As the coronavirus pandemic spreads at unprecedented rates, invading the lungs of people of all ages, ethnicities and medical histories, more companies are ratcheting up their efforts to fight the disease with accelerated schedules for creating new vaccines.
In normal circumstances, vaccine development would take around 10 years. But the pharmaceutical industry is racing to compress this timeline with the support of nonprofit organizations, government agencies and regulatory authorities. In just a few months, more than two dozen companies have announced promising vaccine programs, speeding through the early stages of testing unlike ever before.
On Wednesday, Novavax, a Maryland-based biotech company, said its vaccine candidate had stimulated a powerful immune response in lab and animal experiments, producing antibodies that could fight off the coronavirus. The vaccine, called NVX-CoV2373, is set to begin human trials in Australia in mid-May.
While a final product that would be widely available is still a year or more away, the Novavax effort is one of many ready to test in people.
A vaccine made by the biotech company Moderna is already in a clinical trial, which started March 15. Another one, developed by Inovio Pharmaceuticals, was injected into the first adult volunteers on Monday. The health care giant Johnson & Johnson expects to start clinical trials in September, and has received a nearly $500 million partnership via a division of the U.S. Department of Health and Human Services. And experimental vaccines developed by researchers at the University of Pittsburgh and Baylor College of Medicine are also waiting for permission from the Food and Drug Administration to begin testing in people.
Were all trying to do something which we have almost no precedents for, which is accelerating a vaccine in the middle of a pandemic, said Dr. Peter Hotez, who is a co-director of the Texas Childrens Hospital Center for Vaccine Development at Baylor College of Medicine.
There is no proven treatment or vaccine yet against Covid-19, the illness caused by the coronavirus. A vaccine would be the best way to stop further spread of the coronavirus because it enhances the immune systems natural defenses. Of course, many companies are also struggling with ways to partner with manufacturing ventures to produce enough vaccine so that it would be widely available.
White blood cells that act like scouts for the immune system are constantly looking for things that shouldnt be there. Vaccines train these cells to recognize invading viruses before an infection actually occurs. That way, when coronavirus particles do enter the body, the system is prepared to produce antibodies to neutralize the virus.
More than one million people around the world have already been sickened by the coronavirus. For public health experts and those on the front lines, a vaccine cant come soon enough.
If you could only have a vaccine, just imagine you could walk out your door confident that you were not going to get sick, said Dr. Gregory Glenn, the president for research and development at Novavax. Because of that, everyone is very motivated and working to move things quickly.
The team at Novavax is no stranger to the effort that goes into making vaccines. It had worked on experimental vaccines for both SARS and MERS, which are closely related to the new coronavirus. The company also has vaccines for the seasonal flu and respiratory syncytial virus, which causes colds, in the last stages of clinical trials.
When Chinese scientists posted the genetic sequence of the new coronavirus in January, researchers at Novavax immediately started working on recombinant technology to make a synthetic version of the virus. Researchers used a baculovirus to carry bits of genetic material from the coronavirus into cells. Baculoviruses typically infect insects, so they cannot replicate and cause illness in humans.
We never use the real virus, Dr. Glenn said. But we can fool the immune system to think its been attacked.
By combining the recombinant vaccine with an adjuvant, or substance that increases immune stimulation, Novavax was able to achieve a high neutralization titer in preclinical tests a measure of the protective antibodies that can block the virus.
The company hopes to see a similar effect after giving more than 130 healthy adults two doses of the vaccine. Results of the trial, which will be conducted in Australia, are expected around July.
Moderna and Inovio are pioneering a different approach to their vaccines.
Moderna uses RNA technology, while Inovio has developed DNA technology to package the genetic code of coronavirus spike proteins, which make up the crown around the virus and help it latch on to cells. This approach has the advantage of being able to move to trials faster than vaccines that require the production of viral proteins or a weakened version of the actual virus to induce an immune response. But the technology is still unproven. There are no approved RNA or DNA vaccines for any disease.
Dr. Hotezs team and Johnson & Johnson, on the other hand, are relying on technology that is more similar to Novavaxs approach because it has been used successfully to create other vaccines in the past, including one for Ebola that has been registered in Europe and used in the recent epidemic in the Democratic Republic of Congo.
Some countries already have the manufacturing capabilities that will be needed to scale up vaccine production and keep costs low if everything goes well.
Its not very sexy, but its a reliable approach. We know that it works, Dr. Hotez said.
For now, the first stage of clinical trials for each potential coronavirus vaccine must focus on how safe or toxic the vaccine may be at different dose levels. Researchers will carefully collect the medical histories of volunteers participating in the trials and track their antibody levels, liver enzymes and other indicators of emerging side effects.
One concern is that the vaccines may inadvertently cause a phenomenon known as disease enhancement, in which vaccinated people develop more severe inflammation and disease than those who have never been vaccinated. Studies of early SARS and MERS vaccines noted this troublesome complication in some animal models.
If everything looks good and the vaccine appears to be safe, then well go on to trials with much bigger numbers and look at the vaccine efficacy, said Dr. John Ervin, who is leading the Inovio clinical trial in Kansas City, Mo.
In parallel, companies are planning to continue further animal testing, as well as investing in manufacturing capacity both in the United States and abroad. They will need millions of doses for additional clinical trials and even more if a vaccine eventually goes to market.
