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Old 12-16-2020, 06:51 AM
 
Location: Swiftwater, PA
18,773 posts, read 18,158,423 times
Reputation: 14783

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Quote:
Originally Posted by ocpaul20 View Post
As of 27 hours ago the vaccine was still not approved. Even when approved in GB, it still will have to be approved by our FDA and our FDA might not be willing to cut any deals. So you might be jumping the gun. Wait and see what happens, it is not available now in the US.

 
Old 12-16-2020, 08:54 AM
 
Location: Greenville, SC
6,219 posts, read 5,948,149 times
Reputation: 12161
Quote:
Originally Posted by fisheye View Post
As of 27 hours ago the vaccine was still not approved. Even when approved in GB, it still will have to be approved by our FDA and our FDA might not be willing to cut any deals. So you might be jumping the gun. Wait and see what happens, it is not available now in the US.
There's already a law in place to exclude companies from lawsuits when there's a crisis so there's no special deal needed:

Quote:
The United States, however, already has a law to exclude tort claims from products that help control a public-health crises in the form of the 2005 Public Readiness and Emergency Preparedness, or PREP Act.
(source)

They're providing it at no profit to participating countries, so I think it's understandable that they're asking for those countries to cover any legal repercussions due to supposed side effects etc.

FDA's Accelerated Approval and Fast Track processes predate the pandemic so implying corners are somehow being cut and risk increased is misleading:

https://www.fda.gov/drugs/developmen...-process-drugs

The attention-grabbing headline in the article ocpaul linked suggests there's something shady and secret involved that a whistleblower "exposed" -- the processes here in the U.S. for approval are open and public, and the UK has similarly fast tracked by reducing dependence on EU approval:

https://www.euronews.com/2020/12/03/...ccine-approval

Sorry, I don't see anything shady or secret here. The Great Game India article uses words like "secret" and "shocking" multiple times, but as I said, the fact is the agreements as I read them are that the governments are agreeing to take on legal responsibility for any side effects in exchange for the low price of the drugs. The Great Game India article is further trying to imply that corners have been cut in the approval process -- reducing delivery time by looking for opportunities for parallelism in development and distribution logistics as we've done here in the US and cutting the EU bureaucracy from the approval process as the EU has done is not "cutting corners", it's good project management. Unless of course one believes more bureaucracy somehow improves quality of results and makes things more efficient.

As a consumer of a vaccine when it comes available, I don't see anything in all of this that's giving me concern, But then, I'm not an anti-vaxxer.
 
Old 12-16-2020, 02:01 PM
 
Location: Georgia, USA
37,120 posts, read 41,299,979 times
Reputation: 45186
Quote:
Originally Posted by ocpaul20 View Post
I was going to stop bothering to post these kind-of warning posts, but I came across this article quoting a piece in the UK Guardian saying that there should be resuscitation facilities everywhere where the vaccine is given. This is because the vaccine should not be administered to anyone who has a severe allergy reaction. That means an allergic reaction to nuts, penecillin, etc where they need to carry one of those anaphylactic shock pens.
Yes, that is the current recommendation, based on the experience of two adverse reactions in early vaccinees. Note that those two recovered with no long term effects.

Anyone can have a severe reaction to any vaccine, which is the reason that any place that administers vaccines of any kind is prepared to treat it.

Hopefully the two who had severe reactions will be tested to see what they reacted to, which is possibly one of the lipid ingredients. If so, in the future people with allergies could be tested before getting the vaccine.

Quote:
Originally Posted by ocpaul20 View Post
The US has a no fault system to compensate people who have adverse reactions to vaccines. Without that system we would have no vaccines, much less new ones, because the litigiousness here would put the makers out of business. Anyone who had any symptoms of any kind, caused by the vaccine or not, after getting a vaccine could sue in hopes of getting a settlement.
 
Old 12-16-2020, 05:52 PM
 
Location: PRC
6,957 posts, read 6,884,777 times
Reputation: 6532
Quote:
Yes, that is the current recommendation, based on the experience of two adverse reactions in early vaccinees. Note that those two recovered with no long term effects.
Now, who is misleading us? Are you saying there were only TWO people who had adverse reactions to the testing of these vaccines? It does sound like thats what you are saying.

