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Coronavirus Vaccine .. Updates & Discussion

The SC

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Researchers Announce Promising Coronavirus Vaccine Candidate

The drug is delivered through a Band-Aid-like patch — not a needle.

April 02 2020

Researchers at the University of Pittsburgh School of Medicine announced today that they have developed a promising new COVID-19 vaccine candidate.

Early animal trials have shown promise so far, but human trials are still in the planning stages. The researchers already had a big leg up from past epidemics.

“We had previous experience on SARS-CoV in 2003 and MERS-CoV in 2014,” said Andrea Gambotto, co-senior author of the peer-reviewed paper published in the journal EBioMedicine, and associate professor of surgery at the Pittsburgh School of Medicine, in a statement.

“These two viruses, which are closely related to SARS-CoV-2, teach us that a particular protein, called a spike protein, is important for inducing immunity against the virus,” Gambotto explained. “We knew exactly where to fight this new virus.”

The vaccine dubbed “PittCoVacc” (Pittsburgh Coronavirus Vaccine) works in the same basic way as a flu shot: By injecting lab-made pieces of viral protein into the body to help it build an immunity.

When tested in mice, the researchers found that the number of antibodies capable of neutralizing the deadly SARS-CoV-2 virus surged two weeks after delivery.

Instead of being delivered through a needle, the new drug is administered through a microneedle array, a Band-Aid like patch made up of 400 tiny microneedles. Once the patch is applied, the microneedles, which are made entirely of sugar and protein dissolve, leaving no trace behind.

“We developed this to build on the original scratch method used to deliver the smallpox vaccine to the skin, but as a high-tech version that is more efficient and reproducible patient to patient,” said co-senior author Louis Falo, professor and chair of dermatology at Pitt’s School of Medicine, in the statement. “And it’s actually pretty painless — it feels kind of like Velcro.”

According to the researchers, these patches can be easily manufactured in massive “cell factories” at an industrial scale. The vaccine doesn’t even need to be refrigerated during storage or transport — a massive complication for other vaccines.

“For most vaccines, you don’t need to address scalability to begin with,” Gambotto said. “But when you try to develop a vaccine quickly against a pandemic that’s the first requirement.”
Before starting human trials, the researchers are currently applying for drug approval from the US Food and Drug Administration.

“Testing in patients would typically require at least a year and probably longer,” Falo said. “This particular situation is different from anything we’ve ever seen, so we don’t know how long the clinical development process will take.”

https://futurism.com/neoscope/resea...gn=67332171ad-EMAIL_CAMPAIGN_2020_04_02_06_57
 

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Debate Heats up over Using an Anti-Malaria Drug for COVID-19

Monday, 6 April, 2020 - 17:00
medical_staff_at_a_ward_specialized_in_receiving_any_person_who_may_have_been_infected_with_coronavirus_at_the_rajiv_ghandhi_govt._general_hospital_in_chennai_india_january_29_2020._reuters.jpg

Medical staff at a ward specialized in receiving any person who may have been infected with coronavirus, at the Rajiv Ghandhi Govt. General hospital in Chennai, India, January 29, 2020. (Reuters)

Asharq Al-Awsat

President Donald Trump and members of his administration are growing emphatic in promoting an anti-malaria drug not yet officially approved for fighting COVID-19, even though scientists say more testing is needed before it’s proven safe and effective against the virus.

Trump trade adviser Peter Navarro promoted the drug, hydroxychloroquine, in television interviews Monday, a day after Trump publicly put his faith in the drug to lessen the toll of the coronavirus pandemic.

“What do I know, I’m not a doctor," Trump told reporters Sunday. "But I have common sense.”

The administration's promotion of the drug comes after a heated Situation Room meeting of the White House's coronavirus task force on Saturday, in which Navarro challenged the top US infectious disease expert, Dr. Anthony Fauci, over his concerns about recommending the drug based only on unscientific anecdotal evidence.

Navarro, who has no formal medical training, erupted at Fauci, raising his voice and claiming that the reports of studies he collected were enough to recommend the drug widely, according to a person familiar with the exchange who spoke on the condition of anonymity to describe the Situation Room blow-up.

Fauci has repeatedly said that current studies provide only anecdotal findings that the drug works. Navarro told CNN on Monday: "I would have two words for you: ‘second opinion.’”

Hydroxychloroquine is officially approved for treating malaria, rheumatoid arthritis and lupus, but not COVID-19, reported The Associated Press. Small, preliminary studies have suggested it might help prevent the new coronavirus from entering cells and possibly help patients clear the virus sooner. But those have shown mixed results.

Doctors are already prescribing the malaria drug to patients with COVID-19, a practice known as off-label prescribing. But Fauci has said more testing is needed before it’s clear that the drug works against the coronavirus and is safe for COVID-19 patients.

Navarro told Fox News Channel's “Fox & Friends” that doctors in New York hospitals are already giving out the drug to COVID-19 patients and that health care workers are taking it in hopes it will protect them from being infected. And while he acknowledged the Saturday debate with Fauci, he said that the focus was on whether the administration should take 29 million doses of the drug in Federal Emergency Management Agency warehouses and send them to hard-hit cities.

“The media is trying to blow it up as a big big debate, but I can tell you that within the room the decision was a sound one, and it was unanimous," Navarro said.

Asked about his credentials for pushing the drug, Navarro cited his doctorate in social science.