Companies also have to be prepared for the possibility that some candidates will fizzle out or that demand for a vaccine will decrease by the time one is ready for widespread use. But industry experts are not waiting for this to happen.
The virus is racing through crowded urban areas and slums in certain countries. How do you do social distancing in those places? You dont, Dr. Hotez said.
We are building out a road map for how we how we work as a country for the next two or three years. Thats roughly the time frame that we saw for the 1918 flu pandemic and thats probably likely for Covid-19.
Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY
Imagine generating a vaccine for the novel coronavirus from your immune system.
The virus that causes COVID-19 has swept the globe with about 1.3 million infections and 70,000 deaths through Sunday evening.Development of a widely available vaccine can take a year or more while a virus continues its rampage.
Key to the race to develop a vaccine for the new coronavirus is a technology that uses the virus' genetic code to essentially persuade your body to make its own vaccine.
This techniqueis faster than egg-based manufacturing, which produces the majority of annual flu vaccines and led to delays in distributing a vaccine forH1N1 during the 2009 pandemic.
And it's enablingapossible vaccine for the new coronavirus to be developed in record time.
Coronavirus updates:Get the latest in USA TODAY's live blog
Its quicker to get started, said Clem Lewin, who is working onvaccine candidates for the manufacturer Sanofi Pasteur. All you need is the blueprint for the protein."
Testing still will take time. Scientists must determine whether any of several vaccine candidates fight the virus effectively. If so, they need to determine the proper dose. This tinkering is what could take a year or more.
When the first potential vaccine from the manufacturer Moderna was injected into people on March 16, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he believed the coronavirus vaccine was being developed at a record pace. It took 63 days to go from identifying a viruss genetic sequence to testing a vaccine in people.
Panic, then neglect: Prior pandemics gave us lessons to fight the coronavirus. But funding dried up.
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, speaks at a press briefing with the coronavirus task force on March 17, 2020.(Photo: Evan Vucci/AP)
Several manufacturers pursuing a vaccine for the latest coronavirus have been aided by a technological innovation.
The method that Moderna, Sanofi and others are pursuing is different from traditional vaccinations, in which a weakened or dead version of the virus is introduced into the body, triggering itto createantibodies that would attack the live virus should the person be exposed to it.
In the new approach, pieces of messenger RNA that hold the chemical template of a spike protein from the SARS-CoV-2 virus are injected into a human, said Mark Slifka, a professor of viral immunology at Oregon Health and Science University in Portland, Oregon.
The spikes are what the virus uses to attach to a human cell the first step in sickening someone.
In response to the injection of those molecules, the cells in the body produce the spike protein encoded by that mRNA. That triggers the body tomountan immune response to that viral protein, just as in traditional vaccines.
Essentially, the patient makes their own vaccine, says the narrator of a Moderna video about the vaccine.This cuts out the middleman.
Fauci said volunteers would be given two injections of the potential coronavirus vaccine, the second after 28 days. The doses are 25 milligrams, 100 milligrams and 250 milligrams, he said.
The individuals will be followed for one year both for safety and whether it induces the kind of response that we predict would be protective, Fauci said.
Moderna, the manufacturer conducting the initial tests, projected the first commercially available vaccine in 12 to 18 months. A corporate filing March 23 said CEO Stephane Banceltold Goldman Sachs it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020.
US coronavirus map: Tracking the outbreak
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Most flu vaccines are produced from fertilized chicken eggs, a decades-old process that takes four to five months.The mRNA process ismuch faster.
Delays in producing an H1N1 vaccine spurred health officials to urge development of other technologies, according to a Government Accountability Office report.
Its a state-of-the-art technology for the 1950s, Luciana Borio, then director for medical and biodefense preparedness at the National Security Council, said at a 2018 conference on the 100th anniversary of the Spanish flu pandemic.
A New England Journal of Medicine review of the response to H1N1 found that 78 million doses of the vaccine were eventually produced for 70 countries worldwide, but only after two waves of the illness worldwide.
The most serious operational shortcoming ...was the failure to distribute enough influenza vaccine in a timely way, the report said. The cause: distribution problems, "a shortfall in global vaccine-production capacity and technical delays due to reliance on viral egg cultures for production.
Developing a vaccine is laborious, said Harvey Fineberg, a former president of the U.S. Institute of Medicine and former dean of the public-health faculty at Harvard University.
One step is confirmingthat a possible vaccine doesn't causebad reactions in patients. Then scientists examine how much vaccine is required for an antibody response. And they must verify the vaccine actually protects against infection, which is why it's ideal to test during an outbreak.
All those steps come after scientists identifythe genetic sequence to target for a vaccine.
Its like saying,'Ive got my architectural plans my house must be ready to move into,' Fineberg said. There are a lot of things you need to do between now and being ready to open the door.
(Photo: Getty Images)
The manufacturers pursuing coronavirus vaccines are working closely withthe Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Agency.
Moderna is working on 13 potential vaccines. Sanofi is working on two candidates:an mRNA candidate with the company Translate Bio and another option in collaboration with the Biomedical Advanced Research and Development Agency.
Other companies are pursuing other technologies. GlaxoSmithKline is working with China-based Clover Biopharmaceuticals through a different process to produce a cell-based vaccine.
