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mat
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Interesting development.fair play to our government on the vaccine front, seems we're determined to be the forefront of this - first human trial in a couple of days
Interesting development.fair play to our government on the vaccine front, seems we're determined to be the forefront of this - first human trial in a couple of days
On Tuesday 823 new deaths were announced, but most of these happened in the previous days and weeks. Some even date back to March.BBC and sky say 24 hours.
I’d be surprised, no idea really, the decline in hospital and icu cases suggest it should drop.We were up in the 800s and high 700 s , second half of last week. So if we saw 6 and 7 hundreds this week it would be progress.well pointed out,so are we likely to be back in the 400s tomorrow even better the 300s
It happened a few times in Spain and Italy a few weeks ago. You think things are turning with a lower number on a day and then the next day it’s right back up where the worst numbers were previously.
Ok Matt.Because they have idiots reporting for them.
Oxford Uni must be on the verge of something here if their doing human tests on Thursday, they wouldnt be that far down the road so soon unless they were pretty confident
To be fair I haven’t seen the BBC use that graph before, they have only just started using it. More or less using Gelsons method.@Gelsons Dad, FWIW here's you graph with the BBC basic noddy graph superimposed on top. I am sorry but I really do not see what additional insight your more comprehensive data is revealing (in terms of deducing the effectiveness of school closures etc).
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Oxford Uni must be on the verge of something here if their doing human tests on Thursday, they wouldnt be that far down the road so soon unless they were pretty confident
Oxford Uni must be on the verge of something here if their doing human tests on Thursday, they wouldnt be that far down the road so soon unless they were pretty confident
But Oxford remain confident if it works they can produce a tested vaccine by September, if it’s manufactured in parallel with testing. It’s a risk but one they think is worth taking.on the contrary.
They are entering phase 1 of trials.
This is what’s involved.
Phase I Vaccine Trials
This first attempt to assess the candidate vaccine in humans involves a small group of adults, usually between 20-80 subjects. If the vaccine is intended for children, researchers will first test adults, and then gradually step down the age of the test subjects until they reach their target. Phase I trials may be non-blinded (also known as open-label in that the researchers and perhaps subjects know whether a vaccine or placebo is used).
The goals of Phase 1 testing are to assess the safety of the candidate vaccine and to determine the type and extent of immune response that the vaccine provokes. In a small minority of Phase 1 vaccine trials, researchers may use the challenge model, attempting to infect participants with the pathogen after the experimental group has been vaccinated. The participants in these studies are carefully monitored and conditions are carefully controlled. In some cases, an attenuated, or modified, version of the pathogen is used for the challenge.
A promising Phase 1 trial will progress to the next stage.
Phase II Vaccine Trials
A larger group of several hundred individuals participates in Phase II testing. Some of the individuals may belong to groups at risk of acquiring the disease. These trials are randomized and well controlled, and include a placebo group.
The goals of Phase II testing are to study the candidate vaccine’s safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery.
Phase III Vaccine Trials
Successful Phase II candidate vaccines move on to larger trials, involving thousands to tens of thousands of people. These Phase III tests are randomized and double blind and involve the experimental vaccine being tested against a placebo (the placebo may be a saline solution, a vaccine for another disease, or some other substance).
One Phase III goal is to assess vaccine safety in a large group of people. Certain rare side effects might not surface in the smaller groups of subjects tested in earlier phases. For example, suppose that an adverse event related to a candidate vaccine might occur in 1 of every 10,000 people. To detect a significant difference for a low-frequency event, the trial would have to include 60,000 subjects, half of them in the control, or no vaccine, group (Plotkin SA et al. Vaccines, 5th ed. Philadelphia: Saunders, 2008).
Vaccine efficacy is tested as well. These factors might include 1) Does the candidate vaccine prevent disease? 2) Does it prevent infection with the pathogen? 3) Does it lead to production of antibodies or other types of immune responses related to the pathogen?
