National Institutes of Health Director Dr. Francis Collins speak during a news conference in 2017.
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National Institutes of Health Director Dr. Francis Collins speak during a news conference in 2017.
Matt Rourke/AP
In an bid to help speed up the development of potential treatment options and a vaccine for COVID-19, the National Institutes of Health on Friday announced a new public-private research partnership.
The new initiative will be spearheaded by the NIH but also include the Food and Drug Administration, other parts of the federal government and a list of 16 companies that includes some of the biggest players in the pharmaceutical industry. Among the companies participating in the effort are Pfizer, Johnson & Johnson and Merck.
We need to have all hands on deck from every sector to speed up the process of identifying those treatments that are going to work and to get the vaccines also developed, tested, to make sure theyre safe and effective in the maximum possible speed, said Dr. Francis Collins, director of the NIH, in an interview with NPRs All Things Considered.
The announcement comes after President Trump and public health officials on Thursday unveiled new guidelines for states to begin reopening the country. Health experts say that in order to safely do that, there needs to be more testing, contact tracing and better drugs to treat COVID-19. Ultimately, for things to truly return to normal, an effective vaccine is needed.
Collins said there are already two vaccines in phase one trials, and behind that, a series of more than 40 other vaccines being developed as well. But he cautioned that the public should expect failures along the way.
Somewhere in there may be a winner, even if most of them are losers, he said.
Collins also provided an update on testing of antiviral drug, remdesivir, and shared his thoughts on Dr. Anthony Fauci, the high-profile director of the National Institute of Allergy and Infectious Diseases.
Here are excerpts from the conversation.
Theres a lot of buzz about an antiviral called remdesivir.
Remdesivir is certainly, I think, at the top of most peoples hopeful list, but not yet proven. Just to report, yesterday although not yet peer reviewed, that in a monkey model it looked as if this did provide benefit for COVID-19. Were running a human trial with now 800 participants enrolled more quickly than expected. We will know, I think, in the next two to four weeks whether it worked or not.
[A] question about one of the most prominent faces of U.S. anti-virus efforts, Dr. Anthony Fauci Have you come under any pressure to fire him?
Absolutely not. He is a wonderful public servant, an amazingly smart infectious disease expert. He and I have a nightly phone call every evening to catch up on whats happened with his life down at the White House and mine trying to manage the NIH. Hes the best ally I could ever have.
Listen to the full interview on All Things Considered at the audio link above.
In early January, Hu Aizhen, 65, heard that a new coronavirus had emerged in her home city, Wuhan. She was not worried officials said it was not contagious so she went about her days as usual and prepared for the lunar new year at the end of the month.
Just before the city was put under lockdown, Hu developed pneumonia symptoms. After days of waiting and searching for a hospital, she was tested for the virus. Her result was negative, but tests at the time were known to be inaccurate and she showed obvious signs of the virus. Nevertheless, she was refused treatment by six hospitals.
Hu, who had always been healthy, stayed at home for 10 days, unable to drink or eat, while her health deteriorated. When she took a further turn for the worse, her son tried to get her to a hospital in another district but police stopped them. Under lockdown orders they could not cross into another district. Her son, desperate, shouted at the traffic officers: Are you not people?
When Hu was finally admitted to a hospital on 8 February, she was struggling to breathe. The doctor ordered another test, but it was too late. She regained consciousness briefly, asking her son to pour her some water. Then she died.
Hus son is now suing the Wuhan municipal government for allegedly concealing the seriousness of the virus, among other complaints, according to court documents prepared by Funeng, a public welfare NGO based in Changsha. Hus son is among a small but significant group of residents seeking answers, compensation or simply an apology from officials who took weeks to notify the public of the threat from a virus that went on to claim the lives of at least 4,000 people in China, according to government figures, most of them in Wuhan.
Other cases include a civil servant suing the Hubei provincial government, a mother petitioning for officials to be punished after watching her 24-year-old daughter die of the virus, and a son who rushed his quickly fading mother to a hospital in the suburbs of Wuhan where he was able to get her admitted to intensive care. When he went to pick up supplies for her, he received a phone call from the hospital. His mother had died.
None of this would have happened if they had told us. So many people would not have had to die, said a relative involved in one of the lawsuits. Another said: I want an answer. I want those responsible to be punished under the law.
