As the coronavirus pandemic spreads at unprecedented rates, invading the lungs of people of all ages, ethnicities and medical histories, companies are ratcheting up their efforts to fight the disease with accelerated schedules for creating new vaccines, and beginning clinical trials for potential treatments.
On Wednesday, Novavax, a Maryland-based biotech company, said it would begin human trials in Australia in mid-May for its vaccine candidate. Novavax is one of more than two dozen companies that have announced promising vaccine programs that are speeding through the early stages of testing unlike ever before.
Also on Wednesday, the stem-cell company Mesoblast said it was starting a 240-patient clinical trial, supported by the National Institutes of Health, that would test whether cells derived from bone marrow could help patients who developed a deadly immune reaction to the coronavirus.
In normal circumstances, development of new vaccines and treatments would take years. But the pharmaceutical industry is racing to compress this timeline with the support of nonprofit organizations, government agencies and regulatory authorities.
Novavax said its vaccine candidate had stimulated a powerful immune response in lab and animal experiments, producing antibodies that could fight off the coronavirus.
While a final product that would be widely available is still a year or more away, the Novavax effort is one of many that is ready to be tested 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 in Houston are also waiting for permission from the Food and Drug Administration to begin testing in people.
“We’re 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 Children’s Hospital Center for Vaccine Development at Baylor College of Medicine.
There is no approved treatment for Covid-19, the illness caused by the coronavirus, and researchers and doctors are testing a host of therapies in a desperate bid to save the lives of people who have few other options. President Trump has aggressively promoted two old malaria drugs, which have shown only limited evidence of working as treatments for the coronavirus. He has pushed for the drugs’ broader use in patients without the more rigorous clinical trials typically used to evaluate treatments.
But Mesoblast is taking a more standard approach, testing the cell therapy in 240 patients at more than 20 medical centers around the country, which are part of the Cardiothoracic Surgical Trials Network, a program created by the N.I.H. Patients will be randomly divided into groups that will receive the therapy, and those that will get a placebo. Researchers said the trial could yield initial results within months.
While many people who are infected with the coronavirus experience mild symptoms, others develop a severe case when their immune systems go into overdrive and begin attacking the body’s organs, which is called a “cytokine storm.” This can set off something called acute respiratory distress syndrome, which damages the lungs and is often deadly. Several other treatments are also being tried to calm this storm and reset the immune system.
Dr. Silviu Itescu, chief executive of Mesoblast, said the company decided to test its treatment in these Covid-19 patients because its product had shown good results in children who developed a similar deadly immune reaction called acute graph versus host disease, in which the body’s immune cells can attack healthy cells after receiving a bone-marrow transplant. Their treatment is currently being reviewed by the Food and Drug Administration for use in that disease.
“We put two and two together and said, ‘We think we’ve got something that is safe and could have benefit,’” Dr. Itescu said.
Another stem cell company, Athersys, has said it is also planning a study of stem cells in coronavirus patients with advanced respiratory distress syndrome, but is not as far along.
Nine coronavirus patients at Mount Sinai Hospital in New York have received the Mesoblast treatment on an emergency basis, and doctors there said the initial response was promising. Six patients were removed from ventilation and others were being weaned off or had remained stable — a welcome development when most patients who need ventilator support do not survive.
But Dr. Itescu said that even though the treatment was promising, it was still not clear whether it would work, or whether the early promise was merely anecdotal. Although many drugs are being tried outside of a formal study, he said, “We do think this is the right way, and a randomized, controlled trial is the only way you are going to know whether an approach works.”
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 can’t 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.”
Novavax has 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 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 it’s 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.
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. Hotez’s team and Johnson & Johnson, on the other hand, are relying on technology that is more similar to Novavax’s 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 is 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 that will keep costs low if everything goes well.
“It’s not very sexy, but it’s a reliable approach,” Dr. Hotez said. “We know that it works.”
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 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 we’ll 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,” Dr. Hotez said. “How do you do social distancing in those places? You don’t.”
“We are building out a road map for how we work as a country for the next two or three years,” he continued. “That’s roughly the time frame that we saw for the 1918 flu pandemic and that’s probably likely for Covid-19.”
I have started to do Yoga, Hiit at home, and what am I, or I start to notice, after a few sessions, the abdomen and legs firmer?
