Doctors in Greater Cincinnati are watching COVID-19 vaccine trials expand around the world.Cincinnati Children's Hospital said it is making final preparations and expects to administer a candidate vaccine closer to the end of the month, but no exact date has been announced yet.Doctors are paying close attention to new developments in each study."If we had a vaccine that induced immunity for at least six months, that that would be a very powerful weapon in the fight against COVID-19," Dr. Carl Fichtenbaum said.Fichtenbaum is a Professor of Clinical Medicine at the University of Cincinnati College of Medicine and he is watching COVID-19 vaccine development happening around the globe.There is promise coming from some vaccine studies, such as the one led by Massachusetts-based Moderna, Incorporated, another by researchers at Oxford University and, soon, Cincinnati Children's Hospital will administer doses in a vaccine trial.Fichtenbaum said the newest technology in some projects uses genetic material called messenger RNA to kickstart the immune system."This is the ability for these proteins to get produced and then for the body to react, create antibodies, that are then very well-adapted to stop the virus from causing infection," he said.Fichtenbaum said these multi-phase studies are searching for the right dose, with safety, effectiveness and lasting immunity in mind.Some have found antibody levels after vaccination in humans and in animals.He said an ideal vaccine test uses volunteers from areas where transmission is high-risk, and that could include nursing homes, where a vaccine might be a benefit."It's a matter of getting enough volunteers to enroll in a time period and also getting the right types of volunteers," Fichtenbaum said.He said it could be possible to have a vaccine out to the public in 2021."Vaccination has been a real advance to humanity and it's one of the reasons why we can live into our 70s, 80s and 90s," he said.At Children's Hospital, officials said they are moving as quickly as possible, but also want the study to be precise.Doctors said any approved vaccine will likely be tested in between 50,000 and 100,000 people.They said then, there will be about six to 12 months of follow-up to gather important safety information.
Doctors in Greater Cincinnati are watching COVID-19 vaccine trials expand around the world.
Cincinnati Children's Hospital said it is making final preparations and expects to administer a candidate vaccine closer to the end of the month, but no exact date has been announced yet.
Doctors are paying close attention to new developments in each study.
"If we had a vaccine that induced immunity for at least six months, that that would be a very powerful weapon in the fight against COVID-19," Dr. Carl Fichtenbaum said.
Fichtenbaum is a Professor of Clinical Medicine at the University of Cincinnati College of Medicine and he is watching COVID-19 vaccine development happening around the globe.
There is promise coming from some vaccine studies, such as the one led by Massachusetts-based Moderna, Incorporated, another by researchers at Oxford University and, soon, Cincinnati Children's Hospital will administer doses in a vaccine trial.
Fichtenbaum said the newest technology in some projects uses genetic material called messenger RNA to kickstart the immune system.
"This is the ability for these proteins to get produced and then for the body to react, create antibodies, that are then very well-adapted to stop the virus from causing infection," he said.
Fichtenbaum said these multi-phase studies are searching for the right dose, with safety, effectiveness and lasting immunity in mind.
Some have found antibody levels after vaccination in humans and in animals.
He said an ideal vaccine test uses volunteers from areas where transmission is high-risk, and that could include nursing homes, where a vaccine might be a benefit.
"It's a matter of getting enough volunteers to enroll in a time period and also getting the right types of volunteers," Fichtenbaum said.
He said it could be possible to have a vaccine out to the public in 2021.
"Vaccination has been a real advance to humanity and it's one of the reasons why we can live into our 70s, 80s and 90s," he said.
At Children's Hospital, officials said they are moving as quickly as possible, but also want the study to be precise.
Doctors said any approved vaccine will likely be tested in between 50,000 and 100,000 people.
They said then, there will be about six to 12 months of follow-up to gather important safety information.
When a COVID-19 vaccine becomes available, I will be one of the first in line. But the fact is U.S. adults tend to have low vaccination rates. If the government determines that vaccinations are essential to stemming the spread of the disease, would it could it mandate vaccination compliance? Apparently, it can and it might.
Many medical experts believe that developing one or more COVID-19 vaccines is the key to reopening the economy and returning to our normal lives. For example, the Mayo Clinic says, A vaccine to prevent coronavirus disease 2019 (COVID-19) is perhaps the best hope for ending the pandemic.
The pharmaceutical industry has shifted into overdrive to find a vaccine effective against the coronavirus. Drug maker AstraZeneca hopes to have 30 million doses of its vaccine available in the U.K. by September. And Moderna just announced very promising results from its initial clinical trials.
But heres the problem: The majority of U.S. adults delay or skip vaccinations.
The Centers for Disease Control and Prevention (CDC) encourages adults to be immunized for a range of diseases. The flu vaccine leads the CDCs list that includes tetanus and diphtheria every 10 years, shingles, pneumonia and several others.
Consider the flu vaccine. It is one of the most affordable and accessible vaccines available, and yet the CDC reports the adult vaccination rate over the past decade has ranged between 40 and 45 percent.