Johnson & Johnson, which is working on several possible vaccines,announced last week it wouldinvest$1 billion for vaccine research, development and testing. The company said it could produce 1 billion doses of a vaccine when the time comes.
Sen. Chris Coons, D-Del., said $3.5 billion in the coronavirus spending packagewill help develop manufacturing technologies to ensure a robust, agile, U.S.-based supply chain of vaccines, therapeutics, and active pharmaceutical ingredients.
The biggest challenge we face in the United States is not developing a vaccine, tricky as that step is, Coons said in a statement. Its that we lack the domestic manufacturing capacity to quickly produce a vaccine once its proven and deliver it to the American people.
Lewin of Sanofi said the global health emergency spurred manufacturers to try different technologies.
We and all the other manufacturers are working as quickly as possible to accelerate these programs while ensuring the vaccine is safe and effective, Lewin said. It isnt business as usual for anybody.
Coronavirus(Photo: USA TODAY)
The technology used todevelop a coronavirus vaccine wont affect the annual flu vaccine because they are different viruses requiring different approaches. But evenbefore the pandemic,steps were underwayto hasten changes to the flu vaccine.
President Donald Trump signed an executive orderin September calling onmanufacturers to move away from egg-based vaccines because of critical shortcomings, including the months they take to produce. The order anticipated a pandemic more lethalthanthe 1918 Spanish flu, which killed 675,000 Americans.
William Schaffner, professor of infectious diseases at Vanderbilt University, said one reason tochange vaccine productionis that growing the vaccine in eggs allows mutationsthat make it less effective.
People were working on this already, Schaffner said. That sort of commitment, a presidential commitment, plus the moneys that go with it, really put the pedal to the metal for future research.
Egg-based vaccine manufacturing has been reliable. Developing another process would require a multimillion-dollar investment in an industry with small profit margins, Schaffner said.
Moving away from egg-based production is not like flipping a switch, he said. Im sure all the manufacturers are all thinking about this, but how and how quickly they do it is another matter.
Other options include cell-based and recombinant processes. A cell-based vaccine is grown in a mammal's cells, such as kidney cells from monkeys or dogs, rather than in a hen's eggs. A recombinant vaccine is created synthetically from the DNA, or genetic instructions, of a protein from the flu virus. The DNA is then combined with a baculovirus, which infects invertebrates.
Other changes could address vaccine delivery, perhaps moving from injections to pills or skin patches, Schaffner said.
A loftier goal is to develop what is called a universal vaccine, which could last five years at a time. Such a vaccine could be administered any time of year during a doctor's visit, rather than just in the fall.
Doing that would require changing how the vaccine attacks the flu virus, whichis shaped like a sphere with lollipops protruding from it. Vaccines so far have targeted the candy at the end ofthe lollipop, which changes every year.
A vaccine that targetsthe stem of the lollipop could offer protection for years, Shaffner said. If you get vaccinated, youre vaccinated against a whole series of different influenza viruses,Schaffner said.
The coronavirus pandemic has come during a severe flu season. This years vaccine is about as effective as usual, according to a Centers for Disease Control and Prevention study of cases through Feb. 8. The study found the severity for people up to 49 years old including hospitalizations was worse than other recent seasons, including the severe year of 2017-2018.
Current influenza vaccines are providing substantial public health benefits,"said the study in CDCs Morbidity and Mortality Weekly Report."However more effective vaccines are needed."
Contributing:Elizabeth Weise
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As several companies race to develop a coronavirus vaccine, the public is repeatedly reminded that the finish line is at least 12 to 18 months away. This timeline feels excruciatingly long as the coronavirus pandemic continues to ravage the world around us. But it deserves some context. New technologies combined with international cooperation to fight infectious diseases are enabling faster responses to new disease outbreaks, shaving several years from traditional vaccine development timelines. Here are the key steps in the path to developing a vaccine against coronavirus and an outline of what they mean for time saving and for you.
Vaccines reduce the risk of disease by preparing the immune system the bodys natural defense network to recognize, fight and destroy certain bacteria and viruses. While there are different types of vaccines, they work by introducing enough identifying information about a bacteria or virus to cause an immune response in the body without causing illness (though they sometimes cause symptoms). In response to a vaccine, the body sends immune cells to fight this foreign invader. The first time the body encounters a new virus or bacteria, it takes time to develop an appropriate immune response but, once the invader is eliminated, certain immune cells remain that will recognize and be prepared to protect the body from this invader in the future.
Developing a Vaccine with New Technology
Around 10 January, Chinese scientists developed and shared a full genetic sequence of SARS-Cov2, the virus that causes COVID-19, colloquially called coronavirus. Several companies are using this information to develop vaccines that will contain a small amount of genetic code. Certain cells in the body will take up this genetic information and produce elements of the virus, not infecting the person but triggering the immune system to respond.
In 2000, Gavi, the Vaccine Alliance was launched at the World Economic Forum's Annual Meeting in Davos, with an initial pledge of $750 million from the Bill and Melinda Gates Foundation.
The aim of Gavi is to make vaccines more accessible and affordable for all - wherever people live in the world.
Along with saving an estimated 10 million lives worldwide in less than 20 years,through the vaccination of nearly 700 million children, - Gavi has most recently ensured a life-saving vaccine for Ebola.
At Davos 2016, we announced Gavi's partnership with Merck to make the life-saving Ebola vaccine a reality.