“In the fog of war, we might take more risks than we otherwise would. And, given the track record of the drug over many many years in treating malaria that there are side effects but it’s been used a lot in lesser doses, the decision’s been made by many doctors to prescribe it,” Navarro said. "If it saves lives, that’s a beautiful thing ... I think history will judge who’s right on this debate. I’d bet on President Trump’s intuition on this one.”

Trump has been enthusiastically supporting the drug, and he announced Sunday that his administration has amassed 29 million doses for distribution to areas of the country hard-hit by the coronavirus.

“There’s a study out there that says people that have lupus haven’t been catching this virus,” Trump said at a Saturday briefing on the virus. “You know, maybe it’s true, maybe it’s not. ... There’s also other studies ... that the malaria countries ... have very little of this virus.”

Trump said he would likely take the drug. “I may take it. OK? I may take it. And I’ll have to ask my doctors about that, but I may take it.”

Administration officials say Trump's embrace of the drug stems from his desire to provide “hope” for the American people as the death toll mounts and he looks to avoid political consequences from the outbreak.

Some limited studies have been conducted on the use of hydroxychloroquine and antibiotic azithromycin in concert to treat COVID-19, but they have not included critical control groups that scientists use to validate the conclusions.

A series of 11 patients in France found that an antibiotic-malaria drug combo did not improve how fast patients cleared the virus or their symptoms. Researchers in China reported that cough, pneumonia and fever seemed to improve sooner among 31 patients given hydroxychloroquine compared with 31 others who did not get the drug, but fewer people in the comparison group had cough or fevers to start with.

At least one other world leader has followed on Trump's claims to promote the use of the drugs. Brazil’s President Jair Bolsonaro has repeatedly touted the benefits of hydroxychloroquine and azithromycin. He said he heard reports of 100% effectiveness when administered in the correct dosages, zeroed tariffs for import of the drugs and on March 30 announced army labs were ramping up their chloroquine production. On Sunday, he shared a video on social media of Trump’s personal attorney Rudy Giuliani interviewing a doctor who claimed he has successfully treated hundreds of coronavirus patients with the drugs.

Brazil’s health minister Luiz Henrique Mandetta, who has led the nation’s virus response and endorsed broad isolation measures, said on April 3 that initial tests of chloroquine’s efficacy remain “fragile.” Still, he announced the government would broaden criteria for the drug’s use in “grave” cases. Previously, it had only authorized its use in “critical” cases.

For most people, the virus causes mild or moderate symptoms, such as fever and cough that clear up in two to three weeks. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia, and death.


https://aawsat.com/english/home/article/2219906/debate-heats-over-using-anti-malaria-drug-covid-19
 

Rahil khan

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Possible coronavirus drug identified by Australian scientists:
MONASH UNIVERSITY

  • Australian Scientists have shown that an anti-parasitic drug already available around the world can kill the virus within 48 hours.


  • Scientists from Monash University in Melbourne showed that a single dose of the drug, Ivermectin, could stop the SARS-CoV-2 virus growing in cell culture - effectively eradicating all genetic material of the virus within 48 hours.


  • The next steps are to determine the correct human dosage - ensuring the doses shown to effectively treat the virus in the test tube are safe levels for humans.


  • The use of Ivermectin to combat COVID-19 depends on pre-clinical testing and clinical trials, with funding urgently required to progress the work.


  • Ivermectin is an FDA-approved anti-parasitic drug that has also been shown to be effective in vitro against a broad range of viruses including HIV, Dengue, Influenza and Zika virus.


  • The findings of the study were published today in Antiviral Research.


A collaborative study led by Monash University's Biomedicine Discovery Institute (BDI) in Melbourne, Australia, with the Peter Doherty Institute of Infection and Immunity (Doherty Institute), has shown that an anti-parasitic drug already available around the world kills the virus within 48 hours.

The Monash Biomedicine Discovery Institute's Dr Kylie Wagstaff, who led the study, said the scientists showed that the drug, Ivermectin, stopped the SARS-CoV-2 virus growing in cell culture within 48 hours.

"We found that even a single dose could essentially remove all viral RNA by 48 hours and that even at 24 hours there was a really significant reduction in it," Dr Wagstaff said.

Ivermectin is an FDA-approved anti-parasitic drug that has also been shown to be effective in vitro against a broad range of viruses including HIV, Dengue, Influenza and Zika virus.

Dr Wagstaff cautioned that the tests conducted in the study were in vitro and that trials needed to be carried out in people.

"Ivermectin is very widely used and seen as a safe drug. We need to figure out now whether the dosage you can use it at in humans will be effective - that's the next step," Dr Wagstaff said.

"In times when we're having a global pandemic and there isn't an approved treatment, if we had a compound that was already available around the world then that might help people sooner. Realistically it's going to be a while before a vaccine is broadly available.

Although the mechanism by which Ivermectin works on the virus is not known, it is likely, based on its action in other viruses, that it works to stop the virus 'dampening down' the host cells' ability to clear it, Dr Wagstaff said.

Royal Melbourne Hospital's Dr Leon Caly, a Senior Medical Scientist at the Victorian Infectious Diseases Reference Laboratory (VIDRL) at the Doherty Institute where the experiments with live coronavirus were conducted, is the study's first author.

"As the virologist who was part of the team who were first to isolate and share SARS-COV2 outside of China in January 2020, I am excited about the prospect of Ivermectin being used as a potential drug against COVID-19," Dr Caly said.

