Drug companies defend vaccine monopolies in face of global outcry

bdul Muktadir, the chief executive of Bangladeshi pharmaceutical maker Incepta, has emailed executives of Moderna, Johnson & Johnson, and Novavax offering his company’s help. He said he has enough capacity to fill vials for 600 million to 800 million doses of coronavirus vaccine a year to distribute throughout Asia.

He never heard back from any of them. The lack of interest has left Muktadir worried about prolonged coronavirus exposure for millions of citizens of Bangladesh and other low-income nations throughout Asia and Africa who are at the back of the global queue for shots.

“Now is the time to use every single opportunity in every single corner of the world,” Muktadir, whose company is being promoted by the Bangladesh government for emergency vaccine production, said in a Zoom interview. “These companies should make deals with as many countries as possible.”

The drug companies that developed and won authorization for coronavirus vaccines in record time have agreed to sell most of the first doses coming off production lines to the United States, European countries and a few other wealthy nations.

The slow pace of ramping up production and shortages of raw materials have exacerbated the disadvantages for countries unable to afford the large outlays to reserve early supplies. Billions of people are left with an uncertain wait, with most of Africa and parts of South America and Asia not expected to achieve widespread vaccination coverage until 2023, according to some estimates.

But drug companies have rebuffed entreaties to face the emergency by sharing their proprietary technology more freely with companies in developing nations. They cite the rapid development of new vaccines as evidence that the drug industry’s traditional business model, based on exclusive patents and know-how, is working. The companies are lobbying the Biden administration and other members of the World Trade Organization against any erosion of their monopolies on individual coronavirus vaccines that are worth billions of dollars in annual sales.

The debate about how to immunize more people overseas is picking up greater steam in the United States now that President Biden has promised that most Americans will be vaccinated by July. Some Democrats in Congress, fresh off approving Biden’s $1.9 trillion pandemic rescue package, are determined to make sure Americans don’t forget about the rest of the world as they potentially celebrate Independence Day with a semblance of normalcy.

“We’re spending lots of money to save the hospitality industry, the airlines, travel. It will all come to naught if the rest of the world is not protected,” said Rep. Jan Schakowsky (D-Ill.), who questioned drug executives at a recent House hearing over their refusal to share vaccine patents openly.

The fights over vaccine supply are not just over a moral duty of Western nations to prevent deaths and illness overseas. Lack of supply and lopsided distribution threaten to leave entire continents open as breeding grounds for coronavirus mutations. Those variants, if they prove resistant to vaccines, could spread anywhere in the world, including in Western countries that have been vaccinated first.

“It doesn’t make any sense for rich countries to think they can vaccinate their own and let the rest of the world live off dribs and drabs,” said Brook Baker, a Northeastern University law professor.

Baker advised the World Health Organization last year in creating a technology-sharing pool to help developing countries make coronavirus vaccines.

But no coronavirus vaccine manufacturer has agreed to participate in the program, called the COVID-19 Technology Access Pool, the WHO said. Albert Bourla, the chief executive of Pfizer, last year called the concept “nonsense.”

“Unfortunately, only limited, exclusive and often non-transparent voluntary licensing is the preferred approach of some companies, and this is proven to be insufficient to address the needs of the current COVID-19 pandemic,” the WHO said in response to questions from The Washington Post. “The entire population and the global economy are in crisis because of that approach and vaccines nationalism.”

Last month, United Nations chief António Guterres warned that 10 countries had administered 75 percent of all doses by then and 130 countries had not received a single dose. The WHO-linked vaccine purchasing push, known as Covax, has since delivered some doses to low- and middle- income countries — but dozens of countries remain without a single dose, or with a small quantity that falls woefully short of checking the pandemic.

Of the potential 10 billion to 14 billion vaccine doses the industry hopes to produce in 2021 — a range that relies on optimistic projections — more than two-thirds have been claimed by wealthy and middle-income countries, according to a joint report released by the drug industry and the Coalition for Epidemic Preparedness Innovations earlier this month.

The remaining doses would cover as little as 28 percent of the populations of 92 of the world’s most impoverished nations, according to the report.

