In January 2017, the United States’ Advanced Biomedical Research and Development Authority (BARDA) received a 112-page proposal outlining a strategy to tackle future pandemics. The document listed technologies to be followed for vaccine development, including messenger RNA and adenoviral vectors, and recommended creating a team of 180 scientists, doctors and more experts to carry out the plan. It offered technical details, an organization chart, and a cost of $ 595 million over 10 years.
The US Congress created BARDA in 2006 precisely for this. It is tasked with developing and acquiring medicines and vaccines, and ensuring that the country studies countermeasures to combat bioterrorism and chemical warfare, as well as pandemic influenza and other emerging threats. However, the agency has been small and the proposal, presented by GlaxoSmithKline Plc, would have been one of its most ambitious initiatives. Following the 2014 Ebola outbreak in West Africa, which killed 11,000 people, Glaxo researchers wanted to identify viruses that could cause epidemics. « The idea was to make vaccines against all viruses, » says Moncef Slaoui, who chaired the company’s vaccines division and later would be the Trump administration’s chief advisor to Operation Warp Speed.
Glaxo had an underutilized laboratory and Maryland biotech plant and was already relocating its vaccine researchers there as part of a corporate reorganization. Under the proposal submitted to BARDA, the company would provide staff and facilities in Rockville, while government agencies and nonprofits would fund vaccine development for multiple platform technologies through initial human trials.
That way, if an outbreak occurred, Glaxo would have vaccines ready for end-phase trials.
The drugmaker spent months refining the proposal and had reason to believe it would receive funding. BARDA officials met with Glaxo scientists on multiple occasions and urged the company to submit a formal proposal. After referring her, BARDA evaluated her for several months. Finally, in late 2017, the agency suggested that Glaxo present a plan focused on influenza. That proposal was also not funded, leaving the world without a key virus weapon when the pathogen that causes COVID-19 was discovered.
Since then, vaccines with approaches similar to Glaxo’s have been developed. During the pandemic, many of the vaccines benefited from grants from BARDA and from government research. It was a failure not to plan ahead, a mistake that coincided with the White House decision to disband the pandemic response unit at the National Security Council in 2018 and the inability of the Centers for Disease Control and Prevention. to have a COVID test soon.
By the end of 2019, all infectious disease experts knew that something like the new coronavirus would come sooner or later. However, despite the current tragic situation, the next pandemic does not have to be so serious. Shortly before his inauguration, President Biden proposed spending $ 20 billion to accelerate the distribution of vaccines; it’s a start. But a complete plan will have to be more comprehensive.
1. Surveillance for pathogens
The world cannot eradicate new diseases. People live in close proximity to animals and people travel. In the 21st century alone, humanity has faced outbreaks of SARS in 2003, H1N1 in 2009, MERS in 2012, Ebola in 2014, and now Covid. Candidates that may make us sick in the future include highly virulent filoviruses, including the Ebola and Marburg viruses; mosquito-borne flaviviruses, such as those that cause Zika and dengue; and bat-borne paramyxoviruses, such as Nipah and Hendra viruses.
« Our current strategy is really to let them happen, » says Peter Daszak, a virus hunter at the EcoHealth Alliance, a nonprofit research group. Daszak suggests that we approach viruses in the same way as terrorist networks: track them down to intervene before wreaking havoc.
Daszak estimates that there are 1.7 million unknown mammalian viruses, many of which could make the leap to humans. However, if we knew them better, we could identify the outbreaks that have the greatest potential to become severe, says Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. It would be a kind of National Weather Service for pandemics that would predict the course of emerging pathogens.
In the COVID pandemic, the opposite happened. In February, Milan launched the “Milan does not stop” campaign, which encouraged people to go sightseeing. In the US, authorities hesitated before imposing harsh distancing measures. If the restrictions had been applied a week earlier, 32,000 lives would have been saved, according to Columbia.
2. WHO empowerment
Surveillance and response to a pandemic, almost by definition, is a global effort, which means that it is time to consider a new global alliance to monitor it. The structural deficiencies of the World Health Organization (WHO) are well documented. The main international body tasked with fighting disease has been criticized by the United States and others for being too deferential to China and for its slowness in declaring the outbreak a global emergency. The agency replies that it must put diplomacy first while collecting information and that it cannot force member states to comply. However, the dispute caused the United States to formally withdraw from the WHO last year, further weakening the body at a key moment.
This dispute, like so many aspects of the COVID catastrophe, was predictable. The current pandemic response system is based on transparency. Governments are supposed to alert the international community to the first sign of danger. But of course, leaders, concerned about damaging their national economies or personal political prospects, are often silent.
Thomas Bollyky, director of the global health program at the Council on Foreign Relations think tank, notes that « this is a recurring problem. » China was slow to recognize the SARS outbreak in 2003, and in 2014 it took West African authorities months to admit that the Ebola virus was the cause of mysterious diseases in remote areas. In a recent report, Bollyky and his colleagues recommended developing a system that bypasses government bureaucracies and directly monitors anonymous data.
The WHO could get more teeth, but some argue that the world may need a new coalition of countries to coordinate the response effectively. Richard Hatchett, director of the Coalition for Epidemic Preparedness and Innovation (CEPI), has suggested an alliance with a less cautious approach.
« Infectious diseases are like fires. They need to be turned off when they can be contained, in both cases time is of the essence, ”says Anne Rimoin, an epidemiologist at UCLA, who has been working on Ebola for years in the Democratic Republic of the Congo.
