iBio
This Texas-based biotech company uses modified relatives of the tobacco plant to grow viral proteins for vaccines. The company is partnering with a Chinese vaccine maker to put its FastPharming platform to work on a Covid-19 vaccine. Company officials expect to have a candidate ready for animal testing later this summer.
Baylor College of Medicine / New York Blood Center
Peter Hotezs group is pushing for funding to test their SARS vaccine against the Covid-19. He says they already have about 20,000 doses ready to be deployed for clinical trials. These researchers are simultaneously working on developing a new vaccine from scratch, based on the binding receptor domain of the new virus, SARS-Cov-2, but that will take several years to develop.
University of Queensland
A team of Australian researchers, with funding from CEPI, have developed a vaccine candidate they say is ready to move forward into human testing. It relies on a molecular clamp technology invented in the lab of molecular virologist Keith Chappell, which helps stabilize viral proteins so they have the same shape theyd have on the surface of the virus. The group is now intending to ramp up production for clinical trials.
University of Saskatchewan
Canadian health authorities have given university researchers the green light to start working on a vaccine against Covid-19. Theyve used the viruss published genome sequence to begin building protein-based candidates and are now waiting for live versions of the virus to begin testing in animal models.
University of Oxford / Advent Srl
A team of researchers at the University of Oxfords Jenner Institute had been working on a vaccine against MERS, which they quickly tailored to the new coronavirus, SARS-CoV-2. In February, the scientists signed an agreement with Italian vaccine maker Srl to produce the first 1,000 doses of the new vaccine, ChAdOx1, to supply human trials.
And a few more are developing viral vector-based strategies:
Sanofi
One of the so-called Big Four, Sanofi has been working with BARDA since 2004 on pandemic preparedness, including against SARS. The company has expanded this arrangement to focus on a Covid-19 vaccine using the companys recombinant DNA platform, which involves swapping in parts of the coronavirus RNA with genetic material from a harmless virus. Sanofi expects to have a vaccine candidate to test in animals within six months. Human testing could begin sometime in 2021.
Johnson & Johnson
Johnson & Johnson is expanding on the companys past work with BARDA to develop an Ebola vaccine to pursue a vaccine against Covid-19. With funding from the government agency, the companys plan is to deactivate the virus, producing a vaccine that triggers an immune response without causing infection. The company has not released any information regarding development timelines.
Geovax Labs / BravoVax
Atlanta-based GeoVax signed an agreement in January to work with BravoVax, a private company Wuhan, China, to jointly develop a vaccine against Covid-19. Under the collaboration, GeoVax will be providing its proprietary platforma modified pox virus that can be designed to express viral proteins from SARS-CoV-2.
Tonix
In February, this New Yorkbased biopharma startup announced it is collaborating with the nonprofit Southern Research to develop a live, modified horsepox virus modified to express protein fragments from SARS-CoV-2. Company officials have not released any further timelines.
CanSino Biologics
Chinese vaccine-maker CanSino is reportedly developing a viral vector-based vaccine against Covid-2019 but no further information is available at this time.
Greffex
The CEO of this Houston-based genetic engineering company announced last month that they have completed the design of a vaccine against Covid-19. The company has not released any information about its lead candidate, but Grefex reportedly makes adenovirus-based vector vaccines involving a harmless virus that can be genetically tweaked to express foreign genes, like one for the SARS-CoV-2 spike protein.
And last but not least, is the only company attempting to attenuate a live SARS-CoV-2 virus:
Codagenix
HOUSTON Dr. Peter Hotez says he made the pitch to anyone who would listen. After years of research, his team of scientists in Texas had helped develop a vaccine to protect against a deadly strain of coronavirus. Now they needed money to begin testing it in humans.
But this was 2016. More than a decade had passed since the viral disease known as severe acute respiratory syndrome, or SARS, had spread through China, killing more than 770 people. That disease, an earlier coronavirus similar to the one now sweeping the globe, was a distant memory by the time Hotez and his team sought funding to test whether their vaccine would work in humans.
"We tried like heck to see if we could get investors or grants to move this into the clinic," said Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital and dean of the National School of Tropical Medicine at the Baylor College of Medicine in Houston. "But we just could not generate much interest."