The Ebola vaccine is the result of years of energy and commitment from Merck; the generosity of Canadas federal government; leadership by WHO; strong support to test the vaccine from both NGOs such as MSF and the countries affected by the West Africa outbreak; and the rapid response and dedication of the DRC Minister of Health. Without these efforts, it is unlikely this vaccine would be available for several years, if at all.
Read more about the Vaccine Alliance, and how you can contribute to the improvement of access to vaccines globally - in our Impact Story.
DNA or RNA based vaccines are not made with a weakened or deactivated virus, nor elements of the virus, so they can be produced in the lab. This approach is faster and more reliable than traditional vaccine processing, which uses virus grown in eggs or cell cultures. For example, Moderna, in collaboration with the National Institute of Allergy and Infectious Disease (USA), developed the first COVID-19 vaccine in clinical trials using a genetic platform called messenger RNA (mRNA). It took only 42 days to move from vaccine design to human testing an industry record.
While genetic platforms are promising and fast, there are currently no such vaccines approved for human use. In addition to the many companies pursuing vaccines on this platform, other companies are exploring different vaccine approaches such as using a deactivated version of the virus. The benefit of developing and trying multiple potential vaccines is the increased chance that one of them will be approved for public use. First, however, they must go through clinical trials.
Safety, Efficacy and Approval
Vaccines are given to healthy people to prevent disease. While a COVID-19 vaccine is very much needed, a rush to market without appropriate testing could put healthy people at risk. One area of risk is vaccine enhancement, meaning the disease is more harmful to a vaccinated person.
The clinical trial process is designed to test whether new vaccines are both safe and effective before making them available to the public. The process typically involves several phases and takes approximately ten years, but governments and industry are making efforts to expedite the process, and even intersperse animal testing throughout, while maintaining safety and efficacy standards, as follows:
The first human trial of a COVID-19 vaccine was administered this week.
CEPI, launched at the World Economic Forum, provided funding support for the Phase 1 study. The organization this week announced their seventh COVID-19 vaccine project in the fight against the pandemic.
The Coalition for Epidemic Preparedness Innovations (CEPI) was launched in 2017 at the Forum's Annual Meeting bringing together experts from government, business, health, academia and civil society to accelerate the development of vaccines against emerging infectious diseases and to enable access to these vaccines during outbreaks.
Coalitions like CEPI are made possible through public-private partnerships. The World Economic Forum is the trusted global platform for stakeholder engagement, bringing together a range of multistakeholders from business, government and civil society to improve the state of the world.
Organizations can partner with the Forum to contribute to global health solutions. Contact us to find out how.
The final step in speeding up production of mass quantities of vaccine is early and robust manufacturing.If manufacturing begins during trials, then a vaccine will be available to the public upon approval.However, vaccines that are manufactured before they are approved are done so at risk.A manufacturer loses significant resources if approval does not come or a vaccine is no longer needed in the marketplace.The more vaccines produced, the more risk incurred.
To mitigate this risk and encourage manufacturing, governments, industry and international organizations are working together. CEPI, the Coalition for Epidemic Preparedness Innovations, made an urgent call for $2 billion in funding to support vaccine development, trials and enhanced manufacturing capacity. Gingko Bioworks committed capacity to manufacturing DNA or RNA based vaccines.Government officials are discussing funding support as well.
CEPI calls for $2 billion to develop vaccine against COVID-19.
Image: Statista
What does this mean for you?
The international community is working together like never before to produce a coronavirus vaccine. If a vaccine is developed in the timeline predicted, then people will have a preventative option should COVID-19 recirculate next year. Protection from the virus will save lives and help society return to functioning as normal.
If the virus fizzles out, the innovative and cooperative multistakeholder approaches taken to develop a vaccine will still have a lasting impact. They led to the fastest time from vaccine design to trial, and may lead to the first approvals of vaccines based on genetic platforms. This technology could fundamentally change how scientists are able to develop vaccines that protect people from new diseases making discovery faster, production more reliable and vaccines potentially more cost effective.
Contributors: Professor Gareth Baynam. Clinical Geneticist, Head Western Australian Register of Developmental Anomalies; Program Director, Undiagnosed Diseases Program, Genetic Services of WA; Adjunct Genomic Policy Advisor, Office of Population Health Genomics, WA Health; Ministerial Council for Precision Health
License and Republishing
World Economic Forum articles may be republished in accordance with our Terms of Use.
Written by
Elissa Prichep, Project Lead Precision Medicine, World Economic Forum
The views expressed in this article are those of the author alone and not the World Economic Forum.
With the federal stockpile for personal protective equipment dwindling during the COVID-19 pandemic, the Trump administration reportedly sent shipments to states in a third and "final push" before the private sector takes on the bulk of the effort.
But new details from the Department of Health and Human Services and the Federal Emergency Management Agency released by the House Oversight Committee show that the government did not appear to meet states' specific requests upon delivery. The first two rounds of shipments were based on census data from 2010, while the third round apparently wasn't adjusted for population at all.
Vermont and Texas, for example, which aren't remotely comparable in size, both received 120,900 N95 respirator masks. That's good news for Vermont, but not so much for Texas. To put in perspective, Vermont received 193 respirators for every 1,000 residents while Texas got five per 1,000. While equal distribution sounds nice in theory, it doesn't seem to make much sense in this case. Tim O'Donnell
New South Wales Premier Gladys Berejiklian has warned that social distancing restrictions will be in place in her state "until a vaccine is found".
