Covid-19: Razvoj vakcine, imunitet i primena medikamenata

[Tsai]

4 hours ago, omiljeni said:

ona misli da drugog talasa neće biti na osnovu kolektivnog imuniteta i promenjenih navika stanovništva. meni to ima nula smisla.

 

evo ceo taj intervju, deo o 2. talasu je na 21:00

 

 

 

Wishful thinking + zna ona^tm

[April]

https://nova.rs/region/rusija-ce-registrovati-vakcinu-protiv-koronavirusa-u-avgustu/

Sent from fav toy

[Tsai]

[Milosh76]

Vakcina će, prema rečima Gunzburga, biti davana u desno rame

[Dankan Ajdaho]

https://investors.sorrentotherapeutics.com/news-releases/news-release-details/sti-1499-potent-anti-sars-cov-2-antibody-demonstrates-ability

[vememah]

Quote

 

The first coronavirus vaccine to be tested in people appears to be safe and able to stimulate an immune response against the virus, its manufacturer, Moderna announced on Monday.

The findings are based on results from the first eight people who each received two doses of the vaccine, starting in March.

Those people, healthy volunteers, made antibodies that were then tested in human cells in the lab, and were able to stop the virus from replicating — the key requirement for an effective vaccine. The levels of those so-called neutralizing antibodies matched the levels found in patients who had recovered after contracting the virus in the community.

The company has said that it is proceeding on an accelerated timetable, with the second phase involving 600 people to begin soon, and a third phase to begin in July involving thousands of healthy people. The Food and Drug Administration gave Moderna the go-ahead for the second phase earlier this month.

If those trials go well, a vaccine could become available for widespread use by the end of this year or early 2021, Dr. Tal Zaks, Moderna’s chief medical officer, said in an interview. How many doses might be ready is not clear, but Dr. Zaks said, “We’re doing our best to make it as many millions as possible.”

 

https://www.nytimes.com/2020/05/18/health/coronavirus-vaccine-moderna.html

[mustang]

to za antibodies sam cula pre neki dan al nisam stigla da pretrazim. odlicna vest, plus sto bi se virus totalno neutralisao a ne pojavljivao sezonski

Edited May 18, 2020 by mustang

[vememah]

Quote

Scientists in China believe new drug can stop coronavirus pandemic 'without vaccine'

BEIJING (AFP) - 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 Centre for Genomics, told AFP that the drug has been successful at the animal testing stage.

"When we injected neutralising 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 neutralising 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 (May 17) 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 realised that the single-cell genomic approach can effectively find the neutralising 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 neutralised antibodies can become a specialised 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 Organisation 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 defences 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 neutralising 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 neutralising 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.

https://www.straitstimes.com/asia/east-asia/scientists-in-china-believe-new-drug-can-stop-pandemic-without-vaccine

 

Studija:
https://www.cell.com/cell/pdf/S0092-8674(20)30620-6.pdf

Edited May 19, 2020 by vememah

[precog]

ovo su preklinicke studije, bas je longshot. 

[3opge]

sto se Moderne tice, 8 ljudi i samo press release bez ikakvih detalja o testiranju i to istovremeno sa stocks, daleko je to jos od vakcine koja je potvrdjena.

[vememah]

4 hours ago, 3opge said:

sto se Moderne tice, 8 ljudi i samo press release bez ikakvih detalja o testiranju i to istovremeno sa stocks, daleko je to jos od vakcine koja je potvrdjena.

Ovo su svakako preliminarni rezultati 1. faze od 3 ukupno pošto su objavljeni podaci o tome da su potvrđena antitela za 8 od 45 učesnika na nivoima viđenim kod onih koji su stvarno ozdravili od koronavirusa. I ima detalja o testiranju.

Quote

 

Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29). Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 µg and 100 µg dose levels. All participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose. At day 43, two weeks following the second dose, at the 25 µg dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43, at the 100 µg dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Samples are not yet available for remaining participants.