That was a big missed opportunity, according to Hotez and other vaccine scientists, who argue that SARS, and the Middle East respiratory syndrome, or MERS, of 2012, should have triggered major federal and global investments to develop vaccines in anticipation of future epidemics.
Instead, the SARS vaccine that Hotez's team created in collaboration with scientists at the University of Texas Medical Branch at Galveston is sitting in a freezer, no closer to commercial production than it was four years ago.
"We could have had this ready to go and been testing the vaccine's efficacy at the start of this new outbreak in China," said Hotez, who believes the vaccine could provide cross-protection against the new coronavirus, which causes a respiratory disease known as COVID-19. "There is a problem with the ecosystem in vaccine development, and we've got to fix this."
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Hotez took that message to Congress on Thursday while testifying before the House Committee on Science, Space and Technology. He argued that the new coronavirus should trigger changes in the way the government funds vaccine development.
"It's tragic that we won't have a vaccine ready for this epidemic," Hotez wrote in prepared remarks. "Practically speaking, we'll be fighting these outbreaks with one hand tied behind our backs."
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As of Sunday, there had been well over 100,000 confirmed coronavirus cases globally and at least 3,700 deaths. Public health officials are concerned that the virus, which can lead to respiratory failure brought on by pneumonia, will spread widely in the U.S. and last beyond this year much like the seasonal flu, but more severe and potentially deadlier.
In response, pharmaceutical companies, university researchers and the federal government have been rushing to develop a vaccine. In addition to the official government effort led by the National Institutes of Health, several drugmakers are also scrambling to develop a vaccine that can be tested in humans in the coming months. But even under the rosiest of projections, one won't be ready for more than a year, government officials say.
"I'm cautiously optimistic that we will get a vaccine," Dr. Anthony Fauci, the National Institutes of Health's director for infectious diseases, said in an interview this week. "The thing that's sobering is that it's not a vaccine we're going to have next month, so we're going to have to tough it out through this evolution."
Early efforts to develop a SARS vaccine in animal trials were plagued by a phenomenon known as "vaccine-induced enhancement," in which recipients exhibit worse symptoms after being injected something Fauci said researchers must be mindful of as they work to quickly develop a vaccine to protect against COVID-19.
That kind of research figuring out which vaccine strategies work and which don't potentially could have been completed before the new outbreak, said Jason Schwartz, a professor at the Yale School of Public Health who studies vaccine development. He said the global response to the coronavirus exposes broader flaws in the way medical research is funded, which he says tends to be market-driven and reactive, rather than proactive.
"We have a pattern in our medical research landscape in which outbreaks lead to a surge in research investment, and if and when those outbreaks wane, as they invariably do, other priorities take their place," Schwartz said. "As a result, you lose those opportunities to capitalize on that initial investment, and the cycle starts over again."
The responsibility to fund this type of research must rest with governments and nonprofits, Schwartz said, because for-profit pharmaceutical companies can't be counted on to fund projects that, in most cases, will never make money.
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Some progress was made in the wake of the West Africa Ebola outbreak that ended in 2016. It spurred global leaders to create the Coalition for Epidemic Preparedness Innovations, or CEPI, a private-public partnership that's based in Norway and funded in part by the Bill and Melinda Gates Foundation. The nonprofit group has poured millions of dollars into vaccine development, but Schwartz and other experts say more is needed.
"We need to make sure that there are incentives outside of our traditional business model that can lead to greater investments in that foundational research," Schwartz said.
Dr. James LeDuc, director of the Galveston National Laboratory, said work has resumed on the SARS vaccine that his researchers helped develop with Hotez's team. The laboratory, a high-security biocontainment facility on Texas' Gulf Coast, received a live sample of the new coronavirus last month and will use it to test the vaccine in mice.
But first the lab must breed a colony of mice genetically engineered to replicate the human disease, a process that LeDuc said will take months.
"I think we as a nation and as a society need to be more agile in recognizing that new diseases do occur, and once they've cropped up, they very well may come again, maybe not the same but very similar," said LeDuc, who formerly directed influenza response efforts at the Centers for Disease Control and Prevention. "So it was a shame that we had to stop that work and now are having to try and restart it."
