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Will you take the Vaccine coming out next week


Will you take the Vaccine coming out next week  

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  1. 1. Will you take the Vaccine coming out next week



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Fauci apologises for saying UK 'rushed' vaccine

https://www.bbc.co.uk/news/world-us-canada-55177948

 

The regulator said that Covid vaccines were being developed "in a coordinated in a way that allows some stages of this process to happen in parallel to condense the time needed" adding that it did not mean that "the expected standards of safety, quality and effectiveness" had been bypassed.

"Any vaccine must undergo robust clinical trials in line with international standards, with oversight provided by the Medicines and Healthcare products Regulatory Agency," it said.

"No vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met," the MHRA added.

On Thursday, the UK's deputy chief medical officer Prof Jonathan Van-Tam told the BBC he was "very confident" in the MHRA.

He said there was more than "100 years of medical experience" between the UK regulator and the committee advising which groups of people are vaccinated first.

Dr Fauci's remarks came as the US surpassed 14 million Covid-19 infections in total, with a recorded 276,325 deaths.

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https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-and-modernas-95-effective-vaccines-lets-be-cautious-and-first-see-the-full-data/

Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—let’s be cautious and first see the full data

In the United States, all eyes are on Pfizer and Moderna. The topline efficacy results from their experimental covid-19 vaccine trials are astounding at first glance. Pfizer says it recorded 170 covid-19 cases (in 44,000 volunteers), with a remarkable split: 162 in the placebo group versus 8 in the vaccine group. Meanwhile Moderna says 95 of 30,000 volunteers in its ongoing trial got covid-19: 90 on placebo versus 5 receiving the vaccine, leading both companies to claim around 95% efficacy.

Let’s put this in perspective. First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%. Second, these results refer to the trials’ primary endpoint of covid-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly). Those still remain unknown. Third, these results reflect a time point relatively soon after vaccination, and we know nothing about vaccine performance at 3, 6, or 12 months, so cannot compare these efficacy numbers against other vaccines like influenza vaccines (which are judged over a season). Fourth, children, adolescents, and immunocompromised individuals were largely excluded from the trials, so we still lack any data on these important populations.

I previously argued that the trials are studying the wrong endpoint, and for an urgent need to correct course and study more important endpoints like prevention of severe disease and transmission in high risk people. Yet, despite the existence of regulatory mechanisms for ensuring vaccine access while keeping the authorization bar high (which would allow placebo-controlled trials to continue long enough to answer the important question), it’s hard to avoid the impression that sponsors are claiming victory and wrapping up their trials (Pfizer has already sent trial participants a letter discussing “crossing over” from placebo to vaccine), and the FDA will now be under enormous pressure to rapidly authorize the vaccines.

But as conversation shifts to vaccine distribution, let’s not lose sight of the evidence. Independent scrutiny of the underlying trial data will increase trust and credibility of the results. There also might be important limitations to the trial findings we need to be aware of.

Most crucially, we need data-driven assurances that the studies were not inadvertently unblinded, by which I mean investigators or volunteers could make reasonable guesses as to which group they were in. Blinding is most important when measuring subjective endpoints like symptomatic covid-19, and differences in post-injection side-effects between vaccine and placebo might have allowed for educated guessing. Past placebo-controlled trials of influenza vaccine were not able to fully maintain blinding of vaccine status, and the recent “half dose” mishap in the Oxford covid-19 vaccine trial was apparently only noticed because of milder-than-expected side-effects. (And that is just one of many concerns with the Oxford trial.)

In contrast to a normal saline placebo, early phase trials suggested that systemic and local adverse events are common in those receiving vaccine. In one Pfizer trial, for example, more than half of the vaccinated participants experienced headache, muscle pain and chills—but the early phase trials were small, with large margins of error around the data. Few details from the large phase 3 studies have been released thus far. Moderna’s press release states that 9% experienced grade 3 myalgia and 10% grade 3 fatigue; Pfizer’s statement reported 3.8% experienced grade 3 fatigue and 2% grade 3 headache. Grade 3 adverse events are considered severe, defined as preventing daily activity. Mild and moderate severity reactions are bound to be far more common.

