In January 2017, a lengthy proposal was made in the offices of the Biomedical Advanced Research and Development Authority in Washington. The document was 112 pages and outlined a strategy for stopping future pandemics. A number of vaccine technologies have been described, including messenger RNA and adenovirus vectors, and a team of 180 scientists, doctors, and other experts have been recommended to carry out the plan. There were intricate technical details, an organizational chart, and an estimated cost: $ 595 million over 10 years.
In 2006, Congress created Barda, a division of the United States Department of Health and Human Services, to do just that kind of thing. It is tasked with developing and sourcing medicines and vaccines, and ensuring the country researches countermeasures to combat bioterrorism and chemical warfare, as well as pandemic influenza and other emerging infectious threats. The agency was historically small, however, and pharmaceutical company GlaxoSmithKline Plc’s proposal would have resulted in one of its more ambitious endeavors. After the massive Ebola outbreak in West Africa in 2014, which killed more than 11,000 people, Glaxo researchers wanted to identify viruses that are likely to cause serious epidemics and fight several of them at the same time. “The idea was to only make vaccines against all viruses,” says Moncef Slaoui, who was then chairman of the company’s vaccines division and later served as a scientific advisor to the Trump administration’s Operation Warp Speed.
Glaxo owned an underutilized laboratory and an abandoned biotech facility in Rockville, Md., And was moving vaccine researchers there as part of a corporate reorganization. As part of its Barda proposal, the company would have provided scientific staff and facilities to the Rockville site, while government agencies and nonprofits would have funded vaccine development for multiple “platform” technologies through early human testing and manufacturing. That way, in the event of an outbreak, Glaxo would have prototype vaccines ready for end-stage trials.
A team at the company spent months refining the proposal, according to someone familiar with the efforts, and had reason to believe that it might be funded. Barda officials met with Glaxo scientists several times, toured the Rockville facility, and asked the company to submit a formal proposal, the person recalls. After it was submitted, Barda considered it quietly for several months. Finally, in late 2017, the agency suggested that Glaxo come up with a scaled-down plan that mainly focuses on influenza. That proposal was also never funded, leaving the world with no key weapon against emerging viruses when the pathogen that causes Covid-19 was discovered.
Since then, vaccines have been developed using mRNA and adenovirus vector approaches similar to those originally proposed by Glaxo. Many of the vaccines benefited from grants from Barda during the pandemic and from government sponsored basic research upfront. However, the failure to set up a fuller infrastructure in advance was a missed opportunity to build capacity that could bolster the current vaccine supply. It was a failure, even a refusal to plan a mistake in advance – a mistake related to the White House’s decision to disband the Special Pandemic Response Unit in the National Security Council in May 2018 and the inability of the Centers for Control and Prevention of Disease Consistent Quickly Develop a Covid Test for Widespread Use.
At the end of 2019, every infectious disease expert knew that sooner or later something like the novel coronavirus would come, just as they know today that Covid won’t be the last pandemic. As depressing as the current situation is, the next – and there will be – doesn’t have to be that bad. Shortly before his inauguration, President Biden proposed spending $ 20 billion to expedite the introduction of vaccinations. That is a beginning. But a full plan that can protect the US from mass death, catastrophic economic damage, and (let’s hope) incompetent political leaders wasting public trust must be broader. It will likely have at least five separate research and investment areas. Most of all, it requires careful preparation.
1. Pathogen monitoring
If youThe world cannot eliminate emerging diseases. Too many people live near animals and there are too many international air travel. In the 21st century alone, humanity is struggling with SARS outbreaks in 2003, H1N1 in 2009, MERS in 2012, Ebola in 2014 and now Covid. Candidates who could make the world sick in the future include highly virulent filoviruses, including the Ebola and Marburg viruses; fast-spreading flaviviruses transmitted by mosquitoes, such as those that cause Zika and dengue fever; and bat-borne paramyxoviruses such as Nipah and Hendra.