For weeks, Hotez has been reaching out to pharmaceutical companies and federal scientific agencies and even the Medical Research Council in the United Kingdom asking them to provide the roughly $3 million needed to begin testing the vaccine's safety in humans, but so far none have done so.
"We've had some conversations with big pharma companies in recent weeks about our vaccine, and literally one said, 'Well, we're holding back to see if this thing comes back year after year,'" Hotez said.
He said he hopes the seriousness of the outbreak leads to reforms in how the federal government funds vaccine development, although he notes that he called for similar changes after the SARS and Ebola outbreaks. He said he's particularly worried about the toll the coronavirus will take on elderly nursing home residents and health care workers. But in his testimony to Congress on Thursday, Hotez also made an economic argument.
"Because nobody would invest a few million dollars into these SARS vaccines, we're looking at, I don't know what the number is, $10 billion, $100 billion in economic losses," Hotez said ahead of his appearance in Washington. "The stakes are so high, and the amount of money you're talking about to fund this research is so modest."
An unprecedented, all-out global race to develop a safe vaccineagainst the new coronavirus is underway. The stakes couldn't be higher, as public health officials and world leaders say an effective vaccine or treatment against the virus that causes the disease COVID-19 is necessary to fully restart economies and resume civic life.
As the paceaccelerates,USA TODAY is rounding up some of the week's most notable vaccine developments.
The first U.S. SARS-CoV-2 trial vaccinehas been cleared to go into Phase 2 testing by the Food and Drug Administration, Massachusetts-based Moderna announced Thursday. The vaccine candidate (a potential vaccine that could be used if found safe and effective)iscalled mRNA-1273 andwas first given to volunteers in Seattle on March 16 as Phase 1 testing began.
FDA has completed its review of Moderna's Investigational New Drug application for mRNA-1273, which allows it to now proceed to Phase 2 study. Moderna expects such tests to begin shortly, it said in a news release.
Phase 2 testing is done with several hundred volunteers and looks to see how their immune systems respond to the vaccine and whether it makes them immune to the disease. Safety and side effects are also studied.
Moderna said it is finalizing the protocol for Phase 3 study of mRNA-1273. Those tests are expected to begin in early summer.
Phase 3 trials involve giving a vaccine to large numbers of people to see whether it works, whether it is safe and whether it has unknown or rare side effects. These can range from the thousands to the tens of thousands of volunteers.
Asof Wednesday, the World Health Organization was tracking eight potentialvaccines for COVID-19 (called candidate vaccines)in clinical evaluation. These included four from China, one from England, two from the United States and one from the European Union.
The list also includes 100 candidate vaccines in preclinical evaluation, meaning they are still being tested in test tubes or in animals. The previous version of the list, published on April 20, included 5 candidate vaccines in clinical evaluation and 71 in preclinical evaluation.
New York-based pharmaceutical giant Pfizer on Monday began testing a vaccine candidatefor SARS-CoV-2, the virus that causes COVID-19. In its announcement, the company said it wentfrom pre-clinical studies in test tubes and animals to injecting humans with a possible vaccine in less than four months.
The trials, which are taking place in the United States,are still Phase 1. These testwhether a potential vaccine is safe, has side effects and produces the desired response from the bodys immune system. Vaccines must go through Phase 1, 2and 3testing before they can be licensed. Each phase involves larger numbers of volunteers.
Pfizer is working with German pharmaceutical company BioNTech on the candidate vaccine, dubbed BNT162. The company first tested it in Germany last month on 12 healthy adults. The companies say theyplan to test the candidate vaccine on 360 healthy volunteers in the United States
BNT162 is a messenger RNA vaccine that instructs cells to make a specific piece of protein to match whats on SARS-CoV-2s spike protein. The hope is the protein pieces will cause the body tocreateantibodies that will stop the virus from being able to attach to and invade cells.
Scientists at Oxford Universitys Jenner Institute plan to test a candidate vaccine on more than 6,000 people by the end of May. If it is effective and safe, they could have millions of doses ready in the fall.
The work is being done at the universitys Jenner Institute, named for Edward Jenner, the 18th-century British physician who pioneered the smallpox vaccination. Tests done in six rhesus macaque monkeys seemed to show the candidate vaccine was protective. Now Phase 1human tests are beginning.