As the outbreak spread in China, with thousands of confirmed cases a day at its peak, public anger reached levels not seen in decades, posing a serious threat to the ruling Chinese communist party. When the whistleblower doctor Li Wenliang died from the virus in February, censors could not keep up with the flood of outrage online. It was a moment some compared to the outpouring over the death of Hu Yaobang that precipitated the 1989 Tiananmen Square protests.
A little more than two months on, the resentment is much less visible. Accounts like Hu Aizhens have been replaced by positive stories of the country coming together to defeat the virus, sending needed supplies to the rest of the world and fighting malicious attacks from the US and other countries blaming Beijing for the outbreak.
People are easily led by propaganda, said Shi, a human rights activist based in Hubei province, of which Wuhan is the capital. As the epidemic situation has improved and the propaganda machine works, there has been a reversal. Now people are saying the strong leadership of the party is a good thing.
As Wuhan and the rest of the country slowly return to normal, authorities are carefully monitoring those who might harbour resentment. Zhang Hai, 50, whose father died from the virus in February, was part of a WeChat group of more than 100 people who lost relatives to the virus.
In late March they were told they could retrieve their loved ones remains from funeral homes. No more than five could go together at one time, and they had to be accompanied by a local government representative. Zhang refused to go. Later, the groups host was called in by the police and the WeChat group was deleted.
Now everyone is trying to be very careful, said Zhang, who is calling for the government to issue an apology. I know a lot of families who are incredibly angry.
Tan Jun, a civil servant in Yichang in Hubei province, filed a complaint this month accusing the Hubei provincial government of concealing the outbreak, according to copies of the lawsuit posted online. Tan confirmed the lawsuit but declined to be interviewed. Other residents in Wuhan who spoke to the Guardian said they had been intimidated by local police and forced to promise not to speak out.
People must take responsibility. As a resident of Hubei, I believe it is necessary to stand up and call on the Hubei government to take responsibility, Tan said, according to an article posted on several WeChat accounts that has now been deleted.
While authorities in Beijing have punished local officials by replacing them what observers say is an age-old tactic for deflecting blame from the central government residents say this is not enough.
That is not accountability. That is switching hats, said Wu, 49, who says she contracted the virus in January but was not officially diagnosed until March. In hospital she watched people around her die, including a woman in the next bed. Recently she learned that a classmate of hers who got sick around the same time had passed away.
When I was laying in bed thinking I might soon die, I thought: how did this happen? said Wu, who is suing her hospital for not confirming her as a coronavirus patient when she was released. Regular people have limited access to real information. We rely on the government. We believe what the government says.
Dissent has spread in other ways. Dozens of shop owners at a shopping mall in Wuhan demonstrated this month, demanding rent reductions after months of not being able to open their stores. In Yingcheng, a city west of Wuhan, residents put under lockdown protested against the high prices for food imposed by community management. One of the protesters, Zeng Chunzhi, has reportedly been detained.
People have been awakened. Thats for sure, said Xie Yanyi, a rights lawyer based in Beijing. Xie has filed a request for information from the government, including the origins of the virus and reasons for the delay in informing the public of the outbreak. It may not be many people, but history shows that it is the few who change society and who change history, Xie said.
In Wuhan, most residents are relieved that the worst of the epidemic appears to be over as they watch other countries struggle to contain it. Employees wait in lines outside of office buildings to have their throats swabbed, to make sure they do not have the virus before going back to work.
On the riverbank in Hankou district, a couple kiss in front of what has become a nightly light show of skyscrapers lit up with congratulatory messages. Many residents say they appreciate what their country has done for them.
The chance that cases such as Hus will be accepted and go to court are not high, according to Yan Zhanqing, a co-founder of Funeng. More likely, those involved will be intimidated or harassed. But in some cases, especially determined plaintiffs can get compensation, which is one form of apology.
These cases apply pressure on the government and help more people understand their rights and the governments responsibility, Yan said. This is also a way of documenting history, letting more people know the truth, and not just the governments version of what happened in Wuhan.
WASHINGTON (AP) Three potential COVID-19 vaccines are making fast progress in early-stage testing in volunteers in China and the U.S., but its still a long road to prove if theyll really work.
