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Old Dec 20, 2020, 12:24 pm
  #76  
 
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Originally Posted by doctoravios
Everything points towards all of the current vaccines as being safe and not increasing the rate of serious adverse events. As for long-term efficacy, well, that has yet to be determined.
That's all that really matters and hopefully we will all be able to access a vaccine over the next months.
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Old Dec 21, 2020, 6:13 pm
  #77  
 
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Originally Posted by doctoravios
Everything points towards all of the current vaccines as being safe and not increasing the rate of serious adverse events. As for long-term efficacy, well, that has yet to be determined.
If the virus mutates and necessitates changes in existing vaccines, will modified vaccines have to go through a lengthy trial again?

Or will it be like the flu vaccine which is modified each year without a large scale testing?
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Old Dec 22, 2020, 4:33 am
  #78  
 
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Originally Posted by cockpitvisit
If the virus mutates and necessitates changes in existing vaccines, will modified vaccines have to go through a lengthy trial again?

Or will it be like the flu vaccine which is modified each year without a large scale testing?
It's difficult to know at this stage. I imagine because of the novelty of the platforms they will have to go through safety trials but not necessarily efficacy trials. The manufacturers are almost certainly speaking to the regulators about this now so hopefully they will have a plan on how to achieve this before it becomes necessary.
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Old Dec 22, 2020, 7:34 am
  #79  
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Originally Posted by JGigs
I had my 1st injection on Dec 14th and had myself convinced I would most likely get the placebo. My only concern was what a few others mentioned - what happens if I am required as a healthcare worker to receive another FDA approved covid vaccine prior to my completion of the AZ trial. The response was- AZ was planning on unblinding results for those who had proof they were required by their employer to receive the vaccine.

I do believe I received the vaccine, not the placebo- fever of 101.5 approx. 24 hrs post injection with severe myalgia. Injection site was sore post 72 hours with new joint pain symptoms and severe lethargy and intermittent brain fog today (4 days after). Hoping it passes. I did not expect immune response symptoms to last this long. I reported the fever to study site and they did run my pre injection COVID swap - which came back negative.
Thanks for sharing your experience. I hope your symptoms continue to improve. I had my second jab yesterday and it was much less severe.

Originally Posted by doctoravios
As for long-term efficacy, well, that has yet to be determined.
Are there any correlations in immunology that can help make an inference on the longevity of immunity?
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Old Dec 22, 2020, 8:02 am
  #80  
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Second Does Update
I had my second done is in the AZ trial yesterday. The testing site was packed - looked like they had many first time participants reading their consent and going through the full process. I would guess there were 15 or so in the waiting room. It seems the study site schedules everyone at the same time (I presume to make vaccinations easier when reconstituting the vaccine) but it creates a rather large bottleneck in the waiting room.

Even with the crowd, I was taken back to a room pretty quickly. I had to answer a few questions on health (updates in medications, medical care, and symptoms). They did a quick blood draw (2 vials) and then I waited for the vaccination person to come in. As I understand it, the person dosing is not blind - they are drawing from the vaccine vial or from saline. I'm not sure, however, if that's the same person who performs the injection. In any case, she provided a few tips to help with arm soreness after the injection. Once injected, I had to wait 16 minutes in a room with a handful of others to make sure I didn't have an immediate reaction. Injection site was inspected and I was sent on my way. I was at the site for a little less than a hour for this visit.

The next appointment is scheduled on January 18th for a blood draw and symptom check (I presume). I'll have a phone call next Monday to check in.

Last night I had a little nausea and just felt a little "unwell". I slept most of the night, unlike after the first injection when I woke up with moderate muscle pain. This morning I feel a tired and my arm is sore. I'm also having a little bit of the brain fog mentioned by JGigs - just feeling a little off.

A Practical/Ethical Question:
My wife is a resident physician and has received the first dose of the Pfizer vaccine. Our social circle is 99% other resident and attending physicians who I know are itching for social gatherings within their "vaccination bubble" in January and February. Based on my experience with the AZ trial, I'm fairly confident I received a vaccination and not saline but would an antibody test in mid/late January be the "assurance" I'm looking for to participate in the "vaccine bubble"? Are there ethical considerations to unblinding myself in that way? I'm operating under the premise that if a group is 100% vaccinated using vaccines that show strong protection against disease and nearly perfect protection against severe disease that we may be safe in gathering. (I'm basing that premise on this Q/A from the NY Times: https://www.nytimes.com/2020/12/21/u...s-experts.html).

Last edited by TTT; Dec 22, 2020 at 8:07 am
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Old Dec 22, 2020, 9:22 am
  #81  
 
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Originally Posted by TTT
Are there any correlations in immunology that can help make an inference on the longevity of immunity?
So far, not much, apart from the fact that serology from the phase 1/2 studies seems to hold up for several months. Challenge studies (if they are still going to happen) could help to answer this question, otherwise it's a matter of waiting and looking at follow-up data from the RCTs.

Originally Posted by TTT
A Practical/Ethical Question:
My wife is a resident physician and has received the first dose of the Pfizer vaccine. Our social circle is 99% other resident and attending physicians who I know are itching for social gatherings within their "vaccination bubble" in January and February. Based on my experience with the AZ trial, I'm fairly confident I received a vaccination and not saline but would an antibody test in mid/late January be the "assurance" I'm looking for to participate in the "vaccine bubble"? Are there ethical considerations to unblinding myself in that way? I'm operating under the premise that if a group is 100% vaccinated using vaccines that show strong protection against disease and nearly perfect protection against severe disease that we may be safe in gathering. (I'm basing that premise on this Q/A from the NY Times: https://www.nytimes.com/2020/12/21/u...s-experts.html).
In terms of ethical considerations, these apply to the investigators, not the participants. You are under no obligation to do anything and you are free to withdraw from the study at any time, get your own serology test and even get another vaccine (though I would not recommend this from a clinical perspective).