Fortunately, the same 10-year graph shows a much higher flu vaccination rate among older Americans: Between 65 and 68 percent for seniors. But only about 30 to 35 percent for 18-49 year-olds.
Children typically have much higher vaccination rates because all states require them with certain exemptions before children can enroll in public schools.
While a small percentage of Americans oppose vaccinations on religious or medical grounds, most of the unvaccinated apparently just choose not to.
Will a coronavirus vaccine see a higher uptake rate? Maybe. There is a lot of fear among the public, and that may persuade most adults to be vaccinated.
Costs probably wont be a barrier, either. About 91 percent of the population has health coverage. The Affordable Care Act requires public and private insurance to cover the entire cost of preventive care, which includes vaccines. And the government may ultimately cover vaccination costs for the uninsured.
Even so, it isnt clear that enough adults will choose to be vaccinated to create a herd immunity i.e., when roughly 60 to 80 percent of the population has developed immunity to a disease either by vaccination or having been infected and recovered. Epidemiologists say thats whats needed to end an epidemic.
If the COVID-19 vaccination rate is low, will the federal or, more likely, state governments step in and mandate vaccination?
The Congressional Research Service says the U.S. Supreme Court has ruled that The states general police power to promote public health and safety encompasses the authority to require mandatory vaccinations. And states have all exercised that authority for children, usually allowing for some exceptions.
CRS also says, Congress, as a result of various enumerated powers in the Constitution, likewise has some authority over public health matters, including regulation of vaccination.
Government mandated vaccinations for adults would be a major and controversial step. But then government has taken a number of major and controversial steps recently, such as shutting down the economy.
But just because government can do something doesnt mean it should, which is why finding an effective treatment is so important. The good news is the pharmaceutical industry is doing exactly that. There are currently more than 1,100 clinical trials globally looking for a safe and effective COVID-19 treatment.
A treatment doesnt necessarily mean a cure. We dont have a cure for the flu, either. But Tamiflu helps reduce the symptoms so people can recover sooner. Something similar may be our best bet for COVID-19.
Having an effective treatment wouldnt eliminate the need for an effective vaccine. It would simply mean that those who werent vaccinated would still have the opportunity to reduce the symptoms and return to their normal lives sooner.
Merrill Matthews is a resident scholar with the Institute for Policy Innovation in Dallas, Texas. Follow him on Twitter @MerrillMatthews.
Imagine, if you can, life as it was a few months ago. Shopping for groceries without nervously eyeing anyone who creeps within six feet of you. Sitting down for dinner at a restaurant and actually enjoying the crowd. Watching live sports. These ho-hum aspects of everyday life are now the stuff of fantasy, reminders of a way of life the world is growing more and more desperate to reclaim. A beer in a bar with a friend feels as exotic as a daiquiri on a South Pacific beach.
A more pressing fantasy to fulfill is the one in which hundreds of Americans arent dying on a daily basis from a virus the scientific community still doesnt fully understand. Unlike some other nations, the U.S. has been unable to contain the spread of the virus, which means the development of a vaccine is likely the only way to reclaim any semblance of normalcy. Desperation for one has led to an unprecedented mobilization in which governments, scientists, and the pharmaceutical industry have trained their energy on bringing one to market in record time.
So when will a vaccine be available? Why, with so much interest and resources funneled into the cause, are researchers unable to develop one faster than many are projecting? Why is there so much uncertainty about when the population will be able to receive inoculations, and some pandemic-mutated version of life as we once knew it will be able to resume?
When President Trump was first asked how long Americans would have to wait for a vaccine on March 2nd, he threw out three or four months before deferring to Dr. Anthony Fauci, the nations leading infectious-disease expert. Fauci clarified that it is going to be, at the earliest, a year to a year and a half before a vaccine is deployable, no matter how fast you go.
Just over two months and 80,000 dead Americans later, the Trump administration is promising a vaccine will be available to the American public by the end of the year, the result of an initiative dubbed Operation Warp Speed. Fauci is still sticking to his 12-to-18-month time line. I think it is more likely than not that we will get a vaccine within a year or two, he told senators during a hearing last Tuesday, citing the progress made since the effort began. Its definitely not a long shot.
The progress so far has been encouraging, if not remarkable. Bringing a vaccine candidate for a novel virus through clinical trials typically takes years, usually many of them, but in just four months since COVID-19s genetic sequence was determined in January, a handful of candidates have entered clinical trials. The most promising among them are expected to wrap up human testing by the end of this year. New technologies are being harnessed, companies and governments that typically compete are now collaborating, and billions of dollars in funding has been made available. These are all promising signs, but they dont guarantee a vaccine will be available anytime soon. The time line remains the biggest unanswered question.
According to a 2013 paper by researchers at the University of Rotterdam, in the Netherlands, the average vaccine development time line is 10.71 years. The record is four years, how long it took to develop a vaccine for mumps in the Sixties when regulations werent as stringent. Meanwhile, researchers have been working on an HIV vaccine for close to 40 years. Most experts ballpark the range of potential time frames anywhere from five to 20 years.