All of this is scary. Marburg and Ebola can lead to severe vomiting, diarrhea and bleeding. Hendra and Nipah, too fatal brain swelling. More worryingly, we wait for outbreaks to kill a few dozen people before doing anything about it. “Our current strategy is that we really let them happen,” says Peter Daszak, a veteran virus hunter with the EcoHealth Alliance in New York, a nonprofit research group. Daszak suggests that we tackle emerging viruses as we approach terrorist networks: track them so we can intervene before they can wreak havoc.
Daszak, who searched for bat coronavirus in China and elsewhere for years, estimates that there are around 1.7 million unknown mammalian viruses, many of which could spread to humans with just a few mutations. He and his coworkers estimate it would cost a little more than $ 1 billion to identify two-thirds of these pathogens by sampling wildlife populations around the world. This would give scientists guidance on which viruses pose the greatest risk to humans and allow communities in potential hot spots to focus on reducing the risk of spillover and help governments and research institutions allocate resources for further study.
If we could better understand what is pathogenic, we could work to identify the outbreaks that have the greatest potential to become serious, says Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. Imagine some sort of National Pandemic Weather Service that predicts the progression of emerging pathogens. These official projections would be more authoritative than the jumble of competing disease models, making it easier for governments to take potentially unpopular mitigation measures like closing borders or placing barriers before an outbreak sets in.
The opposite happened during the Covid pandemic. In late February, just before the hospitals were overcrowded, the Milan city government unveiled a campaign called “Milan Doesn’t Stop” encouraging people to visit tourist attractions and go out to dinner. In the US, many local leaders hesitated before taking harsh social distancing measures. If the restrictions had only occurred a week earlier, research from Colombia would have saved 32,000 lives by the beginning of May. “It’s about giving decision-makers enough confidence to feel comfortable doing business,” says Rivers. And an epidemic prediction center would be a relative steal that would cost the U.S. only $ 100 to $ 150 million a year, she estimates. The Biden administration plans to create one.
2. Repair and expansion of the WHO
Pandemic surveillance and response are almost by definition global efforts, which means it is time to consider a new global partnership to oversee them. The structural shortcomings of the World Health Organization are well documented. The main international organization charged with fighting disease has been criticized by the US and others for being overly respectful of China and slow to declare the outbreak a global emergency. The agency replied that it had to remain diplomatic in collecting information and that it could not force Member States to respond. Still, the spit prompted the US to announce last year that it was withdrawing, further weakening the body at a crucial moment.
This dispute, like so many aspects of the Covid disaster, was predictable. The current pandemic response system is based on transparency. Governments should alert the international community to the first sign of danger. But of course, leaders who are concerned about harming their economies or their personal political perspectives are often overwhelmed at the crucial moment and withhold data that the rest of the world needs. China was slow to admit the extent of the problem in Wuhan early last year and did not immediately let international health experts into the city to assess the threat. In the US, President Trump countered the looming crisis by dismissing it and repeatedly assuring Americans that Covid would just go away. “Someday it’s like a miracle, it’ll go away,” he said on February 27, just as the virus took off.
Thomas Bollyky, director of global health programs at the Council on Foreign Relations, points out that none of this is new. “This is a recurring problem,” he says. China was slow to recognize the SARS outbreak in 2003, and in 2014 it took West Africa officials months to discover that mysterious diseases were caused by the Ebola virus in remote areas, allowing it to travel from rural areas where it probably could have been included to cities. In a recent report, Bollyky and his colleagues recommended developing a system that bypasses central government bureaucrats and monitors anonymized data, such as: B. Increasing cases of unexplained pneumonia collected directly from hospitals around the world. It was a locally conducted project, the Seattle Flu Study, that first discovered the spread of Covid in the United States.
In January, an independent panel convened by WHO classified the current epidemic alert system as “slow, cumbersome and indecisive”. In theory, more teeth could be given to the WHO, which Biden has announced that the US will rejoin. However, some argue that the world may need a new coalition of countries to coordinate the response more effectively. Richard Hatchett, chairman of the board of the Coalition for Epidemic Preparedness Innovations (CEPI), an organization that has worked to accelerate the development of Covid vaccines since its inception in 2017, has proposed an alliance that takes a less cautious approach – a “biological NATO” “to defend the world against the development of pathogens. This group could help countries react much more quickly to future threats.” It is not a part of the world against any other part of the world, but the world against the viruses, “says Hatchett.