But what exactly goes into developing a vaccine for a new disease? And how long will that take?
SARS-CoV-2, the virus that causes coronavirus, was only identified a few months ago, and while researchers have been rapidly finding out about the virus and the disease it causes, there's still so much about it we don't understand.
But that doesn't mean the quest for a vaccine is coming from a standing start.
Rapid vaccine development technologies mean that the time it takes to develop a vaccine, which used to be in the order of two to five years, could be condensed down to the 12 18 month timeframe that many experts have been referring to.
And the science that has gone into developing past vaccines also gives researchers a jump on COVID-19.
Even so, creating a new vaccine isn't as simple as taking an existing vaccine and swapping the viruses, said Larisa Labzin, an immunologist from the University of Queensland.
"For each virus or different bacterium that causes a disease, we need a different vaccine because the immune response that's mounted is different," Dr Labzin said.
"Just because we've got a really good vaccine against polio doesn't mean the same thing will work with coronavirus because it's so different."
University of Queensland researchers are one of the groups worldwide working on a potential vaccine for COVID-19.
(Supplied: The University of Queensland)
University of Queensland researchers are one of the groups worldwide working on a potential vaccine for COVID-19.
Supplied: The University of Queensland
Before we had vaccines, the main way to become immune to an illness was to catch it and then recover.
In the process of recovering from an infection, your body develops antibodies and specialised immune cells that learn to fight that particular illness-causing invader, or pathogen.
If you are exposed to the same pathogen in the future, your immune system "remembers" it and dispatches those purpose-built antibodies and specialised immune cells to fight it so you don't get sick again.
"The point of a vaccine is to trick your immune system into thinking it's seen it before without having to go through the whole process of actually getting sick with the virus," Dr Labzin said.
There are a few techniques researchers are exploring for COVID-19 that can be used to stimulate this response in the body, and they each have their pros and cons.
These involve introducing a "live" virus into the body, but one that has been "attenuated" or weakened.
Live attenuated vaccines, such as those used for measles, mumps and rubella, cause a strong immune response, but they take a long time to make and "there's always the possibility that they could mutate within the body or the population to become more dangerous again" Dr Labzin said.
Inactivated vaccines, such as those used for Hepatitis A and the seasonal influenza injection, contain the whole virus, but it's been "killed" by being exposed to ultraviolet light or a chemical.
"The virus is there but it's in a straitjacket. It's still got all its components for the immune system to recognise and mount a response against but it can't cause disease," Dr Labzin said.
The downside of these is that because the virus isn't a threat to the body, the body might not mount much of an immune response to it, and the dose of virus in the vaccine might need to be higher to cause enough of an effect.
Subunit and similar types of vaccines introduce a fragment of the virus into the body, for example, the "spike" protein that sticks out on the shell of a coronavirus.
The spike protein is what actually binds to the receptors in your body and allows the virus to enter your cells.
The idea behind a subunit vaccine is that when the body recognises the protein it creates specialised immune cells that block the receptors, effectively shutting down the door to the virus.
Dr Labzin said there are quite a few subunit vaccines in development for COVID-19 because they have the benefit of being relatively quick to make in comparison to live attenuated and inactivated virus vaccines.
But they carry the same downside of inactivated virus vaccines, in that the challenge is getting the body to recognise the virus fragment as enough of a threat to create an effective immune response.
Unlike the other types, which include the actual virus or portions of it, genetic vaccines simply contain DNA or RNA the code that tells cells what to produce.
These vaccines take advantage of the body's own cells, giving it instructions to create the protein of the virus the vaccine is aiming to protect against.
The body then detects both the genetic material and new protein as foreign and mount an immune response against it.
These types of vaccines are relatively easy and inexpensive to make, but they're newer technology.
Dr Labzin said RNA vaccines were so new there aren't actually any existing vaccines of this type yet.
These vaccines introduce a different type of virus that has been engineered to include proteins of the virus the vaccine is aiming to protect against.
Even though this type of vaccine involves a virus, it can't cause disease but does stimulate an immune response.
"There are licensed vaccines of that type, it has a known track record of working," said Trevor Drew, head of CSIRO's Australian Centre for Disease Preparedness.
A colorised scanning electron micrograph image of a VERO E6 cell (blue) heavily infected with SARS-COV-2 virus particles (orange), isolated from a patient sample.
(Flickr: NIAID)
A colorised scanning electron micrograph image of a VERO E6 cell (blue) heavily infected with SARS-COV-2 virus particles (orange), isolated from a patient sample.
With so many potential avenues to explore, how do researchers and funding bodies know where to direct their efforts?
In an attempt to get an effective COVID-19 vaccine ready as quickly as possible, Dr Lazbin said the World Health Organisation (WHO) and Coalition for Epidemic Preparedness Innovations (CEPI) are "trying to put their eggs in lots of different baskets".
The WHO has released a list of more than 60 vaccines in development all around the world, including a number in Australia.
But even once a vaccine is developed that has promise, there are hurdles it must clear before it can be rolled out around the world.
You might have heard about different phases of clinical trials before. Here's what they mean for the purposes of a COVID-19 vaccine:
Amidst these, the potential vaccine also has to be approved for use by relevant regulatory bodies and, crucially, it has to be manufactured in sufficient amounts and distributed around the world.
