COVID-19: Vaccine/antidote and testing procedures Megathread [Mod Warning - Post #1]

tobefrank321 wrote: »

Covid 19 is a massively complex problem. The idea that a vaccine would solve it overnight is pie in the sky. The solution is going to be complex and time consuming, taking months and maybe even years. Many superspreaders at the moment are asymptomatic, eg the guy who infected 56 people. He believed because he had no symptoms he could go out and mix with people.
Prior to full vaccination superspreader events will be commonplace. Even with vaccination, they will still be common, if you are infectious for 3 days. That means infectious without a persistent cough etc. There's no reason to believe that even when vaccinated, you can't be infectious, if the virus survives in nasal cavities for 3 days.
After that you need a vaccine that protects the elderly and vulnerable, ie those with weakened immune systems. Problem is existing vaccines don't work so well for that category, so what hope a new one?
Its not negativity, its realism. Some people including some "experts" believe once we have a vaccine this thing will be over soon enough. It won't.

I think this post typifies the law of unintended consequences. As the realisation of a vaccine grows ever closer, this thread has become more popular and, ultimately, attracts more ill-informed posters such as that above. God help us in the coming weeks and months

tobefrank321 wrote: »

Haha..ill informed. I wish.

I've read widely on this in the last few months, unlike you. If you had read widely you'd see all the pitfalls of the "put everything in the vaccine basket" brigade like yourself. But hey carry on.

If you stick around (you won't) I've no problem going through the pitfalls in detail.

Oh enlightened one, please inform me.

People seem to think that the five years to develop a vaccine is spent looking at test subjects to see if they have a side effect.

I'm not an immunologist but from what I have read, the normal development of a vaccine goes like this:

1. Someone develops a theory, and a formula.

2. They go through a round of looking for funding for that formula. Someone decides they are worth taking a risk on.

3. They start Phase 1 testing, which is tested on animals. It looks like the vaccine doesn't kill the animal, and doesn't create any massive side effects. It also looks like it prevents infection by the virus in the animals that are similar to us (rhesus monkeys I think?).

4. The scientists write up their findings. They start looking for a second round of funding. They might have to publish their findings in a respected medical journal in order to find a backer for Phase 2. This involves more time, as the Phase 1 results have to be peer reviewed.

5. They find a backer for Phase 2, funding is put in place.

6. Phase 2 is tested on a small amount of humans. It looks like the vaccine doesn't kill or have serious side effects on the humans.

7. The scientists write up their findings. They start looking for a third round of funding. They might have to publish their findings in a respected medical journal in order to find a backer for Phase 3. This involves more time, as the Phase 2 results have to be peer reviewed.

8. They find a backer for Phase 3, funding is put in place.

9. Phase 3 is testing the vaccine on as large a sample of the population as possible, and preferably in an area where the particular virus is prevalent, and then observe for a period of four to six months. The purpose of the large sample is to make sure that any potential side effects for any particular sector of the population now become more apparent. The purpose of testing people in an area where the virus is prevalent is because it is ethically a no no to purposely infect someone with the virus to see if the vaccine works (though I believe they have decided to that in the UK??). So this part is the wait and see game, which is particularly frustrating if you are developing a vaccine for something like Ebola or MERS, because those viruses can just decide to feck off at any moment, and all of a sudden you can no longer prove that your vaccine works.

10. So your vaccine works. You draft up your approval papers and submit it to the regulatory body for approval. However, the regulatory body deals with applications for approval by date submitted. So you could be sitting in a queue for year, before the regulatory body get around to your application.

11. And then you get approved, about five years after you started the project.

Here is what I understand is happening with the Covid vaccine candidates:

1. Some of the front runners, like the Oxford vaccine, already had Phase 1 and partial bits of Phase 2 completed before the coronavirus outbreak in March. So all of a sudden they had a formula which they knew didn't kill animals or people, or cause long term side effects. So they just had to test the animals to make sure the vaccine actually prevented coronavirus infection, which it did.

2. They had all the funding they needed to close out Phase 2 and start immediately on Phase 3, so no drafting and submission and contemplation of begging proposals and peer reviewed publications needed. They didn't need to show that the vaccine prevented infection of the small number of sample volunteers from Phase 2, as that's only needed to get funding for the more widespread testing in Phase 3. Since they already had the money, they moved straight to Phase 3.

3. Need a large number of volunteers? No problem. Need large geographical areas where the virus is prevalent? Wait a moment, ah, here we go, take Brazil, the US, parts of Europe. Sorted.