The university is partnering with the British pharmaceutical company AstraZeneca to move forward with manufacturingshould the candidate vaccine prove effective.
Both have agreed to operate on a not-for-profit basis for the duration of the coronavirus pandemic, with only the costs of production and distribution being covered. Oxford University and its spin-out company Vaccitech, which jointly hold the rights to the technology used to develop the candidate vaccine, will receive no royalties during the pandemic, the university said.
In a video meeting on Monday hosted by the European Union, world leaders, nonprofits and celebrities pledged $8 million to fund laboratories working to develop and produce a vaccine.
The money was for the Access to COVID-19 Tools Accelerator, or the ACTAccelerator, a collaboration between the World Health organization and governments, nonprofits and industry worldwide. It was launched April 24. They all pledged to work with and support the effort.
The collaborations mission statement said in part, We know that as long as anyone is at risk from this virus, the entire world is at risk every single person on the planet needs to be protected from this disease.
China and the United States are among the few countries not taking part in the effort.
The three-hour event fundraising effort on Monday was something like an old-fashioned telethon, with a leader from each country taking a few minutes on the video call to pledge money for the ACTS Accelerator.
To submit adevelopment for the weekly roundup, orshare other vaccine news, please email Elizabeth Weise at eweise@usatoday.com
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The Food and Drug administration (FDA) has given approval to biotech company Moderna to begin the next phase of testing on its coronavirus vaccine candidate, the company announced Thursday (May 7).
There are dozens of vaccine candidates worldwide that are being developed to fight the coronavirus outbreak, and a handful of them are already being tested on humans. Moderna began testing their vaccine on 45 healthy adults in Seattle in March, becoming one of the first companies to begin human clinical trials for a COVID-19 vaccine.
The purpose of phase 1 trials such as the one Moderna just completed, is to understand the safety and dosage of the candidate drug or vaccine, according to the FDA. Now, the testing will move to phase 2, in which the researchers will test the efficacy and side effects of the vaccine on about 600 people.
Related: 13 coronavirus myths busted by science
"The imminent phase 2 study start is a crucial step forward," Stphane Bancel, Moderna's chief executive officer, said in a statement. The goal is to start the "pivotal" phase 3 trial early this summer, he added. Phase 3 trials recruit hundreds to thousands of people to further understand whether or not a vaccine (or drug) is working and to monitor any adverse reactions to it, according to the FDA. After phase 3 trials, the FDA then decides whether to approve the vaccine or drug. The FDA will approve a drug only if "it's safe and effective" and its "benefits outweigh risks," according to the U.S. Centers for Disease Control and Prevention.
Moderna is already making plans to accelerate manufacturing of the vaccine. On May 1, the company announced plans to work with Swiss drugmaker Lonza to make up to 1 billion doses of the vaccine per year to distribute globally, according to CNBC. The first doses are expected to be made in the U.S. Lonza facility in July, CNBC reported. That is, of course, if the vaccine is proven to be safe and effective.
Moderna's vaccine, called mRNA-1273, uses a new technology that hasn't been used in any approved vaccines to date. Most traditional vaccines introduce an inactive or weakened version of the virus itself into the body to train the immune system to create antibodies to fight it, whereas this vaccine takes one step back and uses a molecule called messenger RNA (mRNA) to instruct cells to build viral proteins themselves, according to a previous Live Science report.
Specifically, the mRNA provides instructions to cells to build the coronavirus' spike protein, which the virus uses to infect human cells. The idea is that the immune system will then create antibodies that will recognize that spike protein and fight off the coronavirus.
This technology is faster to produce and is typically more stable than conventional vaccines, according to The New York Times. Other companies, including Inovio, CanSino and Pfizer, are also using this mRNA technology to develop vaccines against the coronavirus.
Originally published on Live Science.
As many provinces ease up on some coronavirus restrictions notably in Quebec, which has decided to reopen some schools the discussion about vaccines has been increasing.
Public health officials in Canada and elsewhere have been cautioning against getting hopes up over a full return to normalcy until either a vaccine is widely available or an effective treatment for Covid-19 is developed. This must also be combined with rigorous testing and contact tracing.