At this time, neutralizing antibody data are available only for the first four participants in each of the 25 µg and 100 µg dose level cohorts. Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.

mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies. The sole incidence of a grade 3 adverse event in the 25 µg and 100 µg dose cohorts was a single participant at 100 µg who experienced grade 3 erythema (redness) around the injection site. To date, the most notable adverse events were seen at the 250 µg dose level, comprising three participants with grade 3 systemic symptoms, only following the second dose. All adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported.

 

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-interim-phase-1-data-its-mrna-vaccine

 

[3opge]

7 minutes ago, vememah said:

Ovo su svakako preliminarni rezultati 1. faze od 3 ukupno pošto su objavljeni podaci o tome da su potvrđena antitela za 8 od 45 učesnika na nivoima viđenim kod onih koji su stvarno ozdravili od koronavirusa. I ima detalja o testiranju.

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-interim-phase-1-data-its-mrna-vaccine

 

da ponovim, ovo je samo news release, nema ozbiljnih radova dostupnih za peer review.

 

 

 

[3opge]

https://www.washingtonpost.com/politics/drug-promoted-by-trump-as-coronavirus-game-changer-increasingly-linked-to-deaths/2020/05/15/85d024fe-96bd-11ea-9f5e-56d8239bf9ad_story.html?fbclid=IwAR3TF1vlv6WjErLjN9jVZ8g-2KsrrbUTFjz5u-x5PRrjXnqyYM10QxQ2LyQ&utm_campaign=wp_main&utm_medium=social&utm_source=facebook

 

Drug promoted by Trump as coronavirus ‘game changer’ increasingly linked to deaths

[vememah]

Oxford kaputt.

Quote

Doubts over Oxford vaccine as it fails to stop coronavirus in animal trials
Experts warn that vaccine may only be 'partially effective' after results of a trial in rhesus macaque monkeys

BySarah Newey, GLOBAL HEALTH SECURITY REPORTER and Paul Nuki, GLOBAL HEALTH SECURITY EDITOR, LONDON18 May 2020 • 12:43pm
The Oxford University vaccine tipped as a "front runner" in the race to develop a coronavirus jab does not stop the virus in monkeys and may only be partially effective, experts have warned.

A trial of the vaccine in rhesus macaque monkeys did not stop the animals from catching the virus and has raised questions about the vaccine's likely human efficacy and ongoing development.

The vaccine, known as ChAdOx1 nCoV-19, is undergoing human trials in Britain. The Government has brokered a deal between Oxford University and the drug company AstraZeneca to produce up to 30 million doses if it proves successful, having ploughed £47 million into the research.

"All of the vaccinated monkeys treated with the Oxford vaccine became infected when challenged as judged by recovery of virus genomic RNA from nasal secretions," said Dr William Haseltine, a former Harvard Medical School professor who had a pivotal role in the development of early HIV/Aids treatments.

"There was no difference in the amount of viral RNA detected from this site in the vaccinated monkeys as compared to the unvaccinated animals. Which is to say, all vaccinated animals were infected," Dr Haseltine wrote in an article on Forbes. 

Jonathan Ball, professor of molecular virology at the University of Nottingham, said the vaccine data suggests that the jab may not be able to prevent the spread of the virus between infected individuals.   

"That viral loads in the noses of vaccinated and unvaccinated animals were identical is very significant. If the same happened in humans, vaccination would not stop spread," he said. "I genuinely believe that this finding should warrant an urgent re-appraisal of the ongoing human trials of the ChAdOx1 vaccine."

The trials investigating the immune response to the Oxford vaccine in rhesus macaque monkeys were carried out at the National Institute of Health's Rocky Mountain Laboratory in the US, with initial results published in a press release at the end of April. 

The results were said at the time to be encouraging, but publication of the full trial results last week showed the vaccine did not prevent the animals catching the virus, although there was evidence it may reduce the severity.