Dr Wagstaff made a previous breakthrough finding on Ivermectin in 2012 when she identified the drug and its antiviral activity with Monash Biomedicine Discovery Institute's Professor David Jans, also an author on this paper. Professor Jans and his team have been researching Ivermectin for more than 10 years with different viruses.

Dr Wagstaff and Professor Jans started investigating whether it worked on the SARS-CoV-2 virus as soon as the pandemic was known to have started.

The use of Ivermectin to combat COVID-19 would depend on the results of further pre-clinical testing and ultimately clinical trials, with funding urgently required to keep progressing the work, Dr Wagstaff said.

Read the full paper in Antiviral Research titled: The FDA-approved Drug Ivermectin inhibits the replication of SARS-CoV-2 in vitro: https://www.sciencedirect.com/science/article/pii/S0166354220302011

https://www.eurekalert.org/pub_releases/2020-04/mu-pcd040320.php
 

The SC

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Human testing beginning on second coronavirus vaccine candidate

Human testing is beginning on a second coronavirus vaccine candidate after approval from the Food and Drug Administration, Inovio Pharmaceuticals announced Monday.

The company said the first phase of clinical testing is set to begin this week with a study of 40 healthy adult volunteers.

Each participant will receive two doses of the drug, INO-4800, four weeks apart. The initial immune responses and safety data from the study are expected by late summer, according to Inovio.

Preclinical data has shown “promising immune response results across multiple animal models,” the company said in the release.

“This is a significant step forward in the global fight against COVID-19. Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods,” J. Joseph Kim, Inovio’s president and CEO, said in the release.

The Inovio program is supported in part by the Bill and Melinda Gates Foundation.

The drug is a DNA vaccine that is designed to prevent COVID-19 infection. Inovio said the preclinical results for the potential COVID-19 vaccine are consistent with a completed phase one vaccine study for MERS, which is also caused by a coronavirus.

Inovio said it plans to head into a second phase of the study “as rapidly as possible” and said thousands of doses of the drug have been manufactured to support ongoing phase one and phase two trials.

This is the second COVID-19 vaccine trial to be launched. A vaccine developed by the National Institutes of Health and collaborators at Moderna Inc. administered its first shot in a trial for the potential vaccine in mid-March.
The novel coronavirus is believed to have originated in China late last year and has rapidly spread around the globe, with more than 1.3 million cases confirmed worldwide and nearly 76,000 deaths from the virus, according to data compiled by Johns Hopkins University.


https://thehill.com/policy/healthca...nning-on-second-coronavirus-vaccine-candidatehttps://thehill.com/policy/healthca...nning-on-second-coronavirus-vaccine-candidatehttps://thehill.com/policy/healthca...nning-on-second-coronavirus-vaccine-candidatehttps://thehill.com/policy/healthca...nning-on-second-coronavirus-vaccine-candidate


With record-setting speed, vaccinemakers take their first shots at the new coronavirus

The coronavirus that for weeks had been crippling hospitals in her hometown of Seattle changed Jennifer Haller’s life on 16 March—but not because she caught it. Haller, an operations manager at a tech company in the city, became the first person outside of China to receive an experimental vaccine against the pandemic virus, and in the days since, she has been flooded by an outpouring of gratitude. “There’s been overwhelming positivity, love, and prayers coming at me from strangers around the world,” Haller says. “We all just feel so helpless, right? This was one of the few things happening that people could latch on to and say, ‘OK, we’ve got a vaccine coming.’ Disregard that it’s going to take at least 18 months, but it’s just one bright light in some really devastating news across the world.”

The vaccine Haller volunteered to test is made by Moderna, a well-financed biotech that has yet to bring a product to market. Moderna and China’s CanSino Biologics are the first to launch small clinical trials of vaccines against coronavirus disease 2019 (COVID-19) to see whether they are safe and can trigger immune responses. (The CanSino vaccine trial also began on 16 March, according to researchers from the Chinese military’s Institute of Biotechnology, which is collaborating on it.) An ever-growing table put together by the World Health Organization now lists 52 other vaccine candidates that could soon follow. “This is a wonderful response from the biomedical community to an epidemic,” says Lawrence Corey, a virologist at the Fred Hutchinson Cancer Research Center who has run vaccine trials against a dozen diseases but is not involved with a COVID-19 effort. “It’s both gratifying and problematic in the sense of how do you winnow all this down?”

Broadly speaking, these vaccines group into eight different “platforms”—among them old standbys such as inactivated or weakened whole viruses, genetically engineered proteins, and the newer messenger RNA (mRNA) technology that is the backbone of the Moderna vaccine—and their makers include biotechs, academia, military researchers, and a few major pharmaceutical companies. On 30 March, Johnson & Johnson (J&J) announced what it said could be a $1 billion COVID-19 vaccine project, with about half the money coming from the U.S. Biomedical Advanced Research and Development Authority if milestones are met.

Many viruses, including HIV and hepatitis C, have thwarted vaccine developers. But the new coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), doesn’t appear to be a particularly formidable target. It changes slowly, which means it’s not very good at dodging the immune system, and vaccines against the related coronaviruses that cause SARS and Middle East respiratory syndrome (MERS) have worked in animal models. Corey heads the United States’s HIV Vaccine Trials Network, which has seen one candidate vaccine after another crash and burn, is optimistic about a SARS-CoV-2 vaccine. “I don’t think this is going to be that tough.”