While vaccines have long been part of medicine, developing specific ones and making sure they are safe is neither speedy nor simple. Stuart A. Thompson, a fellow Canadian who grew up in Burlington, Ontario, and who is now a writer and graphics director over on the Opinion side of The Times, recently polled vaccine experts about what it would take to accelerate that development, and created a series of interactive graphics illustrating the effects of various assumptions.
[Read: How Long Will a Vaccine Really Take?]
I urge you to read the article and look at its graphics to get an informed sense of what lies ahead. But the quick newsletter version of Opinions finding is that most experts are skeptical about the 18-month timeline frequently being cited.
As Stuart points out, after 40 years of research into H.I.V., here is what we have to show for our vaccine efforts: a few Phase 3 clinical trials, one of which actually made the disease worse, and another with a success rate of just 30 percent.
Now that process has been frustrated because H.I.V. mutates significantly. The current coronavirus does not. But the history of H.I.V. vaccines is nevertheless a sobering caution.
On the optimistic side, the Jenner Institute at Oxford University had a head start on developing a vaccine for the coronavirus that should allow it to start tests using 6,000 people by the end of the month.
[Read: In Race for a Coronavirus Vaccine, an Oxford Group Leaps Ahead]
Most experts assume that ultimately, the world will need several vaccines and perhaps a mix of different vaccine technologies. Canadian researchers in several provinces are among the scientists around the world putting in extra hours to develop a new coronavirus vaccine.
But when we do finally come up with one thats effective and safe, Canada will face another major issue.
Even if tomorrow we had a vaccine available, we currently dont have manufacturing capacity to produce it rapidly, Volker Gerdts, director and chief executive of the Vaccine and Infectious Disease Organizations International Vaccine Centre at University of Saskatchewan, told me this week.
Dr. Gerdtss labs are among those in Canada working on a vaccine. They also received 12 million Canadian dollars from the federal government to certify that their manufacturing systems can safely produce vaccines for humans.
Canada, Dr. Gerdts told me, relies on imports for many vaccines. And while the country has several labs that can make vaccines, many of them concentrated in the Montreal area, Dr. Gerdts estimated their combined capacity at just a few million doses a month.
Its going to take some time before we have enough vaccine for everyone, he said.
Several factors will affect that timeline. Research groups are exploring new approaches to vaccines that will be more time consuming to make in large volumes, for example.
And while the government is funding projects to increase the countrys vaccine manufacturing capacity, Dr. Gerdts cautioned that even the testing his lab is now doing, to show that production will be safe and effective, cant be hurried without substantial risk. He estimated that the University of Saskatchewan wont be able to start vaccine production for about 18 months.
Many of the proposed vaccines, including the one being developed in Saskatoon, will be made in fermenting tanks if they prove to be effective and safe. Thats led to suggestions that breweries and distilleries, factories with very large fermenters already in place, could be transformed into vaccine factories.
But Dr. Gerdts dismissed that idea, saying that it would be impossible to clean them sufficiently to safely produce vaccines.
Just imagine you had a vaccine and you had a fungus growing in it because you had some fungal spores in that room, he said. It would be a disaster.
And if thats not enough of a delay, Dr. Gerdts said that once vaccines become available, setting up operations to make them wont be just a matter of following a recipe.
Canadians, Dr. Gerdts said, will need patience when it comes to a coronavirus vaccine.
We dont want to panic people and say even if we have vaccine, there is not going to be enough for you so and get your gun now and make sure you get in line, he said. We dont want to get to that point. But I think what we all understand is that Canada needs more manufacturing capacity and thats being recognized. And I think this is a good exercise for when the next pandemic comes.
Finally, James Gorman, The Timess science writer at large, reports that we may all develop a case of the summertime blues. A study by scientists at the University of Toronto and in Switzerland is the latest to conclude that the return of warm weather wont drive away the virus.
A native of Windsor, Ontario, Ian Austen was educated in Toronto, lives in Ottawa and has reported about Canada for The New York Times for the past 16 years. Follow him on Twitter at @ianrausten.
Were eager to have your thoughts about this newsletter and events in Canada in general. Please send them to nytcanada@nytimes.com.
