CDC Notifies States, Large Cities To Prepare For Vaccine Distribution As Soon As Late October

[mefordis]

Were participants in the trial purposely exposed to COVID?

I think that's the only way to test the efficacy. I read they are not taking high risk people in the studies, just young, healthy people. If I were elderly, I'd want a study done on my age group for the vaccine. The swine flu vaccine in 1976 killed a lot of elderly, then they took it off the market. A lot of them had heart attacks 12 hours after getting the vaccine.

 

[_19disnA]

As far as who got what, in both cases, the first shot and the booster, my wife had some minor side effects (sore arm, chills, typical vaccine stuff) and I had none, so we suspect she got the real thing and I got the placebo.

Can you comment on what your told to do/not do as part of the study? Were you expected to avoid large indoor gatherings, wear a facemask in public, frequent hand washing or avoid touching your face? Were you advised to stay home during the study or were there any similar restrictions? Also curious if you were told how they would determine if the test vaccine you were given was successful in preventing covid?

 

[RamblingMad]

I am just totally amazed how completely unprepared for covid. Yes at some point we will have a vaccine and will need to give it to millions, why are we not training those people NOW. I totally can see a vaccine ready to go and it is a 3 month wait to get it. Have we learned anything from testing, no we have not

Production and distribution is going to be challenging. Bill Gates has talked about this from the start. The government has to put up funds, so that vaccine producers can set up their supply chain whether it works or not. Companies aren’t going to risk their own capital doing this if they think their vaccine might not work. So if they don’t get funding, they’ll wait as long as necessary to preserve capital until everything has been approved and ready to go. This will push out the timeline.

 

[Hikergirl]

I think that's the only way to test the efficacy. I read they are not taking high risk people in the studies, just young, healthy people. If I were elderly, I'd want a study done on my age group for the vaccine. The swine flu vaccine in 1976 killed a lot of elderly, then they took it off the market. A lot of them had heart attacks 12 hours after getting the vaccine.

I can't find anything that says they were exposed.
I did find something that mentioned participants will be followed for 2 years following their 2nd vaccination.
I guess maybe even though they have enough data for approval they want more. I wonder why, maybe it's just to use up that grant money.

 

[mom2rtk]

I think that's the only way to test the efficacy. I read they are not taking high risk people in the studies, just young, healthy people. If I were elderly, I'd want a study done on my age group for the vaccine. The swine flu vaccine in 1976 killed a lot of elderly, then they took it off the market. A lot of them had heart attacks 12 hours after getting the vaccine.

Maybe it varies by trial, but I heard they were seeking out high risk individuals so there was at least a decent chance they would have some exposure to the virus.

 

[georgina]

No, vaccine volunteers are not purposely exposed to the virus. There is a group advocating for 'human challenge trials' (called 1day sooner) but I don't think they are considered ethical.

 

[disneychrista]

Can you comment on what your told to do/not do as part of the study? Were you expected to avoid large indoor gatherings, wear a facemask in public, frequent hand washing or avoid touching your face? Were you advised to stay home during the study or were there any similar restrictions? Also curious if you were told how they would determine if the test vaccine you were given was successful in preventing covid?

my understanding is just the opposite. They wanted people who were most likely to contract COVID. Not those avoiding it.

The only way to know if the vaccine is effective would be to have the test subjects be exposed to the disease.

 

[Pyotr]

my understanding is just the opposite. They wanted people who were most likely to contract COVID. Not those avoiding it.

The only way to know if the vaccine is effective would be to have the test subjects be exposed to the disease.

If that’s the case where do I sign up?

I’ve actually looked and I don’t believe they’re having any trial groups in my area. I’m high risk of contracting it due to my employment, so I would be a perfect candidate.

 

[aggiedog]

As for exposure for the trial volunteers, the goal was to do the trials in areas with a relatively high prevalence of the virus, then compare eventual positivity rates between the control placebo group and the ones that got the vaccine after a period of time. So they need an actual period of time to tell if it works unless it is sooo effective they can tell very early that the ones that got the actual vaccine have a significantly reduced rate of positive infections. That does happen, for the good or bad, in some studies. They can be shut down early when it becomes evident that the treatment is super effective or if it has serious adverse consequences.

 

[DLgal]

Were participants in the trial purposely exposed to COVID?

No, but the trials kind of "end" when a certain number of test subjects have tested positive for covid and then they analyze whether those people were placebo or vaccine recipients, as well as see how the vaccine may affect the severity of illness. It's a complicated process but they have a minimum number of people that have to test positive in each study group in order to move forward in determining how effective the vaccine is. They extrapolate out the results to the larger study population.

 

[Mackenzie Click-Mickelson]

Were participants in the trial purposely exposed to COVID?

I believe there are few trials going on in my area.

One should have been started really recently and is the vaccine created by Oxford University but then purchased by AstraZeneca. That one is 30K people with about 1,500 being from my area. From what I read it will be the 2nd/3rd phase of the trial with the first being more than 1,000 participants with good results and only mild side effects of "mostly headaches, body aches and fatigue reported." No serious side effects reported with the first phase.