One way the trial’s raw data could facilitate an informed judgment as to whether any potential unblinding might have affected the results is by analyzing how often people with symptoms of covid-19 were referred for confirmatory SARS-CoV-2 testing. Without a referral for testing, a suspected covid-19 case could not become a confirmed covid-19 case, and thus is a crucial step in order to be counted as a primary event: lab-confirmed, symptomatic covid-19. Because some of the adverse reactions to the vaccine are themselves also symptoms of covid-19 (e.g. fever, muscle pain), one might expect a far larger proportion of people receiving vaccine to have been swabbed and tested for SARS-CoV-2 than those receiving placebo.

This assumes all people with symptoms would be tested, as one might expect would be the case. However the trial protocols for Moderna and Pfizer’s studies contain explicit language instructing investigators to use their clinical judgment to decide whether to refer people for testing. Moderna puts it this way:

It is important to note that some of the symptoms of COVID-19 overlap with solicited systemic ARs that are expected after vaccination with mRNA-1273 (eg, myalgia, headache, fever, and chills). During the first 7 days after vaccination, when these solicited ARs are common, Investigators should use their clinical judgement to decide if an NP swab should be collected.

This amounts to asking investigators to make guesses as to which intervention group patients were in. But when the disease and the vaccine side-effects overlap, how is a clinician to judge the cause without a test? And why were they asked, anyway?

Importantly, the instructions only refer to the first seven days following vaccination, leaving unclear what role clinician judgment could play in the key days afterward, when cases of covid-19 could begin counting towards the primary endpoint. (For Pfizer, 7 days after the 2nd dose. For Moderna, 14 days.)

In a proper trial, all cases of covid-19 should have been recorded, no matter which arm of the trial the case occurred in. (In epidemiology terms, there should be no ascertainment bias, or differential measurement error). It’s even become common sense in the Covid era: “test, test, test.” But if referrals for testing were not provided to all individuals with symptoms of covid-19—for example because an assumption was made that the symptoms were due to side-effects of the vaccine—cases could go uncounted.

Data on pain and fever reducing medicines also deserve scrutiny. Symptoms resulting from a SARS-CoV-2 infection (e.g. fever or body aches) can be suppressed by pain and fever reducing medicines. If people in the vaccine arm took such medicines prophylactically, more often, or for a longer duration of time than those in the placebo arm, this could have led to greater suppression of covid-19 symptoms following SARS-CoV-2 infection in the vaccine arm, translating into a reduced likelihood of being suspected for covid-19, reduced likelihood of testing, and therefore reduced likelihood of meeting the primary endpoint. But in such a scenario, the effect was driven by the medicines, not the vaccine.

Neither Moderna nor Pfizer have released any samples of written materials provided to patients, so it is unclear what, if any, instructions patients were given regarding the use of medicines to treat side effects following vaccination, but the informed consent form for Johnson and Johnson’s vaccine trial provides such a recommendation:

“Following administration of Ad26.COV2.S, fever, muscle aches and headache appear to be more common in younger adults and can be severe. For this reason, we recommend you take a fever reducer or pain reliever if symptoms appear after receiving the vaccination, or upon your study doctor’s recommendation.”

There may be much more complexity to the “95% effective” announcement than meets the eye—or perhaps not. Only full transparency and rigorous scrutiny of the data will allow for informed decision making. The data must be made public.

Peter Doshi, associate editor, The BMJ.

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From what I have seen up to now this is a topic where nuance can not exist. 

If I was in an at risk group I would 100% get the vaccine straight away. As I am not in the at risk groups I likely will be back of the queue; which is fine by me as I would really like to see how this works at scale over the medium term. 

The mRNA vaccines look an extremely promising breakthrough though. Let us hope there are no surprises.

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Voted yes, were I not a healthy 33 year old I'd be first in line. It's a miracle they've got one out so quickly, we've never vaccinated against a coronavirus in history I understand and the mRNA technology is new, people were saying a vaccine might never come so to be here so quickly is a feat of modern science indeed.

I'm far from a vaccine expert but it seems mad to me that all 3 that were in Phase III have been successful, people were also saying I recall that it's about a 10% (or at least very low) success rate from phase I to III so I was banking on their being 11 or so that far in the pipeline.

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Given my age is under 50 it will be well, well into next year before I will be offered a vaccine.

Will I take it?  Yes.  

