Kamala Harris says she wouldn't trust Trump on safety of Covid vaccine before election

[Iron]

Depends what you mean.

The basic pre-trial scientific development time is comparable to other vaccines, and it is entering more extensive trials in a time frame similar to other vaccines. This would suggest that notionally, at a scientific level it is following a development course similar to others. That said, there are significant concerns. Firstly, a lack of transparency in supporting information about its development, and suggestions of ethical breaches in the safety trials. Either might lead to rejected approval in many countries.

If we mean approval, Russia has most definitely rushed approval for use (in Russia) as it plainly had not completed (or even started) the trials normally demanded. I don't see other countries ready to approve it for that reason, or much evidence of it being rolled out in Russia despite approval. That (and the name) is why I think the approval was a PR stunt by the Russian government: they wanted to put up Russia to the world as a country that could keep pace with the West, Japan, China, etc. If the vaccine ends up effective and well used, great. If not, oh well. But they got their headlines even if the latter is true.

Did they inject the vaccine before the finished the trials?
I heard there are some 30 countries lining up to Russia for their vaccine. It is very likely this is a PR move. I think they want to avoid quarantine despite the virus, Russia was in lockdown for an extended period of time

 

[Agema]

Did they inject the vaccine before the finished the trials?

Clinical trials exist in phases:
Phase 1: basic safety (very small scale on healthy volunteers)
Phase 2: expanded safety and basic efficacy (small scale)
Phase 3: expanded safety and expanded efficacy (large scale)
- Approval -
Phase 4: post-approval monitoring

They did phase 1 before approval, possibly phase 2 partial or complete.

 

[bluegate]

Right now, the companies who are in phase 3 of their Vaccination trials in the US are Pfizer, BioNTech , AstraZeneca , and Moderna.

They are currently investigating a side effect, so expect a little delay on that front.

 

[lil devils x]

They are currently investigating a side effect, so expect a little delay on that front.

Yea, so far it is just one person with possible side effect from my understanding:

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.

AstraZeneca's Covid-19 vaccine study has been put on hold due to a suspected adverse reaction in participant in the U.K.

www.statnews.com

"In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter.

The spokesperson described the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.”

An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers."

HOWEVER, it also says this is impacting the other manufacturer trials as well, so hopefully this is sorted soon, as I REALLY want at least one of these to be successful so that I can safely leave my house again.

One of my primary concerns about all of the vaccine trials right now is due it being rushed, they may not be able to get enough diversity of test subjects. Knowing how it will react in different groups, for example, Rh negative blood groups, the different Native American populations and other minority populations, or people who have complications from other conditions is areal concern here. Differing immune response in different demographics is concerning. Especially when I am actually in that group and also being in a high risk group due to my lung condition and REALLY needing these vaccines to work.

 

[Agema]

They are currently investigating a side effect, so expect a little delay on that front.

A full hold is perhaps unusual, unless the apparent side effect were relatively severe. Of course, it may turn out to an illness due to something else entirely.

 

[lil devils x]

A full hold is perhaps unusual, unless the apparent side effect were relatively severe. Of course, it may turn out to an illness due to something else entirely.

I think with the worlds biggest spotlight on them, they are not going to risk any mistakes. That is why I am pretty confident that if the vaccine does come from a reputable company, they will not be willing to risk messing it up this time. Messing up here is just too much of a risk for a company that plans on being in business afterwards. The entire world is watching this.

They can get away with mistakes here and there with most other things, just not the vaccine that saves the world from a pandemic.

 

[tstorm823]

A full hold is perhaps unusual, unless the apparent side effect were relatively severe. Of course, it may turn out to an illness due to something else entirely.

How does one even put a full hold on vaccine trials? Isn't a large part of it waiting and observing?

 

[Agema]

How does one even put a full hold on vaccine trials? Isn't a large part of it waiting and observing?

They stop giving it to any new patients.

If you imagine a Phase 3 trial is deemed to warrant 1000 subjects, they don't want to start all 1000 of them on the drug/vaccine at the same time, because it turns out there's a problem, they've just harmed a lot of people. So they might stagger it, say 20 a week: this means they can catch problems earlier before it goes to more people. Clinical trials normally take over five years in total: phase 1 is usually a few months to a year, phase 2 about 1-2 years, and phase 3 probably averages out around 2-3 years. (Phase 4 never really stops in a sense, although the intensity of study will definitely decrease over time.)