One concern is whether people develop durable immunity to SARS-CoV-2, which is crucial given that vaccines try to mimic a natural infection. Infections with the four human coronaviruses that typically cause minor colds don’t trigger long-lasting immunity. Then again, researchers have found long-lasting immune responses to the viruses causing SARS and MERS, and genetically they are far more like SARS-CoV-2. And unlike cold-causing viruses, which stay in the nose and throat, the new coronavirus targets the lower respiratory tract, where the immune response to a pathogen can be stronger, says Mark Slifka, an immunologist who studies vaccines at the Oregon National Primate Research Center. “When you get an infection in the lungs, you actually get high levels of antibodies and other immune cells from your bloodstream into that space.”

Even with this all-out effort, Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), predicts getting a vaccine to the public “is going to take a year, a year and a half, at least.” And Fauci adds “at least” because side effects, dosing issues, and manufacturing problems can all cause delays. Already some are calling for an ethically fraught shortcut to speed up clinical trials: giving people candidate vaccines and then intentionally attempting to infect them to see whether they’re protected.

A new vaccine might also be made available to health care workers and others at high risk even before phase III efficacy trials are completed. And Stanley Perlman, a veteran coronavirus researcher at the University of Iowa, suggests a vaccine that only offers limited protection and durability could be good enough—at first. “In this kind of epidemic setting, as long as you have something that tides us along and prevents a lot of deaths, that may be adequate,” he says.

A better spike


On 13 January, 3 days after Chinese researchers first made public the full RNA sequence of SARS-CoV-2, NIAID immunologist Barney Graham sent Moderna an optimized version of a gene that would become the backbone of its vaccine. Sixty-three days later, the first dose of the vaccine went into Haller and other volunteers participating in the small trial at the Kaiser Permanente Washington Health Research Institute. In 2016, Graham had made a Zika virus vaccine that went from lab bench to the first volunteer in what he then thought was a lightning-fast 190 days. “We beat that record by nearly 130 days,” he says.

Studying the 3D structures of the RSV surface protein, Graham discovered that the dynamic molecule had different orientations before and after fusing with the cell. Only the pre-fusion state, it turned out, triggered high levels of neutralizing antibodies, so in 2013 he engineered a stable form of the molecule in that configuration. “It was so clear at that point that if you didn’t have structure, you didn’t really know what you were doing,” Graham says. An RSV vaccine that built on this concept has worked well in early trials.

The experience came in handy in 2015, when a member of Graham’s lab made a pilgrimage to Mecca, Saudi Arabia, and came back ill. Worried that it might be MERS, which is endemic in Saudi Arabian camels and repeatedly jumps into humans there, Graham’s team checked for the virus and instead pulled out a common cold coronavirus. It was relatively easy to determine the structure of its spike, which then allowed the team to make stable forms of the spikes for the SARS and MERS viruses, and, in January, for SARS-CoV-2’s. That’s the basis of the Moderna COVID-19 vaccine, which contains mRNA that directs a person’s cells to produce this optimized spike protein.

Still a new strategy, no mRNA vaccine has yet reached a phase III clinical trial, let alone been approved for use. But producing huge numbers of vaccine doses may be easier for mRNA vaccines than for traditional ones, says Mariola Fotin-Mleczek of the German company CureVac, which is also working on mRNA vaccine for the new coronavirus. CureVac’s experimental rabies vaccine showed a strong immune response with a single microgram of mRNA. That means 1 gram could be used to vaccinate 1 million people. “Ideally, what you have to do is produce maybe hundreds of grams. And that would be enough,” Fotin-Mleczek says.

Many companies are relying on time-tested techniques. Sinovac Biotech is making a SARS-CoV-2 vaccine by chemically inactivating whole virus particles and adding an immune booster called alum. Sinovac used the same strategy for a SARS vaccine it developed and tested in a phase I clinical trial 16 years ago, says Meng Weining, a vice president at Sinovac. “We immediately just restarted the approach we already know.” The company’s SARS vaccine worked in monkeys and although there were concerns that an inactivated coronavirus vaccine might trigger the sort of antibody enhancement disease that occurred with the RSV vaccine, Meng stresses that no such problems surfaced in their animal studies.

Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai, says inactivated virus vaccines have the advantage of being a tried-and-true technology that can be scaled up in many countries. “Those manufacturing plants are out there, and they can be used,” says Krammer, who co-authored a status report about COVID-19 vaccines that appears online in Immunity.

CanSino is now testing another approach. Its vaccine uses a nonreplicating version of adenovirus-5 (Ad5), which also causes the common cold, as a “vector” to carry in the gene for the coronavirus spike protein. Other vaccine researchers worry that because many people have immunity to Ad5, they could mount an immune response against the vector, preventing it from delivering the spike protein gene into human cells—or it might even cause harm, as seemed to happen in a trial of an Ad5-based HIV vaccine made by Merck that was stopped early in 2007. But the same Chinese collaboration produced an Ebola vaccine, which Chinese regulators approved in 2017, and a company press release claimed its new candidate generated “strong immune responses in animal models” and has “a good safety profile.” “I think pre-existing Ad5 immunity and HIV vaccine risk are not a problem,” Hou Lihua, a scientist working on the project at the Institute of Biotechnology, wrote in an email to Science, noting that the Ebola vaccine trial results adds to their confidence that these will not be issues.