Chinas CanSino Biologics has begun the second phase of testing its vaccine candidate, Chinas Ministry of Science and Technology said Tuesday.
In the U.S., a shot made by the National Institutes of Health and Moderna Inc. isnt far behind. The first person to receive that experimental vaccine last month returned to a Seattle clinic Tuesday for a second dose.
NIH infectious disease chief Dr. Anthony Fauci told The Associated Press there are no red flags so far and he hoped the next, larger phase of testing could begin around June.
More on the Virus Outbreak:
A third candidate, from Inovio Pharmaceuticals, began giving experimental shots for first-step safety testing last week in the U.S. and hopes to expand its studies to China.
Initial tests focus on safety, and researchers in both countries are trying out different doses of different types of shots.
But moving into the second phase is a critical step that allows vaccines to be tested in many more people to look for signs that they protect against infection.
Last week, CanSino filed a report showing it aimed to enroll 500 people in this next study, comparing two doses of the vaccine to dummy shots. As of Monday, 273 of the volunteers had been injected, state media said.
Looking ahead, Fauci said if the new coronavirus continues to circulate widely enough over the summer and fall, it might be possible to finish larger studies slightly sooner than the 12 to 18 months hed originally predicted maybe toward mid to late winter of next season.
Please let me say this caveat: That is assuming that its effective. See, thats the big if, Fauci stressed. Its got to be effective and its got to be safe.
During a news conference in China, authorities also cautioned that the studies must be done properly.
Although we are in an emergency, we cannot lower the standards of safety and effectiveness in the reviews of vaccines, said Wang Junzhi, a Chinese biopharmaceutical expert. The public is paying huge attention.
The World Health Organization this week counted more than five dozen other vaccine candidates in earlier stages of development being pursued around the world. Many research groups are teaming up to speed the work; in an announcement Tuesday, vaccine giants Sanofi and GSK became the latest to partner on a candidate.
On the WHOs list are a wide variety of ways to make vaccines -- so if one approach doesnt pan out, hopefully another one will.
CanSinos vaccine is based on a genetically engineered shot it created to guard against Ebola. The leading U.S. candidates use a different approach, made from copies of a piece of the coronavirus genetic code.
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AP camera operator Borg Wong contributed to this report from Beijing.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.
Lars Hagberg/The Canadian PressA sign for the University of Waterloo is seen here on April 29, 2019, in Waterloo, Ont. Waterloo is one of several universities in Canada working on a COVID-19 vaccine.
Researchers at the University of Waterloo say they are developing a new nasal sprayCOVID-19 vaccine that can be delivered non-invasively.
In anews releasepublished Thursday, the public research university in southwestern Ontario says the vaccine will work by using bacteriophage, which allows it to replicate within bacteria in the body.
The DNA-based vaccine is being designed to work in the nasal cavity and lower respiratory tract. It would target tissues in the body to stimulate a virus-like particle (VLP) response, which would trigger an immune system response.
When complete, our DNA-based vaccine will be administered non-invasively as a nasal spray that delivers nanomedicine engineered to immunize and decrease COVID-19 infections, University of Waterloo Prof. Roderick Slavcev,who specializes in designing vaccines, pharmaceuticals and gene-therapy treatments, said in a statement.
Researchers say the VLP will look like the disease that causes COVID-19, but its actually harmless. It would bind to the same receptors that the virus targets, limiting the potential for infection.If successful, the spray will help the body in two ways: by building immunity to the virus while limiting the severity of the infection, serving as both a therapeutic and a vaccine.
Multiple professors and university teams are chipping in with their expertise to help with the research. The university says every aspect of the vaccine is being specifically engineered to fight COVID-19 and still must be tested.
A grant from the Natural Sciences and Engineering Research Council of Canada is helping fund this work, which has yet to be peer reviewed.
Earlier this week, Health Canada approved Spartan Biosciences portable COVID-19 test. The handheld DNA analyzer from the Ottawa-based company is the size of a cup of coffee and can produce results within an hour without relying on a laboratory. The federal government and the government of Ontario have already ordered these tests called the Spartan Cube.
On the vaccine front, Waterloo is one of many areas in Canada where COVID-19 research is ongoing.