While these experts allow that a COVID-19 candidate could be licensed not to mention manufactured and distributed within 12 to 18 months, they also note that it is highly unlikely. Its more than just the optimistic side of the spectrum, says Dr. Peter Hotez, dean of Baylors College of Tropical Medicine. Its the unprecedented side of the spectrum. Thats the part that concerns me. Weve never done it. It doesnt mean its impossible and were not trying, but its never been done.
Rolling Stone spoke with experts to get a better understanding of the complicated, delicate process of developing a vaccine that will be injected into the arms of hundreds of millions if not billions of healthy people, and what the quarantined masses can expect from the effort in the coming months.
One of the reasons we could see a vaccine within the next year or two is a dramatically shortened research runway. Scientists typically need years to study a virus and secure funding to develop a vaccine candidate. The latter is especially difficult. One of the reasons you dont see a lot of [investment] in this space is because the time horizons are long, the risk is high, and most things dont advance, Hotez says.
Hotez and his longtime collaborator Dr. Maria Elena Bottazzi spent nearly 20 years developing a vaccine for SARS-1, which infected hundreds in Asia and Canada in the early 2000s, but ultimately had to put it on the shelf before entering clinical trials because they ran out of funding. But the time Hotez, Bottazzi, and others spent researching coronaviruses like SARS and MERShas given scientists a huge head start in the race to develop a vaccine for SARS-Cov-2, the novel coronavirus that causes COVID-19.
Our SARS vaccine went through a very robust series of tests to evaluate purity, quality, functional ability, induce the right immune response, and ensure safety, says Bottazzi, who along with Hotez is now working to develop a COVID-19 vaccine. You can extrapolate a lot because these viruses are very similar.
This base of knowledge has emboldened scientists to forge ahead where in the past more research may have been warranted. Though this may increase the likelihood of failure, its a worthwhile risk considering the sheer number of players in the game. There are more than 115 vaccine candidates currently in development. Only a few of them need to succeed to cover the global need. If you really want to get to that time line of one year to 18 months, it means simultaneously advancing a lot of candidates forward, Hotez says. Its really the safety testing that is going to take longer than anything else.
Testing a vaccine candidate typically involves running it through preclinical trials in which it is tested on animals, followed by three phases of clinical trials, starting small with a few dozen human subjects before broadening to tens of thousands.
Researchers working to develop a COVID-19 vaccine want to compress this process, which invariably takes years of trial and error, into a few months. Testing is being done on humans and animals concurrently, and less time will be taken to study the results of each phase of human trials before moving onto the next. As Hotez puts it, developers have been charged with trying to do things in parallel, rather than serially. For example, Moderna, a biotech company that has received $430 million in federal funding, recently announced plans to begin Phase III trials in early summer. Meanwhile, they havent even entered Phase II yet, and only began Phase I in March.
As Fauci noted while speaking to senators last Tuesday, at least eight COVID-19 vaccine candidates have entered clinical development. Moderna is one of them, and on Monday the company announced their candidate appears to be safe and to have generated an immune response in the eight people it was tested on in March. The company has been a favorite of Fauci, who praised its progress while speaking to senators. But its also using a technological platform messenger RNA, or mRNA that has never yielded a licensed vaccine. There is no mRNA vaccine like this yet, says Dr. Rino Rappuoli, chief scientist at GlaxoSmithKline, one of the worlds leading vaccine manufacturers. We dont know how effective its going to be. Its kind of an unknown.
There are other risks to accelerating the testing process. Experts have cautioned about the potential for a vaccine to make the disease worse, an issue that emerged in animal testing for SARS-1. COVID-19 also has a relatively high asymptomatic infection rate (between 20 and 40 percent), which means a larger testing pool is ideal, and the likelihood of re-exposure, which is far greater than that of SARS-1, means a longer-term evaluation period is preferable. Unfortunately, its not an option. When you have an emergency, you can change the ratio between the risks that you want to take to the benefit youre going to gain, Rappuoli says.
Researchers are confident the sheer number of candidates spread across different platforms will result in a variety of safe, effective options that can satisfy the global need even if the majority of them fail. We have multiple candidates and hope to have multiple winners, Fauci said on Tuesday. In other words, [were taking] multiple shots on goal.
This doesnt necessarily mean anyone is going to score. The same University of Rotterdam study that set the average vaccine development timeline at 10.71 years also found that only six percent of vaccines that enter clinical trials go on to enter the market, and this is after years of research, approvals, and testing. The harried nature of the race to develop a COVID-19 vaccine only increases the likelihood any given candidate will fail.
