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Covid-19: Razvoj vakcine, imunitet i primena medikamenata


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2 hours ago, vememah said:

Ta vakcina ne sprečava širenje virusa već samo čini da se zaraženi ne razbole. To može značiti da će u zemljama u kojima se ona bude koristila nastradati oni koji ne budu smeli/mogli/hteli da je prime.

 

ne znam, tekst je izrazito optimistican, ne znam odakle je preuzet.

i nije mi sasvim jasno to sto si rekao - ova vakcina, kako pise u tekstu, podstice stvaranje bas velike kolicine antitela. zar se virus uglavnom ne zaustavlja imunizacijom velikog procenta populacije? nijedna vakcina nije efikasna za 100% onih koji je prime.

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On 9.7.2020. at 13:56, slow said:

Hemofiltracija snižava nivo citokina u krvi?

 

da. Dijaliza koja se radi kod bubrežnih bolesnika uklanja male molekule, a hemofiltracija i hemodijafiltracija krupne. 

 

Ima tu još opcija, npr ECMO koja zamenjuje rad i srca i pluća kada je on kompromitovan.

 

Ima opcija koje rade intenzivisti da čovek preživi, ali u ovoj zemlji... 

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7 hours ago, Aleksija said:

ne vredi, sad se svi utrkuju da objave sto optimisticniju ili sto pesimisticniju vest... moramo sacekati, ocigledno.

 

To je ubedljivo najgore u ovoj infodemiji, ili je spasonosno čudotvorno rešenje tu, samo što nije ili pak nema nikakve nade i svi će dumremo. Plus što izgleda više ne postoji bilo koji fizički simptom koji se ne povezuje sa koronom. 

Ne znam koliko uopšte ima više smisla pratiti. 

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Moderna coronavirus vaccine shows 'promising' safety and immune response results in published Phase 1 study, but more research is needed

By Jacqueline Howard and John Bonifield, CNN

 

Updated 4:34 AM ET, Wed July 15, 2020

 

(CNN)A Covid-19 vaccine developed by the biotechnology company Moderna in partnership with the National Institutes of Health has been found to induce immune responses in all of the volunteers who received it in a Phase 1 study.

These early results, published in the New England Journal of Medicine on Tuesday, showed that the vaccine worked to trigger an immune response with mild side effects -- fatigue, chills, headache, muscle pain, pain at the injection site -- becoming the first US vaccine candidate to publish results in a peer-reviewed medical journal
The vaccine is expected to begin later this month a large Phase 3 trial -- the final trial stage before regulators consider whether to make the vaccine available.
Moderna noted in a press release on Tuesday that, if all goes well in future studies, "the Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021."
 
 
In the Phase 1 study, "the goal was to look at safety and then to look at immune responses," said Dr. Lisa Jackson, a senior investigator at Kaiser Permanente Washington Health Research Institute in Seattle who was involved in the study. Early data from the study previously was released in May.
"We thought the immune responses look promising, but we don't know whether the levels we're seeing would actually protect against infection. It's really hard to know that until you do the actual efficacy trial," she said. "So we're laying the groundwork for the trial that will provide those answers."
Moderna expects to start the company's largest study yet of its Covid-19 vaccine candidate mRNA-1237 on July 27, according to details released separately on Tuesday. It's expected to be the first in the United States to begin Phase 3 trials.
For now, the new study "provided information rapidly that could be used to determine what dose to go forward with Phase 2 and Phase 3 trials. That's a critically important decision to make and so having that information available so soon after the vaccine trial was initiated is pretty remarkable," Jackson said.
A Phase 1 study typically studies a small number of people and focuses on whether a vaccine is safe and elicits an immune response.
In Phase 2, the clinical study is expanded and the vaccine is given to people who have characteristics -- such as age and physical health -- similar to those for whom the new vaccine is intended, according to the US Centers for Disease Control and Prevention. In Phase 3, the vaccine is given to thousands of people and tested for efficacy and again for safety.

'We want to know whether the vaccine is safe and effective'

The Phase 1 study included 45 healthy adults, ages 18 to 55, who received two vaccinations of the mRNA-1237 vaccine candidate 28 days apart. Some of the volunteers enrolled in the trial at Kaiser Permanente in Seattle and others at Emory University in Atlanta.
The volunteers were separated into groups where they either received the vaccine at a dose of 25, 100 or 250 micrograms. They received their first vaccination between March 16 and April 14.
"The first dose sort of sets the immune system up, it's called priming," Jackson said. "So that when you then administer the same thing again, there's a booster response. There's an augmented response. So we did not think that one vaccination would be sufficient to get the level of response that we wanted to see."
The researchers found "no trial-limiting safety concerns" after volunteers received their two doses of vaccine, but there were some mild to moderate side effects, such as some pain at the injection site, and there were more of those the higher the dose of the vaccine.
After the first vaccination, adverse events were reported by five participants in the 25-microgram group, 10 in the 100-microgram group, and eight in the 250-microgram group. Then after the second vaccination, such events occurred in seven of 13 participants in the 25-microgram group, all 15 in the 100-microgram group, and all 14 in the 250-microgram group, with three of those participants reporting "one or more severe events," according to the study.

The most commonly reported systemic adverse events following second vaccination at the 100-microgram dose were fatigue, among 80%; chills, among 80%; headache, among 60%; and myalgia or muscle pain, among 53%; all of which were transient and mild or moderate in severity, as noted in Moderna's press release.
The study data also showed that the vaccine induced an antibody response. Antibodies are the proteins the body makes to fight infection.
Specifically, all participants developed neutralizing antibodies to the virus at levels similar to those seen in people who've naturally recovered from Covid-19, according to the study. Neutralizing antibodies bind to the virus, disabling it from attacking human cells.
The researchers measured two types of immune responses, Jackson said.
"Those two types of responses support each other. We know that the antibodies are being produced and it appears that there's function after vaccination that serves to block the ability of the virus to enter cells. So it neutralizes the activity of the virus," she said.
 
Why expert is cautious about Covid-19 vaccine trial results

 

Why expert is cautious about Covid-19 vaccine trial results 02:22
But more research is needed.
"What do we really want to know? We want to know whether the vaccine is safe and effective, that's what we want to know," said Dr. Paul Offit, a member of the NIH panel that's setting a framework for vaccine studies in the United States, who was not involved in the new study.
With the study, "we know that it's safe in 45 people, which is not going to be the 20 million people or 200 million people who are going to get it here in the United States," said Offit, who is also director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children's Hospital of Philadelphia.
"So we know that it doesn't have a very common side effect problem, that's what we know," he said. "Then we don't know anything about efficacy, which is what we really want to know. Is this vaccine going to work? The only way to know that is to do a so-called Phase 3 trial."
Edited by 3opge
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