Give the profile of Irene Alda on Instagram has been the best thing that could have happened to me now that I am so much time at home. This yoga instructor teaches a discipline that is defined as Yiit, that is to say, yoga+hiit. For those that missed workout in the fitness room, the TRX, the machines of strength and dumbbells, the possibility to practice this discipline at home is a real gift because it has it ALL:
· You do not need any itemwork with your own body. Great, if you don’t have gym gear at home.
· Incorporates cardioperfect for our heart to pump and to move the oxygen, so complicated when you can’t even walk.
· You work a lot of the flexibility so that the body acquires a very harmoniouswithout mark too the muscles.
How Bubonic Plague Has Helped Russia Fight the Coronavirus
MOSCOW — In a remote alpine meadow in Kyrgyzstan a few years ago, a teenage boy killed and skinned a marmot. Five days later, his parents carried the sweating, delirious boy to a village hospital where he died of bubonic plague.
Like a ghost from the medieval past, the plague still makes occasional, unwelcome appearances in remote regions of the former Soviet Union, where it survives today in wild rodents.
Over the centuries, with improved public hygiene, the plague declined as a threat. Today, as a bacterial infection, it is treatable with antibiotics, if caught in time.
But the plague was still a lethal menace in the 1920s and also an embarrassment for the Soviet Union, which established a specialized state agency to track and contain it.
Successors to that agency still exist in Russia and in half a dozen other countries that were once Soviet republics, and, with their ready quarantine plans and trained personnel, they have become a mainstay of the regional response to the coronavirus.
It is too early to tell if the former Soviet antiplague centers, as the sites were called, have made any difference in the coronavirus outbreak, which so far has infected more than 21,000 Russians, killing 170.
At most, the legacy Soviet system helped delay the spread, and it is just one data point in assessing why the coronavirus moved more slowly in Russia, Ukraine and other former Soviet countries than in Western Europe and the United States. Luck, border closures or officials covering up the true numbers of deaths could also explain the low numbers.
Infections are in any case now shooting up, and those countries seem to be headed the way of the rest of the world toward bulging hospitals and morgues. But employees of the antiplague centers say their early work helped, becoming a silver lining to the region’s long-lingering plague problem.
“Of course, it helped” early on, said Ravshan Maimulov, director of a regional antiplague service in Kyrgyzstan who examined the teenage plague victim when he died in 2013. He used the same quarantine plan that he had instituted after the boy’s death to respond to the coronavirus in March.
When the 15-year-old had arrived at the village hospital, “the body was still damp from sweat and I felt swelling under the armpits and chin,” Mr. Maimulov said. But the boy was too far gone to save, and he died within hours.
Mr. Maimulov, 57, trained at a Russian antiplague institute called Microbe. After the boy’s death, he had the authority to immediately put in motion plans for a lockdown, even though at that point they had only a partial diagnosis.
He relayed the news to a regional governor in code — they would need to implement “Formula 100” — lest word leak and inhabitants of the village, Ichke-Zhergez, should try to flee before the door slammed shut.
“We needed to prevent them all from running away,” he said. By the next morning, police checkpoints were in place and the village was sealed.
On his recommendation, the authorities in the surrounding Issyk-Kul region used the same approach in March in introducing coronavirus lockdowns. “We worked under the operative plan for the plague,” Mr. Maimulov said in a telephone interview. The region of about half a million people has reported three coronavirus cases, he said. Kyrgyzstan has reported five deaths.
The Microbe institute, originally dedicated wholly to bubonic plague but later expanded to tackle other infections such as cholera, yellow fever, anthrax and tularemia, models the spread of the coronavirus.
Starting in January, directors of antiplague centers in the Eurasian Economic Union, the Moscow-led trade alliance of Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia, held conference calls about the coronavirus. And a plague institute in Odessa, Ukraine, is among agencies responding to the coronavirus there, officials said.
“The very fact that Russia and the other former Soviet states are, exactly, former Soviet states means a common legacy,” in health care, said Dmitri Trenin, director of the Carnegie Moscow Center. A legacy of focus on epidemics helped, he said. Soviet health care had haphazard success at treating individuals but “could respond like the military to epidemics,” he noted.
Other analysts of former Soviet medical services say that, in the longer term, the Soviet legacy will prove no gift. The capacity to counter epidemics had degraded while little was done to improve an ability to treat patients, according to Yevgeny S. Gontmakher, a professor at the Higher School of Economics and an authority on Russian health care.
“The plague doctors were the elite of a hundred years ago, not today,” he said.
In Kyrgyzstan, Mr. Maimulov works in a wooden laboratory in what had been, until a few weeks ago, the medical backwater of plague control. Most years, he plans for campaigns of spraying insecticide into rodent burrows, to kill fleas and slow the spread in animals.