3. Genetic sequencing
Tracking and tracing a virus is often seen as a laborious process that involves generating patient contact lists and then calling each of those people to find out who else might have been infected. Gene sequencing, in contrast, can track the spread of a virus with molecular precision. Frequent and intensive sequencing would help answer questions such as how widely a given strain spreads within a community and whether the strain can mutate.
Thanks to the ubiquity of genetic sequencing machines, it only costs about $ 50 to sequence the entire genome of a virus. This information provides clues for contact trackers about the pathway of the pathogen and enables large-scale mutation tracking. Unfortunately, in the United States only 3 out of every 1,000 COVID patients have their virus samples sequenced.
One of the current leaders in coronavirus sequencing is the UK, which has processed more than 200,000 samples, about 5 percent of its cases. That was what helped detect variant B.1.1.7, which could be more contagious.
Since it has already been found in dozens of countries, it is expected to become the dominant strain in the US. Biden has recognized the problem and announced plans to increase sequencing capacity, choosing Eric Lander, a genomics expert at the Broad Institute of MIT and Harvard, as scientific advisor.
4. Develop more vaccines, faster
Vaccines have been the most spectacular triumph in this pandemic. There are already two effective options in the U.S. market, and a third Johnson & Johnson vaccine could be approved in a few weeks, after the company reported Phase III results on January 29 showing strong protection against severe COVID. However, there is a clear opportunity for improvement. “We need strategies that allow us to move even faster,” says David Ho, who directs the Aaron Diamond AIDS Research Center in Columbia.
Early investment in mRNA technology by the US government helped Moderna take its vaccine to human trials in a record 66 days. But it still took more than four months of phase I and II trials to confirm its safety and find the correct dose before the crucial phase III trial could begin in late July. There are no shortcuts in this final stage, which focuses on efficacy in humans, but Moderna could have tested candidates for known coronaviruses in advance and arrived months earlier for the phase III trial, according to CEO Stéphane Bancel.
Bancel estimates that it would cost between $ 200 million and $ 300 million to initiate the first human trials of mRNA vaccine prototypes for the ten most worrying virus classes, so that with some adjustments, they are ready for large-scale testing. Bancel’s plan is similar to the proposal Glaxo tried to sell to BARDA in 2017.
An area for future investment: vaccines and medicines that offer protection against multiple viruses. Existing COVID vaccines stimulate antibodies against a specific spike protein that the virus uses to enter cells. Instead, researchers could create a vaccine that triggers an immune response against that entire spectrum of spikes, which varies much less between strains, thus allowing protection against numerous COVID-like diseases, says Vineet Menachery, a coronavirus specialist at the Medical Center. from the University of Texas at Galveston.
Something similar should be done with antiviral drugs, says Ralph Baric, a coronavirus expert at the University of North Carolina who conducted research before the pandemic showing that remdesivir, an antiviral developed by Gilead Sciences to fight Ebola, was promising against coronaviruses. Remdesivir was approved for the US market on May 1 in part because it had already been tested in patients during a 2018 outbreak in the Democratic Republic of the Congo, so only phase III trials focused on COVID were required. But remdesivir must be given intravenously, which has limited its use to hospitalized patients. Merck & Co. is working on a Covid drug that could be taken in pill form, but unlike Gilead’s drug, it had not yet started phase I trials when the pandemic hit. The results of the efficacy tests are expected to be presented in April.
5. Fine-tune distribution and logistics
Distributing tests and vaccines is not rocket science, but adapting logistics in a medical system as large and complicated as the US can take months of advance planning and coordination, and databases must be developed to keep track. That work was not done in 2020, as the Trump administration insisted that state governments be responsible for managing testing, purchasing and distributing personal protective equipment, and implementing vaccination protocols.
This has been, in hindsight, the most unfortunate and most preventable failure. « A national and international crisis needs the full intervention of the federal government, » says Peter Hotez, a vaccine researcher and dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. « It is one of the reasons why we have lost 400 thousand lives in the country, due to that strange insistence. »
Biden’s plan for the federal government to establish mobile clinics and community vaccination centers in gyms and stadiums could speed up the vaccination process. But once we get through the immediate crisis, the nation must take stock of its supply chains for essential drugs, testing equipment and supplies, and then provide incentives for companies to build more capacity where it is needed. « Our federal government has no idea which supply chains are vulnerable, » says Julie Swann, a health systems expert at North Carolina State University. When Hurricane Maria hit Puerto Rico in 2017, one of the largest US manufacturers of serum bags lost power, exacerbating an existing shortage of an essential medical item. This year, to mention one of many examples, a shortage of pipette tips needed for automated lab machines slowed down COVID testing, forcing labs to scramble for supplies.
Not only do we not have an effective way of accounting for basic medical supplies, we are also unable to track public health data on patients and diagnostic capabilities; it’s all logged into a hodgepodge of outdated and often incompatible federal, state, and local computer systems. Not knowing where the worst outbreaks are makes it difficult to identify where to send supplies.
During the current crisis, all of this has been more difficult than necessary. This is because the response to a pandemic requires foresight, something that was in short supply in recent years. « Nobody expected something like this, » Trump said March 24 in one of his many false statements about the virus.
In fact, many experts had been predicting a pandemic for years, but could not persuade anyone to do so.
In the opinion of Slaoui, the former scientific advisor to Operation Warp Speed, politicians worry about fighting epidemics when they have already occurred: “When the outbreak occurs, all governments are on top of the industry. And then, when the bud dissolves, everyone looks the other way. «
That is what happened in the world after SARS, MERS, and Ebola. Now, with 2 million deaths in the world and a year of economic devastation, it should be more difficult to look the other way.
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This text is part of the Bloomberg Businessweek Mexico magazine special of ‘A very free market’. Check here the fast edition of this issue