After a vaccine candidate makes it through clinical trials, it must be licensed by a regulatory agency. In the U.S., its the Food and Drug Administration, which typically takes around a year to license new drugs. This isnt a typical situation. When you are under pressure like now, the regulatory agencies that usually take a long time just to respond to you, now you can talk to them every day, Rappuoli says. They are very eager to accelerate the global collaboration between vaccine developers, pharma, and regulatory agencies.
This should be easy then, right? More or less, but some worry it may be too easy. The FDA will be under a tremendous amount of political pressure to license a vaccine candidate, and its commissioner, Stephen Hahn whom Rolling Stone recently highlighted as one of the four men responsible for Americas failure to respond to the coronavirus doesnt exactly inspire confidence. There was a moment when Donald Trump said the FDA was working with them, says Dr. Paul Offit, director of the Vaccine Education Center at the Childrens Hospital of Philadelphia and member of the FDAs vaccine advisory committee. That worries me.
Also of concern to Offit is the prospect of the FDA forgoing the approval process entirely. I worry theyre going to use Emergency Use Authorization to get around the FDA, he says. I think that would be a mistake. I really do. Although we see regulation as burdensome, you want the FDA to regulate these products. You want someone to take a long hard look at what the data are before they license it for use in this country.
It wouldnt be the first time an unapproved vaccine was deployed. In 2014, an Ebola vaccine still in clinical trials was given to front-line workers in West Africa. The experiment was a success and the vaccine was ultimately approved in 2019, but by the time it was first administered, researchers had been studying its potential effects for years, not months. Theres no time to do that in-depth of a functional evaluation, Bottazzi says. The FDA should follow due process based on evidence, but theyre also put in the very not normal position of having to do it fast, and they may [not be able to look at] the full study of evidence.
The decision over whether to license a vaccine immediately will hinge on a risk-benefit analysis. How dire is the immediate need for those most at risk? How easily could the vaccine be manufactured and distributed to them? To what extent are alternative treatments an option?
As with every aspect of this accelerated development process, scientists are having to make such determinations on the fly. Hotez has faith in the FDA to make the right decisions, but in the end its hard to know what to expect because the situation is so unprecedented. [The FDA] tends to insulate themselves pretty well from all the hype, and they tend to look at things without bias, Hotez says. Theyre really good scientists trying to think through this so I dont think theyre going to be swayed. But who knows whats going to happen.
Developing a safe and effective vaccine in a few months would be one type of miracle. Manufacturing hundreds of millions of doses of it, and then distributing those doses equitably, may be an even greater challenge that will require an unprecedented level of international collaboration, both among nations and between governments and private interests.
First and foremost, its going to require establishing infrastructure to produce hundreds of millions (if not billions) of doses of specific vaccines before they can be proven safe and effective. Johnson & Johnson, which has received nearly $460 million in federal funding, is already working on operationalizing factories, as are Moderna, Pfizer, and other developers near the front of the race. Bill Gates announced on The Daily Show recently that his foundation is contributing billions to help seven unnamed companies that are developing vaccines to ramp up their manufacturing in advance.
We will be producing vaccines at risk, Fauci told senators, which means we will be investing considerable resources in developing doses even before we know if any given candidate or candidates work.
A recent report from Politico outlined several of the complications with scaling the production of a vaccine, including a shortage of the types of glass and stoppers needed to construct vials, which could cause delays down the line. Once manufactured, the vaccine doses need to be stored and transported in a controlled temperature. This is just in the U.S. Everything has a challenge because youre using different techniques and machinery, Hotez says. Things are done differently in India than they are in Brazil.
Then theres distribution. Assuming some of these vaccines will get licensure in a very optimistic scenario, then the question is how many doses will be available, Rappuoli says. A million? 10 million? 100 million? A billion? How are you going to make this decision? Where should the vaccines go? This is going to need a lot of collaboration globally. Otherwise, countries are going to be very conservative and say they need it for themselves.
It could depend on where the first vaccines proven safe and effective originate. If theyre produced overseas, the U.S. could have trouble getting them. One of the most promising candidates in being developed by a group at Oxford University, which hopes to have a few million doses ready by September, but because pharmaceutical companies typically demand world-exclusive rights, theyve yet to work out a deal with an American manufacturer. At the same time, Sanofi, the French pharmaceutical giant developing two candidates in a collaboration with GlaxoSmithKline, has said the U.S. will have first dibs because it has invested in taking the risk, as the companys CEO recently told Bloomberg.
The potential for a global competition over vaccine doses is why Fauci and others have stressed the importance of putting a diversity of candidates through trials. No single vaccine or vaccine platform alone is likely to meet the global need, and so a strategic approach to the multipronged endeavor is absolutely critical, he wrote along with three other top scientists in a paper published this week in Science.
They concluded by emphasizing the need for cooperation: Cost, distribution system, cold chain requirements, and delivery of widespread coverage are all potential constriction points in the eventual delivery of vaccines to individuals and communities. All of these issues require global cooperation among organizations involved in health care delivery and economics.
