs. Photos of him and his wife, Natasha, were a staple of fashion spreads.
Serum received a $300 million grant from the Gates Foundation to supply as many as 200 million doses of Covishield and another vaccine in development to the Gavi Alliance, the public-private partnership that is overseeing Covax, the program to donate vaccines to poor countries.
Serum pledged between January and March to sell about 1.1 billion vaccine doses in coming months, according to a review of purchase agreements supplied by UNICEF. By the time India largely stopped vaccine exports, Serum had exported only about 60 million doses, about half to Gavi. India had claimed more than 120 million.
AstraZeneca has served Serum a legal notice over delivery delays. Serum has just “temporarily deferred” its commitments, Mr. Poonawalla said, citing the Indian government’s halt of exports.
“This is something coming from India,” he said. “It’s not the supplier that is defaulting.”
The world is grappling with the ripple effect. A spokesman for Gavi said that India’s decision to prioritize “domestic needs” is having “a knock-on effect in other parts of the world that desperately need vaccines.” Still, in a sign of the lack of options for getting vaccines, Gavi on Thursday signed a purchase deal with an American vaccine company, called Novavax, involving doses to be made by Serum.
people are being turned away from vaccination centers that have run out of doses.
Serum has missed its expansion targets. Mr. Poonawalla said last fall that by early this year, Serum Institute would be pumping out 100 million doses per month, of which about four in 10 would go overseas.
But after a fire at a facility that was supposed to help the company ramp up vaccine production, Serum’s capacity has remained at about 72 million doses per month. A grant of more than $200 million from the Indian government should help the company reach its goal by summer, he said.
Understand the Covid Crisis in India
Mr. Poonawalla has also cited raw materials supplies. In April, he asked President Biden on Twitter to “lift the embargo” on raw material used to make Covid-19 vaccines. White House officials said Mr. Poonawalla mischaracterized his situation. Still, the United States said it would send raw materials to the Serum Institute to increase its vaccine production, though Mr. Poonawalla said they haven’t yet arrived.
Mr. Poonawalla has also come under scrutiny for charging different prices to the central government, to India’s states and to private hospitals. Two weeks ago, Serum said it would charge state governments about $5 per dose, about $3 more than what it charges Mr. Modi’s government.
Last week, following criticism, Mr. Poonawalla lowered the price to $4. Still, the critics point to an interview in which Mr. Poonawalla said that he was making a profit even at the central government’s price.
Mr. Poonawalla said that Serum could sell at a lower price to India’s central government because it was ordering larger volumes.
“People don’t understand,” Mr. Poonawalla told The New York Times. “They just take things in isolation and then they vilify you, not realizing that this commodity is sold at $20 a dose in the world and we’re providing it for $5 or $6 in India. There’s no end to the cribbing, the complaining, the criticizing.”
includes four to five armed personnel.
In an interview with The Times of London newspaper published last week, he described receiving constant, aggressive calls demanding vaccines immediately. “‘Threats’ is an understatement,” he told the paper.
He played down the threats in his interview with The New York Times, and his office declined to disclose further specifics. Still, the comments caused an uproar in India. Some politicians demanded that he name names.
tweeted that Mr. Poonawalla’s departure to London was “shameful” and that he should reduce prices.
The Serum Institute is planning a major expansion in Britain, investing nearly $335 million for research and development, to fund clinical trials, to build out its sales office and to possibly construct a manufacturing plant, Mr. Poonawalla’s office said.
“Everyone is depending on us to be able to give this magic silver bullet in an almost infinite capacity,” Mr. Poonawalla said. “There’s this tremendous pressure from state governments, ministers, the public, friends, and they all want the vaccine. And I’m just trying to equitably distribute it as best I can.”
Selam Gebrekidan in London and Bhadra Sharma in Kathmandu, Nepal, contributed reporting.
The Covid-19 vaccine developed by AstraZeneca and the University of Oxford brought in $275 million in sales from about 68 million doses delivered in the first three months of this year, AstraZeneca reported on Friday.
AstraZeneca disclosed the figure, most of which came from sales in Europe, as it reported its first-quarter financial results. It offers the clearest view to date of how much money is being brought in by one of the leading Covid vaccines.
AstraZeneca, which has pledged not to profit on its vaccine during the pandemic, has been selling the shot to governments for several dollars per dose, less expensive than the other leading vaccines. The vaccine has won authorization in at least 78 countries since December but is not approved for use in the United States.