The dire international situation contrasts sharply with the optimism spreading in the United States.

The United States has committed nearly $20 billion in subsidies for vaccine development and advance purchase agreements of hundreds of millions of doses, mostly spread across six private companies. The upfront investment was intended to reduce the private-sector financial risk of rapidly developing the vaccines. It worked. Emergency FDA authorization of three vaccines — from Pfizer, Moderna, and Johnson & Johnson — arrived in record time.

Two more are in the near-term pipeline for Food and Drug Administration review: shots made by AstraZeneca and Novavax. A sixth vaccine candidate supported with U.S. funds, from Sanofi, has been delayed for further clinical trials after it did not trigger a sufficient immune response in elderly people.

These exclusive franchises are on track to generate billions of dollars in revenue for the companies. The Moderna vaccine, which was co-developed with the United States government and supported with $483 million in taxpayer backing, is expected to bring in $18.5 billion for the company this year, Moderna said in February.

Pfizer, which partnered with Germany’s BioNTech, a company that received German subsidies, has predicted it will get $15 billion from sales of its vaccine, an estimate that is considered conservative. Pfizer did not accept U.S. government funding.

Both the Pfizer and Moderna vaccines are based on novel messenger RNA technology that holds potential for other vaccines and drugs against an array of diseases. That makes the technology especially valuable.

Drug companies are lobbying the Biden administration to block a push at the WTO by India, South Africa and about 80 other countries for a temporary waiver on patent protections for the new vaccines. The pharmaceutical industry argues that innovation as well as vaccine quality and safety depend on maintaining exclusive intellectual property rights.

“Eliminating those protections would undermine the global response to the pandemic,” industry executives and the Pharmaceutical Research and Manufacturers of America, their powerful lobbying group, warned President Biden in a letter this month. Biden has sided with the drug companies so far. The United States on March 10 joined Britain, the E.U. and Switzerland in blocking the push for waivers.

The United States, which initially declined to join Covax under President Donald Trump, last month pledged $4 billion to help pay for vaccine purchases. But there is just not enough supply in the pipeline for Covax to satisfy demand in developing countries, say experts on global health.

“The starting point is that we need to make more vaccine,” said Mara Pillinger, an associate in global health policy and governance at Georgetown’s O’Neill Institute for National and Global Health Law. “Any conversation about allocating the limited supply we have now will never get us where we need to be.”

The companies say they are working furiously to produce more vaccine doses, using their own factories and licensing agreements with contract manufacturers with the highest degree of expertise and the most capacity, most of them in North America, Europe and India.

Step-by-step manufacturing instructions are just as important as intellectual property rights, because vaccines require multiple complex steps to produce. It takes highly specialized equipment and workers trained in biopharmaceutical manufacturing.

“WHO criticism of industry is showing a lack of understanding for the complexity of vaccine manufacturing and global supply chain and a disrespect for the daunting challenge of literally trebling global vaccine capacity for one single disease almost overnight,” Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, said in an email.

“COVID-19 vaccine makers have been making agreements with other vaccine makers, wherever they are in the world,” he said. “Speed is of the essence; and for these relationships to be established quickly, you need trust, as well as a total shared commitment to the quality and safety of COVID-19 vaccines produced.”

Most of the companies have announced plans to sell vaccine to Covax or directly to poorer nations.

AstraZeneca has been the most aggressive about creating technology transfer deals and has priced its vaccine the lowest, for as little as $2.15 per dose in Europe. But European countries have created a crisis atmosphere around the vaccine by suspending doses after blood clots appeared in a tiny number of individuals who received the shots.

Biden earlier this month announced an initiative to produce 1 billion doses of Johnson & Johnson’s single-shot vaccine in India, at the company’s manufacturing partner there, Biological E, by the end of 2022. Those doses would be targeted to the developing world and could help boost total production as high as 3 billion in 2022, a company executive told Reuters. The company’s vaccine is produced by a network of nine contractor companies, most in North America and Europe. It said in a statement that “we continue to seek out new partnerships.”

