The vaccine IP sideshow

Companies need to transfer the technology so production can ramp up quickly; how is up to them

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The pharmaceutical industry is under pressure to rapidly expand COVID-19 vaccine production capacity to meet global demand. It isn’t just the moral imperative of assuring the world’s less developed countries have equal access to the life-savings jabs. Given the scientific uncertainty about the new vaccines’ effectiveness against emerging variants, an uncontrolled pandemic anywhere is a potential threat to the vaccinated everywhere.

Over the past several months, non-governmental organizations have pressed global vaccine manufacturers to share their intellectual property and technical expertise with experienced generic manufacturing firms, which are anxious to ramp up production. Their campaign received a huge boost earlier this month when the Biden administration backed waiving the vaccines’ IP protections in response to the pandemic spiraling out of control in India and some South American countries.

The drug makers pushed back by arguing that merely turning over a recipe will not get the job done. Vaccine manufacturing is complex and requires highly specialized equipment, chemicals and technical expertise that are in short supply, they say. Allowing generic manufacturers into the space could lead to an explosion of counterfeit vaccines. And, in a repeat of the industry’s standard argument to ward off price controls, industry officials say anything that limits industry profitability will erode their incentives for future research. “Who will make the vaccine next time,” the former CEO of Allergan wrote on Twitter.

The debate will take center stage at several international meetings over the next several weeks. Initial discussions ahead of the G20 Global Health Summit, meeting in Rome on Friday, suggest the world’s leading economies will snub the U.S. request to endorse IP waivers, according to a Reuters report. Instead, the European Union, with German Chancellor Angela Merkel in the lead, are encouraging Big Pharma vaccine makers to voluntarily transfer their IP rights and related know-how to generic manufacturers. The EU counters that expanded production would be greatly enhanced by the U.S. lifting its export restrictions on the raw materials and machines needed to make vaccines.

How many doses? And what kind?

In a world with nearly 8 billion people, at least a third of whom live in extreme poverty, vaccinating everyone – or at least the two-thirds needed to achieve herd immunity – represents a huge technical and logistical challenge under the best of circumstances. Not all COVID-19 vaccines are well suited to local conditions. The mRNA vaccines produced by Pfizer/BioNTech and Moderna, for instance, need to be stored at very low temperatures. Public health officials in countries where most people dwell in remote rural areas may prefer more easily stored vaccines, even if they are somewhat less effective.

The good news is that ramping up the local public health infrastructure to deliver vaccines is a manageable challenge given the extensive work of the World Health Organization and philanthropies over the past half century. The campaign to end smallpox, which was finally eradicated in 1980, proved that mass vaccination programs in even the poorest regions can succeed with proper financial and technical support. A mass measles vaccination campaign in Africa in the first decade of this century succeeded in eliminated over 90% of cases.

Producing enough COVID-19 vaccines to supply those channels is the real bottleneck. COVAX, launched a year ago by the World Health Organization, Gavi and the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI), set a goal of making 2 billion doses available to its 191 member countries by the end of this year. That number would be sufficient to vaccinate frontline healthcare workers and people at highest risk of contracting severe COVID-19.

CEPI issued a comprehensive paper on the global supply chain in early March. It estimated the world will need at least 11 billion doses by the end of this year. Approximately 5 billion doses of projected supply have already been pledged to high-income countries, leaving global supply far short of demand.

Seth Berkley, CEO of Gavi, the Vaccine Alliance, which administers COVAX for the WHO, said in a recent commentary in Time Magazine that “global access to vaccines is not happening fast enough, and it is in everyone’s interest that we get there soon.” He called on the world’s developed countries to end export bans that limit trade in vital ingredients and vaccine components.

Though the U.S. has relaxed some of its restrictions, many are still in place. A State Department spokesman, when pressed on the matter earlier this week, said “the United States first and foremost is engaged in an ambitious and, so far, successful effort to vaccinate the American people.”

Berkley also called on wealthy countries to release more of its pre-bought vaccines. The Biden administration earlier this week released another 20 million doses of the Pfizer/BioNTech and Modern vaccines, bringing the total pledged to developing countries to 80 million. COVAX also needs an additional $1.7 billion to purchase the 2 million doses that vaccine manufacturers pledged to sell COVAX at reduced prices.

Nibbling the hand that feeds you

The WHO-backed group is leery of challenging the global pharmaceutical industry. Its long-term strategic approach, honed over several decades, involves negotiating with big companies for lower prices for a range of essential drugs and vaccines. But in the midst of a devastating pandemic, it’s asking governments and industry to support technology transfer to scale up production.

“In addition to sharing intellectual property, we also need manufacturers to share the critical know-how needed to make them,” Berkley wrote. He noted the major vaccine makers have already transferred the technology to their contract manufacturers, which is “one reason the world was able to get COVID-19 vaccines quickly and in such volumes. Technology transfers clearly works.”

Yet the major manufacturers continue to resist working with companies they can’t control, since they might become competitors down the road. Earlier this week, Politico’s European edition reported that at least four experienced drug manufacturers (Biolyse in Canada, Incepta in Bangladesh, Teva in Israel, and Bavarian Nordic in Denmark) have failed in their efforts to negotiate IP and tech transfer agreements with the four Big Pharma firms with approved vaccines.

An AstraZeneca spokesperson trotted out all the usual excuses, according to the Politico report. The process for making vaccines is very complex; there are a limited number of facilities around the world capable of making its vaccine; and its technical staffers were too busy to help bring new players up to speed.

Teva is the world’s largest generic drug manufacturer and has decades of experience meeting various nations’ regulatory standards for good manufacturing practices. World Trade Organization director general Ngozi Okonjo-Iweala claimed Pakistan, Bangladesh, Indonesia, South Africa and Senegal have facilities that can be retooled to produce COVID-19 vaccines.

There’s no doubt that vaccine manufacturing is complex. As Dr. Peter Hotez and colleagues noted in an article in Foreign Affairs last week, patent waivers (sometimes called compulsory licensing) “may be necessary but will at best remain a modest element of any truly global effort to produce vaccines.”

Companies will not only have to temporarily waive their IP protections, but they will have to support new market entrants’ efforts to ramp up production. The current pandemic is the perfect opportunity to build hubs of manufacturing excellence to support vaccine research and production, where on-site professionals can be trained by experts on leave from the big drug companies, they wrote.

Clearly looking to a world where the emergence of new and threatening pathogens will be a more frequent occurrence, global funders need to “invest in preparing researchers and manufacturers to adapt to multiple different vaccine technologies,” they wrote. “Diversity is critical: there is no way to predict which vaccine technology will be optimal to use against a particular pathogen, so researchers and manufacturers need to be prepared to ramp up efforts on any one of them.”

There isn’t a moment to waste. The mutating SARS-CoV-2 virus doesn’t care how the private companies that bring new drugs and vaccines to market and global governments and public health authorities resolve their differences over intellectual property rights and technology transfer. The global population awaiting vaccines couldn’t care less if those vaccines get made by the original manufacturers or by generic firms.

The only item that should be on the G20 agenda on Friday is deciding what immediately needs to get done to ramp up production as quickly as possible.