How is vaccine efficacy determined? How is vaccine efficacy determined? - Page 5 - Talk of The Villages Florida

How is vaccine efficacy determined?

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Old 11-22-2020, 08:23 PM
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Did you not bother to read my post? The testing involves a large enough sample size to produce a statistically significant result. I would guess that you are not a scientist and have never had a course in statistics. Please stop second guessing the professionals.

Agree.

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Old 11-22-2020, 09:33 PM
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Originally Posted by Raywatkins View Post
Not sure about the 2 vaccines mentioned in the thread, but a friend of mine here in the UK is participating in the Oxford/Astra Zeneca trial.
He had blood taken before the first injection along with nasal and throat swabs.
He has had to provide swabs each week.
Before second jab he had to give blood again.
He will give a further blood sample before he completes the trial. (He may have done that now as I haven’t seen him for a few weeks due to the national lockdown here in UK.)
There is ongoing study to see how long protection lasts.
This trial either uses the real vaccine or the one for measles as the placebo.
They apparently look for antibodies in the blood.
Hope that helps.
The Astra Zeneca vaccine is not mRNA. The study being done in UK is a different protocol. They are in phase 3 immunizing volunteers with either the Covid test vaccine or a saline vaccine, not measles. They are following the groups by measuring anti-Covid antibodies, T cell immunity, as well as PCR test positive symptomatic illnesses
The protocol is HERE

There are to be 30,000 subjects in this study, 20K will receive the active vaccine and 10K the placebo.
In earlier phase testing they did not use a saline placebo, instead they used a meningococcal vaccine placebo. Those results are HERE Your relative may have been a participant in this earlier phase testing.
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Old 11-22-2020, 09:44 PM
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Originally Posted by Byte1 View Post
There have been no reported deaths related to the vaccine trials. Where did that come from?
And who said it was going to be six months before "we" get our vaccinations?
What's with all the "misinformation" being spread as fact?
In the interest in getting correct information in this thread, I must point out there was one death in the early AstraZeneca vaccine trial in a person in Brazil. They broke the blinding and the death was in the placebo group not in the active Covid vaccine group.
As others have pointed out, when you have nearly 100,000 people in studies there will be deaths because people die. As far as I can find, there have not yet been any reported deaths in the active vaccine arm of the ongoing studies. But there will be. And there will also be deaths in the placebo arm.
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Old 11-22-2020, 09:51 PM
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Originally Posted by blueash View Post
In the interest in getting correct information in this thread, I must point out there was one death in the early AstraZeneca vaccine trial in a person in Brazil. They broke the blinding and the death was in the placebo group not in the active Covid vaccine group.
As others have pointed out, when you have nearly 100,000 people in studies there will be deaths because people die. As far as I can find, there have not yet been any reported deaths in the active vaccine arm of the ongoing studies. But there will be. And there will also be deaths in the placebo arm.
I have been wondering about the death in the trial. I could not find out at the time if the individual was in the placebo group or not. Very happy that you posted this now. We re so lucky to have you at TOTV.
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Old 11-23-2020, 04:53 AM
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The Oxford/Astra Zeneca trial results show a 70% immunity rate, which was a little dissapointing.
However, they have subsequently found that giving a small dose vacination first, followed by a larger booster, the immunity rate went up to 90%.
Trials and research contiue.

Covid-19: Oxford University vaccine shows 70% protection - BBC News
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Old 11-23-2020, 07:06 AM
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Originally Posted by biker1 View Post
Did you not bother to read my post? The testing involves a large enough sample size to produce a statistically significant result. I would guess that you are not a scientist and have never had a course in statistics. Please stop second guessing the professionals.
Yes, I read your post. Your point being there is a large enough sample size so the scientists can evaluate the efficacy. No, I'm not a scientist nor ever took a course in statistics. That is why I questioned how the efficacy is determined.
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Old 11-23-2020, 07:09 AM
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Originally Posted by jklfairwin View Post
From what I read, all participants were not tested at the end of the trial period. Only those who had symptoms were tested. So there may have been many more who contracted covid but were asymptomatic so not tested and not counted. While they may have been unsymptomatic, the consensus is that asymptotic infected people can still spread it to others. So while the efficacy numbers look great, and may in fact be so, it must be taken with a few grains of salt.
How can a trial be conducted and not all participants be tested at the end of the trial? I find that to be negligent on the part of the people conducting the trial. Hope this information you read about is totally wrong about not testing all participants. Actually, that just makes no sense at all.
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Old 11-23-2020, 07:12 AM
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Originally Posted by Robbie0723 View Post
Agree.

There are two kinds of people in the world, those who can learn and those who won't.

Most frightening are those who think being contrarian and obtuse is a substitute for educational and intelligence...
Sorry but I do not agree. My concerns about how the trial participants conducted themselves with regards to using safe practices vs no safe practices when they went out into the community were very valid. Your remarks are not called for.
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Old 11-23-2020, 07:16 AM
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Originally Posted by Velvet View Post
I have been wondering about the death in the trial. I could not find out at the time if the individual was in the placebo group or not. Very happy that you posted this now. We re so lucky to have you at TOTV.
I posted this article some time ago on this forum.......

