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Saturday, Feb 04, 2023

PHARMAFIA: Why Pfizer Fights to Control Secret of $36 Billion Covid Vaccine Recipe?

PHARMAFIA: Why Pfizer Fights to Control Secret of $36 Billion Covid Vaccine Recipe?

The high-stakes dispute over price, profit and control that is shaping the pandemic endgame
Two of the most powerful figures in the fight against the pandemic faced off in July during a closed-door virtual summit on how to get more vaccines to the world’s poorest people.

Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, called out a “shocking imbalance” in the supply of vaccines. He said it was unacceptable that manufacturers pursuing the highest prices had overwhelmingly supplied rich countries—and now were pushing booster shots for the same wealthy few—according to a half-dozen people who were listening. “Honestly I’m not seeing the commitment I would expect from you,” Tedros told the vaccine developers on the call.

Pfizer Inc. chief executive Albert Bourla, whose company’s miracle shot has inoculated more than a billion people, responded, saying Tedros was speaking “emotionally.”

“Actually, I’m not being emotional,” Tedros said, stressing that there was an urgent need to get more vaccines into arms.

Their previously unreported exchange laid bare an uncomfortable truth: Vaccine inequality didn’t happen by itself. It was the result of decisions by corporate executives and government officials. Nearly a year after the first shots went into arms, Western vaccine producers and public health officials are still struggling to find common ground to close a yawning gap between some nations; only 6% of people in Africa were fully inoculated as of early November. A sticking point in that effort is who gets to control secret vaccine formulas worth billions of dollars.

The broad implications of today’s lopsided global supply are clear. Americans and Europeans flush with vaccines are beginning to put the pandemic in the past, while the coronavirus still rolls across much of the world. Yet the demands, debates and decisions that brought vaccine producers to this point are only now coming into focus. Pfizer, Moderna, AstraZeneca and Johnson & Johnson began a year ago on similar footing—sending most of their doses to wealthy countries rather than poor ones. But then they took different paths, data compiled by London-based Airfinity shows.

Moderna, which had never produced a licensed drug product before Covid, barely expanded from supplying wealthier nations until recently, mostly because of export restrictions and early supply commitments to the U.S. and Europe, Chief Executive Officer Stephane Bancel told Bloomberg on Nov. 1. The single-dose Johnson & Johnson vaccine, which arrived months after the three others, turned out to be a relatively small player. AstraZeneca, which initially pledged to sell its vaccine at cost during the pandemic, quickly ramped up its supply to poorer countries, largely by licensing its formula to a producer in India.

Then there was Pfizer. With its German partner BioNTech, the New York-based company produces and distributes the biggest supply of one of the most effective vaccines, which is expected to generate $36 billion in revenue this year. The distribution data show Pfizer is the No. 1 Covid vaccine source for the wealthiest countries. Pfizer further cemented its front-runner status in the pandemic when it announced in early November that it had developed a Covid pill that cut hospitalizations and deaths by 89%. It hasn’t spelled out how it will price or distribute the pill, but since production is limited in the near term, vaccines remain the central weapon against the pandemic.

In recent months, Pfizer has begun to ramp up vaccine deliveries quickly outside the richest nations. As of Nov. 7, it had shipped more than 658 million doses to low- and middle-income countries out of 2 billion delivered, the company said. By the end of the year, it expects that figure to reach 1.1 billion doses out of some 3 billion produced.

Yet there is one point on which the Pfizer CEO won’t budge: his vaccine’s secret formula. Countries led by India and South Africa have been pushing a proposal at the World Trade Organization to waive intellectual-property rights for Covid vaccines and treatments. Bourla, who has called IP rights the “blood of the private sector,” has been the most outspoken among fellow CEOs in resisting calls to share his technology—even though proponents say it would mean, in theory, that others could produce more doses.

“The waiver proposal is based on the incorrect notion that vaccine access is limited due to current levels of manufacturing,” Pfizer said in a statement in response to questions for this story. “The industry is already well on its way to produce enough vaccines for the entire world by the middle of next year.”

U.S. Trade Representative Katherine Tai’s announcement in early May that the Biden Administration would support the IP waiver delivered a gut-punch to the pharmaceutical industry, reversing decades of support in Washington D.C. for intellectual-property protections. Inside Pfizer it set off a scramble, with executives holding meetings questioning how the company could have been blindsided on the issue, according to people familiar with the situation.