The disease cannot be fully stamped out. “They are rodents, they reproduce quickly,” he said. “It’s not worthwhile to kill them.”
The family of the 15-year-old boy were herding sheep in the mountains and trapping marmots for fur as a sideline. The boy skinned the marmot with a razor blade. Though the Black Death typically spreads by flea bite, in this instance the boy caught it simply by nicking his finger.
Eventually, 32 villages were put under quarantine while about 700 nurses went door to door looking for infection. Marmot hides were collected and burned. But the antiplague team had acted quickly enough. The boy was the only confirmed case.
Oleg Matsnev contributed reporting.
A strength training and cardio that you can do at home in 15 minutes
That we are confined does not mean that we train: it is one of the key guidelines to maintain a healthy life style, also in these circumstances. So, today I bring you this training that combines strength work and cardioto get a full workout without the need to use more material objects that you have at home.
This training, although we followed, consists of two parts: an anaerobic, in which we will seek to increase the strength due to our body weight and other cardiovascular to finish the training. All training will be able to complete from the same room of our house.
We begin with the part of strength in which we will perform the following exercises one after another without stretching a lot of break times. We will not set a specific time, but the idea is that you will not recover at all between sets and you get to the next series somewhat tiredbut you can complete it.
Funds triceps on chair
And finally we ended up with a small interval training of high intensity with a structure Tabata in which we will do a single exercise. In this case we opted for the burpees since this is an exercise very complete and in addition, with little time, it will speed up our body and help to burn a lot of calories. If you want to, you can choose another: the skipping, the hopping with jumping rope or jumping jacks are good examples.
Choose the exercise that we choose we will do six or eight sets of 20 seconds of work and 10 seconds of rest, thus completing between three and four minutes of cardiovascular work.
As always, so you can be sure to perform each exercise properly we will explain them one by one.
We started working our legs with a squats free of weight and deep. We put the feet with a separation similar to the width of our shoulders, the soles of the feet well supported on the floor and the toes facing forward.
In this position we bring the buttocks back slightly, while keeping your back as upright as possible at all times and flex the knees to perform a movement similar to that which we would want to sit in a chair that was behind us. Keep in mind that the weight must fall on our heels and not on the toe.
Funds triceps on chair
To work our arms, mainly the back, we’re going to make funds with a chair or on a chair. We place ourselves in front of the chair or armchair, we support the hands with the fingers facing forward and support our feet on the ground.
From this position flexionaremos our elbows until they form an angle of about 90 °, directing always our elbows back. After, we will stretch our elbows to return to the initial position.
Remember, if you are a beginner, you can put your knees bent and your feet close to your glutes for ease of movement, loading and less weight. If you’re already an expert, keep your legs straight and feet clear of the buttocks.
To work the pectoral there is nothing better than a few pushups at home. We can do them with your feet flat, if we have strength, or on our knees if we are beginners or we are unable to complete the 12 repetitions.
We will stand on the floor with the palms of your hands directly beneath your shoulders, and the forefoot of both feet or knees on the floor. In this position flexing our elbows, guiding them backuntil the chest touch the ground and return to stretch your arms to complete one repetition.
To work our back home we will perform a rowing invested using a table and our body weight. We will stand under the table (you can also use a chair, though you will have less travel in the motion), and hold both sides of the table with the hands.
In this position we force by bending our elbows and getting close to our chest to the table all possible: it is a movement of pull similar to the rowing that we can do in the gym or in a dominated. Then down, controlling the movement until your arms are fully stretched to complete a repetition.
We ended up with this cardiovascular exercise in format Tabatathat will help us to finish the training by burning calories. The burpees put together different movements to work virtually the whole body: a squat, a push and a vertical jump. Remember that in this training we’ll do six to eight sets of 20 seconds of work and 10 rest.
We begin standing in a relaxed position, with the legs open to the width of our hip. Perform a squat and we support our hands in the soil: with a leap, we carry our legs backward up into a pushup position or plank front. From there, we made a bending, touching our chest with the floor, or relying directly on the floor if we are newbies. We return to the pushup position and, with a jump, collect the legs forward: we go back to stand up and chain a vertical jump, to help us bringing our arms up.
This article was originally posted by Victor Falcon in march of 2019 and has been revised for republication.
Videos | Tutograma and Vitónica
Image | iStock
In Vitónica | A circuit of functional training that you can do in your own home
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