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before they start the vaccine program, which, hopefully will be tomorrow

They most likely won't have fda approval by then, but in any case fda approval for both Pfizer and Moderna should be very soon, within a week.

Which vaxes are they discussing? What channel is the hearing on? Maybe I can find it on a vpn channel.....

Which vaxes are they discussing? What channel is the hearing on? Maybe I can find it on a vpn channel.....

I linked the hearing from the CNN website.I couldn't find it on TV.

I think they're just discussing the Pfizer vaccine.

[This message edited by number4 at 3:15 PM, December 10th (Thursday)]

LOL... one of these advisory committee members is streaming from her bedroom; well, I assume it's her bedroom! But there's definitely a headboard and side table with a lamp on it.

And we have another streaming from his bedroom.

Very interesting discussion.

Lots of discussion about whether to approve EUA for 16-17 year olds. It wouldn't surprise me if this gets EUA for 18 and older based on what I'm hearing.

Voting now... then each member (23 of them) has an opportunity to speak to their vote.

The question they're voting on is: Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?

There are so many concerns about giving this to 16 and 17 y/o due to minimal data, that I think this may not pass and they will restructure the question and vote again. Just my two cents.

This is just an advisory committee, but they voted 17 yes, 4 no, and one abstain.

The FDA can take this information, and decide if they want to accept this as is or change the language.

I am FOR the vaccine.

So: snafu..... According to Pfizer's criteria they should have never received the vax. The UK needs to tighten up on their distribution procedures.

According to Sanjay Gupta on CNN, this is not entirely correct as far as they should have never received the vaccine.

He said that many people who know they have issues with allergies can still get the vaccine but they would have to take a dose of Benadryl ahead of time... and I think that he said there were other options too.

(I don't remember the details because I don't deal with human medicine and I don't have allergies and neither do my kids... so I watched for curiosity only... I didn't plan on having this conversation )

Ergo, to anyone reading this, make sure that you are upfront with medical history before you get this (or any) vaccine. Definitely don't listen to me or to a doctor on TV...

So, yea, pharmaceuticals start ramping up production long before the final FDA approval; is it risky? Could be, but the clinical trials/studies have been so favorable to that point, that they're willing to take that risk.

This is where (part of) Operation Warp Speed came into play. The US Govt agreed to pay for 100M doses of the Pfizer (and the same for other potential vaccines) back in the summer before there was Phase III data. This was a gamble, but it allowed the companies to invest in production of the vaccine ahead of approval. If the vaccine trials failed, the brunt of the financial loss would have been on the Gov, not the company.

I'm in Pfizer's Phase III trial. Don't know if I got the vaccine or the placebo, but there is discussion about unmasking us so those who didn't get it would be able to (before the end of the two year trial).

If I didn't get it in the trial, I'll be the first in line to get it. And if I did get it, I'll sign up to get it again when my antibodies go away (as an insurance policy).

The side effects are rare, and at most made folks feel crappy for a day. That's a hell of a lot better than being in a hospital for a week, or on a vent or dying. I'll take a sore arm, chills, muscle aches for a day over dying every day...and twice on Sundays.

idk where Sanjay Gupta got his info, but I got mine from Pfizer's own indications, which were obviously aimed at being very conservative given that typically people are only warned not to take it if allergic to any ingredients in the vax. Pfizer went the extra mile on this, warning against people with ANY allergies getting it and making sure to take it at a place with resuscitation facilities.

Those instructions somehow didn't trickle down to the vax givers and 2 NHS nurses who were vaxed had reactions and used their epi-pens. The fact that they already had epi-pens on them suggests a history of allergic reactions, and indicates Pfizer's info was not followed to the letter.

So yeah, snafu.

WornDown - they are still trying to figure out what to do about people who got the placebo. Typically, they would be followed for 1-2 years (still in placebo group) to have a group for comparison to the vaxed group. However, it could be considered unethical to withhold an effective treatment from people who could benefit from it.

There are a few options:

1. break the blind and give placebo patients the vax. Scientists don't want to do this because it will reduce the amount and the validity and therefore value of future data from the rest of the trial.

2. Dr. Fauci suggested a valid and ethical way of proceeding: turn it into a crossover trial, ie give the placebo to the original vax group and vice-versa. The trial could have originally been planned that way and still be valid and ethical. This issue is that the original design is expected to be more powerful for estimating the effect of the vaccine compared to placebo. So this would be a way of 'rescuing' the trial from the ethical and validity perspectives, with the 'cost' coming in terms of loss of power.

3. Try to force people to stay in their assigned groups. Again, this suffers from the ethical concern that a treatment is being withheld from people who could benefit from it (Tuskgegee anyone??). Plus I'm sure that several individuals have already figured out which group they are in, so the study is not completely blinded anymore and people who got the placebo may be inclined to drop out of the trial and get the vax. This will complicate any further data analysis.