Vaccines are also being developed by research teams at Dalhousie University, McMaster University, the University of Alberta, Laval University, the University of British Columbia, the University of Saskatchewan, the University of Manitoba and Western University. Companies such as Medicago,Entos Pharmaceuticals and AbCellera Biologics are also conducting research work in Canada.
In March,Quebec City-based Medicago said it could begin human trials of a vaccine as soon as July or August.
Vaccines must be properly tested in laboratories before they can be approved for human use, a process which could take months to years. Earlier this month, Prime Minister Justin Trudeau said estimates from health experts on when a new COVID-19 vaccine might be ready range from six to 18 months.
With files from Daniel Tencer and The Canadian Press
Also on HuffPost:
Every week there are numerous scientific studies published. Heres a look at some of the more interesting ones.
Another COVID-19 Vaccine Looks Promising
According to the World Health Organization, there are 70 vaccines being developed worldwide for COVID-19, with three already in human clinical trials. The furthest along is one by CanSino Biologics and the Beijing Institute of Biotechnology, which is in Phase II. The others are by U.S. companies, Inovio Pharmaceuticals and Moderna. Another institution, the University of Pittsburgh, also announced that in laboratory tests their COVID-19 vaccine, delivered via a fingertip-sized patch, showed positive results in laboratory mice, producing antibodies specific to SARS-CoV-2 at enough amounts to neutralize the virus. The research was published in EBioMedicine, published by The Lancet.
We had previous experience on SARS-CoV in 2003 and MERS-COV in 2014, said co-senior author Andrea Gambotta, associate professor of surgery at the Pitt School of Medicine. These two viruses, which are closely related to SARS-CoV-2, teach us that a particular protein, called a spike protein, is important for inducing immunity against the virus. We know exactly where to fight this new virus. Thats why its important to fund vaccine research. You never know where the next pandemic will come from.
It uses a more traditional process than the mRNA one being used by Moderna. The virus is being called PittCOVacc, and uses laboratory-manufactured pieces of viral protein to build immunity. Its a process similar to that used in seasonal flu shots. They also leveraged a new technique to deliver the drug, called a microneedle array, to increase the potency of the vaccine. The fingertip-sized patch has 400 tiny needles that deliver the spike protein pieces into the skin. It goes on like a Band-Aid. The needles are built from sugars and the antigens, and they just dissolve.
We developed this to build on the original scratch method used to deliver the smallpox vaccine to the skin, but as a high-tech version that is more efficient and reproducible patient to patient, said Louis Falo, co-senior author and professor and chair of dermatology at Pitts School of Medicine and UPMC. And its actually pretty painlessit feels kind of like Velcro.
They are currently submitting an Investigational New Drug (IND) with the U.S. Food and Drug Administration (FDA) and hope to begin Phase I human clinical trials in the next few months.
Genetic Mechanisms of Inflammatory Bowel Disease
Researchers at Children's Hospital of Philadelphia identified a genetic variant that causes the development of inflammatory bowel disease (IBD). The pathway is linked to other immune disorders. More than 240 genetic regions are already associated with IBD, but each region has multiple markers and not all are causative. The researchers focused on the single nucleotide polymorphism (SNP) rs1887428, located on the promoter region of the JAK2 gene. The protein coded by the gene controls the production of blood cells. The team found that two transcription factors, RBPJ and CUX1, recognize the DNA sequence altered by the rs1887428 SNP, and while it only has mild influence on JAK2 expression, it was amplified by other proteins in the JAK2 pathway.
Possible Mechanism of Link Between Obesity and Breast Cancer
Breast cancer (and other cancers) and obesity are associated, but the reason for that link isnt well understood. Researchers from the University of Louisville published research suggesting that the fatty acid binding protein family, especially FABP4, plays a critical role. Fat tissue produces FABP4 within fat cells, which processes and distributes water-insoluble long-chain fatty acids. Normally, some FABP4 enters the bloodstream, but the higher fat volume, the more FABP4 is secreted. They believe two mechanisms are in play. Within cells, FABP4 increases in certain tumor-associated macrophages, which accumulate in tumors and promote cancer growth. And second, when elevated levels of FABP4 circulate outside the fat cells, it promotes breast cancer by directly interacting with breast cancer cells.