As for vaccine bubbles, I am hesitant about this approach and I don't want to make value judgements, but I think it is ill-advised for physicians (of all people) to be doing this if we are expecting the general population to follow exactly the same precautions as they did prior to being vaccinated.
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Old Dec 22, 2020, 9:30 am
  #82  
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Originally Posted by doctoravios

In terms of ethical considerations, these apply to the investigators, not the participants. You are under no obligation to do anything and you are free to withdraw from the study at any time, get your own serology test and even get another vaccine (though I would not recommend this from a clinical perspective).
What would your clinical considerations be in advising against getting another vaccine?

As for vaccine bubbles, I am hesitant about this approach and I don't want to make value judgements, but I think it is ill-advised for physicians (of all people) to be doing this if we are expecting the general population to follow exactly the same precautions as they did prior to being vaccinated.
That's a fair point and one that I generally plan to follow even knowing our vaccine status. At a minimum, following the local public health guidance will be necessary (in our area it's fewer than 10 people gathering). But I could see some doctors getting together for a small dinner party or game night post-vaccine with more frequency. But I agree, even if it is "safe" for the participants, those in the medical field should be models of exemplar behavior for the community.
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Old Dec 22, 2020, 10:07 am
  #83  
 
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Originally Posted by TTT
What would your clinical considerations be in advising against getting another vaccine?
Just that we have no idea of the impact of combining multiple types of COVID-19 vaccine in the same individual, although it shouldn't take long before the trials on this begin.
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Old Dec 22, 2020, 10:10 am
  #84  
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Originally Posted by doctoravios
Just that we have no idea of the impact of combining multiple types of COVID-19 vaccine in the same individual, although it shouldn't take long before the trials on this begin.
Got it - thanks! I imagine any prior vaccine case studies might not apply, but I wonder about the two different types of the polio vaccine - is there issue with getting both?
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Old Dec 22, 2020, 3:34 pm
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Originally Posted by TTT
Got it - thanks! I imagine any prior vaccine case studies might not apply, but I wonder about the two different types of the polio vaccine - is there issue with getting both?
The polio vaccines (live attenuated/killed virus) are entirely different to the COVID-19 ones and so not comparable. The issue with the live attenuated oral polio vaccine is it back mutates to wild type virus. So in areas of low prevalence, you have to switch to the injected killed virus vaccine and there is absolutely no problem in doing this - in fact most people over the age of 25 will have received both types of polio vaccine during their lifetime. As an aside, there was a lot of disagreement between Salk and Sabin on the most effective approach for polio vaccination. The reality is that using both vaccines is the ideal way to eradicate it, if we ever achieve that in our lifetimes (I live in hope that we will).

Just for the sake of clarity, there is absolutely no way the mRNA or adenoviral vector COVID-19 vaccines could lead to the production of SARS-COV-2 virus in the body following immunisation. It is impossible. Nonetheless, we don't know anything yet about the immunological dynamics of using multiple different types of COVID-19 vaccine in the same individual. Although I think it is extremely unlikely there would be any safety issues, clinical trials are still necessary to evaluate this approach with respect to efficacy. For example, using a chimpanzee vector followed by human vector could reduce problems associated with adenoviral vector immunity (hence the collaboration between Sputnik-V and AstraZeneca). I would certainly be wary of the risk of vector immunity from repeated administration of adenoviral vector vaccines. This is an area we know next to nothing about and we need good quality data on this if we are to use adenoviral vector platforms for vaccines on an annual basis.
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Old Dec 23, 2020, 2:26 am
  #86  
 
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Have we had any update on the efficacy of the vaccine at the half/full dosage schedule, and if this might be approved any time soon?
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Old Dec 24, 2020, 5:26 pm
  #87  
 
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Originally Posted by Dan1113
Have we had any update on the efficacy of the vaccine at the half/full dosage schedule, and if this might be approved any time soon?
A few posts up quoting the telegraph newspaper says the MHRA in the UK are looking to approve the AZ vaccine next week- 28/29th December was mentioned so we possibly should know more then.
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Old Dec 30, 2020, 2:47 am
  #88  
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Oxford University/AstraZeneca vaccine authorised by UK medicines regulator

The [UK] Government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca’s Covid-19 vaccine for use. This follows rigorous clinical trials and a thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness.

The Joint Committee on Vaccination and Immunisation (JCVI) will also publish its latest advice for the priority groups to receive this vaccine.

... the JCVI has advised the priority should be to give as many people in at-risk groups their first dose, rather than providing the required two doses in as short a time as possible.

Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer term protection.
https://www.gov.uk/government/news/o...ines-regulator
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Old Dec 30, 2020, 4:45 am
  #89  
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Here is the UK patient information leaflet, and below that is the information leaflet for heathcare professionals involved with vaccine delivery. Pages 7 and 8 of the HCP leaflet gives some interesting insights on impact by timing.

There are currently 2 manufacturing sites, one in Liverpool UK, the other in Nijmegen NL, but there are other manufacturing sites about to start, and these may result in slightly changed leaflets, but nothing consequential.
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Old Dec 30, 2020, 7:59 am
  #90  
 
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With two vaccines now, does this mean the speed of the roll-out doubles, as they can now vaccinate 2 million people a week, or is there a bottle neck in the number of people (doctors, nurses, etc.) who can give the vaccine? Wondering if the estimate I saw that had me getting the vaccine in July means that it could be sooner - closer to the end of Spring?
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