4. Wait four months to six months, or longer if any issues show up. This is the non-negotiable part that cannot be time compressed, and this is where we are right now, impatiently waiting for what the outcome will be.

5. Results of Phase 3 for the frontrunners are expected in November. Papers will be drafted and submitted to the regulatory bodies in December. No sitting in a queue for a year - the regulatory bodies are clearing their schedules. The regulatory bodies will do their usual scrutiny that they do for every vaccine candidate, and I wager will look even closer on this one as their necks are all on the line.

6. Approval in April 2021. Job done. But heck, what if all the front runners don't actually work, or it turns out that the regulatory body sees some serious failings in their finding as don't approve them? Then we've got the backline of candidates.

7. These candidates did not have the advantage of having Phase 1 and 2 completed. But what they do have is secure lines of funding. So they can now do Phase 1 and Phase 2 at the same time (which they have been doing for the past six months). If test results are favourable, they move straight to Phase 3, and I think some of the backline are in that space right now. All going to plan, they could submit results of their Phase 3 in Feb/Mar/April next year, and we could have another (or the first) candidate approved by summer 2021.

At no point do I believe that anything in frontrunner candidates has been rushed. The reason it takes so long for a vaccine candidate to be approved normally is the endless rounds of applying for funding to move up from the various levels and the sitting in the queue for approval. As far as I can see, none of the Oxford, Pfizer or J&J candidates have shortened down their normal testing timeframes, nor would the regulatory bodies allow them to do that. And while you might think that the regulatory bodies will be put under pressure to approve a frontrunner candidate, I think they are going to be particularly picky before approving. This is a formulation that half the world may end up getting injected with. The implications of a rush job approval would be colossal. You'd have 40 year jail sentences for any negligent individuals in those bodies and I know that will be playing on their mind as they review.

eigrod wrote: »

And you can be sure that the same outlets will move on to the next potential pandemic as soon as there’s nothing negative left to say about this one.

The thing is they completely undermine their credibility. Will be a boy who called wolf situation for whatever comes down the line.

Maxpfizer wrote: »

Who wants to be sitting here in 10 years saying "that covid vaccine had bad consequences for a few thousand people"? How do we know how it will interact with other conditions and medications etc?

Don't be so negative or they will bite you

D.Q wrote: »

Boards is truly blessed to have such a learned cohort of posters.

Read the articles!

They cite world leading experts - its not my opinion its theirs.

JDD wrote: »

You'd have 40 year jail sentences for any negligent individuals in those bodies and I know that will be playing on their mind as they review.

In what part of the world you can have 40 year jail sentence for such a mistake?
Not in Europe, I guess.

Martin in the Dail
"Even when a working vaccine has been developed successfully, its manufacture and distribution would take many months and Ireland would still be dealing with Covid-19", he said.

Someone might want to tell him that manufacturing has already been on going for months and that supply chains are already being set up & that Ireland will get its share of the EU advance purchase.

To me it stinks of there being no plan in place here for rollout or when vaccine rollout does begin in Q1 2021 he can come out and take credit. The man is actually clueless

I suspect political and scientific leaders worldwide are trying to walk a tightrope. They want to give people hope and tell them to hold on, and they also want people to be realistic. I think the UK scientific discussion is more useful than ours in many ways.

There's a high likelihood that we will know in a month or two that we have vaccines (probably multiple).
There's a high likelihood that they will be approved for use by high risk groups pretty quickly.
It's realistic to think it will take 6 months+ for enough vaccine to be made for everyone who wants one.
It's also realistic to think that regulators will want to see more data, so most people who are not in at-risk groups shouldn't expect a vaccine before the second half of next year and should behave accordingly.
It's also realistic to say that vaccines won't immediately solve everything, but things will gradually get better.

To be fair, if Mehole comes out now saying 'oh ya vaccine soon' then compliance will drop substantially

stephenjmcd wrote: »

Martin in the Dail
"Even when a working vaccine has been developed successfully, its manufacture and distribution would take many months and Ireland would still be dealing with Covid-19", he said.

Someone might want to tell him that manufacturing has already been on going for months and that supply chains are already being set up & that Ireland will get its share of the EU advance purchase.

To me it stinks of there being no plan in place here for rollout or when vaccine rollout does begin in Q1 2021 he can come out and take credit. The man is actually clueless

How much of a share of the EU vaccine programme would come to Ireland?

Sweet.Science wrote: »

Firemen got informed a vaccine will be distributed within the next couple of months

Would you have a source for that? Ireland's powers to be have been eerily quiet about it.

EU agreed 300 million doses of Oxford so that’s 11 million per member but I doubt it will be divided like that.