A muscular global health coalition could also provide funding to eradicate “wet markets” where wild animals are sold for food and stop jungle deforestation, bringing animals (and the viruses they carry) closer to humans . And it could help train more field workers in distant locations, rather than relying on the current ad hoc system of a mix of nonprofits, universities and volunteers working with WHO to address emerging threats. “Infectious diseases are like forest fires. You need to eradicate them if they can be contained,” says Anne Rimoin, an epidemiologist at UCLA. “In both cases, time is of the essence.”
Rimoin has been working on Ebola in the Democratic Republic of the Congo for years. There the mega city of Kinshasa borders the second largest rainforest in the world, in which many animals loaded with viruses cavort. She has tried to build infrastructure to respond to outbreaks, relying mostly on individual private donors. Sometimes she looks for basic equipment herself, tracks down donated laboratory equipment in the USA and checks dozens of additional bags on her flights to Africa.
3. Genetic sequencing
Tracking and tracing a virus has typically been viewed as a labor-intensive process of making lists of patient contacts and calling those people one by one to determine who might still be infected. In contrast, gene sequencing offers the tempting way to track the spread of a virus with molecular precision. Frequent, intensive virus sequencing would help answer questions about how far a particular strain is spreading in a community like a school, and whether the strain could mutate to become resistant to existing vaccines.
Thanks to the ubiquity of high-speed gene sequencing machines, sequencing the entire genome of a virus costs only about $ 50. This information provides clues to contact tracers about the pathogen and enables large-scale tracking of mutations. Unfortunately, only about 3 in 1,000 Covid patients in the United States have sequenced their virus samples. Much of the work has been done in academic laboratories that have been removed from the frontline facilities that have access to detailed patient records and do daily contact tracing.
One of the current leaders in virus sequencing is the UK; It processed more than 200,000 samples, about 5% of its drop load. This helped the UK catch variant B.1.1.7, which epidemiologists say could be more communicable. Since it has been found in dozens of countries, it is expected to become the dominant strain in the United States. The lack of virus sequencing in the country “is a major failure of our public health system,” says Marc Lipsitch, an epidemiologist at Harvard. “Hopefully this is a wake-up call.”
Biden recognized the problem, announced plans to dramatically increase sequencing capacity, and selected Eric Lander, a renowned genomics expert at the Broad Institute of MIT and Harvard, to be his scientific advisor.
4. Develop more vaccines, faster
Vaccines were the most spectacular success story of the current pandemic to date. There are already two highly potent options in the U.S. market, and a third Johnson & Johnson vaccine could be approved within weeks after the company reported Phase III results on Jan. 29 showing it was a strong one Offers protection against severe Covid. However, there are clear areas for improvement. “We need strategies that can move us even faster,” says David Ho, director of the Aaron Diamond AIDS Research Center in Columbia. Ho estimates that we could easily have shaved four to five months after the time of the drug and vaccine if more preparation had been made.
Early US government investments in mRNA technology helped Moderna Inc. get its vaccine candidate into human trials within 66 days. However, it took more than four months of Phase I and Phase II trials to confirm safety and find the right dose before the pivotal Phase III trial could begin in late July. There’s no shortcut to this final phase, which focuses on effectiveness in humans, but Moderna could have pre-tested candidates for known coronaviruses, potentially allowing it to start a large phase III study months earlier, so CEO St & # 233; Phane Bancel. “Autumn would have looked so different if we had a vaccine in July,” he says.
Bancel said it would cost $ 200-300 million to get prototype mRNA vaccines for the 10 most worrisome classes of viruses through early human trials so they’d be ready for large-scale testing with a few tweaks. It could cost another $ 1 billion or $ 2 billion to maintain a replacement manufacturing facility along with a supply of raw materials for millions of cans. In January, Moderna announced, in a small step towards that goal, that it had started work on a vaccine against the Nipah virus, which has killed hundreds in multiple outbreaks in Asia since 1999.