Other COVID-19 vaccine platforms include a laboratory-weakened version of SARS-CoV-2, a replicating but harmless measles vaccine virus that serves as the vector for the spike gene, genetically engineered protein subunits of the virus, a loop of DNA known as a plasmid that carries a gene from the virus, and SARS-CoV-2 proteins that self-assemble into “viruslike particles.” J&J is using another adenovirus, Ad26, which does not commonly infect humans, as its vector. These different approaches can stimulate different arms of the immune system, and researchers are already “challenging” vaccinated animals with SARS-CoV-2 to see which responses best correlate with protection.

Many researchers assume protection will largely come from neutralizing antibodies, which primarily prevent viruses from entering cells. Yet Joseph Kim, CEO of Inovio Pharmaceuticals, which is making a DNA COVID-19 vaccine, says a response by T cells—which clear infected cells—proved a better correlate of immunity in monkey studies of the company’s MERS vaccine, which is now in phase II trials. “I think having a balance of antibody and T cell responses probably is the best approach.”

Kim and others applaud the variety of strategies. “At this early stage, I think it makes sense to try anything plausible,” he says. As Stéphane Bancel, CEO of Moderna, says, “Nobody knows which vaccines are going to work.”

Final products


Spurring many of the efforts in the nascent COVID-19 field has been the Coalition for Epidemic Preparedness Innovations (CEPI), a nonprofit set up to coordinate R&D for vaccines against emerging infectious diseases. So far, CEPI has invested nearly $30 million in vaccine development at Moderna, Inovio, and six other groups. “We have gone through a selective process to pick the ones that we think have the greatest likelihood of meeting our goals—which we think ought to be the world’s goals—of speed, scale, and access,” says CEPI CEO Richard Hatchett. But he is rooting for other candidates as well. “We don’t want to be in a situation where we have [one] successful vaccine and we have a contamination event [during manufacturing] and suddenly we don’t have any vaccine supply.”

CEPI invests in manufacturing facilities at the same time it puts money into staging clinical trials. “By doing things in parallel rather than in serial fashion, we hope to compress the overall timelines,” Hatchett says. After reviewing phase I data and animal model data, CEPI plans to move six of the eight products into larger safety studies to arrive at three that are worthy of full-scale efficacy trials that enroll perhaps 5000 participants.
CEPI has less than $300 million in its coffers for the effort, and Hatchett estimates the price tag at $2 billion. He says CEPI hopes to raise this money from governments, private philanthropies, industry, and the United Nations Foundation.

Seth Berkley, who heads Gavi, the Vaccine Alliance, argued in an editorial in the 27 March issue of Science that the world needs to come together even more to streamline the search for a COVID-19 vaccine. “If ever there was a case for a coordinated global vaccine development effort using a ‘big science’ approach, it is now,” Berkley wrote, stressing that there must be extraordinary sharing of data, coordination of clinical trials, and funding. “You can’t move 100 vaccines forward,” he says.

Moderna and J&J both say that if everything goes perfectly, they could launch an efficacy trial with about 5000 people by late November and determine by January 2021 or so whether the vaccine works. Meng says that, depending on approval from Chinese regulatory agencies, Sinovac could move its vaccine through small phase I and II tests by June. But, because of China’s success at controlling its epidemic, the company may have to find another country that has high transmission of SARS-CoV-2 to stage an efficacy trial quickly.

Haller has had no serious side effects from the mRNA injected into her arm but realizes that the phase I study will not determine whether the vaccine is effective. “The chances of the one that I got being really anything? I don’t know,” Haller says. “This is just the first of many, many vaccines, and it’s just stupid luck that I was the first one.”

With reporting by Kai Kupferschmidt.
*Correction, 1 April, 11 a.m.: A World Health Organization table inaccurately described Sinovac’s inactivation process as using formaldehyde. The company does chemically inactivate the virus but does not want to disclose specifics.



https://www.sciencemag.org/news/202...akers-take-their-first-shots-new-coronavirus#https://www.sciencemag.org/news/202...akers-take-their-first-shots-new-coronavirus#
 

Ivan

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First trial for potential Covid-19 drug shows it has no effect

WHO draft put online states remdesivir does not benefit severe coronavirus patients


Sarah Boseley Health editor
The Guardian
Thu 23 Apr 2020 20.35 BST


'
Remdesivir, a drug thought to be one of the best prospects for treating Covid-19, failed to have any effect in the first full trial, it has been revealed.

The drug is in short supply globally because of the excitement it has generated. It is one of the drugs Donald Trump claimed was “promising”.

In a “gold standard” trial of 237 patients, some of whom received remdesivir while others did not, the drug did not work. The trial was also stopped early because of side-effects.

News of the failure was posted on a World Health Organization clinical trials database, but later removed. A WHO spokesman said it had been uploaded too soon by accident.


“A draft document was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed. The manuscript is undergoing peer review and we are waiting for a final version before WHO comments,” said Tarik Jasarevic, a WHO spokesperson.

The drug, made by the US company Gilead Sciences, is an antiviral that was trialled in Ebola, but which failed to show benefits in Africa.

In the race for drugs that might work against Covid-19, many doctors have given remdesivir to patients on “compassionate grounds” without waiting for trials. Because of the interest in it, the world’s biggest trial of possible treatments for Covid-19 at Oxford has not been able to include it, because researchers could not obtain supplies.