As mentioned, there are multiple research groups investigating different approaches to developing a vaccine for COVID-19. Most of these are still at the preclinical phase, although a few in the WHO document are in Phase I trials.
Last week, the CSIRO announced it had begun testing potential vaccines on ferrets at its Australian Animal Health Laboratory in Geelong.
This pre-clinical stage, which is expected to take three months, involves testing potential vaccines for effectiveness as well as evaluating how best to deliver the vaccine, such as via an injection into the muscles or a nasal spray.
The CSIRO site is a pipeline for a number of potential COVID-19 vaccines.
Professor Drew, who is leading CSIRO's COVID-19 virus and vaccine work, said the facility had actually been preparing for these tests since before COVID-19 even broke out.
"We called it Disease X. we didn't know what would come but we knew something would come," he said.
"And then suddenly COVID emerged as the disease."
Ezekiel Uba Nwose, a medical scientist at Charles Sturt University, said you could only speed up processes by so much.
"Normally vaccines take up to five years or more to develop, but ... the relevant authorities can decide to speed up on the conventional protocols to fast-track bringing it to trials," Dr Nwose said.
"No matter what, it needs to undergo trials and validation.
"With the COVID-19 vaccine, I think the earliest several authorities have indicated the earliest we are going to get it is 2021."
Yes, it's possible, Dr Labzin said. Every virus is different and what has worked in the past may not work for the new coronavirus.
"We don't have vaccines against any coronavirus yet," she said.
SARS, MERS and some forms of the common cold are caused by other coronaviruses.
But she's optimistic.
"I think that by taking so many different approaches we should be able to."
President Donald Trump speaks during the daily briefing on the novel coronavirus, COVID-19, in the Brady Briefing Room at the White House on April 6, 2020, in Washington, DC.
Mandel Ngan | AFP | Getty Images
While the coming days in the nation's coronavirus fight look bleak, President Donald Trump gave Americans some reason to hope. "There's tremendous light at the end of the tunnel," he said at a White House press briefing Monday.
"Currently, ten different therapeutic agents are in active trials and some are looking incredibly successful," he said. "But they have to go through a process and it's going to be a quick process based on what the FDA told me." He said another 15 potential treatments are working toward clinical trials, "so they're advancing rapidly."
Trump echoed comments made earlier Monday by World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus, who said the research to develop vaccines and treatments to fight the coronavirus has "accelerated at incredible speed."
Tedros said more than 70 countries have joined WHO's trial to accelerate research on effective treatments and "about 20 institutions and companies are racing to develop a vaccine."
"The viral genome was mapped in early January and shared globally which enabled tests to be developed and vaccine research to start," Tedros said at a news conference at WHO headquarters in Geneva.
White House health advisor Dr. Anthony Fauci said last week that the first human trial testing a potential vaccine to prevent COVID-19 is "on track" with public distribution still projected in 12 to 18 months, which would be the "ultimate game changer" in the fight against the pandemic.
U.S. health officials have been fast-tracking work with biotech companyModernato develop a vaccine to prevent COVID-19. Theybegan their first human trialson a potential vaccine March 16.
New York state last month began the first large-scale clinical trial looking at hydroxychloroquine as a possible treatment for the coronavirus after the Food and Drug Administration fast-tracked the approval process.
Chloroquine has gained a lot of attention aftera small studyof 36 COVID-19 patients published March 17 in France found that most patients taking the drug cleared the coronavirus from their system a lot faster than the control group. Adding azithromycin,commonly known as a Z-Pak, to the mix "was significantly more efficient for virus elimination," the researchers said. A small study in China also found that combining chloroquine with azithromycin was "found to be more potent than chloroquine."
"Stay inside and let's win this and let's get our country as soon as we can. I think it's going to be sooner than people think. Things are going really well," Trump said.
The head of a top Russian research center told President Vladimir Putin on Tuesday that his lab was ready to starthuman trials of experimental coronavirus vaccines in June.
Rinat Maksyutov, head of the Vektor State Virology and Biotechnology Center, said his facility proposed first-phase clinical trials of three vaccines from June 29, on 180 volunteers.
Maksyutov was speaking during a video-link meeting between Putin and the heads of top research centers.
"Groups of volunteers have already been formed," he told Putin, adding that a lot of people wanted to take part in the trials.
"We have already received more than 300 applications."
Maksyutov said scientists at the top-secret lab complex located in Koltsovo outside the Siberian city of Novosibirsk had developed several prototype vaccines.
Tests were currently underway on mice, rabbits and other animals to determine the most promising by April 30, he said.
Vektor planned pre-clinical studies by June 22 before launching the testing in humans, Maksyutov added.
But the first human trials could begin in May "if the Health Ministry allows it."
Vektor has vaccine platform technologies that have already been tested in humans for other infections and could be used for the coronavirus, he added.
The Vektor laboratory complex conducted secret biological weapons research in the Soviet era and stockpiles viruses ranging from Ebola to smallpox.
Russiaon Tuesday reported 7,497 coronavirus cases and 58 fatalities but the real number of infections is believed to be much higher.
Coronavirus is spreading around the world, but there is still no drug that can kill the virus or vaccines that can protect against it. Research is happening at breakneck speed like never before to produce a vaccine for the deadly disease. The international community has said it would take at least a year to develop a vaccine for COVID-19.