Using Cellular Machinery Without the Cells to Develop Drugs
Northwestern University and ShanghaiTech University leveraged cell-free synthetic biology to produce a drug that kills SARS-CoV-2 in cell cultures. They indicate they could create the new drug by taking the molecular machinery out of cells and using that machinery to make a product in a safe, cheap and quick way. The molecule is called valinomycin. By using this method, they were able to increase production yields more than 5,000 times in only a few quick design cycles.
Glucose Metabolism Linked to Alzheimers Disease
Researchers with the National Institutes of Healths National Institute on Aging conducted the largest study so far on proteins related to Alzheimers and identified proteins and biological processes that regulate glucose metabolism that are associated with Alzheimers. The study was published in the journal Nature Medicine.
The study was part of the Accelerating Medicines Partnership for Alzheimers Disease (AMP-AD). The investigators assayed the levels and analyzed the expression patterns of more than 3,000 proteins in brain and cerebrospinal fluid samples collected at centers across the U.S.
This is an example of how the collaborative, open science platform of AMP-AD is creating a pipeline of discovery for new approaches to diagnosis, treatment and prevention of Alzheimers disease, said Richard J. Hodes, NIA director. This study exemplifies how research can be accelerated when multiple research groups share their biological samples and data resources.
The study involved analyzing protein expression patterns in more than 2,000 human brain and almost 400 cerebrospinal fluid samples taken from both healthy individuals and Alzheimers patients. They analyzed how the protein modules relate to Alzheimers and other neurodegenerative diseases. They observed changes in proteins related to glucose metabolism and an anti-inflammatory response in glial cells in brain tissues from both Alzheimers patients and people with documented brain pathology who were cognitively normal. This also would seem to support increasing evidence that brain inflammation is involved in the disease as well.
In Alzheimers patients, they found that how cells extract energy from glucose is increased in both the brains and spinal fluid of Alzheimers patients. The proteins observed were also elevated in preclinical Alzheimers patients, which is to say, people with brain pathology of the disease who had not shown cognitive decline.
Antibodies from recovered patients and biotech companies could help
Editors note: The Economist is making some of its most important coverage of the covid-19 pandemic freely available to readers of The Economist Today, our daily newsletter. To receive it, register here. For our coronavirus tracker and more coverage, see our hub
DURING THE flu pandemic of 1918-19 doctors at an American naval hospital developed a treatment which, according to the American Journal of Public Health, had a decided influence in shortening the course of the disease and in lowering the mortality. It involved clotting and then centrifuging blood from people who had got over the disease so as to separate out the antibodies it contained, then giving those antibodies to patients in dire need.
Since then antibody-rich convalescent plasma (CP) has been used as a treatment for various diseases, including SARS and the pandemic strains of H1N1 and H5N1 influenza. Now covid-19 has joined the list. A recent study in Wuhan found that severely ill covid-19 patients treated with CP did significantly better than patients matched with them by age, gender and severity of infection had done earlier in the epidemic.
Michael Joyner of the Mayo Clinic, which leads a CP research effort in America, expects randomised control trials to begin in a few weeks. They will not just look at CPs potential as a treatment, but also as a prophylactic. If that worked, it would be a sort of halfway house on the road to a vaccine.
Even though CP donors get the other components of their bloodcells, platelets and the likereturned to them after the antibodies have been removed, the process is still something of a palaver, requiring a lot of medical attention. Despite the fact that various companies are trying to make a go of it, it is hard to see it scaling up all that far. But there is an alternative. Antibodies are proteins, and that means a bit of genetic engineering will allow cell lines at biotechnology and pharma companies to mass produce them. The resulting product should be less prone to contamination, more consistent, and easier to scale up than CP.
This approach has already been successful against Ebola. Regeneron, an American biotech company, developed a cocktail of three antibodies which recognised different parts of the proteins coat. Trials in the Democratic Republic of Congo showed this therapy to be better than remdesivir, a drug designed to block the Ebola vaccines reproduction which is now, as it happens, being tested as a medicine for covid-19.
Regeneron is now making a pair of antibodies that target the SARS-CoV-2 spike protein. It hopes to have produced enough to start trials soon. As with CP, it is possible that such antibodies may temporarily confer immunity on the uninfected, as well as helping the infected fight the disease.
