Coronavirus good news thread

SmallTown

Well-known member
It won't be safe if people get infected. Flu vaccines are 30 to 70% effective, which doesn't bode well for a totally new vaccine.
Yes but there is "safe" and "safe" The side effects of a vaccine could easily be worse than the disease.

That's why we have phase 3 trials and that's why they last so long.
 

FabioPorkpie

Well-known member
Yes but there is "safe" and "safe" The side effects of a vaccine could easily be worse than the disease.

That's why we have phase 3 trials and that's why they last so long.
Despite all of that, several experts, including those running the Oxford trial, have frequently talked about rolling their vaccines out this coming winter, or the New Year, IF the trials go well. Are they selling a bit of false hope?
 

FabioPorkpie

Well-known member
Just had a quick look and with H1N1 they had 5 vaccines approved by November 2009, having started the first trials in July 2009. Presumably they had to go through the same stringent trials, but how did they get those vaccines rushed through in such a short space of time?
Not asking to be difficult, I’m just genuinely interested in the process and you are obviously very knowledgeable about the sector and better informed than most of us.

https://www.cdc.gov/flu/pandemic-resources/2009-pandemic-timeline.html
 

SmallTown

Well-known member
Despite all of that, several experts, including those running the Oxford trial, have frequently talked about rolling their vaccines out this coming winter, or the New Year, IF the trials go well. Are they selling a bit of false hope?
I'm afraid so. It's simply not possible to have completed safe trials by then. Unless they started last year, unlikely as the virus didn't exist.
 

borolad259

Administrator
Staff member
I find it crazy that this virus has become so partisan. Once again I feel glad I am not in the vulnerable group- because this isn't going away. Got to make sure we protect the vulnerable as best as possible as a society.
The virus isn't partisan, it's just that there is a a large proportion of the population with immunity (or resistance) and a small portion without.

It's great news that Sars Cov 2 specific T cells were found in 50% of healthy, uninfected individuals in a recent singapore study. There is also now evidence that Sars Cov 1 immunity is effective with Sars Cov 2, which might help to explain why certain far eastern countries that had Sars Cov 1 badly, have done very well with Sars Cov 2.

Anyway, the fact that T cell immunity appears to be 1, widespread and 2, long lasting is great news. It means that this should become a relatively insignificant disease in time.

https://www.sciencedaily.com/releases/2020/07/200716101536.htm
 

hopesoboro

Well-known member
The virus isn't partisan, it's just that there is a a large proportion of the population with immunity (or resistance) and a small portion without.

It's great news that Sars Cov 2 specific T cells were found in 50% of healthy, uninfected individuals in a recent singapore study. There is also now evidence that Sars Cov 1 immunity is effective with Sars Cov 2, which might help to explain why certain far eastern countries that had Sars Cov 1 badly, have done very well with Sars Cov 2.

Anyway, the fact that T cell immunity appears to be 1, widespread and 2, long lasting is great news. It means that this should become a relatively insignificant disease in time.

https://www.sciencedaily.com/releases/2020/07/200716101536.htm
That's confidence for your!
Hope you're right 🤓
 

Liamo

Well-known member
It's just the length of time a phase 3 trial will take. It's not just efficacy they need to prove, it's things like side effects. These can take a lot longer to manifest themselves.
I'm not sure where this idea of vaccines having long-term side effects comes from. There's no evidence to support it, as far as I can tell.

A search of medical literature sites turns up no valid scientific studies showing long-term, adverse side effects of vaccines showing up years afterwards. If anything, vaccines actually actually suffer from the opposite problem - that their effects tend to dissipate over time, sometimes vanishing completely, which is why many vaccines require periodic booster shots.

Vaccines are not like therapeutic drugs that are taken daily and sometimes for long periods, leading to cumulative effects. Vaccines work by producing an immediate boost to the body's immune system but as mentioned, those effects generally wane as time passes, sometimes until their effects are no longer even detectable.

In the vaccines that have turned out to have serious adverse effects, (such as the rotavirus vaccine causing intussusception) these show up relatively quickly, usually within a week or two, so would typically show up in phase one or two trials. The effects of a vaccine only ever decrease as the years go by, they never increase (they can stay relatively steady but again, many vaccinolologists suspect the effects of a coronavirus vaccine may not last more than a year or two).

I've mentioned this before, but the Oxford vaccine which looks like it could be the first one available, is based on an adenovirus vaccine vector that has been used safely in thousands of subjects, from 1 week to 90 years of age, in vaccines targeting over 10 different diseases for over a decade with no signs of any serious adverse effects yet. The only difference is that they have spliced a tiny non-replicating snippet of the genetic code for the SARS-CoV-2 spike protein which is incapable of causing infection in humans into the vaccine construct, in place of the genetic code for the various other pathogens they have used previously.

Here's a link to a video where Professor Adrian Hill of the Oxford University team, addresses the safety issue. As he says, no safety steps or regulatory procedures are being altered or missed out. He also mentions some of the reasons why vaccine development is moving quickly, such as a much faster response from regulators. In the past, they would sometimes take months to review results and approve subsequent phases, partly due to a lack of manpower and/or urgency.

 
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Liamo

Well-known member
It's simply not possible to have completed safe trials by then.
I can find no scientific basis for that statement. Can you provide one?

As I've mentioned before, there is no requirement stated by any regulatory body that phase 3 trials must last any specific length of time, nor any absolute scientific necessity for it as far as I'm aware. Yes, it's typical for phase 3 trials to last longer but I can't find anything saying they have to or giving a scientific reason why they must, so long as safety and efficacy can be reliably established.

Here's an extract from an article linked to from the US CDC website, talking about the different phases of vaccine development:
One Phase III goal is to assess vaccine safety in a large group of people. Certain rare side effects might not surface in the smaller groups of subjects tested in earlier phases. For example, suppose that an adverse event related to a candidate vaccine might occur in 1 of every 10,000 people. To detect a significant difference for a low-frequency event, the trial would have to include 60,000 subjects, half of them in the control, or no vaccine, group (Plotkin SA et al. Vaccines, 5th ed. Philadelphia: Saunders, 2008).
Based on what that says, the concern about rare side effects is more to do with the number of people tested than the length of the phase.
 

SmallTown

Well-known member
I can find no scientific basis for that statement. Can you provide one?

As I've mentioned before, there is no requirement stated by any regulatory body that phase 3 trials must last any specific length of time, nor any absolute scientific necessity for it as far as I'm aware. Yes, it's typical for phase 3 trials to last longer but I can't find anything saying they have to or giving a scientific reason why they must, so long as safety and efficacy can be reliably established.

Here's an extract from an article linked to from the US CDC website, talking about the different phases of vaccine development:


Based on what that says, the concern about rare side effects is more to do with the number of people tested than the length of the phase.
Years working in the Pharma industry including working for quite a few biotech firms and one charity that staged trials has taught me that.
Moreover I’ve given you the scientific basis, that you need long term trials to test the efficacy over a general population and ensure there are no long term side effects
 
Afraid not. That's why I said I worked in biopharma.

The have to follow the same Good Clinical Practice Rules. Vaccines are no different to any other drug in that regard
But as mentioned, since you don't have the same 'cumulative effects' with vaccines that you might have with other therapeutic drugs, maybe it's possible to reduce the timescale of Phase 3 more safely? - I don't know.... just asking.
 
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