Quote:
The frequency and severity of systemic AEs were higher in the younger than the older age groups. Within each age group, the frequency and severity of systemic AEs was higher after Dose 2 than Dose 1, except for vomiting and diarrhea, which was generally similar regardless of dose. For both age groups, fatigue, headache and new/worsened muscle pain were most common.
Actually, I heard that 2 people DIED from the testing group and 4 DIED from the placebo group. I do not think the governments would bother to make big deal out of only 2 people in a sample set of something like 38,000 having a reaction to the vaccine. Yet if some people died from their reactions, (6 out of 38,000) then I can see why they issued guidelines that people who are pregnant and/or super sensitive should not have the vaccine. The table which has a summary of results is in the link I placed in the post above.

Quote:
Israel’s Midaat Association responded to the report on the deaths, explaining that when vaccines are administered to at-risk populations “there may be unfortunate cases. One should not infer from this about the safety of the vaccine, but welcome the transparency required from the pharma companies in the drug approval process.”
The association noted that in large trials of tens of thousands of people, death can occur without any connection to the trial, but that companies such as Pfizer are required to report those deaths.

“According to the published data, six of the participants in the experiment died, two of whom received the vaccine and four of the control group,” said Dr. Uri Lerner, the scientific director for Midaat. “After an in-depth examination, no connection was found between the experiment and the cause of death.”
Source

I think it is important that people are informed properly and fairly, NOT just from one side or the other. The government and Big Pharma has more money at its disposal and so will try to spin things in such a way that people are persuaded to have the vaccine. (see the above quoted piece)

It should be an individual choice WITHOUT ANY INFLUENCE (including future limitations on travel or access to facilities) whether to have the vaccine or not.

You guys really cannot see the increase of control here?

Last edited by ocpaul20; 12-16-2020 at 06:07 PM..
 
Old 12-16-2020, 08:12 PM
 
Location: Georgia, USA
37,120 posts, read 41,299,979 times
Reputation: 45186
Quote:
Originally Posted by ocpaul20 View Post
Now, who is misleading us? Are you saying there were only TWO people who had adverse reactions to the testing of these vaccines? It does sound like thats what you are saying
No, I am saying the recommendation for people with severe allergies to not take the vaccine at this time is based on two people having severe allergic reactions to that vaccine, and they were not in clinical trials. They were among the first to get it after it was authorized for use for the general public.

All vaccines can have adverse reactions. Most are the usual sore arms, fevers, muscle aches, and fatigue for a day or two. They go away without treatment except for OTC meds to help with discomfort. The symptoms are caused by the immune system doing its job.


Quote:
Actually, I heard that 2 people DIED from the testing group and 4 DIED from the placebo group. I do not think the governments would bother to make big deal out of only 2 people in a sample set of something like 38,000 having a reaction to the vaccine. Yet if some people died from their reactions, (6 out of 38,000) then I can see why they issued guidelines that people who are pregnant and/or super sensitive should not have the vaccine. The table which has a summary of results is in the link I placed in the post above.
No, those six did not die "from their reactions". The four in the placebo group only got shots of salt water.

None of the deaths were due to the vaccine. The deaths have nothing to do with the recommendations about pregnancy or allergies. The pregnancy situation is due to there being no pregnant trial participants. The allergy recommendation is as above.

https://www.fda.gov/media/144246/download#page=50

"Details of the 6 reported deaths among all enrolled participants include:
• One participant in the older BNT162b2 group experienced an SAE [serious adverse event] of arteriosclerosis and died 3 days after Dose 1.
• One participant in the older BNT162b2 group experienced an SAE of cardiac arrest 60 days
after Dose 2 and died 3 days later.
• One participant in the younger placebo group experienced an SAE of unevaluable event
(unknown of unknown origin; no additional information currently available at the time of this
report) 8 days after Dose 1 and died the same day.
• One participant in the older placebo group experienced an SAE of hemorrhagic stroke
15 days after Dose 2 and died the next day.
• One participant in the younger placebo group experienced an SAE of death (cause unknown;
no additional information currently available at the time of this report) 34 days after Dose 2.
• One participant in the older placebo group experienced an SAE of myocardial infarction 16
days after Dose 1 and died the same day."