Dig deeper:For our latest coverage of the covid-19 pandemic, register for The Economist Today, our daily newsletter, or visit our coronavirus tracker and story hub
This article appeared in the Briefing section of the print edition under the headline "Survivors as saviours"
I certainly dont trust the government, but neither am I credulous (see above). And its not just me. Last year, in 2019, a Pew poll found that only seventeen percent of Americans state they can trust the government just about always or most of the time, being three percent and fourteen percent, respectively. Eighty-three percent of Americans are not anti-vaccine, and to conflate government mistrust with it, thereby smearing what can be fairly termed as almost all Americans, is partisanship parading as scientific objectivity.
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In GlobalDatas Coronavirus Disease (Covid-19): Pipeline and Clinical Trial Analysis April 2020 thematic report, 1,561 visitors of GlobalDatas Pharmaceutical Technology website responded to the question How confident are you that Pharma/Biotech Companies will be able to develop an effective vaccine for Covid-19 within the next 12 months? A strong majority (80%) were optimistic about the development of a vaccine, with 52% being very confident, 28% somewhat confident, and only 20% who expressed no confidence at all. However, considering that vaccines typically take years to develop, expectations surrounding the potential availability of a Covid-19 vaccine should be tempered.
Covid-19 therapeutics could be available within a matter of months, as off-the-shelf solutions may already be available and ready for clinical trials. Assuming rapid trial initiation, these trials could produce readouts in a matter of weeks. Data are already available for multiple candidate therapies, including chloroquine/hydroxychloroquine, ritonavir + lopinavir, remdesivir, and favipiravir, among others. Notably, these data have been produced less than five months after the discovery of the virus, demonstrating that short studies for Covid-19 treatments can indeed be completed quite rapidly, although the data are less clear than desired. However, it is unrealistic to expect vaccines to follow a similar timeframe for multiple reasons.
Vaccines work by training the immune system to respond to components of pathogens, and accordingly must be highly specific to the pathogen of interest. As the virus responsible for Covid-19 is new, its components are poorly understood, making it difficult to decide which parts might be more immunogenic and thus more likely to lead to a successful vaccine. While several vaccines have entered clinical trials, such as Modernas messenger ribonucleic acid (mRNA) vaccine mRNA-1273, the amount of time dedicated to the R&D of these candidates has been substantially shorter than other vaccines that have entered clinical trials. Part of the reason these vaccines were able to enter Phase I studies so quickly is because they rely on new vaccine technologies, such as DNA, mRNA, or adenoviral vector-driven vaccines, which can be developed rapidly relative to older technologies. However, no vaccine using these technologies has ever been commercialised, and data supporting their efficacy is thin. As such, enthusiasm surrounding their likelihood of success may be met with disappointment.
Prophylactic vaccines confer active immunity against a potentially disease-causing pathogen. Even if a vaccine is effective, the protection it confers must be measured against time because exposure to the pathogen could take weeks, months, or even years. This means that the endpoint for the time after immunisation needs to be longer rather than shorter in order to ensure that the pathogen is likely to have been encountered. If a trial is too short, an immunised patient might not be exposed to the disease, which could either make it difficult to differentiate the treatment from placebo or could confer a false sense of efficacy, as the rate of disease in the vaccinated group would be lower.
Even if a vaccine were to rapidly demonstrate efficacy in both Phase I and II trials, there would need to be significant manufacturing efforts initiated prior to proof of efficacy. Waiting for trial results could significantly delay the delivery of the vaccine to the public. However, increasing production prior to the release of the trial results is risky due to the possibility of failure to meet endpoints, so most developers usually avoid this option. The availability of a vaccine will likely depend heavily on the geography where it is developed and who is recommended to receive it upon licensure. For example, a Covid-19 vaccine developed in the US might initially be recommended for older patients in the US who are at increased of disease, while younger patients and those in other regions might have to wait for later releases of the vaccine.
While it is technically possible for a Covid-19 vaccine to be available in 12 months, there are multiple factors that suggest this to be closer to wishful thinking than anything remotely certain.
Figure 1: Industry Perspective on Vaccine Development. Credit: GlobalData
GlobalData is this websites parent business intelligence company.