Why?  Principally so that I reduce my chances of catching COVID 19 and passing it to my elderly relatives and killing them.  But also because it looks like a nasty illness and I'd rather not be in bed feeling terrible for a fortnight either.

What about the fact it's been approved faster than normal?  All my friends who work in healthcare have told me all sorts of reassuring things along these lines like:
- it's had a lot of resources thrown at it
- normally one source of delay is that they struggle to get volunteers for drugs trials, and they've been inundated
- COVID19 is actually quite easy to build a vaccine against compared to a lot of diseases

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What I find very odd though is that people seem more frightened of the [UNKNOWN] long term effect of the vaccine, than the [ALSO UNKNOWN!] long term effects of COVID19.

Some people's false logic seems to be "I'm only 35 so I KNOW the virus isn't dangerous to me, whereas who knows how dangerous this vaccine is", despite not seeing to appreciate that we also don't know the long term effects of COVID either beyond a few months.

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 I did actually volunteer for a trial which I assumed would be high risk, so I'm not risk averse or anti vaxxer per se.

 There is a big difference between volunteering for something one knows to be dangerous and even life threatening but for altruistic purposes (and trouser some cash), as opposed to reluctantly complying with something that is considered "safe" but does not require 100% population coverge to be effective...in my mind anyway. 

 

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https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-and-modernas-95-effective-vaccines-lets-be-cautious-and-first-see-the-full-data/

... leading both companies to claim around 95% efficacy.

Let’s put this in perspective. First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%. populations.

But as conversation shifts to vaccine distribution, let’s not lose sight of the evidence. Independent scrutiny of the underlying trial data will increase trust and credibility of the results. There also might be important limitations to the trial findings we need to be aware of.I

Most crucially, we need data-driven assurances that the studies were not inadvertently unblinded, by which I mean investigators or volunteers could make reasonable guesses as to which group they were in

One way the trial’s raw data could facilitate an informed judgment as to whether any potential unblinding might have affected the results is by analyzing how often people with symptoms of covid-19 were referred for confirmatory SARS-CoV-2 testing. Without a referral for testing, a suspected covid-19 case could not become a confirmed covid-19 case, and thus is a crucial step in order to be counted as a primary event: lab-confirmed, symptomatic covid-19. Because some of the adverse reactions to the vaccine are themselves also symptoms of covid-19 (e.g. fever, muscle pain), one might expect a far larger proportion of people receiving vaccine to have been swabbed and tested for SARS-CoV-2 than those receiving placebo.

In a proper trial, all cases of covid-19 should have been recorded, no matter which arm of the trial the case occurred in. (In epidemiology terms, there should be no ascertainment bias, or differential measurement error). It’s even become common sense in the Covid era: “test, test, test.” But if referrals for testing were not provided to all individuals with symptoms of covid-19—for example because an assumption was made that the symptoms were due to side-effects of the vaccine—cases could go uncounted.

Neither Moderna nor Pfizer have released any samples of written materials provided to patients, so it is unclear what, if any, instructions patients werecrutiny of the data will allow for informed decision making. The data must be made public.

Peter Doshi, associate editor, The BMJ.

 WTF?  Amazed that ALL participants were not tested weekly,even the Danmsak 3000 trial they did that. What possible reason not to bother weekly testing all subjects?

 By the same author, seems a lack of elderly,children and minorites included in testing.

 Also a PCR test +ve isn't the same as a covid 'event', side effects can be quite severe and temporarily incapacitating. Results of just a couple of hundred events becomes policy for tens of millions. 

 I question the methodolgy here and it's surrounding secrecy.  

In a September interview Medscape editor in chief Eric Topol pondered what counts as a recorded “event” in the vaccine trials. “We’re not talking about just a PCR [polymerase chain reaction test]-positive mild infection. It has to be moderate to severe illness to qualify as an event, correct?” he asked.8

https://www.bmj.com/content/371/bmj.m4037

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I will take it when I can, but will continue to take precautions even after I’ve had it, until a significant proportion have had it (e.g 60%) or the case rate has fallen significantly.

In case it doesn’t work for me.

I am not worried about the vaccine, I am worried about complacency caused by it.

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No rush, not against it, are kind of pleased will be thousands more offered it in front of me......