Quote:
I think it is important that people are informed properly and fairly, NOT just from one side or the other. The government and Big Pharma has more money at its disposal and so will try to spin things in such a way that people are persuaded to have the vaccine. (see the above quoted piece)

It should be an individual choice WITHOUT ANY INFLUENCE (including future limitations on travel or access to facilities) whether to have the vaccine or not.

You guys really cannot see the increase of control here?
Sure, it is an issue of control: control of an extremely contagious, potentially fatal viral infection.
 
Old 12-16-2020, 08:53 PM
 
Location: Greenville, SC
6,219 posts, read 5,948,149 times
Reputation: 12161
Quote:
Originally Posted by ocpaul20 View Post
I think it is important that people are informed properly and fairly, NOT just from one side or the other. The government and Big Pharma has more money at its disposal and so will try to spin things in such a way that people are persuaded to have the vaccine. (see the above quoted piece)

It should be an individual choice WITHOUT ANY INFLUENCE (including future limitations on travel or access to facilities) whether to have the vaccine or not.

You guys really cannot see the increase of control here?
I agree with all of this, and I agree that governments (here in the U.S., particularly at the state and city level) are using this pandemic as an opportunity to exert control. I'm a libertarian, and will seriously oppose our government's trying to force people to get it, or have an ID you have to use to travel. I'll also refuse to go along with a lockdown imposed by petty bureaucrats on a power trip who don't even follow their own policies. But I will take the vaccine when available because I'm an at-risk individual and spin aside, I believe the vaccines are being developed, manufactured, and distributed in a safe manner. I'll take whatever risk is involved rather than spending the rest of a short life in misery on a respirator.
 
Old 12-17-2020, 09:06 AM
 
Location: New Jersey
4,183 posts, read 5,067,201 times
Reputation: 4233
Quote:
Originally Posted by Vasily View Post
...I'm a libertarian, and will seriously oppose our government's trying to force people to get it, or have an ID you have to use to travel...
Do you similarly oppose the use of passports ?
 
Old 12-17-2020, 11:16 AM
 
Location: Greenville, SC
6,219 posts, read 5,948,149 times
Reputation: 12161
Quote:
Originally Posted by JG183 View Post
Do you similarly oppose the use of passports ?
Within the United States, yes. I shouldn't need an ID to go from one state to another.
 
Old 12-17-2020, 03:56 PM
 
Location: New Jersey
4,183 posts, read 5,067,201 times
Reputation: 4233
Once again, to get this thread back on topic.

https://www.reuters.com/article/heal...-idUSKBN28Q2IJ

What a waste -- over 1 year after the lab leak, "investigators" are being allowed in.
The CCP has long since erased all evidence
 
Old 12-17-2020, 07:43 PM
 
Location: PRC
6,957 posts, read 6,884,777 times
Reputation: 6532
Quote:
Originally Posted by JG183 View Post
Once again, to get this thread back on topic.

https://www.reuters.com/article/heal...-idUSKBN28Q2IJ

What a waste -- over 1 year after the lab leak, "investigators" are being allowed in.
The CCP has long since erased all evidence
If the situation was different and if another country was suspected of releasing the virus, do you think those other countries would open up their Class 4 biological lab to "international" investigators to look around and see what they were doing? Dont be so naive.

As I am sure we have said before, the Wuhan lab partnered with other countries including the US to investigate viruses. If it was unsafe to do that, why would these other countries go ahead with the partnership? Maybe because there are benefits to doing research in different countries such as a more liberal set of rules for example. I am sure there are other instances of partnerships at governmental level, at university level and at a business level too - thats the way the modern world works and it is only government posturing which seems to divide countries.

I suppose you think an individual Communist has different goals, aims, and wishes to anyone else? Of course not. From a government's point of view, If there were no "baddies" we could not have wars which keep the bankers making profits and keeps the population focused on disasters.
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