The next month, Pfizer agreed to sell 500 million doses at cost to the U.S. for distribution to low-income countries, a program that’s since doubled to 1 billion shots. After making that deal, the drugmaker turned away from negotiations for a large new supply agreement with Covax, the WHO-backed program to deliver vaccines to poorer countries. “Their approach has been, let us control supplies and we’ll work with countries to increase donations,” Brook Baker, a law professor at Northeastern University, says of Pfizer. “The industry knows the waiver is a threat to their business model.”

Bourla’s message to poorer countries is to hurry up and buy his product—which he’s selling on a sliding scale. For richer countries, Bourla has compared a shot’s cost to the price of a takeout meal, or about $20. It’s half that for middle-income nations, and at cost for the rest. “They should place their orders for 2022,” Bourla said in a Nov. 2 Bloomberg TV interview. Asked if his vaccine allocations consider a country’s incidence of Covid, he said no. “We are taking it in relation with how many doses we have and who wants to get them,” he said. “Most of the discussions right now are with middle and high-income countries. Mainly with high income.”

Any criticism of Pfizer’s approach comes after what can only be described as an extraordinary effort to develop a badly needed medicine. From the first days of the pandemic, the New York-based company threw everything it had at finding an effective vaccine—and then did so in record time in what is undoubtedly one of the greatest and swiftest scientific breakthroughs in history.

Without Bourla at the helm, it might not have happened. As CEO, he took a gutsy gamble on a partnership with BioNTech to develop a shot using unproven mRNA technology, calling it Project Lightspeed. He told everyone in the company to spend whatever it took to find a vaccine that worked. He even greenlit the building of Pfizer’s own high-tech delivery system to ensure the doses, which needed to be kept at minus 70 degrees Celsius, remained stable and got delivered en masse.

Winning that bet has made Pfizer, by many measures, the front runner in the global Covid vaccine race. It had the first shot approved by a western drug agency, and the vaccine is generating the most revenue and profit ($20 billion in pretax profit in 2021, including the 50% share that goes to BioNTech, according to estimates by Bloomberg Intelligence). It was the first vaccine approved for booster shots. At the end of October, it became the first shot authorized in the U.S. for children under 12.

Moderna, which will generate less than half of Pfizer’s Covid vaccine revenue, is expected by analysts to earn $12.2 billion before taxes this year. Johnson & Johnson pledged to sell its vaccines at no profit during the pandemic. AstraZeneca switched to a for-profit model on Nov. 12, saying the pandemic was moving into an “endemic” phase—one in which the disease is only found among particular people or in certain areas.

Pfizer said its first deals of the pandemic were mostly with higher-income countries in part because less-wealthy nations it approached had chosen to place orders with other companies. “Country readiness” also presented a barrier to poorer countries, Pfizer said, including the ability to handle the doses at ultra-cold temperatures, as well as “issues with demand and vaccine confidence.”

Once deals are finalized, actually producing and moving the vials can take time. Of the doses Pfizer pledged to sell to the U.S. for redistribution abroad, some eight in 10 aren’t scheduled to be delivered until next year. Moderna reached an agreement with Covax on May 3 to supply as many as 500 million doses, but most of those will ship next year as well.

India and South Africa saw that disparity coming long before shots started going into arms. In October 2020, they co-sponsored the proposal at the WTO to temporarily waive intellectual-property rights. While Bourla led public opposition to the effort, rivals were less confrontational. Moderna promised not to enforce its Covid-19 related patents during the pandemic. AstraZeneca backed a so-called “third way” model based on not-for-profit pricing and licensed technology transfers to manufacturers around the world. Johnson & Johnson has pursued a similar approach, negotiating manufacturing deals for its vaccine in South Africa and India, though production has been far lower.

The WTO’s tradition of reaching decisions by consensus makes the waiver idea a long-shot, but the odds shortened with the U.S.’s announced support in May. Several other countries have since followed. More than 120 now say they support or are officially sponsoring a waiver, which will be discussed at a WTO ministerial meeting starting at the end of this month. The European Union opposes it and has instead put forward a series of measures that it argues will allow developing countries to use existing trade tools to expand their production capacities. The U.K., Switzerland and Norway also have resisted the proposal.

Tai told reporters on Nov. 10 that the U.S. will push the waiver proposal at the ministerial meeting, calling it “a very powerful message from the developing countries at the WTO that they need relief in this pandemic.”

Pharmaceutical companies have argued that lifting IP restrictions won’t help vaccinate people more quickly. At a Sept. 7 press briefing organized by the Geneva-based International Federation of Pharmaceutical Manufacturers Association, Bourla and his colleagues said that there was no need to waive intellectual-property rights to vaccines because the industry was making enough for everyone.