The trial of the drug in China, on patients with severe Covid-19 symptoms, may give some doctors pause. Gilead, however, claimed there were still signs that it could be useful, possibly in patients with milder versions of disease.

In the trial, 158 patients were randomly assigned to be given remdesivir, while 79 others had standard care with a placebo instead. There was no difference between the groups with respect to recovery time. Just under 14% of those on remdesivir died, compared with nearly 13% of those not taking the treatment.

“In this study of hospitalised adult patients with severe Covid-19, [which] was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” said the report on the WHO website.


The report added: “Remdesivir was stopped early in 18 (11.6%) patients because of adverse effects, compared with 4 (5.1%) in the control group.” There were no details in the short report of the side effects that caused the trial to be halted.

Just a week ago, it emerged that researchers in Chicago were excited by the results of a Gilead-run trial of remdesivir in 125 patients. Nearly all those people were discharged within a week, according to STAT News, which follows the pharmaceutical industry. However, there was no placebo group, which meant researchers could not be sure that it was the drug that made the difference, and not something else.

Remdesivir is one of a handful of drugs that have been enthusiastically backed by doctors and politicians as potential cures for Covid-19. There has also been a rush to give patients hydroxychloroquine, a less toxic version of the antimalarial chloroquine. That has led to shortages for people who need to take it for lupus, a disease that affects the immune system.

Scientists who want to see proper trials conducted are likely to point to the remdesivir trial failure as strong evidence of the dangers of giving out even tested drugs on compassionate grounds for a disease that is so novel.'
 

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PakSword

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Bad news.

This drug created excitement all over the world.

Now we should be waiting for Hydroxychloroquine and Azitromycin trial results.

First trial for potential Covid-19 drug shows it has no effect

WHO draft put online states remdesivir does not benefit severe coronavirus patients

Sarah Boseley Health editor
The Guardian
Thu 23 Apr 2020 20.35 BST


'
Remdesivir, a drug thought to be one of the best prospects for treating Covid-19, failed to have any effect in the first full trial, it has been revealed.

The drug is in short supply globally because of the excitement it has generated. It is one of the drugs Donald Trump claimed was “promising”.

In a “gold standard” trial of 237 patients, some of whom received remdesivir while others did not, the drug did not work. The trial was also stopped early because of side-effects.

News of the failure was posted on a World Health Organization clinical trials database, but later removed. A WHO spokesman said it had been uploaded too soon by accident.


“A draft document was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed. The manuscript is undergoing peer review and we are waiting for a final version before WHO comments,” said Tarik Jasarevic, a WHO spokesperson.

The drug, made by the US company Gilead Sciences, is an antiviral that was trialled in Ebola, but which failed to show benefits in Africa.

In the race for drugs that might work against Covid-19, many doctors have given remdesivir to patients on “compassionate grounds” without waiting for trials. Because of the interest in it, the world’s biggest trial of possible treatments for Covid-19 at Oxford has not been able to include it, because researchers could not obtain supplies.


The trial of the drug in China, on patients with severe Covid-19 symptoms, may give some doctors pause. Gilead, however, claimed there were still signs that it could be useful, possibly in patients with milder versions of disease.

In the trial, 158 patients were randomly assigned to be given remdesivir, while 79 others had standard care with a placebo instead. There was no difference between the groups with respect to recovery time. Just under 14% of those on remdesivir died, compared with nearly 13% of those not taking the treatment.

“In this study of hospitalised adult patients with severe Covid-19, [which] was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” said the report on the WHO website.


The report added: “Remdesivir was stopped early in 18 (11.6%) patients because of adverse effects, compared with 4 (5.1%) in the control group.” There were no details in the short report of the side effects that caused the trial to be halted.

Just a week ago, it emerged that researchers in Chicago were excited by the results of a Gilead-run trial of remdesivir in 125 patients. Nearly all those people were discharged within a week, according to STAT News, which follows the pharmaceutical industry. However, there was no placebo group, which meant researchers could not be sure that it was the drug that made the difference, and not something else.

Remdesivir is one of a handful of drugs that have been enthusiastically backed by doctors and politicians as potential cures for Covid-19. There has also been a rush to give patients hydroxychloroquine, a less toxic version of the antimalarial chloroquine. That has led to shortages for people who need to take it for lupus, a disease that affects the immune system.

Scientists who want to see proper trials conducted are likely to point to the remdesivir trial failure as strong evidence of the dangers of giving out even tested drugs on compassionate grounds for a disease that is so novel.'
 

The SC

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Chinese COVID-19 Vaccine Effective in Monkeys

"This is old school but it might work."

by Victor Tangermann / 9 hours ago

Researchers at Beijing pharmaceutical company Sinovac Biotech have developed an experimental COVID-19 vaccine that it says protected macaques from infection, Science Magazine reports.

The vaccine was based on a tried-and-true formulation that included an inactivated version of the virus SARS-CoV-2, as detailed in a preprint uploaded to the server bioRxiv on April 19.

“These data support the rapid clinical development of SARS-CoV-2 vaccines for humans,” reads the paper.
The team at Sinovac injected eight macaque monkeys with two different doses. Three weeks after injection, they introduced the coronavirus straight into the money’s lungs. There were reportedly no side effects.

None of the monkeys developed an infection beyond a small “viral blip.” A less fortunate control group of monkeys developed severe pneumonia after being infected by the virus.