According to Elissa Prichep, Precision Medicine Lead, World Economic Forum, the actual time to create coronavirus vaccine in a traditional way would take at least 10 years. However, with the advancement of technologies and international cooperation, the vaccine might be out between 12 and 18 months.
Prichep says creating a vaccine expeditiously, without appropriate testing, could put healthy people at risk. "One area of risk is vaccine enhancement, meaning the disease is more harmful to a vaccinated person," Prichep said.
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Traditionally, a vaccine for any disease is developed in four stages. In the first phase, a study is done on healthy people to evaluate the vaccine for safety and immune response. For COVID-19 trial, this would typically take one to two years. In the second stage, a study will be done on hundreds of random people. This will further evaluate the safety, assesses the efficacy and informs optimal dose and vaccine schedule. Typically, this would take two to three years. In the third phase, another randomised, placebo-controlled study of thousands of people to evaluate safety and efficacy. This will take two to four years to reach any conclusion. After this, a government body approves new vaccines reviews the trial data and other information in the licensing application. In the fourth phase, post-approval studies happen that monitor effectiveness in real-world conditions.
However, for COVID-19 vaccine, medical scientists are shaving several years from traditional vaccine development timelines. They are using the full genetic sequence of SARS-Cov2, the virus that causes COVID-19, to develop vaccines that will contain a small amount of genetic code. The human body cells will take up this genetic information and produce elements of the virus, not infecting the person but triggering the immune system to respond.
To create a coronavirus vaccine, scientists are creating DNA or RNA based vaccines that can be produced in the lab. This approach is faster and more reliable than traditional vaccine processing, which uses viruses grown in eggs or cell cultures. Gingko Bioworks has committed the capacity to manufacturing DNA or RNA based vaccines.
The innovative approach, applied for this vaccine, could change how scientists develop future ones. The discovery of COVID-19 vaccine could make production more reliable and vaccines potentially more cost effective. The Coalition for Epidemic Preparedness Innovations ( CEPI) has made an urgent call for $2 billion in funding to support coronavirus's vaccine development, trials and enhanced manufacturing capacity.
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Survivors of COVID-19 who spent time on a ventilator may be at risk of long-term disability and illness.
By Kelly ServickApr. 8, 2020 , 10:50 AM
Sciences COVID-19 reporting is supported by the Pulitzer Center.
The next few months will be full of grim updates about the spread of the new coronavirus, but they will also be full of homecomings. Patients hospitalized with severe COVID-19, some having spent weeks breathing with the help of a mechanical ventilator, will set about resuming their lives. Many will likely deal with lingering effects of the virusand of the emergency treatments that allowed them to survive it.
The issue were all going to be faced with the most in the coming months is how were going to help these people recover, says Lauren Ferrante, a pulmonary and critical care physician at the Yale School of Medicine. Hospital practices that keep patients as lucid and mobile as possible, even in the throes of their illness, could improve their long-term odds. But many intensive care unit doctors say the pandemics strain on hospitals and the infectious nature of the virus are making it hard to stick to some of those practices.
While COVID-19 is sending even young, previously healthy people to the intensive care unit(ICU), older adults are at greatest risk of both severe disease and long-term impairment, says Sharon Inouye, a geriatrician at Harvard Medical Schools Hebrew SeniorLife health care system. Its taken us a long, long time to [develop] some best practices for geriatric care in the hospital and ICU, and I just see all of that being eroded during this crisis.
COVID-19s immediate assault on the body is extensive. It targets the lungs, but a lack of oxygen and widespread inflammation can also damage the kidneys, liver, heart, brain, and other organs. Although its too early to say what lasting disabilities COVID-19 survivors will face, clues come from studies of severe pneumoniaan infection that inflames the air sacs in the lungs, as COVID-19 does. Some of these infections progress to acute respiratory distress syndrome (ARDS), in which those sacs fill with fluid. That condition sometimes leads to scarring that can cause long-term breathing problems, Ferrante says, but studies show that most ARDS patients eventually recover their lung function.
After any severe case of pneumonia, a combination of underlying chronic diseases and prolonged inflammation seems to increase the risk of future illnesses, including heart attack, stroke, and kidney disease, says Sachin Yende, an epidemiologist and critical care physician at the University of Pittsburgh Medical Center. His team reported in 2015, for example, that people hospitalized for pneumonia have a risk of heart disease about four times as high as that of age-matched controls in the year after their release, and about 1.5 times as high in each of the next 9 years. COVID-19 might prompt a big increase in these sorts of events, he says.
Patients who spend time in an ICU, regardless of the illness that put them there, are also proneto a set of physical, cognitive, and mental health problems after leaving known as postintensive care syndrome. The new coronavirus might put ICU survivors at particular risk for some of these problems, says Dale Needham, a critical care physician at Johns Hopkins Universitys School of Medicine. One reason is the exceptionally severe lung injury it can cause, which leads many patients to spend prolonged periods on a ventilator under deep sedation. A patient with ARDS caused by other illnesses might rely on this life support for 7 to 10 days, Needham estimates, but some coronavirus patients require more than 2 weeks.