Pfizer, which says it plans to produce 2 billion doses of vaccine in 2021, has begun selling its vaccine directly to countries. The company said 36 percent of its production will be reserved for middle- and low-income countries, with nonprofit pricing baked in for the poorest nations.

“We are firmly committed to equitable and affordable access of coronavirus vaccines for people around the world,” Pfizer spokeswoman Amy Rose said in an email.

Moderna has said it will make nearly 1 billion doses in 2021. It has only a few commitments outside of the United States and Europe. It has been criticized for not yet agreeing to supply doses to Covax.

Moderna last year said it did not intend to enforce its patents against any companies making coronavirus vaccines. The announcement generated positive headlines. But as a practical matter, it is unlikely to have an impact on the supply of vaccine in the developing world.

In a Zoom call on Feb. 3, John Lepore, Moderna’s senior vice president for government engagement, told vaccine advocates the company is reluctant to share details about how to make its vaccine, according to advocates who participated in the call and were interviewed by The Washington Post. Lepore said Moderna sees its mRNA vaccine delivery system as a proprietary platform for other drugs and vaccines in the future, the participants said.

“He saw this as fundamental to them maintaining proprietary technology,” said one of the people on the call, James Love, director of Knowledge Ecology International, a nonprofit advocacy group that is critical of many monopolistic practices in the drug industry. “Can they really keep the genie in the bottle that long?”

Moderna did not comment on the conversation but referred to the October patent pledge. “Our patent pledge stated that, while the pandemic persists, Moderna will not use its patents to block others from making a coronavirus vaccine intended to combat the pandemic. There was no mention of a commitment to transfer our know-how beyond our chosen partners,” Moderna spokesman Ray Jordan said in an email.

Pakistan has received a small trickle of vaccine doses from China and none from Western drug companies, even though it is the world’s fifth-largest country, with about 220 million people.

Wajiha Javed, head of public health and research at Pakistani drug company Getz Pharma, sees a prolonged crisis on the horizon under the current vaccination plan.

She said she has sent proposals to multiple coronavirus vaccine manufacturers to accelerate vaccine supply to Pakistanis and other customers in the developing world. Getz also has been met with silence, she said in an interview.

“We say we are ready to do tech transfer, import licensing, fill-finish,” she said. “We offer everything. We are desperate. Nobody even bothers to answer back.”

Experts on global health and pandemics are looking for ways to break through the logjam and create more supply.

“Basically, you need a global version of Operation Warp Speed,” said Thomas J. Bollyky, a senior fellow at the Council on Foreign Relations and director of its Global Health Program, referring to the Trump administration’s effort to develop vaccines in the United States. “Operation Warp Speed did not just spend money. It coordinated, it aligned all the inputs involved, it played a general-contractor role.”

Bollyky ventured that the WHO may have lacked the money or clout to take on big pharma. He envisioned a diplomatic push, perhaps led by the Group of 20.

The high cost of HIV medications, protected by drug industry patents, prevented the treatments from reaching Africa in the late 1990s and created enormous pressure for distribution of low-cost pills. In 2001, the World Trade Organization carved out an exemption to international patent protections for public health emergencies. For vaccines, the industry has said it has scrambled to build new manufacturing capacity fast enough.

Some argue that drug companies have already proved they can transfer the new vaccine production to contract manufacturers and licensees in a matter of months, so there is no reason they can’t continue to expand to a wider roster of companies.

“This idea that it would take too long to stand up is a dodge,” said Pillinger, at Georgetown’s O’Neill Institute. “They are sharing the IP where they see that it is in their financial interest to do so to make the effort worthwhile.”

Muktadir, the pharmaceutical chief executive in Bangladesh, already makes and sells a number of vaccines and other drugs throughout the developing world. Even after his appeal to help in the global pandemic response was reported by the Associated Press, he said he has heard nothing from the vaccine companies.

Bangladesh qualifies as a “least developed country” under WTO rules, which gives it an automatic intellectual property waiver until 2033. But Muktadir said he is not interested in attempting to break any of the vaccine patents. He wants to work with the industry for tech transfer, not against it.

“Incepta is a very, very large, capable, high-quality manufacturing place,” he said, ”and we are left out because we are in Bangladesh.”