No one really knows. There are so many variables involved in the production of a vaccine, and the mad dash to develop one in response to COVID-19 is so unprecedented that there is no way to predict when, how, or by whom a scalable candidate will emerge.
What most experts agree on, however, is that the 12-to-18-month time frame floated by Fauci is on the more optimistic side. When you say 12 to 18 months, I dont see how you can possibly learn everything you need to know in that time, Offit says. I understand that were panicked about the virus, but I worry corners might be cut. I honestly think that if everything went perfectly you could make this vaccine in five years.
Rappuoli believes it is technically possible to have a vaccine ready in 12 to 18 months, but acknowledges that getting one licensed in that time frame not to mention manufactured and distributed is probably a best-case scenario. I think we can shorten the time line, he says. How much we can shorten it depends on how successful were going to be and how aggressive the need for a vaccine will be. In the most optimistic scenario, we could have a licensed vaccine in one year. Reasonably in 18 months. Conservatively, I think in three years we should have a licensed vaccine.
Rappuolis estimate is in line with what other experts have expressed since COVID-19 overtook the United States: late 2021 or 2022, as a best-case scenario. Its not going to be easy, Hotez says. Its going to have to be a very carefully orchestrated dance between the epidemiological models, the scientists, the business community, and government leaders to work this out. Its doable, but its not going to be easy.
Tackling the coronavirus is also going to require far more than the development of a vaccine. Regardless of any absolutist reassurances Trump or his administration may relay to the nation, there are no black-and-white answers for how to move past COVID-19. The economy will not magically return to where it was a year ago as businesses begin to reopen, nor will society suddenly shed fears of dense gatherings when officials relax stay-at-home orders. The creation of a safe, effective vaccine, whenever it happens, will be one of many steps albeit a crucial one on what will inevitably be a years-long journey out of the fog of the pandemic. This is an important reality to accept for Americans desperate for a return to a normalcy.
We have to get over this idea that everybody just hunkers down for a year and then one day the vaccine is available and everybody goes on a picnic on the National Mall, Hotez cautions. Its not going to work that way.
A recent study conducted by events analytics firm Performance Researchin partnership with Full Circle Research Co. and published by Varietycould mean bad news for Hollywood. Seventy percent of respondents said they prefer to watch new movies from homea continuation of a worrisome trend for the film industry. Thirteen percent of those respondents said they would watch from a local cinema, and the last 17% were unsure.
It may seem as if the news is constantly reporting about the masses of people who are rushing to be social again now that states are opening back up, but most people plan to remain cautious before jumping back into the mix. The studysurveyed 1,000 people to see what the entertainment industry is facing when it comes to earning back public confidence in attending venues again.
The most notable findings state that 52% of respondents said they will attend fewer large public events, even after the CDC and local governments say its safe to do so. Sixty percent of respondents say the idea of attending a public event will scare them for a while. The study covered Broadway, live concerts, and movie theaters, and the answers are similar across the board. The most challenging stat for the entertainment industry was this one: Ninety percent of respondents want a COVID -19 vaccine before going back to public venues.
One of the more surprising findings had to do with movie genrelong dominated by IP-driven sure bets like superhero movies and basically everything that comes out of Disney. But here, comedy had the most allure, with 43% of respondents naming it as the genre they most preferred to see on a big screen. Drama was the next most popular, with 35% of respondents, and superhero movies came in third, with 33% of respondents. Nineteen percent of respondents were interested in horror.
Its not surprising that people will remain cautious for a while, but if were being optimistic, maybe we can read these responses as a sign that people will demand that Hollywood rearrange some of its priorities. Comedy has been on the decline in box office numbers for the past couple of years, but the need for laughter in high anxiety times is clutch.
Emory holds COVID-19 vaccine trial
An Atlanta man has received his second injection as part of a COVID-19 vaccine trial by Emory.
ATLANTA - While Norman Hulme shelters in place working from home as a graphic artist for Emory University, he takes comfort knowing the injections, the multiple blood draws and every note in his daily journal could make a big difference in the fight against the COVID-19.
"To be able to participate in a trial vaccine was really important to me. The ultimate goal is to have a vaccine that everybody can use," Hulme told FOX 5's Portia Bruner.
One month and two injections into the 14-month-long Emory COVID-19 vaccine trial, Hulme said he's more than willing to log every step of his journey. Monday, at the Emory Hope Clinic, he received the second of two injections necessary to determine whether participants develop antibodies.
"It's kind of like getting a flu shot they just put it in the arm of your choice and then observe you for an hour afterward to make sure there's no immediate reaction. I have to keep a diary of any other things like pains or headaches or any nausea," said Hulme, who has not experienced any side effects following his two injections.
The 65-year-old Decatur man is one of the first Americans to test this experimental vaccine against the coronavirus. Researchers first gave it to a small group of younger adults in March. The Emory University graphic artist received his first injection in April with other men and women between the ages of 56 and 70.
"I think everybody has to do their part for this because really because it really does impact literally everyone in the world.