Many COVID-19 patients who need a ventilator never recover. Although survival rates vary across studies and countries, a report from Londons Intensive Care National Audit & Research Centre found that 67% of reported COVID-19 patients from England, Wales, and Northern Ireland receiving advanced respiratory support died. A study in a smaller patient group in China found that only 14% survived after going on a ventilator.
Those who survive a long period on a ventilator are prone to muscle atrophy and weakness. Keeping a critically ill patient movingraising their arms and legs, and eventually helping them sit up, stand, and walkcan reduce that weakness and get them off the ventilator faster. But because SARS-CoV-2is so infectious, bringing rehab specialists into patients rooms can be a challenge, Needham says.
In Needhams ICU at Johns Hopkins, these specialists are donning protective gear to help people on ventilators stay moving. But Ferrante says that at many major hospitals, including hers, a shortage of such equipment has kept physical therapists away from COVID-19 patients. And even when people are well enough to leave the ICU or the hospital, many still have the virus, she says, and may have to wait until theyre not contagious to get inhome care or visit a rehab facility.
Another risk for hospitalized patients is deliriuma state of confused thinking that can lead to long-term cognitive impairments such as memory deficits. What were finding in COVID is that theres a ton of delirium, says E. Wesley Ely, a pulmonologist and critical care physician at Vanderbilt University whose team is preparing to publish those findings. The virus itself is partly to blame, Ely says. He suspects this coronavirus, like the ones that cause severe acute respiratory syndrome(SARS) and Middle East respiratory syndrome, can directly infiltrate and damage the brain. And bodywide inflammation caused by the virus can also limit blood flow to the brain and kill brain cells.
Making matters worse, doctors commonly prescribe sedative drugs to suppress violent coughing and help patients tolerate the distress and discomfort of a breathing tube. But these drugs can increase the risk of delirium, Ely says. And as hospitals run short of the most commonly used sedatives, theyre turning to benzodiazepines, a class of drugs that can cause intense and prolonged delirium, he says.
Over the past 20 years, Ely and colleagues have developed a checklist, now adopted by many ICUs, to improve patient care and outcomes. Among its priorities: a daily interruption of narcotics and sedatives plus a decrease of ventilator pressure to test whether patients can wake up, breathe, and tolerate the ventilator without drugs. (If they cant, doctors are urged to restart these drugs at a lower dose.) But the practice requires close monitoring, and in ICUs overstretched by COVID-19, I think thats getting skipped, Ely says. Everybody out there is trying to do their best, he notes. But lets not throw out all the things weve learned in the last 20 years.
The threat of infection has limited the bedside interactions that can help patients stay calm and reduce the need for delirium-inducing drugs. If you could design a system to be bad for how you care for older adults, you would make it such that no one could go in the room, and the family would not be allowed to visit, and everyone has to go in with face masks and all gowned up, so theyre completely frightening, Inouye says. Doctors do need to sedate and restrain agitated patients to keep them from pulling out their IV or breathing tubes, she says. And yet Im wondering, could we possibly take 2 minutes to try to calm them, to have someone there whos gloved and masked, to hold their hand and stroke their arm?
Early reports from ICUs battling COVID-19 suggested patients should be put on ventilators early in the course of the disease, says C. Terri Hough, a pulmonary critical care physician at the University of Washington, Seattle. That was our approach here for our first handful of patients. Part of the logic was that a less invasive alternativedelivering a high flow of oxygen into the nosemight send the patients viral particles into the surrounding air, increasing the risk of infecting others. And if a patient declined quickly, doctors would be forced to do a riskier emergency intubation. But Houghs team quickly got worried about all the downsides of early ventilation, she says. She and her colleagues are now trying to tease apart subtypes of respiratory failure in coronavirus patients to help them decide which patients need ventilators and when. As we learn the faces of the disease, were seeing our practices shift, she says. If were putting more people on ventilators than maybe we need to, that certainly is going to affect the population health after recovery.
Poor survival odds and the potential for long-term complications force difficult conversations for older patients, families, and clinicians. I was initially really upset when I was hearing about the rationing of ventilators from older adults, Inouye says. But when COVID-19 broke out at her 91-year-old mothers assisted living facility, she and her sister made plans to tell hospital staff that if their mother got sick, she did not want to be kept on a ventilator when the hope of recovery was slight. (The facility has now passed 14 days without a new coronavirus case.)
Because of the decision-making about my moms case, and because of realizing how scarce the ventilators are, I do think we have to take it one-on-onewe have to go by what that persons wishes are and what their familys wishes are, she says.
As hospitals struggle through the current surge of cases, researchers are also trying to look ahead. Elys team is testing a tablet-based rehabilitation program for people who have cognitive impairment after being hospitalized for a critical illness, which he describes as Sudoku and Scrabble on steroids. Yendes team is piloting a care approach for discharged pneumonia and sepsis patients that includes monitoring them using computers and smartphones and visiting them at home or treating them remotely in hopes of preventing readmission to the hospital.
Others are preparing for a surge in mental health problems, among them anxiety, depression, and post-traumatic stress disorder following the psychological stress of severe disease. A study of people hospitalized for SARS found that more than one-third had moderate to severe symptoms of depression and anxiety 1 year later. Hough and her collaborators are testing a mobile app that promotes mindfulness and coping skills in people leaving the hospital.
The global emergency could lead to a stronger support system for survivors of any critical illness, Hough says. This were-all-in-this-together attitude around coronavirus may actually provide hope that wasnt there before.