Scientists around the world are racing to find ways out of the new coronavirus pandemic. Some are working to develop new drugs and vaccines, while others are looking to see whether therapies we already have may help against COVID-19.
In the latter category, researchers have dusted off one intriguing compound in our collective medicine cabinet a century-old vaccine to fight tuberculosis, a bacterial disease that affects the lungs. A couple of early analyses, which have yet to be peer-reviewed, have found that countries that require this vaccine, called Bacillus CalmetteGurin (BCG), seemed to have been hit less severely, in terms of both number and severity, by the coronavirus that causes the disease COVID-19.
Could this vaccine be protecting people from COVID-19? The short answer is: We don't know. But several clinical trials around the world are now examining whether this vaccine could protect against this new foe.
Related: 13 coronavirus myths busted by science
"I was originally quite skeptical" that the studies could tease apart all of the other factors that could be causing some countries to be hit harder with COVID-19 than others, said Paula Cannon, a distinguished professor of molecular microbiology and immunology at the University of Southern California's Keck School of Medicine, who is not a part of any of these studies. Among those factors are the quality of the healthcare system, measures put in place to fight the disease and testing capacity. Still, it is a "provocative idea" and the "data is tantalizing," Cannon said.
Dozens of countries, including Japan and China, require children typically newborns to receive the BCG vaccine as protection against tuberculosis, an infection that is typically more common in lower-income countries. Other countries, such as Spain, France and Switzerland, used to require the vaccine but stopped because the risk of catching the disease in those countries lessened, according to one of the preprint studies published in medRxiv on March 28. Other countries, such as the U.S., Italy and the Netherlands never had such a universal vaccine policy for the BCG vaccine.
But scientists have long known that "almost by lucky accident," the BCG vaccine doesn't just protect against tuberculosis, it also helps fight other viruses, respiratory infections in particular, Cannon said. The vaccine, "in some sort of unexpected and magical way, is like a broad immune booster," she said.
For example, one study conducted in Guinea-Bissau in West Africa found that children who were vaccinated with BCG had about a 50% reduction in overall mortality, largely because the vaccine reduced respiratory infections and sepsis, or blood poisoning, according to the medRxiv study. Other studies, mostly conducted in animals, have found similar broad-spectrum protections from the BCG vaccine.
The BCG vaccine is made up of weakened forms of live Mycobacterium bovis, closely related to the bacteria that causes tuberculosis. It was first developed in the 1920s in Paris and later shipped all over the world.
Now, countries from Japan to Denmark have their own BCG vaccines, made using different formulations of live bacteria and each one has varying degrees of immune boosting ability, said Dr. Ofer Levy, the director of the precision vaccines program at Boston Children's hospital and a professor at Harvard Medical School.
Typically, live vaccines provide a "strong and long-lasting immune response" and sometimes even "lifelong protection" against the germ, whereas inactivated forms of vaccines, such as those in flu shots don't provide immunity that's "as strong," according to the U.S. Department of Health and Human Services.
While most vaccines prompt one arm of the immune system the adaptive immune system to create antibodies that target very specific pathogens, the BCG vaccine taps into the other arm, the innate immune system. This system doesn't discriminate against pathogens and releases immune cells rather quickly to fight any foreign substance. The BCG vaccine thus boosts the body's production of non-specific immune cells.
The medRxiv study and another preliminary study recently published in Research Gate came to similar conclusions: there seemed to be a correlation between countries that require BCG vaccines and a reduced spread and severity of COVID-19 cases. For example, Portugal which has required BCG vaccines for infants has over 16,000 cases of COVID-19 but only 535 deaths whereas neighboring Spain has over 169,000 cases and over 17,000 deaths.
Similarly, Ireland, with 9,655 cases and only 334 deaths, requires the BCG vaccination, whereas the U.K. with 89,554 cases and 11,346 deaths no longer does. Based on these numbers, Ireland has a fatality rate 3.5% whereas the U.K. has a fatality rate of 12.7%. Of course, there are big population number differences across these countries, along with other variables that could affect death and infection rates.
These preliminary studies are "very flawed," because many factors such as differences in wealth and testing ability, can affect the outcomes Levy told Live Science. But the authors are "doing the best they can in a very difficult situation." While there's no direct evidence that BCG vaccines will reduce people's risk of developing COVID-19, "I'm enthusiastic about the hypotheses," Levy said.
