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Big Pharma May Pose an Obstacle to Vaccine Development

As the danger of the coronavirus grew worldwide, threatening to spread in the United States, the Centers for Disease Control and Prevention warned on Tuesday that, “It’s not so much a question of if this will happen anymore but rather more a question of exactly when this will happen and how many people in this country will have severe illness.”

Crash efforts are underway for a vaccine. Anthony Fauci, the National Institutes of Health’s director for infectious diseases, said that if one is ready to be deployed in a year, it “would be the world’s record.” Faster than that would mean, says Dr. Fauci, “cutting dangerous corners.”

Dr. Fauci and officials at other government and international health organizations know that any vaccine developed in a lab will ultimately be manufactured by large pharmaceutical firms. At this critical juncture with coronavirus, no health expert would publicly criticize drug companies, but privately they complain that pharma is a major speed bump in developing lifesaving vaccines.

Pharmaceutical industry concerns about profits, as well as potential liability for adverse reactions to the inoculation, often keep them from moving quickly enough to develop or distribute effective vaccines when there emerges a novel virus, like the one that has set off the Covid-19 outbreak.

That was undoubtedly the case the last time Congress approved a national vaccination program in 1976 for swine flu, when 45 million Americans were inoculated. For several months, four drug firms — Merck’s Sharp & Dohme, Merrell, Wyeth, and Parke-Davis — refused to sell to the government the 100 million doses they had manufactured until they got full liability indemnity and a guaranteed profit.

The federal government feared the consequences of delaying the inoculations for a pathogen that was a close variant of the one responsible for history’s most deadly pandemic in 1918. It finally assumed full responsibility in case the vaccine caused any injuries or deaths. It also authorized the drug firms to earn a “reasonable profit.”

While the four pharmaceutical companies got millions, the Department of Justice ultimately had to assign 10 attorneys to defend full time more than 4,000 legal claims for damages from Guillain-Barré, a rare but serious disorder in which the immune system assaults healthy nerve cells. Taxpayer-funded settlements and judgments eventually topped $100 million.

The chilling effect of that tsunami of litigation inhibited the federal government from underwriting any mass immunizations in subsequent decades. There was no national program in 2009 when a novel influenza-A virus became a pandemic and infected an estimated 60 million Americans and killed 12,469. Instead, the Food and Drug Administration approved four vaccines that were biological cousins of existing flu inoculations. They were widely distributed to those groups most at risk, but were less effective for adults than for children.

Since then, the United States and its European allies have relied on an array of public and private entities, including nongovernmental organizations, academia, philanthropies, and the drug industry to respond to outbreaks of dangerous pathogens. When Ebola emerged in West Africa in 2014-15, the slow response and wasted resources were attributed to a lack of international coordination.

In 2017, a new organization was started to change the way the world researched and developed vaccines to combat new infectious diseases. It is the Coalition of Epidemic Preparedness Innovations (CEPI), a Norway-based public-private partnership whose slogan is “New Vaccines for a Safer World.” The World Health Organization had a list of pathogens for which it wanted vaccines developed, but pharmaceutical companies had shown little interest since the outbreaks were in Africa and Asia, where they had concluded the financial returns were too small to justify any investment.

Before Covid-19 was identified last December, CEPI had raised three-fourths of the $1 billion it determined was necessary to fund the innovative research for expedited development of vaccines to treat new epidemics. Japan, Germany, Canada, Australia and Norway, as well as the Wellcome Trust and the Bill & Melinda Gates Foundation, had given $460 million. In the last two years, CEPI has used that money to provide grants for some leading edge biotechnologies that could revolutionize vaccine research and production.

But what has played mostly out of public view over that same time was the organization’s failed effort to get large pharmaceutical firms to agree to be partners without insisting on substantial profits or proprietary rights to research that CEPI helped to finance and produce. That did not surprise many industry observers who knew that since the 1930s, the National Institutes of Health had spent over $900 billion on grants that drug firms relied on to patent brand-name medications.

Médecins Sans Frontières (Doctors Without Borders) encouraged a policy by which all countries would have equal and affordable access to CEPI-funded vaccines. The organization initially embraced those principles in a detailed policy paper in which it agreed to set prices to insure “equitable access” during a pandemic. Drug firms would have to share all vaccine research data. Contracts for manufacturing vaccines would be submitted first to a public review board. And CEPI retained the right to access intellectual property that companies developed with CEPI funding, even if they left the program.

Drug companies on CEPI’s scientific advisory panel, including Johnson & Johnson, Pfizer, and Japan’s Takeda, pushed back. CEPI mostly capitulated in a December 2018 two-page declaration in which it jettisoned specifics but gave lip service to its founding mission of “equitable access to these vaccines for affected populations during outbreaks.”

Last March, Doctors Without Borders wrote an open letter expressing its “concern and disappointment” about CEPI’s “vague, toothless and weak new policy.” It also concluded that CEPI had taken “an alarming step backwards. …the revised policy marks a concerning pivot away from CEPI’s early commitments to access, transparency and openness, and to breaking new grounds in terms of public responsibility. It betrays the interests of everyone who invested in CEPI because they wanted to change the deadly status quo.”

Covid-19 is the ultimate test case for whether drug firms might at last become full partners in a public-private partnership to develop as quickly as possible a vaccine that could save an untold number of lives.

“What matters more to the drug companies?” an infectious disease researcher involved in vaccine development said to me last week. “Keeping trade secrets and boosting the bottom line or taking a leading role in stemming the Covid-19 outbreak?”

How that is answered in the coming weeks might well determine how science and medicine deal not only with the looming pandemic but with future supergerm and viral pandemics that scientists consider inevitable.