It's also due to the fact they can't necessarily find 1000 subjects at the same time. They need approved and arranged partners (e.g. clinics / hospitals) to host the trials, supply subjects and take care of medical things; plus everything needs to be run strictly to guidelines. This requires contracts, payments, training and oversight and so imposes bureaucratic limits: even the average Big Pharma doesn't have the administrative capacity to do that for hundreds and hundreds of clinics simultaneously. Therefore in practice there are limited places where they can host the trials, and they are limited to the rate at which those places can take in subjects.

This is the advantage of organisations like the NIH or NHS stepping in: they are much more able to mobilise big healthcare resources quickly.

 

[lil devils x]

They stop giving it to any new patients.

If you imagine a Phase 3 trial is deemed to warrant 1000 subjects, they don't want to start all 1000 of them on the drug/vaccine at the same time, because it turns out there's a problem, they've just harmed a lot of people. So they might stagger it, say 20 a week: this means they can catch problems earlier before it goes to more people. Clinical trials normally take over five years in total: phase 1 is usually a few months to a year, phase 2 about 1-2 years, and phase 3 probably averages out around 2-3 years. (Phase 4 never really stops in a sense, although the intensity of study will definitely decrease over time.)

It's also due to the fact they can't necessarily find 1000 subjects at the same time. They need approved and arranged partners (e.g. clinics / hospitals) to host the trials, supply subjects and take care of medical things; plus everything needs to be run strictly to guidelines. This requires contracts, payments, training and oversight and so imposes bureaucratic limits: even the average Big Pharma doesn't have the administrative capacity to do that for hundreds and hundreds of clinics simultaneously. Therefore in practice there are limited places where they can host the trials, and they are limited to the rate at which those places can take in subjects.

This is the advantage of organisations like the NIH or NHS stepping in: they are much more able to mobilise big healthcare resources quickly.

In addition, they also have to have enough people of different demographics so they can have a better idea of the immune response to be expected from different populations.Like the Moderna article linked above stated, they were slowing down their trial enrollment due to trying to diversify their enrollment. This is one of my primary concerns though because when you have to consider things like health conditions, Rh negative blood types and different immune responses in Native American groups than Europeans, it can be difficult to even obtain enough people from that group to participate in the study. Especially when we have all these studies going on at once, trying to find enough people of the demographic needed to be tested can be challenging when you are also competing with other researchers doing similar trials for their vaccine as well at the same time.

 

[Gordon_4]

I think this will all just turn out like the Spanish Influenza. Hundreds of scientists will work around the clock to desperately find a cure only for the virus to naturally peter out and life moves on.

After it killed 50 million people and infected 500 million. You will forgive me if I don’t want COVID-19 to follow the same, or God help us, a proportionate pathway before going away.

 

[Specter Von Baren]

After it killed 50 million people and infected 500 million. You will forgive me if I don’t want COVID-19 to follow the same, or God help us, a proportionate pathway before going away.

It's not like I want it to go that way either ya know. To me it just seems like what'll likely happen is all.

 

[tstorm823]

It's not like I want it to go that way either ya know. To me it just seems like what'll likely happen is all.

Basically already has. Deaths don't go down while reopening places if you're not doing that already.

 

[Eacaraxe]

I think this will all just turn out like the Spanish Influenza. Hundreds of scientists will work around the clock to desperately find a cure only for the virus to naturally peter out and life moves on.

You say this, acting like social distancing, mask and shelter-in-place mandates, and increased public sanitation, weren't spread-mitigating policies developed during the Spanish flu pandemic. And, no "Spanish influenza" didn't "naturally peter out and life move[d] on"; H1N1 was responsible for at least a dozen other major epidemics and pandemics in the century since.

2009? that was (a mutated version of) Spanish flu. Why did it kill "only" a half million people instead of 50 million? Because the work during the Spanish flu outbreak, and other major outbreaks, led to methodological improvements and eventually the flu shot twenty years later.

 

[Specter Von Baren]

You say this, acting like social distancing, mask and shelter-in-place mandates, and increased public sanitation, weren't spread-mitigating policies developed during the Spanish flu pandemic. And, no "Spanish influenza" didn't "naturally peter out and life move[d] on"; H1N1 was responsible for at least a dozen other major epidemics and pandemics in the century since.

2009? that was (a mutated version of) Spanish flu. Why did it kill "only" a half million people instead of 50 million? Because the work during the Spanish flu outbreak, and other major outbreaks, led to methodological improvements and eventually the flu shot twenty years later.

I don't see why you think I disagree with any of that.