“This is old school but it might work,” Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai, who co-authored a status report on COVID vaccine candidates, told Science Mag. “What I like most is that many vaccine producers, also in lower–middle-income countries, could make such a vaccine.”

Critics say, though, that the sample size in Sinovac’s trial was too small to produce generalizable results. Questions also remain about the viability of the vaccine candidate for use in humans — especially considering that monkeys don’t experience the same severe symptoms of COVID as humans.

In a separate Sinovac experiment, the researchers mixed a cocktail of antibodies from patients in China, Italy, Switzerland, Spain, and the United Kingdom with the virus.

According to the team, the antibodies “potently neutralized 10 representative SARS-CoV-2 strains, indicative of a possible broader neutralizing ability.”
And that’d be good news.
“This provides strong evidence that the virus is not mutating in a way that would make it resistant to a #COVID19 vaccine,” tweeted of Oregon Health & Science University immunologist Mark Slifka on Wednesday.
Sinovac Biotech is now planning trials on thousands of human subjects.


https://futurism.com/neoscope/doctors-use-lethal-injection-drugs-covid19-patients
 

casual

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Chinese COVID-19 Vaccine Effective in Monkeys

"This is old school but it might work."

by Victor Tangermann / 9 hours ago

Researchers at Beijing pharmaceutical company Sinovac Biotech have developed an experimental COVID-19 vaccine that it says protected macaques from infection, Science Magazine reports.

The vaccine was based on a tried-and-true formulation that included an inactivated version of the virus SARS-CoV-2, as detailed in a preprint uploaded to the server bioRxiv on April 19.

“These data support the rapid clinical development of SARS-CoV-2 vaccines for humans,” reads the paper.
The team at Sinovac injected eight macaque monkeys with two different doses. Three weeks after injection, they introduced the coronavirus straight into the money’s lungs. There were reportedly no side effects.

None of the monkeys developed an infection beyond a small “viral blip.” A less fortunate control group of monkeys developed severe pneumonia after being infected by the virus.

“This is old school but it might work,” Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai, who co-authored a status report on COVID vaccine candidates, told Science Mag. “What I like most is that many vaccine producers, also in lower–middle-income countries, could make such a vaccine.”

Critics say, though, that the sample size in Sinovac’s trial was too small to produce generalizable results. Questions also remain about the viability of the vaccine candidate for use in humans — especially considering that monkeys don’t experience the same severe symptoms of COVID as humans.

In a separate Sinovac experiment, the researchers mixed a cocktail of antibodies from patients in China, Italy, Switzerland, Spain, and the United Kingdom with the virus.

According to the team, the antibodies “potently neutralized 10 representative SARS-CoV-2 strains, indicative of a possible broader neutralizing ability.”
And that’d be good news.
“This provides strong evidence that the virus is not mutating in a way that would make it resistant to a #COVID19 vaccine,” tweeted of Oregon Health & Science University immunologist Mark Slifka on Wednesday.
Sinovac Biotech is now planning trials on thousands of human subjects.


https://futurism.com/neoscope/doctors-use-lethal-injection-drugs-covid19-patients
here's the link
https://www.sciencemag.org/news/202...nkeys-new-coronavirus-chinese-biotech-reports
 

The SC

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This COVID-19 Vaccine Could Be Ready by September

"It is a very, very fast clinical program."

As various teams race to develop a vaccine for the coronavirus, one group at Oxford University says that — if everything goes perfectly — theirs could be available as soon as September.

The vaccine was demonstrated to be effective in macaques, primates often used in biomedical research because they’re similar to humans, but has yet to be tested in people, The New York Times reports. But with scheduled clinical trials involving 6,000 participants, it will soon become clear whether the vaccine is actually as promising as it currently seems.

The scientists at Oxford’s Jenner Institute for vaccine research had a bit of a head start, the NYT reports. They’re working on an accelerated timeline because they had previously shown that a vaccine similar to the one they’re now developing that inoculated against a different coronavirus was safe for use in humans.

That’s the first crucial benchmark for regulatory approval, but not by any means a guarantee that the new vaccine will work.

“It is a very, very fast clinical program,” Emilio Emini, a vaccine program director at the Bill and Melinda Gates Foundation, told the NYT.

Even on top of accelerated testing, the group would need to get an emergency approval from the U.K. government if it wants to hit that September target.

But if everything goes to exactly as planned, the NYT reports that the group would be able to send out millions of vaccines by then — allowing the start of inoculation programs several months ahead of current timelines.

https://futurism.com/neoscope/covid...gn=eab51f1a6b-EMAIL_CAMPAIGN_2020_04_29_06_42
 

Bill Adams

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Seems like Madagascar has produced some sort of cure for coronavirus, but WHO is dragging their feet to verify if it actually works.
 

Indos

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Scientists in China believe new drug can stop pandemic 'without vaccine'
  • Qian Ye and Matthew Knight
    Agence France-Presse
Beijing, China / Tue, May 19, 2020 / 12:30 pm

2020_05_19_95605_1589863213._large.jpg

This picture taken on May 14, 2020 shows Sunney Xie (right), director of Peking University's Beijing Advanced Innovation Center for Genomics, with a member of his research team at their laboratory in Beijing. - The Chinese laboratory says it has developed a drug it believes has the power to bring the COVID-19 coronavirus pandemic to a halt, shortening the recovery time for those infected and even offering short-term immunity from the virus. (AFP/Wang Zhao)

A Chinese laboratory has been developing a drug it believes has the power to bring the coronavirus pandemic to a halt.