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I think the Oxford vaccine and Chinese vaccine are certainly in the more advanced clinical phase as is the German vaccine. The two US vaccines are, of course, much talked about but we really dont know whether these RNA vaccines will really work like theyre considered to, Biocon founder Kiran Mazumdar Shaw told Business Insider as a part of its special series Hangout with BI.
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According to him, the risk of vector-based vaccines in India is that theres a strong possibility that people are already immune to certain adenoviruses because theyve already been exposed to them. This results in the possibility that the vaccine wont take. Every idea out there, every platform has pluses and minuses, he said.
Ordinarily it takes at least five years to develop a viable vaccine. But in these unprecedented times, its possible that a solution could present itself in a matter of months.
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The ones in the US may not be the best for Indian patientsThe US coronavirus vaccine candidates need to be stored at -80 degrees Celsius and have to be delivered intravenously. Were much more comfortable with a jab and a low-cost vaccine, which is what the Oxford and Chinese vaccines are all about. These are more typical and conventional vaccines, she explained.
China has the lead closely followed by the Indian project underway at OxfordChina is currently leading the charge to develop a coronavirus vaccine. Cansino Biological and the Beijing Institute of Biotechnology are using an Ebola-based candidate to develop a adenovirus type 5 vector coronavirus vaccine, currently in Phase-1 and Phase-2 of clinical trials.
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Coming in second is the University of Oxford, which is using a non-replicating viral vector approach based on MERS, influenza, TB, chikungunya, Zika and others to develop its coronavirus vaccine.
The Serum Institute of India (SII) the worlds largest vaccine maker is already manufacturing Oxfords vaccine even though it doesnt have approval yet. It's taking the risk of producing up to 400 million doses by the end of the year, if all goes well.
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See also:Dont hold your breath Biocon founder Kiran Mazumdar Shaw says India's Covid-19 vaccine will enter clinical trials in 9 months
Moderna skyrockets 16% to record high after FDA clears coronavirus vaccine for phase 2 study
Researchers at Pfizer Inc. and New York University are working on a never-before-tried coronavirus vaccine that the pharmaceutical company says could be available by September.
The vaccine, which carries genetic code known as messenger RNA, attempts to reprogram the deadly pathogen rather than manipulate the live virus.
"It is probably the fastest way of having a vaccine available to stem this pandemic, based on the data that I have seen," said Kathrin Jansen, who leads vaccine research for Pfizer.
Full coverage of the coronavirus outbreak
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The vaccine instructs a person's cells to make proteins associated with the coronavirus without making the person sick. Researchers hope the body's immune system will then kick in, creating the antibodies needed to fight off COVID-19.
"Messenger RNA is something the body produces on its own normally," said Mark Mulligan, chief of infectious diseases at NYU Langone Health. "It's kind of a new thing, but it's really not anything that's too different from what the body does for itself."
But Dr. Peter Hotez, co-director of the Texas Children's Center for Vaccine Development at Baylor University, said no RNA vaccine has been licensed because they have worked well only in laboratory animals.
"Those immune responses have not translated into ... good human immune responses," he said.
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Mulligan said he is optimistic about a trial underway at NYU, but he added that "the data will speak for itself."
"This is the science," he said. "You don't have to have faith or belief. The answer will come from the investigations that we do."
The vaccine is one of dozens under review in the global fight against the pandemic.
Tom Costello is an NBC News correspondent based in Washington, D.C.
Tim Stelloh is a reporter for NBC News, based in California.
This week, the Bill and Melinda Gates Foundation announced it will donate A$10 million to help fund an Australian trial testing whether a very old vaccine, BCG, can be used against a new threat, COVID-19.
So what is the BCG vaccine and what might its place be in the fight against coronavirus?
The BCG vaccine has been used for nearly a century to protect against tuberculosis, a bacterial disease that affects the lungs. Tuberculosis is caused by a bacterium called Mycobacterium tuberculosis.
BCG is short for Bacillus Calmette-Gurin, as it was created by Lon Charles Albert Calmette and Jean-Marie Camille Gurin in the early 1900s.
To make the vaccine, they used Mycobacterium bovis, a bacterium found in cows and closely related to Mycobacterium tuberculosis. They grew it on a nutrient-rich jelly in the lab for nearly 13 years. The bacterium adapted to this comfortable lifestyle by losing elements in its DNA it no longer needed, including elements that cause disease.