4. Try to ameliorate dropout by doing a nested second study using just the placebo group. Give some proportion the vax and the rest the placebo. This doesn't need to be 50-50, the percent getting the vax could be higher by some amount, based either on expected power or on an ad hoc basis or on some other criterion (eg, 75-25, or 2-1, or whatever).

There could be other options as well. Of these options, the best way to preserve the validity and ethics of the trial are 2 and 4.

Trials do end up getting stopped early all the time. The usual criterion for this is that the difference between treatment and placebo/control reaches a sufficiently high value at some point in time that it would be unethical to continue the trial.

It is problematic to stop a trial early if the placebo group is doing much better than the treatment: this is because the effect estimate in the middle of the study will likely be biased unless there is sufficient (statistical) POWER at that point in the study. This is an unusual situation, since studies are designed to have good power at the END of the study, not the middle. However, it does happen.

An example is the Women's Health Initiative and other HRT studies provide notable examples - these were stopped due to specific types of HRT being associated with increased incidence of breast cancer, blood clots in the lungs, strokes, and heart attacks/coronary events). The trials were stopped.

On the other hand, if the treatment is much better than the control then some may consider it unethical to not provide the control individuals with the treatment.

When a clinical trial is stopped early like this, it is called 'stopped early for benefit' (or sometimes a truncated randomized controlled trial). It is scientifically advised to avoid this, becase the treatment effect tends to be overestimated compared to what it would be were the trial carried out to the end. Why is this bad? Because any NEGATIVE (side) effects may not have had a sufficient time to show up. So the overall performance of the treatment will be exaggerated.

They have just announced the approval of the vaccine. Administration of the vaccine will begin soon.

Reading here, I am in awe of the knowledge of my fellow SI-ers. To he able to come here and get this quality of information regarding this and so many other topics is amazing.

ZMW, I am personally familiar with some of the trial scenarios you describe. I have participated in two drug trials I'm not sure what the first one was considered, but I was administered the real vaccine. They called it and urged everyone to get the vaccine.

The second was a double blind drug trial to prove or disprove a certain drug's efficacy in preventing disease. I needed to stop half-way through that trial as I experienced extreme side effects, so I was sure I had received the drug, not a placebo. A woman who was participating with me had the drug but had no side effects. Go figure. It was called early and unblinded because it had been proven.

I contacted the local people administering a COVID Vaccine to participate once again, but that one was looking more for people who were out and about with more of a potential to be exposed. By the time other trials came here, I had changed my mind about traveling to participate.

My daughter carries a epi pen. Her reason is due to blueberries and strawberries, The smell can make her throat close. I don’t put a lot of credence in the NHS nurses carrying epi pens, no knowledge of what they are allergic to.

Can someone explain this to me?

When I get blood drawn, I can watch it - haven't always been able to do this, but I can watch the needle after it's inserted into my vein, and watch the blood come out of my arm, no problem. I think it's fascinating.

But, for the last few days, on all the news channels, as the vaccine has been rolled out across the world, and we are seeing videos of people getting their shots, I have to look away. It bothers me to see a needle going into someone else's arm. Come to think of it, when I get my own flu shot, I can't look.

Why does it bother me to watch a needle with some serum go into an arm, but it doesn't bother me to watch blood coming out of my arm??

The needles sure look like they go in deep.

But it's a GOOD day. In more ways than one it's a great day. I found myself feeling hopeful today.

Just saw this reposted on FB from a friend who works at John Hopkins from Dr. Tom Frieden:

An mRNA vaccine doesn't actually contain the virus itself. Think of it as an email sent to your immune system that shows what the virus looks like, instructions to kill it, and then - like a Snapchat message - it disappears. Amazing technology.

So my Rheum confirmed I can have the vaccine!!!!

So Now I'm running around with my sleeve rolled up looking for someone to poke me. LOL.

Seriously our company hasn't rolled out the plan on vaccinating everyone. Hoping it comes today, if Not I am emailing the HR lady because there is a chance I may not be working from home much longer, and with my autoimmune stuff, and immunosuppressant's, I need it.

HFSSC also should be in line to get it ASAP.

Yeah Tush!

My MD friend, went to a conference on the vaccine, this past weekend. She has a background in molecular biology. She explained that their is no active virus in the vaccine. She said the allergies had to do with something to do with PEG, which is in Miralax etc. Poly something.

Anyway, no medical advise, thought I would share.

.HFSSC also should be in line to get it ASAP.

Damn skippy. First in line if I can get there. I finally feel like I get to fight back.