The outbreak first emerged in China late last year before spreading across the world, prompting an international race to find treatments and vaccines.

A drug being tested by scientists at China's prestigious Peking University could not only shorten the recovery time for those infected, but even offer short-term immunity from the virus, researchers say.

Sunney Xie, director of the university's Beijing Advanced Innovation Center for Genomics, told AFP that the drug has been successful at the animal testing stage.

"When we injected neutralizing antibodies into infected mice, after five days the viral load was reduced by a factor of 2,500," said Xie.

"That means this potential drug has [a] therapeutic effect."

The drug uses neutralizing antibodies -- produced by the human immune system to prevent the virus infecting cells -- which Xie's team isolated from the blood of 60 recovered patients.

A study on the team's research, published Sunday in the scientific journal Cell, suggests that using the antibodies provides a potential "cure" for the disease and shortens recovery time.

Xie said his team had been working "day and night" searching for the antibody.

"Our expertise is single-cell genomics rather than immunology or virology. When we realized that the single-cell genomic approach can effectively find the neutralizing antibody we were thrilled."

He added that the drug should be ready for use later this year and in time for any potential winter outbreak of the virus, which has infected 4.8 million people around the world and killed more than 315,000.

"Planning for the clinical trial is underway," said Xie, adding it will be carried out in Australia and other countries since cases have dwindled in China, offering fewer human guinea pigs for testing.

"The hope is these neutralized antibodies can become a specialized drug that would stop the pandemic," he said.

China already has five potential coronavirus vaccines at the human trial stage, a health official said last week.

But the World Health Organization has warned that developing a vaccine could take 12 to 18 months.

Scientists have also pointed to the potential benefits of plasma -- a blood fluid -- from recovered individuals who have developed antibodies to the virus enabling the body's defenses to attack it.

More than 700 patients have received plasma therapy in China, a process which authorities said showed "very good therapeutic effects".

"However, it [plasma] is limited in supply," Xie said, noting that the 14 neutralizing antibodies used in their drug could be put into mass production quickly.



Prevention and cure

Using antibodies in drug treatments is not a new approach, and it has been successful in treating several other viruses such as HIV, Ebola and Middle East Respiratory Syndrome (MERS).

Xie said his researchers had "an early start" since the outbreak started in China before spreading to other countries.

Ebola drug Remdesivir was considered a hopeful early treatment for COVID-19 -- clinical trials in the US showed it shortened the recovery time in some patients by a third -- but the difference in mortality rate was not significant.

The new drug could even offer short-term protection against the virus.

The study showed that if the neutralizing antibody was injected before the mice were infected with the virus, the mice stayed free of infection and no virus was detected.

This may offer temporary protection for medical workers for a few weeks, which Xie said they are hoping to "extend to a few months".

More than 100 vaccines for COVID-19 are in the works globally, but as the process of vaccine development is more demanding, Xie is hoping that the new drug could be a faster and more efficient way to stop the global march of the coronavirus.

"We would be able to stop the pandemic with an effective drug, even without a vaccine," he said.
 

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Coronavirus: Immune clue sparks treatment hope
By Victoria Gill & Rachael BuchananBBC News
  • 22 May 2020
UK scientists are to begin testing a treatment that it is hoped could counter the effects of Covid-19 in the most seriously ill patients.

It has been found those with the most severe form of the disease have extremely low numbers of an immune cell called a T-cell.

T-cells clear infection from the body.

The clinical trial will evaluate if a drug called interleukin 7, known to boost T-cell numbers, can aid patients' recovery.

It involves scientists from the Francis Crick Institute, King's College London and Guy's and St Thomas' Hospital.

They have looked at immune cells in the blood of 60 Covid-19 patients and found an apparent crash in the numbers of T-cells.

Prof Adrian Hayday from the Crick Institute said it was a "great surprise" to see what was happening with the immune cells.

"They're trying to protect us, but the virus seems to be doing something that's pulling the rug from under them, because their numbers have declined dramatically.

In a microlitre (0.001ml) drop of blood, normal healthy adults have between 2,000 and 4,000 T-cells, also called T lymphocytes.

The Covid patients the team tested had between 200-1,200.

'Extremely encouraging'
The researchers say these findings pave the way for them to develop a "fingerprint test" to check the levels of T-cells in the blood which could provide early indications of who might go on to develop more severe disease.

But it also provides the possibility for a specific treatment to reverse that immune cell decline.

Manu Shankar-Hari, a critical care consultant at Guy's and St Thomas' Hospital, said that around 70% of patients that he sees in intensive care with Covid-19 arrive with between 400-800 lymphocytes per microlitre. "When they start to recover, their lymphocyte level also starts to go back up," he added.
Interleukin 7 has already been tested in a small group of patients with sepsis and proved to safely increase the production of these specific cells.

In this trial, it will be given to patients with a low lymphocyte count who have been in critical care for more than three days.

Mr Shankar-Hari said: "We are hoping that [when we increase the cell count] the viral infections gets cleared.

"As a critical care physician, I look after patients who are extremely unwell and, other than supportive care, we do not have any direct active treatment against the disease.

"So a treatment like this coming along for in the context of a clinical trial is extremely encouraging for critical care physicians across the UK."

BBC
 

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