This process is called attenuation and it results in a live but weakened microbe that can be given to humans as a vaccine.
Read more: Coronavirus: could the pandemic be controlled using existing vaccines like MMR or BCG?
BCG is offered to infants in some parts of the world where there are still high rates of tuberculosis. It protects 86% of the time against some rarer forms of tuberculosis more common in children.
But it only protects about 50% of the time in adults.
Scientists and clinicians generally feel we need a better vaccine for tuberculosis. However, epidemiologists have noticed children who received BCG had significantly better overall health, with fewer respiratory infections and fewer deaths.
Immunologists suspect this is caused by a type of immune response called trained immunity.
Trained immunity is distinct from how we traditionally think of immunity, or immune memory, because it engages different types of immune cells.
There are two main types of cells within our immune system: innate cells, which respond rapidly to microbes that cause disease, and adaptive cells, which initially respond quite slowly.
Adaptive cells include B cells, which make antibodies to block infection, and T cells, which can kill infected cells. Importantly, adaptive cells can remember particular microbes for years, or even decades, after we first encounter them.
This phenomenon is called immune memory.
When adaptive immune cells encounter the same microbe a second or subsequent time, they respond much more quickly, and the immune system can effectively clear an infection before it causes disease. Immune memory is why often we dont get infected with a specific microbe, like chickenpox, more than once.
Most of our current vaccines exploit immune memory to protect us from infection.
Read more: Where are we at with developing a vaccine for coronavirus?
For decades, scientists believed innate cells lacked the ability to remember previous encounters with microbes. However, weve recently learnt some innate cells, such as monocytes, can be trained during an encounter with a microbe. Training can program innate cells to activate more quickly when they next encounter a microbe any microbe.
Some live attenuated vaccines, such as BCG, can trigger trained immunity, which can enhance early control of other infections. This raises the tantalising possibility that BCG could train innate cells to improve early control of the SARS-CoV-2 virus, to reduce COVID-19 disease or even prevent infection.
And as a bonus, BCG could potentially protect us against other pathogens too.
We dont know yet whether BCG will reduce the severity of COVID-19, but the vaccine has some interesting features.
First, BCG is a potent stimulator of the immune system. Currently, its used alongside other therapies to treat bladder cancer and melanoma, because it can stimulate immune cells to attack the tumour.
BCG also seems to benefit lung immunity. As we mentioned, children who have had the vaccine appear to get fewer respiratory infections.
Theres a study underway in Melbourne looking at whether BCG can reduce symptoms of asthma in children.
And finally, BCG has been shown to limit viral infection. In one study, human volunteers were given BCG or a placebo one month before being infected with a virus. Volunteers who received BCG had a modest reduction in the amount of virus produced during infection compared to those who received the placebo.
Read more: Explainer: what is TB and am I at risk of getting it in Australia?
However, BCG can cause side-effects to be mindful of. It usually causes a small raised blister on the skin at the vaccine site and it can cause painful swelling in the surrounding lymph nodes.
Importantly, because its a live bacterium, it can spread from the vaccine site and cause disease, called disseminated BCG, in people who are immunodeficient, like people with HIV. This means BCG cant be given to everyone.
The ultimate test of BCG as a preventative measure for COVID-19 is to run randomised clinical trials, which are now underway.
Researchers across Australia and the Netherlands are preparing to give BCG to the people who have arguably the highest risk of COVID-19: frontline health-care workers.
These phase III trials will collect data on whether workers vaccinated with BCG have fewer or less severe COVID-19 infections.
If BCG is shown to be effective, well face other challenges. For example, supply of the vaccine is currently limited. Further, there are many different strains of BCG and they might not all provide the same protection against COVID-19.
Protection would likely start to wane relatively quickly. When trained immunity was tracked in humans after BCG, it started waning from three to 12 months after vaccination.
Protection would also not be as strong as what we see with many traditional vaccines, such as the MMR vaccine which protects against measles 94.1% of the time.
Read more: Here's why the WHO says a coronavirus vaccine is 18 months away
So BCG would be most helpful for people at high risk of exposure, but it wouldnt replace a traditional vaccine based on immune memory.