Here's the qualification for that trial: "Adults over the age of 18 who are considered high-risk for coming into contact with COVID-19 will be recruited into the study, and participants will be randomized to determine who receives the vaccine. Individuals who are staying home and drastically limiting contact with others likely will not be eligible."

Additional information: "Two out of every three participants will receive the vaccine, with the third receiving a placebo. (Once the trial is concluded, participants receiving the placebo will be eligible to receive the vaccine.)"

 

[beckicnm]

I'd like to hear from the healthcare workers who will probably be mandated to take the vaccine as soon as it rolls out. Do you feel this vaccine is safe and effective enough to make you comfortable taking it?

I will consider a coronavirus vaccine that is approved by the EMA (EU) or another respectable agency. I have no faith at this point that the FDA/CDC actually have their priorities right. I would not be surprised if jobs are threatened over this.

 

[Jonfw2]

Well if you are Ok with it having just enough data to be approved without any guarantee it's long term safe then by all means get the vaccine (if you did have the placebo) and line your children up for it.
I'll wait.

You can wait. That's fine. But i'll absolutely get it for my daughter when it's approved.

 

[Jonfw2]

Can you comment on what your told to do/not do as part of the study? Were you expected to avoid large indoor gatherings, wear a facemask in public, frequent hand washing or avoid touching your face? Were you advised to stay home during the study or were there any similar restrictions? Also curious if you were told how they would determine if the test vaccine you were given was successful in preventing covid?

Great questions. I'll explain it like this: we were not specifically encouraged to do anything, but it was pretty clear that if we just stayed home and never went anywhere at all that we wouldn't be of much used to them.

They will determine if it's working in two ways: one, bloodwork. They take blood samples after 1, 2, and 3 months (and then a few months after that) to see if you've developed antibodies and/or T cells. Two, they compare the the rate of placebo people who acquired Covid during the study to the rate of "real vaccine" people who acquired covid. The goal, of course, is that few, if any, of the "real vaccine" people will get Covid.

Also, to answer a question someone else posed, they do not ever purposely expose people to the real virus- it's illegal.

 

[aggiedog]

Sorry, don't mean to be political. The timing and reality of the announcement, however, made most experts question why make that announcement in the first place. Same with other announcements made by the CDC lately, which got one person fired for overstating efficacies of other treatments. I don't think you can completely separate facts from motivation in this case.

 

[mousefan73]

My advice as an American living in Europe. Look at any news, announcements, approvals the CDC/NIH/FDA Make and compare to the rest of the world. Many in the vaccine race, Pfizer for example, who got billions from operation warp speed also got billions from the EU and other nations. The US is not the only nation doing everything to get their citizens a vaccine. Also many of these companies, including Pfizer are working with other foreign companies ( Germany in this case). I would question is the US was the only western nation approving and distributing a vaccine by end of October and the EU is holding off. Pharma is global.

I can say general word overseas is is all goes well an emergency use ok CAN be available END this year for certain groups. But 2021 will be mass vaccinations. Of course countries are already preparing for production / distribution NOW. Doesn’t mean one is coming very soon.

 

[Hikergirl]

I believe there are few trials going on in my area.

One should have been started really recently and is the vaccine created by Oxford University but then purchased by AstraZeneca. That one is 30K people with about 1,500 being from my area. From what I read it will be the 2nd/3rd phase of the trial with the first being more than 1,000 participants with good results and only mild side effects of "mostly headaches, body aches and fatigue reported." No serious side effects reported with the first phase.

Here's the qualification for that trial: "Adults over the age of 18 who are considered high-risk for coming into contact with COVID-19 will be recruited into the study, and participants will be randomized to determine who receives the vaccine. Individuals who are staying home and drastically limiting contact with others likely will not be eligible."

Additional information: "Two out of every three participants will receive the vaccine, with the third receiving a placebo. (Once the trial is concluded, participants receiving the placebo will be eligible to receive the vaccine.)"

Yes that is the one I read about. I don't know how many people are involved with the other trials, but for me personally a tiny fraction of the population getting the vaccine, and an even smaller fraction of them actually getting the virus isn't enough for me to jump in line for it.
I can respect other's decision to get it, but I'll definitely wait. I will continue to wear my mask, and social distance because I've been doing it for months and no COVID so it seems to be working just as well as a trial vaccine at this point.

 

[JimMIA]

I would advise against getting a COVID-19 vaccine produced by ANY auto manufacturer, but I am unaware of any automakers involved in COVID vaccine research at this time. Thanks for the reminder.

I kind of agree with you, Doc -- but that might make an interesting issue for the "I WANT TO ARGUE!" thread!

 

[cabanafrau]

This is 2020.

Yet that hasn't enabled humanity to come up with much beyond a shambolic response to this virus thus far. Many can't even seem to accept the idea that it's probably safest to wear a mask to avoid exposure to as many respiratory droplets from others as possible.

I'm all for vaccines. I do however expect them to be fully vetted before rolling up my sleeve.

 

[Heather07438]

https://www.coronaviruspreventionnetwork.org/clinical-study-volunteer/
^For those interested in finding out more about various trials that may start in their area. You take a quick survey and I'm guessing they send that to the different trials. We can still change our mind if chosen after we learn specifics about that study.

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
^That's a good overview for the different types of vaccines in the running.