It's difficult to draw firm conclusions, but there's enough scientific evidence to prompt clinical trials, and his team is looking into starting one in the U.S, he said. Clinical trials analyzing the protective effects of the vaccine against COVID-19 are already underway in other countries, including Australia and the Netherlands.
"I'm kind of puzzled," by the implication that the BCG vaccine might be able to protect for such a long period of time once someone has received it as a baby, Cannon said. Indeed, it's not clear how long the BCG vaccine effects can last.
The second study, which also has not been peer-reviewed, analyzed how countries with re-vaccination policies or booster shots fared in the COVID-19 pandemic. That study found that countries without re-vaccination policies had a 5.2% case fatality rate, versus a0.6% case fatality rate in countries that required re-vaccination.
"The big kind of asterisk, if you like, against all of these studies, is that they are really dealing with massively incomplete information," Cannon said. "We're all guessing what the true infection rates and the case fatality rates are because there isn't widespread uniform testing in every country."
Still, "I applaud the authors for at least, you know, doing what they could with the available data and providing some very provocative hypotheses," she said. "The good news is they're very testable."
In another world, we would be doing animal experiments to test this hypothesis. In this world, amid the coronavirus pandemic, we don't have time for that, she said. But the BCG vaccine has a "very safe track record," and likely can be tried in those who aren't old and who don't have weakened immune systems (since this is a live vaccine, it can potentially cause more side effects for older people or those with weakened immune systems), she added.
The human immune system is like an orchestra, "it's massively interconnected and what the BCG vaccine seems to do is maybe it gives like a little bit of extra control to the conductor," Cannon said. "So in the symphony of immune attack against respiratory viruses, the orchestra is able to go full blast, straightaway, all together, in sync, rather than kind of playing catch up."
Originally published on Live Science.
YELLOWSTONE NATIONAL PARK Before Covid-19 ever existed and long before we started using the phrases, Stay at Home and Shelter in Place in daily conversation, Yellowstone National Park had already contributed to the battle over the deadly virus.
It all started in Yellowstones famous, colorful and numerous hot springs.
Yellowstone has the largest concentration of hydrothermal features in the world, said Annie Carlson, Yellowstone National Park Research Coordinator.
Its in those hot spots where unique heat loving bacteria called thermophiles and extremophiles, have evolved. Anyone can see many of those springs just by touring the parks thermal features on designated boardwalks.
Back in the mid 1960s researcher Thomas Brock was taking a hot spring walk just like many people do every year. But he was intrigued by the organisms living in the extremely hot and acidic springs. Shortly afterward he identified a unique bacteria.
The bacterial species that they identified is called Thermus Aquaticus. Said Carlson.
And thats where the connection to the pandemic comes in. In 1985, scientists took an enzyme from that bacteria to invent a new laboratory process.
The enzymes solved a problem in DNA labs. Up until then, the enzymes used to map DNA were all destroyed by the heat the process generated. The Yellowstone enzyme was different because it thrives in such hot environments.
This gave researchers a way to quickly replicate small DNA strands in a process called PCR or a polymerase chain reaction.
So, one key molecule from a Yellowstone hot spring led to the DNA mapping we now take for granted in crime study, genealogy, and medicine, including vaccines, like the one being developed for Covid-19.
Carlson said, Medically its a very important technique.
That breakthrough, though decades old, still has a lot of potential. Carlson said, You can imagine that with any infectious disease in the future that could be used.
Yellowstones unique heat loving bacteria are so promising that a quarter of all the annual research permits in the park are issued to scientists looking for new and valuable bacteria.
Carlson said those scientists, Are really pushing the envelope with extremophile and thermophile research.
That research goes way beyond medicine. Some scientists are searching for the origins of life on earth and others are even looking for clues to life that may exist on other planets. The next time you visit Yellowstone, you may see some of those scientists, who have received special permits to carefully tiptoe between thermal areas sampling the unique life that lives there.
DIGITAL EXTRA: Extended interview with YNP Research Coordinator Annie Carlson
EXTENDED INTERVIEW with Annie Carlson, YNP Research Coordinator