28-year-old volunteer in AstraZeneca COVID-19 vaccine trial dies | Healthcare Finance News
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Old 11-23-2020, 07:43 AM
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Sorry but I do not agree. My concerns about how the trial participants conducted themselves with regards to using safe practices vs no safe practices when they went out into the community were very valid. Your remarks are not called for.
Regrets Coffeebean, that comment was not directed towards you. You are clearly trying to understand and learn.
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Old 11-23-2020, 07:54 AM
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Originally Posted by coffeebean View Post
How can a trial be conducted and not all participants be tested at the end of the trial? I find that to be negligent on the part of the people conducting the trial. Hope this information you read about is totally wrong about not testing all participants. Actually, that just makes no sense at all.
Participants are requested to report in weekly and for any symptoms or positive test results throughout the study.

Antibodies are rechecked at 6, 12 and 24 months.

Full protocol here:

https://pfe-pfizercom-d8-prod.s3.ama...l_Protocol.pdf


8.11.2.4. Visit 4 – 6-Month Follow-up Visit: (175 to 189 Days After Visit 2)

• Record SAEs as described in Section 8.3.

• Record nonstudy vaccinations as described in Section 6.5.

• For participants who are HIV positive, record HIV viral load and CD4 count results from the most recent test performed since Visit 3 (if any).

Collect a blood sample (approximately 20 mL) for immunogenicity testing.

• Record details of any of the prohibited medications specified in Section 6.5.1 received by the participant if required for his or her clinical care.

• Ask the participant to contact the site staff or investigator (this could be via the COVID-19 illness e-diary) immediately if he or she experiences any respiratory symptoms as detailed in Section 8.3.

• Schedule an appointment for the participant to return for the next study visit.

• Complete the source documents.

• The investigator or an authorized designee completes the CRFs.

• Record any AEs that occur within the 48 hours after the blood draw as described in Section 8.3.
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Old 11-23-2020, 01:15 PM
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Now we have data from the AstraZeneca [AZ] trials. Be very cautious in comparing their results with the Pfizer and Moderna data. The AZ protocol is entirely different from the other two. They were testing different doses as they went along. Some people got a full dose initial shot followed by another full dose A smaller group got a 1/2 dose followed by a full dose. In this small group they report 90% efficacy.

VERY IMPORTANT Both Pfizer and Moderna defined a Covid illness as the person had SYMPTOMS and a positive Covid test. They were not tested unless they were symptomatic with something more than trivial symptoms. But the AZ protocol required that the volunteers have PCR Covid tests on a regular schedule whether they had symptoms or not. So the AZ failure rate includes asymptomatic and low symptomatic positives. A 70% efficacy of everyone vs a 90% efficacy for sick prevention is a very different criteria and until the breakdown of positives, symptomatic vs not symptomatic, in the AZ study is made available you cannot use efficacy numbers to decide.

In favor of the AZ vaccine are: Only requires refrigeration, no freezing, no super low freezing. Much less expensive to produce, less expensive to ship and store. The technology is old and has a well established safety profile. While I have no concerns about mRNA, it is new and does not have an established long term safety profile.
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Old 11-23-2020, 01:15 PM
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Thank you, I must have missed it.
  #74  
Old 11-23-2020, 01:27 PM
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For crying out loud, people. You all rush to be the first to get your Flu vaccination without even caring whether or not it has side effects, yet you want to know every nuance of how the C19 vaccine is produced, how it is tested, what color it is and whether or not you are the right age or ethnicity to warrant receiving it. If you do not want the shot then don't get it, period. We don't need to hear about how your cousin's sister-in-law's friend was in the test group and they "said".........
It's not even available yet, and you are worried about whether or not someone else should get the shot. I think some of you just want a permanent mandate for mask wearing. I don't blame some of you for covering your face but some folks will eat an apple and take an aspirin if someone tells them it will let them remove the mask. If you think that the vaccine is coming out too fast, then don't get. Wait until all your friends have had it for a year and then if you are still around to ask for it, go and pay a hand full of money to get it. When it first comes out, it will be free but who knows for how long. Take a chance and get it, or don't. Who cares? The way I see it, when the test is over 30000 recipients with no one dying a horrible death and no one growing hair on the palms of their hands, what is the harm. What is the chance that you will be the one in a million that may be different and have problems with it?
I still don't know if I will get it, but that is not because I do not believe in it. I just seem to be immune to a lot of illnesses and have to think about the chances of tampering with a good thing. But, that is just me. My spouse will get the vaccination. If they told me that in order to rid myself of the stupid mask requirement, I had to get the shot....I would be the first in line.
We have two vaccines about to be released for consumption. They both are in the 90's% efficiency. That is better than our flu vaccines which average about 40-60% some years. If you are willing to get the flu shot, then I do not see what the problem is with getting the C19 shot.
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Old 11-23-2020, 01:53 PM
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Originally Posted by Robbie0723 View Post
Regrets Coffeebean, that comment was not directed towards you. You are clearly trying to understand and learn.
Apology accepted.
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