This is in contrast to a Chinese vaccine trial in April that did appear to stop the development of Covid-19 in monkeys. That trial, by Sinovac Biotech, a privately held Beijing-based company, used a modified version of the full Sars-Cov-2 virus in its vaccine, while the Oxford vaccine uses a common cold virus to try and provoke an immune response.  

In the Oxford monkey trial, six monkeys were infected with single doses of ChAdOx1 nCoV-19 and exposed to coronavirus. A control group of three non-vaccinated monkeys were also infected. Both the immunised and non-immunised monkeys were then monitored for seven days for signs of developing Covid-19. 

One measure of infection is an increased breathing rate as the virus attacks the lungs – three of the vaccinated animals displayed this symptom. On autopsy, the researchers found the virus in the vaccinated monkeys' lungs.

On the upside, none of the vaccinated monkeys displayed pneumonia which suggests that, while not stopping the virus, it may be partially protective.

Dr Haseltine said this was "encouraging", but that "experience with other vaccines tells us that is not a firm guarantee that such will be the case for humans".

"It is crystal clear that the vaccine did not provide sterilising immunity to the virus challenge, the gold standard for any vaccine. It may provide partial protection," he said.

The doubts about the vaccine come after Alok Sharma, the Business Secretary, said that the speed at which Oxford was pushing ahead with development was "genuinely unprecedented" and that the first clinical trials were "progressing well".

Mr Sharma also announced £84 million of additional funding to further accelerate the vaccine research at Oxford University and another UK vaccine candidate being developed by Imperial College. The following graphic shows how scientists are trying to produce a vaccine:



Separate funding was announced for a UK vaccine manufacturing capacity – the Vaccines Manufacturing and Innovation Centre – in Oxford. This will be able to manufacture a range of vaccines depending on what works.

Despite the findings, there is still "cautious optimism" about the Oxford vaccine among some experts. In the study all of the animals administered with a single shot of the vaccine generated antibodies against the virus within 28 days. 

"The most important finding to me is the combination of considerable efficacy in terms of viral load and subsequent pneumonia, but no evidence of immune-enhanced disease," said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine. 

"It is encouraging to see these results and suggests cautious optimism for the Oxford vaccine trial being done in humans."

Dr Penny Ward, a visiting professor in pharmaceutical medicine at King's College London, said: "Single doses of the vaccine produced high quantities of neutralising antibody in both species. 

"It is helpful to see that monkeys vaccinated with this Sars-CoV-2 vaccine did not have any evidence of enhanced lung pathology and that, despite some evidence of upper respiratory tract infection by Sars-Cov-2 after high viral load virus challenge, monkeys given the vaccine did not have any evidence of pneumonia."

But Eleanor Riley, professor of Immunology and Infectious Disease at the University of Edinburgh, said there was both good and bad news in the most monkey trials:

“Whilst the vaccine induced neutralising antibodies and vaccinated animals experienced less severe clinical symptoms than unvaccinated animals (good), the neutralising antibody titres were low and insufficient to prevent infection and – importantly – insufficient to prevent viral shedding in nasal secretions (worrying).

“If similar results were obtained in humans, the vaccine would likely provide partial protection against disease in the vaccine recipient but would be unlikely to reduce transmission in the wider community.”

https://www.telegraph.co.uk/global-health/science-and-disease/doubts-oxford-vaccine-fails-stop-coronavirus-animal-trials/

 

PDF sa rezultatima:
https://www.biorxiv.org/content/10.1101/2020.05.13.093195v1.full.pdf

Edited May 22, 2020 by vememah

[vememah]

U Lancetu su objavljeni rezultati 1. faze kliničkog ispitivanja druge kineske vakcine, one firme CanSino, vakcina se uglavnom dobro podnosi uz privremene efekte poput temperature, umora, glavobolje ili bola u mišićima.

 

 

 

 

Edited May 22, 2020 by vememah