Bit like having a seat number on a plane and sitting back at check-in whilst everyone gets up rushes to get on, standing, waiting and queuing all bunched up together......knowing the plane won't leave without you, and have a guaranteed seat.;)

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I'm a bit hesitant to take the moderna or Pfizer vaccine as both are from private companies. Plus the UK government has given legal immunity on the Pfizer vaccine which concerns me.

I would take other Oxford vaccine, even though it had a 70% success rate, it seems to be the more trustworthy option plus it should be refined and improved over the next few months.

Having said that, I  not sure if I'll be given the choice of which vaccine to take.

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I voted no. Not because I won't take it but because I won't be seeking it out necessarily. I'll be right at the back of the queue due to being 33 and healthy, but unless they send me a letter urging me to book an appointment, I won't be bothering. 

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I'm a bit hesitant to take the moderna or Pfizer vaccine as both are from private companies. Plus the UK government has given legal immunity on the Pfizer vaccine which concerns me.

I would take other Oxford vaccine, even though it had a 70% success rate, it seems to be the more trustworthy option plus it should be refined and improved over the next few months.

Having said that, I  not sure if I'll be given the choice of which vaccine to take.

You do realise the Oxford vaccine is astrazenica 

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 WTF?  Amazed that ALL participants were not tested weekly,even the Danmsak 3000 trial they did that. What possible reason not to bother weekly testing all subjects?

 By the same author, seems a lack of elderly,children and minorites included in testing.

 Also a PCR test +ve isn't the same as a covid 'event', side effects can be quite severe and temporarily incapacitating. Results of just a couple of hundred events becomes policy for tens of millions. 

 I question the methodolgy here and it's surrounding secrecy.  

In a September interview Medscape editor in chief Eric Topol pondered what counts as a recorded “event” in the vaccine trials. “We’re not talking about just a PCR [polymerase chain reaction test]-positive mild infection. It has to be moderate to severe illness to qualify as an event, correct?” he asked.8

https://www.bmj.com/content/371/bmj.m4037

If you give the tests to healthy adults with no diseases do not give to children, and the two main groups that are seriously affected like the elderly and patients with diabetes then i am not surprised that they are getting 90%+

 

 

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I will take it when I can, but will continue to take precautions even after I’ve had it, until a significant proportion have had it (e.g 60%) or the case rate has fallen significantly.

In case it doesn’t work for me.

I am not worried about the vaccine, I am worried about complacency caused by it.

I’ll be doing the same as you. Never doubt on the ability of anti-mask anti-vaccine bed-wetters to mess things up for everyone else. 

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I'm a bit hesitant to take the moderna or Pfizer vaccine as both are from private companies. Plus the UK government has given legal immunity on the Pfizer vaccine which concerns me.

I would take other Oxford vaccine, even though it had a 70% success rate, it seems to be the more trustworthy option plus it should be refined and improved over the next few months.

Having said that, I  not sure if I'll be given the choice of which vaccine to take.

The government will give legal immunity to all the vaccine companies.

It's nothing to do with risk simply best value for money. If the companies are required to carry the risk they will increase the price of the vaccine to cover the cost of insuring it, which will include profits for the insurance companies and their mark up for handling the process.    

Edited by Confusion of VIs
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I'm in an at risk group because of the drugs I'm taking so yes without a doubt. The group is still only about five ok the list so probably March.

Hopefully won't have to worry so much when I go out 

Also had a flu jab three months ago.

Edited by spacedin
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Given the roll out is the at risk people first it's likely the casualty rates will drop early on (if it works of course) it maybe the urgency to get a majority take up goes away as the single biggest problem get solved.

If it doesn't work with at risk people then the less/not at risk majority won't be interested anyway because it doesn't work🤔

I do wonder if cv19 would be over before less/not at risk even get the chance anyway.

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Given the roll out is the at risk people first it's likely the casualty rates will drop early on (if it works of course) it maybe the urgency to get a majority take up goes away as the single biggest problem get solved.

If it doesn't work with at risk people then the less/not at risk majority won't be interested anyway because it doesn't work🤔

I do wonder if cv19 would be over before less/not at risk even get the chance anyway.

If it doesn't work with at risk groups, possible as vaccines work less well with people whose immune systems are already weakened, the only way to protect them would be for enough the people it does work on to take it to achieve herd immunity.  

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