These studies are important to give us options. We need a complete toolkit for control of COVID-19, consisting of anti-viral and anti-inflammatory drugs and vaccines. But an effective COVID-19 vaccine is likely still many months, even years, away.
By repurposing an old, well-characterised vaccine, we could bridge this gap and provide some protection to our health-care workers as they confront COVID-19.
That's not because the virus is particularly widespread in this community in north central New Mexico, nestled between a national forest and an Apache Nation reservation.
It's because in New Mexico, tests are free and plentiful. Some residents of Tierra Amarilla went to a one-day free testing event in town a few weeks ago, and if they missed that they can drive to a permanent testing center 45 minutes away. If residents don't have transportation, the Department of Health will come and test them in Tierra Amarilla.
So far, the state has performed 89,032 coronavirus tests. That's more than any other state with around the same population. New Mexico has conducted around the same number of tests or more than states such as Oklahoma, Nevada and South Carolina, which have considerably larger populations.
But not every state is like New Mexico. Months after federal officials said coronavirus testing would be plentiful, the tests are still hard to find in some parts of the country.
"We want to test for this the way we test for HIV, that you can do it without worrying. That's not the case in many parts of the country," said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. "We have a patchwork of testing across the country."
Limited testing, despite promises
More than two months later, that's still not the case.
It's not just a matter of having the tests themselves, but also having supplies like swabs and chemical reagents that are needed to run the tests.
"We've never been able to get to full capacity because we are missing things in the supply chain," Michigan Gov. Gretchen Whitmer on CNN's State of the Union on May 3.
"We don't know how we're going to get that system in place," Davidson said.
Even labs associated with large academic medical centers are experiencing shortages.
"There are limited supplies and there are differences in which labs have been able to order which supplies and how much of the order shows up," said Heather Pierce, the senior director for science policy and regulatory counsel at the Association of American Medical Colleges.
It's a variable situation, she added.
"One lab that has everything that it needs for one week doesn't necessarily know what it's going to get the next week," she said.
Need for more tests
As recorded cases of coronavirus continue to rise in the United States by 20,000 to 30,000 per day, public health officials have emphasized that more testing will bring the numbers down and help the nation find a pathway out of the pandemic.
Once there is widespread testing, health experts say infected people can be identified and isolated, and close contacts can quarantine themselves at home.
Dr. Anthony Fauci, the nation's leading infectious disease expert, estimated on April 25 that the US is conducting approximately 1.5 to 2 million coronavirus tests per week.
"We probably should get up to twice that as we get into the next several weeks," Fauci said the same day during a Covid-19 briefing by the National Academy of Sciences.
Finding fixes
Last week, the White House released a testing blueprint that said the federal government should be the "supplier of last resort."
It's up to the states to come up with testing plans and "to identify and overcome barriers to efficient testing," including "misallocation of supplies" and "logistical failures," according to the blueprint.
Some states have had more success than others.
New Mexico has more than 80 testing sites in all 33 counties. Not all operate at the same time -- some are permanent, others are drive-through or open for a few hours a day.
The state offers free testing to anyone with symptoms of coronavirus, anyone who's been in close contact with someone who's had the virus, or anyone at high risk for contracting the virus, such as an essential worker or a nursing home resident.
"We believe testing is critical. We always have, and so it's a priority," said Kathy Kunkel, New Mexico's secretary of health.
Some other states have also made it relatively easy for people to get tested.
On April 2, Utah launched a website where residents can find out if they qualify for free testing at a drive-through. So far, nearly 20,000 tests have been administered by the "TestUtah" initiative.
Despite the federal blueprint, Michigan hopes to receive some relief from the federal government. On May 3, a senior Trump administration official told CNN that the administration is sending the state 450,000 additional swabs and other supplies to help it meet its goal to perform 450,000 tests in May, which is more than three times the number of tests performed there from the beginning of the outbreak through the end of April.
Others also see reason for optimism.
"Over the last several weeks it's become easier for me to order tests for people," said Adalja, the Hopkins physician. "But the point is doctors and people have to be comfortable ordering tests and not worrying about supply chain issues."
Ryan Nobles and Sara Murray contributed to this story.
