Kilkis wrote:The only significant risk that has been taken with any of the current vaccines is financial.
In normal times nobody would significantly finance the development of a vaccine until there was some evidence it would work. This time dozens of candidate vaccines received funding, both commercial and public, with very little evidence at all just some solid ideas.
In normal times nobody would move through the different phases before the previous phases were full evaluated. This time, once safety was established and some evidence that it might succeed, the decision to move to the next phase was taken.
In normal times it would take an inordinate length of time to recruit enough volunteers to participate in trials. Because of the world wide threat of this pandemic and the damage it was obviously causing to both public health and worldwide economies volunteers were recruited at a rate far higher than usual. High enough to run many trials in parallel
In normal times the numbers of active cases and their density in the general population would be so low that it would take a long time for enough people to became infected either in the vaccine group or the placebo group. That means that it normally takes a very long time before the trials have enough cases to evaluate how efficacious the vaccine is. This time the intensity of the spread of the disease is so high cases are produced very quickly and hence the efficaciousness of the vaccine can be evaluated more quickly.
In normal times nobody would start manufacturing a vaccine until it had been through all the trials and obtained approval. Because of the urgency, manufacturing started as soon as the formulation of the vaccine was known and very early trials showed that it had a good chance of succeeding.
In normal times regulators would not start evaluating data until trials were complete and all data presented. This time regulators engaged with the vaccine manufacturers at an early stage and carried out some evaluation in parallel with each stage.
If in the end any vaccine failed because it was shown to be unsafe or not to be efficacious in large scale trials then all that money, time and energy would have been wasted. That was the risk and that is what allowed the process to move quickly. The evaluation of risk to health and efficaciousness has been just as thorough as any other trial. That is scientific reality.
TweetTweet wrote:COVID-19 vaccination is likely to be the biggest mass-medication program ever unleashed on the public. We have a right to know the inside track on what’s really going on. Let’s demand vaccine transparency.
TweetTweet wrote:•Will vaccines be needed? Yes Could the virus burn out before vaccines are ready? No
•Will the vaccines work? Yes We need proper efficacy studies. We have them Even normal Phase I to III studies that take several years haven’t accurately predicted effectiveness in the real world. Yes they have What about mutations? Either the vaccine works as is, most probable outcome, or we re-engineer periodically like flu vaccines.
•Will the vaccines be safe? How can you tell in the space of a few months if the vaccine increases the risk of autoimmune diseases, autism or Alzheimer’s? Because it's been tested on tens of thousands of people.
•How will the commercial vaccines be made? Using the same production methods as used to produce trial samples but scaled up. It’s highly likely that genetic engineering technology will be used. For example, the mRNA vaccines that rely on the body being instructed to produce copies of virus proteins. Are you OK with that ethically? Yes Will you be told if your vaccine is genetically engineered? The information is published on each vaccine type
•When will vaccines be released? Already in the UK. Just started today in the USA. After EMA approval for Greece. Probably by 29 December or possibly 23 December. It could be as early as the start of 2021. Sooner in some countries later in others.
•What will be added to help activate and preserve the vaccine? Aluminum, a nerve poison, is a likely adjuvant. As far as I know mRNA vaccines do not employ an adjuvant/
•What will be the exact composition of each vaccine? Will there be any residues from animal tissues or contaminants? No or at least not in any meaningful amounts. Quality control of production is part of the vaccine approval process. Each batch is independently tested.
•How many need to be vaccinated? Bill Gates wants nearly everyone vaccinated, the World Health Organization is suggesting 70 percent of the global population, but some scientists suggest as little as 20 percent herd immunity from naturally acquired infections can hold the virus in check, as it does with another coronavirus, the one causing the common cold. The 70 % figure is based on an R0 of about 3. IF 70 % are immune Reff drops just below 1 and the virus cannot accelerate. A higher figure would be better. The 20 % figure is based on the hypothesis that a small number of people do most of the spreading. Empirical evidence demonstrates that it doesn't work. R0 = 3 is an average across the population and hence takes into account that some spread more than others.
•How many commercial vaccines will be released? Most pundits are suggesting at least two. I would guess more than that. I think EMA and MHRA are assessing at least 4 then there are vaccines being developed elsewhere in the world. The Russian vaccine is already in use and I think there are several being developed in China.
•How many doses will be needed or recommended for different population groups? It’s likely from experience with previous coronavirus vaccines (SARS, MERS) that immunity won’t last much more than 12 months that's clever since there are currently no vaccines for SARS or MERS in most people, so annual vaccination is likely to be recommended. There may even be a need for boosters. All the current candidates require 2 doses initially with some, i.e. 2/3/4, weeks in between. We will only know if annual boosters are needed when a large number of people have been vaccinated.
•What delivery systems will be used? Prefilled single-dose syringes, single or multidose vials, nasal spray and micropatches are some of the options being considered. The ones being used now are vials. I am not certain if they are single dose or multi dose. It may vary from vaccine to vaccine.
•Will the data be transparent? Yes. Peer reviewed papers are starting to be published. Not unless we raise a stink! They may be talking about trying to be transparent—but let them answer these 15 questions and then let’s think about calling the approach transparent.
•Will vaccination be mandatory, or will rights be affected for those not vaccinated? We just don’t know. The chances are that some countries or states will likely take the mandatory route. As far as I am aware in the UK, the EU and the USA vaccination will be voluntary. It is possible that some restrictions may be placed on non-vaccinated people in some countries. That is up to individual governments to decide.
•Will the public be informed about vaccine industry indemnity and compensation claims for those injured? Yes. It may be different in different countries and depends on the regulatory regime. The UK has decided to indemnify the manufacturers and use a government compensation scheme for anyone who is damaged. They haven’t been before The UK has used the same scheme for previous vaccines—so let’s make it happen this time. What have they been trying to hide from us?
•Who will gain financially from mass vaccination? They may call it nonprofit, but that’s only in the short-term. The likes of Bill Gates are set to make billions if COVID-19 vaccines are added to the vaccination schedule in most countries. Bill Gates does not manufacture vaccines so I am not sure how he will make a profit? He makes donations to vaccine manufacturers to assist them to develop vaccines and he makes donations to the WHO so those vaccines can be made available to poor countries.
COVID-19 vaccination is likely to be the biggest mass-medication program ever unleashed on the public. We have a right to know the inside track on what’s really going on. Let’s demand vaccine transparency. You can find out more about this issue on our website, http://www.anhinternational.org.
There and on our YouTube channel, you’ll also find our short film, The Uncertain Promise of a Covid Vaccine: What We’re Not Being Told. Furthermore, you can download a copy of our Vaccine Transparency Manifesto and send it to your elected representatives, asking them to get behind it—for the true good of the public.
TweetTweet wrote:Your post is a long list of meaningless nonsense wrapped up in a mistaken appearance of sensible words.
Perhaps you can answer the posed questions?
Keltz wrote:...Good. We are talking at the same level now. If you want to know such searching questions on the vaccination of Covid-19 I would suggest you go to the established sources of medical and governmental opinion and knowledge...
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