The Covid vaccine represented just under 4 percent of AstraZeneca’s revenue for the quarter; it was nowhere near the company’s biggest revenue generator. By comparison, the company’s best-selling product, the cancer drug Tagrisso, brought in more than $1.1 billion in sales in the quarter.
said this week that it would make available to the rest of the world up to 60 million doses of its supply of AstraZeneca shots, pending a review of their quality.
If the company does win authorization from the U.S. Food and Drug Administration, it could help shore up confidence in a vaccine whose reputation been hit by concerns about a rare but serious side effect involving blood clotting. The F.D.A.’s evaluation process is considered the gold standard globally.
Johnson & Johnson, whose vaccine was authorized for emergency use at the end of February, reported last week that its vaccine generated $100 million in sales in the United States in the first three months of the year. The federal government is paying the company $10 a dose. Like AstraZeneca, Johnson & Johnson has pledged to sell its vaccine “at cost” — meaning it won’t profit on the sales — during the pandemic.
Vaccines from Pfizer and Moderna cost more, and neither company has said that it will forego profits. Pfizer has said that it expects its vaccine to bring in about $15 billion in revenue this year; Moderna said it anticipates $18.4 billion in sales.
Both companies are scheduled to report their first-quarter results next week.
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.”
For weeks, New Yorkers have witnessed the alarming rise of a homegrown variant of the coronavirus that has kept the number of cases in the city stubbornly high. City officials have repeatedly warned that the variant may be more contagious and may dodge the immune response.
On that second point, at least, they can now breathe easier: Both the Pfizer-BioNTech and Moderna vaccines will effectively prevent serious illness and death from the variant, two independent studies suggest.
Antibodies stimulated by those vaccines are only slightly less potent at controlling the variant than the original form of the virus, both studies found.
“We’re not seeing big differences,” said Michel Nussenzweig, an immunologist at Rockefeller University in New York and a member of the team that published one of the studies on Thursday.
possible explanation: Antibodies from vaccinated people are distributed across a broader range of parts of the virus, so no single mutation has a big impact on their effectiveness — making vaccines a better bet against variants than immunity from natural infection.
The variant first identified in New York, known to scientists as B.1.526, raced through the city after its initial discovery in November. It accounted for one in four diagnosed cases by November and nearly half of cases as of April 13. The variant that brought Britain to a standstill, B.1.1.7, is also circulating widely in New York. Together, the two add up to more than 70 percent of coronavirus cases in the city.
second study, Dr. Landau’s team found that the Pfizer and Moderna vaccines are only marginally less protective against the variant that devastated Britain and against forms of the variant discovered in New York that don’t contain the Eek mutation.
Several laboratory studies have shown that antibodies induced by the Pfizer and Moderna vaccines are slightly less powerful against a third variant, one identified in South Africa, which also contains Eek. Other vaccines fared worse. South Africa suspended use of the AstraZeneca vaccine after clinical trials showed that the vaccine did not prevent mild or moderate illness from the variant that was circulating there.
“It already started out as a lower level in terms of the immunity that it generated,” Dr. Nussenzweig said of the AstraZeneca vaccine. Referring to the Pfizer and Moderna shots, he said, “We’re so lucky in this country to have these vaccines compared to the rest of the world.”
Florian Krammer, an immunologist at the Icahn School of Medicine at Mount Sinai who was not involved in either of the new studies, said he was more concerned about other countries’ vaccine programs than about the variants themselves.
“I am less concerned about variants than I was two months ago,” he said, but added: “I’m worried about countries that don’t have enough vaccine and that don’t have that vaccine rollout. I’m not worried anymore about the U.S., honestly.”
Dr. Landau’s team also tested monoclonal antibodies used to treat Covid-19 against the variants. They found that the cocktail of monoclonal antibodies made by Regeneron worked as well against the variant discovered in New York as against the original virus.
The studies are reassuring, but they indicate that the Eek mutation is one to watch, said Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Research Center in Seattle.
“This could certainly be a step toward the virus becoming somewhat more resistant to infection- and vaccine-mediated immunity,” Dr. Bloom said. “I don’t think it’s something that people need to immediately become alarmed about, but it definitely impresses us as important.”
Dr. Bloom led the analysis comparing vaccine-induced antibodies with those produced by natural infection. He found that the most powerful antibodies bind to multiple sites in a key part of the virus. Even if a mutation affects the binding in one site in this region, antibodies that target the remaining sites would still be protective.
Antibodies induced by the vaccine cover many more sites across this region than those from natural infection — and so are less likely to be affected by a mutation in any one site.
The study looked only at antibodies stimulated by the Moderna vaccine, but the results are likely to be the same for the Pfizer-BioNTech vaccine, he added.
“This could potentially be a good thing as the virus is creating mutations,” Dr. Bloom said.