Emory, Kaiser Permanente Washington and the Vaccine Research Center at the NIH are testing this experimental vaccine made by the biotech Moderna. The vaccine uses genetic material from that spike protein on the surface of this coronavirus to help the immune system recognize and fight the deadly virus.
"This is really our World War. this is really our moment as people and global citizens and I think everyone needs to do their part wherever they can fit in and this little bit seemed to be what I could do with this point in time," said Hulme has who not contracted coronavirus.
]]> The new Covid-19 vaccine candidate was created using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins. Credit: pearson0612 from Pixabay.
India-based Bharat Biotech has entered into an exclusive agreement to develop a Covid-19 vaccine candidate created at Thomas Jefferson University in Philadelphia, US.
Infectious Diseases expert professor Matthias Schnells lab created the vaccine candidate in January using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins.
This approach, used as a vehicle or carrier vaccine, is known to generate a strong immune response, authorised for the whole population, including children and pregnant women.
In preliminary tests in animal models, the vaccine demonstrated a strong antibody response in mice. Currently, the researchers are evaluating if vaccinated animals are protected from Covid-19 infection and results are expected to be available next month.
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Schnell noted: Our partnership with Bharat Biotech will accelerate our vaccine candidate through the next phases of development. We will be able to complete animal testing and move to Phase I clinical trial rapidly.
As part of the licence agreement, the company gets exclusive rights to develop, market and deliver Jeffersons vaccine globally, excluding some countries such as the US, Europe and Japan, where Jefferson is seeking partners.
With the Indian governments Department of Biotechnology support, the company intends to advance the vaccine candidate into human trials as early as December this year.
Bharat Biotech CEO Dr Krishna Mohan said: In view of the imminent demand for an effective vaccine, Bharat Biotech is pleased to collaborate with Thomas Jefferson, USA towards developing a new vaccine for Covid-19 using an inactivated rabies vector platform.
Bharat Biotech is committed to global public health and will be involved in an end to end development of the vaccine including comprehensive clinical trials to achieve commercial licensure.
Last month, Bharat Biotech partnered with FluGen and the University of WisconsinMadison (UWMadison) to develop and evaluate a Covid-19 vaccine candidate, CoroFlu.
By Leslie Moreno, WRAL reporter
Chapel Hill, N.C. Researchers are closer to creating a vaccine for COVID-19. The news has been met with both comfort and fear.
A professor at the Carolina Population Center in Chapel Hill says theres a long history of concern when it comes to vaccines. Because of the current rush to find a solution to the coronavirus outbreak, these fears may be intensified.
A lot of companies are throwing every bit of effort they have at producing one, fast,Paul Delamater said.
According to the World Health Organization, more than 70 potential vaccines are currently being developed, all of which are at various stages of development.
I do think people will want to get the vaccine a little more than like the regular vaccine every year, Delamater, said.
But some people are hesitant.
Its way too soon in my opinion," Trenton Lassiter said. "Usually it takes months and years to develop a vaccine for viruses.
Lassiter also said he feels a vaccine is being rushed. He has concerns about long-term side effects and the amount of time in which the vaccine would be created.
Im hearing that the normal procedures arent being followed as far as developing the vaccine, compared to other viruses in the past, because theyre in such a tight schedule. Some things arent being checked off like they would be, so theyre rushing through the process," Lassiter, said.
Delamater said these fears are very common, especially with such a new virus.
The people that refuse to take vaccines tend to do so for a couple of reasons one is concerns about the contents of the vaccine and not wanting it in their body and the other is the state or the nations role, Delamater, said.
According to latest figures from the Johns Hopkins Coronavirus Resource Center, the virus has infected more than 4.5 million people across the world, killing over 300,000.
The FDA can fast-track vaccines, and that would speed up the testing and approval process.
A lot of things have to go right before we can start vaccinating the population, Delamater, said.
According to the World Health Organization, if all goes well, researchers hope to have a vaccine out by the second half of 2021.
CHICAGO (Reuters) - Two studies in monkeys published on Wednesday offer some of the first scientific evidence that surviving COVID-19 may result in immunity from reinfection, a positive sign that vaccines under development may succeed, U.S. researchers said on Wednesday.
FILE PHOTO: A woman holds a small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/Illustration
Although scientists have assumed that antibodies produced in response to the new coronavirus virus are protective, there has been scant scientifically rigorous evidence to back that up.
In one of the new studies, researchers infected nine monkeys with COVID-19, the illness caused by the novel coronavirus. After they recovered, the team exposed them to the virus again and the animals did not get sick.
The findings suggest that they do develop natural immunity that protects against re-exposure, said Dr. Dan Barouch, a researcher at the Center for Virology and Vaccine Research at Harvards Beth Israel Deaconness Medical Center in Boston, whose studies were published in the journal Science.
Its very good news, Barouch said.
Several research teams have released papers - many of them not reviewed by other scientists - suggesting that a vaccine against the virus would be effective in animals.