Next Steps: Approval and Licensure
After a successful Phase III trial, the vaccine developer will submit a Biologics License Application to the FDA. Then the FDA will inspect the factory where the vaccine will be made and approve the labeling of the vaccine.
After licensure, the FDA will continue to monitor the production of the vaccine, including inspecting facilities and reviewing the manufacturer’s tests of lots of vaccines for potency, safety and purity. The FDA has the right to conduct its own testing of manufacturers’ vaccines.
thanks for that,quite an extensive trial periodon the contrary.
They are entering phase 1 of trials.
This is what’s involved.
Phase I Vaccine Trials
This first attempt to assess the candidate vaccine in humans involves a small group of adults, usually between 20-80 subjects. If the vaccine is intended for children, researchers will first test adults, and then gradually step down the age of the test subjects until they reach their target. Phase I trials may be non-blinded (also known as open-label in that the researchers and perhaps subjects know whether a vaccine or placebo is used).
The goals of Phase 1 testing are to assess the safety of the candidate vaccine and to determine the type and extent of immune response that the vaccine provokes. In a small minority of Phase 1 vaccine trials, researchers may use the challenge model, attempting to infect participants with the pathogen after the experimental group has been vaccinated. The participants in these studies are carefully monitored and conditions are carefully controlled. In some cases, an attenuated, or modified, version of the pathogen is used for the challenge.
A promising Phase 1 trial will progress to the next stage.
Phase II Vaccine Trials
A larger group of several hundred individuals participates in Phase II testing. Some of the individuals may belong to groups at risk of acquiring the disease. These trials are randomized and well controlled, and include a placebo group.
The goals of Phase II testing are to study the candidate vaccine’s safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery.
Phase III Vaccine Trials
Successful Phase II candidate vaccines move on to larger trials, involving thousands to tens of thousands of people. These Phase III tests are randomized and double blind and involve the experimental vaccine being tested against a placebo (the placebo may be a saline solution, a vaccine for another disease, or some other substance).
One Phase III goal is to assess vaccine safety in a large group of people. Certain rare side effects might not surface in the smaller groups of subjects tested in earlier phases. For example, suppose that an adverse event related to a candidate vaccine might occur in 1 of every 10,000 people. To detect a significant difference for a low-frequency event, the trial would have to include 60,000 subjects, half of them in the control, or no vaccine, group (Plotkin SA et al. Vaccines, 5th ed. Philadelphia: Saunders, 2008).
Vaccine efficacy is tested as well. These factors might include 1) Does the candidate vaccine prevent disease? 2) Does it prevent infection with the pathogen? 3) Does it lead to production of antibodies or other types of immune responses related to the pathogen?
Next Steps: Approval and Licensure
In the US
After a successful Phase III trial, the vaccine developer will submit a Biologics License Application to the FDA. Then the FDA will inspect the factory where the vaccine will be made and approve the labeling of the vaccine.
After licensure, the FDA will continue to monitor the production of the vaccine, including inspecting facilities and reviewing the manufacturer’s tests of lots of vaccines for potency, safety and purity. The FDA has the right to conduct its own testing of manufacturers’ vaccines.
This whole process takes many months and very often can fail at any of the stages.
Where's that Spurs fan from a while back? He'd put you both to shame.Yes. They are doing what I started doing when the data first became available. But from their graph you have no idea how close to final values they are and from mine you do.
But Oxford remain confident if it works they can produce a tested vaccine by September, if it’s manufactured in parallel with testing. It’s a risk but one they think is worth taking.
again sadly not true.
Phase 1 trials can take from months to 1 year.
Phase 2 trials can take from months to 2 years.
Phase 3 trials can take from months to 3 years.
They will not cut corners in any phase until they are sure.
it will NOT be ready by September.
It will not be manufactured until it is approved.
It will take months more to produce it in the billions of doses needed.
They are injecting two groups and injecting one with a meningitis vaccine and one with their new vaccine. I think there's 500 people involved.thanks for that,quite an extensive trial period