“If you let the current industry, our industry now, work hard and do what they need to do, like Albert [Bourla] was indicating, I think that it will be sufficient.” said Paul Stoffels, Johnson & Johnson’s chief scientific officer. He said it takes current producers a year to 18 months to get plants up to full capacity with the new Covid vaccines using existing know-how. “It will take different companies so much longer,” he said. At the briefing, Bourla, as he has done since, urged countries to place their orders.

At the WHO, Tedros was paying attention. “I was appalled,” he said the next day at a press briefing. “I will not stay silent when companies and countries that control the global supply of vaccines think the world’s poor should be satisfied with leftovers.”

The secret formula that Bourla is protecting is much more complicated than a simple recipe. Pfizer’s shot has more than 280 materials made by suppliers in 19 countries, many of which are protected in one form or another. For a manufacturer to produce a vaccine, it would have to negotiate multiple licenses to waive protections on everything from lipids to mRNA strands and trade secrets used in the manufacturing process. The waiver proposal could in theory do that in one go.

The threat of such a comprehensive waiver moved some producers to raise the issue during vaccine sales talks. In South Africa, Pfizer and Johnson & Johnson pressed officials to drop the country’s waiver campaign during months of talks over terms of a supply contract, according to two people familiar with the discussions. Bloomberg first reported the demands in April. Both drugmakers declined to comment on questions about those negotiations with the country.

Supplies to some low- and middle-income countries were also delayed by company demands to be shielded from any liabilities associated with the vaccines. While all vaccine developers asked for some kind of indemnity protection, Pfizer stood out by asking nations to renounce legal recourse against it for any negative consequences of the vaccine, including manufacturing errors or negligence, according to interviews with half a dozen officials and a review of documents and contracts.

Those demands, made of countries including Argentina, Brazil, Colombia and India, sought legal immunity similar to the sort Pfizer enjoys in the U.S. In Colombia, the company also asked the government to waive sovereign immunity, the international framework under which nations are largely exempt from prosecution and lawsuits, and demanded disputes be governed by New York State law. By contrast, AstraZeneca agreed to settle any disputes in Colombian courts and didn’t ask the government to waive sovereign immunity.

South Africa’s then-Health Minister Zweli Mkhize singled out Pfizer’s insistence that the government put up collateral to cover claims as the reason for a delay in signing a contract, which it did in April. “We have found ourselves in a precarious position of having to choose between saving our citizens’ lives and risking putting the country’s assets into private companies’ hands,” he wrote in an April 14 letter to parliament, seen by Bloomberg.

For India, which has the third-highest official Covid death toll worldwide, demands for full indemnity have stymied vaccine supply talks with Pfizer, Moderna, and Johnson & Johnson, according to N.K. Arora, head of India’s national technical advisory group on vaccinations. “We are keen for whatever vaccines we can get,” Arora says. “But the conditions should be fair.”

Pfizer said in a statement that it seeks indemnity and liability protections in all its agreements, and that the company has requested sovereign immunity waivers so that it has the ability to enforce contracts. Regarding India, it denied that indemnity demands derailed supply talks. “There were and are several factors at play in ongoing conversations,” Pfizer said. Johnson & Johnson didn’t respond directly to a question on supply talks, though it said that it believes its manufacturing partner in the country “will be an important part of our global COVID-19 vaccine supply chain network.” Moderna declined to comment.

Pharmaceutical companies have taken an alternate route in a bid to satisfy the call to expand distribution—but without giving up their IP rights—by signing additional production deals, either to bottle or produce doses starting next year.

In July, Pfizer said it would aim to start bottling its shot in 2022 at a small South African company called Biovac, with a target of 100 million doses a year for the African Union, but the plan doesn’t include mRNA drug substance production. In August, it announced a similar bottling deal with Brazil’s Eurofarma Laboratorios. At the end of October, Germany’s BioNTech announced a memorandum of understanding with the governments of Rwanda and Senegal and the Institut Pasteur de Dakar to start building an mRNA vaccine manufacturing facility in Africa in mid-2022. Pfizer wasn’t part of that agreement, but if the facility produces Covid-19 vaccines, they could be sold under the partnership between the two companies.

Moderna may take a different route. It’s in talks with the Medicines Patent Pool, a United Nations-backed nonprofit that aims to make drugs and technologies more widely available, about taking part in its mRNA vaccine hub in South Africa, according to Marie-Paule Kieny, chair of the group and a former top WHO official. The company will also make up to 110 million shots available to the African Union, it said last month. Those doses will be priced at $7 each.

Pfizer has not engaged with the Medicines Patent Pool on its vaccine, but it is talking to the group about widening access to its Covid pill. As with vaccines, there will be a battle over who gets to be first in line.

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