In the second study, Barouch and colleagues tested 25 monkeys with six prototype vaccines to see if antibodies produced in response were protective.
They then exposed these monkeys and 10 control animals to SARS-CoV-2, the official name of the novel coronavirus.
All of the control animals showed high degrees of virus in their noses and lungs, but in the vaccinated animals, we saw a substantial degree of protection, Barouch said. Eight of the vaccinated animals were completely protected.
These studies, which have been peer reviewed, do not prove that humans develop immunity or how long it might last, but they are reassuring.
These data will be seen as a welcome scientific advance, Barouch said.
Reporting by Julie Steenhuysen; Editing by Bill Berkrot
This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses
The pharmaceutical executive tapped to lead the Trump administrations program to develop a vaccine for Covid-19 will divest his shares in one of the leading vaccine-development companies after controversy arose surrounding his holdings.
News media reported Monday that Moncef Slaoui who was named last week as head of the administrations Operation Warp Speed effort to rapidly develop Covid-19 vaccines would divest his stock options in Cambridge, Massachusetts-based Moderna, worth more than $10 million. Slaouis 156,000 options in Moderna reportedly increased in value by at least $3 million following the companys announcement Monday of preliminary data from the Phase I study of mRNA-1273, its vaccine against SARS-CoV-2. Slaoui resigned from Modernas board of directors following his appointment to lead Operation Warp Speed.
Shares of Moderna rose 30% on the Nasdaq when markets opened Monday and closed at 20% above their Friday closing price following the announcement of early data from the Phase I study.
Data from the study, which the National Institute of Allergy and Infectious Diseases is sponsoring, showed that among the first eight participants enrolled in the 25- and 100-microgram dosing cohorts, levels of neutralizing antibodies were equivalent or in excess of those seen in patients who have recovered from Covid-19. The study is enrolling 105 participants in total across three dosing cohorts, the third of which is receiving the vaccine at 250 micrograms. However, the company plans to abandon the 250-microgram dose in further testing of the vaccine, with the upcoming placebo-controlled Phase II study using 50- and 100-microgram doses and the Phase III study planned to start in July using a dose somewhere between 25 and 100 micrograms.
The other company in the lead to develop a vaccine against the Covid-19 virus is Tianjin, China-based CanSino Biologics, which has a Phase II study underway in China and plans to develop its adenovirus-based vaccine in Canada as well. Meanwhile, Pfizer and BioNTech recently began dosing participants in the trial of their vaccine, which like Modernas is a messenger RNA vaccine.
Photo: Centers for Disease Control and Prevention
Aggressive public health measures tostem the tidal wave of coronavirus infections have left people isolated,unemployed and wondering when it will all end. Life probably wont gocompletely back to normal until vaccines against the virus are available,experts warn.
Researchers are working hard on thatfront. At least six vaccines are currently being tested in people, says EstherKrofah, chief executive of the FasterCures center at the Milken Institute in Washington,D.C. We expect about two dozen more toenter clinical trials by this summer and early fall. That is a huge number,Krofah said at an April 17 briefing. Dozens more are in earlier stages oftesting.
In unpublished, preliminary results of a test of one vaccine, inoculated people made as many antibodies against the coronavirus as people who have recovered from COVID-19 (SN: 5/18/20). The mRNA-based vaccine induces human cells to make one of the viruss proteins, which the immune system then builds antibodies to attack. That study was small, only eight people, but a second phase of safety testing has begun.
But vaccinestake time to test thoroughly (SN: 2/21/20). Even with acceleratedtimelines and talk of emergency use of promising vaccines for health care workersand others at high risk of catching the virus, the general public will likelywait a year or more to be vaccinated.
In the meantime, new treatments may helpsave lives or lessen the severity of disease in people who become ill.Researchers around the world are experimenting with more than 130 drugs to findout if any can help COVID-19 patients, according to atracker maintained by the Milken Institute.
Some of those drugs are aimed atstopping the virus, while others may help calm overactive immune responses thatdamage lungs and other organs. Although researchers are testing a battery ofrepurposed drugs and devising new ones, there is still a great deal ofuncertainty over whether the drugs help, or maybe even hurt.
The wait is frustrating, but theres still much doctors and scientists dont know about how this new coronavirus affects the body. Getting answers will take time, and finding measures to counter the virus that are both safe and effective will take even more. Early results suggest that the antiviral drug remdesivir can modestly speed recovery from COVID-19 (SN: 5/13/20). It is not a cure, but the drug may become the new standard of care as researchers continue to test other therapies.
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Antiviral drugs interfere with a viruss ability to replicate itself, though such drugs are difficult to create. Remdesivir is being tested in half a dozen clinical trials worldwide. The drug mimics a building block of RNA, the genetic material of the coronavirus (SN: 3/10/20). When the virus copies its RNA, remdesivir replaces some of the building blocks, preventing new virus copies from being produced, laboratory studies have shown.