Bancel’s proposal is similar to the concept Glaxo tried to resell Barda back in 2017. A spokeswoman for the Department of Health and Human Services said that Barda’s Congressional funding at the time was focused on defending against influenza, as well as biological, chemical and radiological weapons; Coronavirus countermeasures, including vaccines, are being sought. Some people also saw the proposal as too tightly corporate and competing with groups like CEPI, supported by the Bill & Melinda Gates Foundation and others, to develop vaccines against emerging threats. Glaxo declined to go into detail on why it failed to attract funds, but said in a statement that it is committed to pandemic-related research efforts.
A tempting area for future investment: vaccines and drugs that protect against multiple viruses. The existing Covid vaccines spur antibodies against the unique spike protein that the virus uses to enter cells. According to Vineet Menachery, a coronavirus specialist at the University of Texas Medical, researchers could instead create a shot that sets off an immune response against the strain of these spikes that varies much less between strains while also offering protection against numerous Covid-like diseases Galveston office. It’s difficult and it might not work, but the potential payoff would be immense. In November, the National Institutes of Health announced plans to fund research into broad-acting coronavirus vaccines.
Something similar should happen to antiviral drugs, says Ralph Baric, a coronavirus researcher at the University of North Carolina who did crucial research before the pandemic and showed that remdesivir, an antiviral drug developed by Gilead Sciences Inc. to fight Ebola, shows promise against coronaviruses. Remdesivir was partially approved for the US market on May 1 because it had already been extensively tested in patients during an outbreak in the Democratic Republic of the Congo in 2018, so only phase III trials against Covid were required. However, remdesivir must be given through an IV, which has limited its use to hospitalized patients. Merck & Co. is working on a coronavirus drug that could be taken as a pill, but unlike Gilead’s drug, it hadn’t started Phase I trials at the start of the pandemic, which put it on a much slower path. The results of the effectiveness studies are expected by April.
5. Iron out sales and logistics
Getting tests and vaccines out to people is not rocket science. It’s not even normal science. Adjusting the logistics of a medical system as large and complex as the US, however, can take months of planning and coordination, and databases must be developed to keep track of things. Not enough of that work happened in 2020 when the Trump administration insisted that state governments conduct tests, purchase and distribute personal protective equipment, and implement vaccine distribution protocols.
This, in hindsight, was arguably the most unfortunate and easiest to avoid failure. “A national and international crisis requires full federal government intervention,” said Peter Hotez, vaccine researcher and dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. “It’s one of the main reasons we lost 400,000 American lives because we insisted so bizarrely.”
Biden’s plan to have the federal government set up mobile clinics and community vaccination centers in gyms and stadiums could move things forward. (It probably should have been the plan from the start.) But once we get past the immediate crisis, the US needs to take stock of its supply chains for basic drugs, equipment and test supplies and then incentivize companies to build more capacity there, 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, it cut power to one of the largest U.S. manufacturers of saline IV bags, compounding the existing shortage of essential medical supplies. This year, to name just one of many examples, a shortage of plastic pipette tips needed for automated laboratory machinery slowed Covid testing, forcing laboratories to battle for supplies.
Not only do we not have an effective way of counting medical staples, but we are also unable to properly track patient public health data and testing capacity. It’s all logged into a collection of outdated and often incompatible computer systems at the federal, state, and local levels. If you don’t know where the outbreaks are worst, it can be difficult to determine where to send the supplies. “We’re flying blind,” says Swann. Government databases need “more integration so that we know where our inventory is in real time”.
During the current crisis, this was all more difficult than necessary. That’s because responding to a pandemic requires foresight, which has been in short supply in recent years. “Nobody ever expected anything like this,” Trump said on March 24 in one of his many false statements about the virus. In fact, many experts had been predicting a pandemic for years, but they couldn’t persuade anyone to do enough about it.
Slaoui, the former advisor to Operation Warp Speed, says policy makers don’t seem interested in fighting epidemics until soon after they emerge. “When the outbreak is there, every government is spread over you as an industry,” he says. “And when the outbreak clears, everyone looks away.”
This has happened in too much of the world after SARS, MERS and Ebola. With 2 million deaths worldwide and a year of economic devastation, it should be harder to look the other way now.
(Except for the headline, this story was not edited by GossipMantri staff and published from a syndicated feed.)