Early results in COVID-19 patients given the drug outside of a clinical trial showed that 68 percent needed less oxygen support after treatment, as reported online April 10 in the New England Journal of Medicine (SN: 4/29/20). The drug went to very sick patients, including those who needed oxygen from a ventilator or through tubes in the nose. Other researchers have disputed those results, questioning the study methods and statistical analyses, which may have given an exaggerated impression of good outcomes. The studys authors say they have reanalyzed the data and still conclude that remdesivir has benefits.
Soon after, the U.S. National Instituteof Allergy and Infectious Diseases announced that hospitalized patients withCOVID-19 who got intravenous remdesivir recoveredmore quickly than those on a placebo: in 11 days versus 15. Those findingshad not been reviewed by other scientists at the time of the announcement. Thedug provides researchers with a baseline for comparing other treatments. Wethink its really opening the door to the fact that we now have the capabilityof treating, Anthony Fauci, director of the NIAID said April 29 in a newsbriefing at the White House.
Antiviral medications used against HIV are also being tested against COVID-19. The combination of lopinavir and ritonavir stops an HIV enzyme called the M protease from cutting viral proteins so that the virus can replicate itself. The SARS-CoV-2 virus produces a similar enzyme. But early results from a small study in China showed that the combination didnt stop viral replication or improve symptoms (SN: 3/19/20), and there were side effects.
For now, the Society of Critical CareMedicine recommendsagainst using the drugs, and the Infectious Diseases Society of Americasays patients should get the drugs onlyas part of a clinical trial. Several large trials may report results soon.
The HIV drugs may not work well against SARS-CoV-2, even though the viruses have similar M proteases: The coronaviruss enzyme lacks a pocket where the drugs fit in the HIV version of the enzyme.
This illustrates why antiviral drugs areso difficult to develop. Designing a drug requires knowing the 3-D structure ofthe viruss proteins, which can take months to years. But researchers arealready getting some close-up views of the new coronavirus. A team in Chinaexamined the structure of the coronaviruss M protease and designed smallmolecules that could block a part of the protein necessary to do its job. Theteam describedtwo such molecules, dubbed 11a and 11b, April 22 in Science.
In test tubes, both molecules stopped the virus from replicating in monkey cells. In mice, 11a stuck around longer in the blood than 11b, so the researchers tested 11a further and found it seemed safe in rats and beagles. More animal tests will probably be needed to show whether it stops the virus, then multiple stages of human tests will have to follow. The drug development and testing process often takes on average 10 years or more, and can fail at any point along the way.
Meanwhile, hundreds of thousands of people worldwide have already recovered from COVID-19, and many are donating blood that might contain virus-fighting antibodies. Clinical trials are under way to test whether antibodies from recovered patients blood plasma can help people fight off the virus (SN: 4/25/20, p. 6). More such trials are planned.
Stopping the virus is only half the problem. In some people seriously ill with COVID-19, their immune system becomes the enemy, unleashing storms of immune chemicals called cytokines. Those cytokines trigger immune cells to join the fight against the virus, but sometimes the cells go too far, causing damaging inflammation.
Some of the drugs used to calm cytokines in cancer patients (SN: 6/27/18, p. 22) may also help people with COVID-19 ride out the storm, says cancer researcher Lee Greenberger, chief scientific officer of Leukemia and Lymphoma Society. Several of those drugs are being tested against the coronavirus now.
Hydroxychloroquine, a drug approved totreat autoimmune disorders such as lupus and rheumatoid arthritis, became ahousehold word after President Trump touted it as a possible COVID-19treatment.
The drug is being tested in numerouslarge clinical trials around the world to see if it might help calm cytokinestorms in COVID-19 patients as well. But so far, there is no solid evidence thatit works either to prevent infection in people or to treat people who alreadyhave the disease.
And in some studies the drug has caused serious side effects, including causing irregular heartbeats, says Raymond Woosley, a pharmacologist at the University of Arizona College of Medicine in Phoenix. People with heart problems, low potassium or low oxygen levels in their blood are at higher risk of these side effects, he says. And those are exactly the kinds of patients who are most vulnerable to COVID-19. So, the very sickest COVID patients are those at most risk for these life-threatening arrhythmias and cardiac effects.
Results of some rigorous clinical trialsof hydroxychloroquine are expected this summer. Meanwhile, the U.S. Food andDrug Administration allows the drug to be used when no other treatment isavailable and patients cant join a clinical trial.
Todays enthusiasm for any drug thatseems promising feels familiar, says Woosley. He remembers the excitement overAZT, the first drug used to fight HIV in the 1980s. It wasnt the best drug tocombat the AIDS epidemic, and better ones came later. Likewise, the firsttreatments for COVID-19 might be better than nothing, but not the best we willultimately get.
Meanwhile, we wait.
With hundreds of clinical trials going on around the world, some answers may come soon. But for now, keeping the coronavirus contained will probably require aggressive testing, tracing and isolating contacts of people who have the virus and continued social distancing.
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