COVID-19 vaccine news/updates

[chiver78]

I couldn't find a single spot where vaccine trials are being discussed, so I thought I'd create a thread for it. 

this morning's news is about AstraZeneca/U of Oxford pausing their Phase 3 clinical trial due to one volunteer experiencing a serious adverse effect. 

Bloomberg link

One of the most promising coronavirus vaccines has stumbled, delivering a reality check about the odds of clinical development and the safety risks involved.

The news that AstraZeneca Plc paused tests of its experimental shot after one patient became ill is a routine event for the pharma industry. It could be a harbinger of something worrisome or entirely unrelated to the vaccine.

But in a world crippled by the pandemic, the setback comes as a reminder that vaccines can fail, or worse, that they can sometimes deliver more harm than good -- a disclaimer for politicians and governments promising that a Covid-19 fix is around the corner. Drugmakers just this week pledged to make safety a priority and take the time necessary to let science prevail.

The halt “shows the perils of rushing to market,” said Sam Fazeli, an analyst for Bloomberg Intelligence, adding that no vaccine candidate is immune to such misfortunes, especially now that the experimental products are being injected in tens of thousands of people in the last crucial phase of clinical tests.
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click the link for full article. 

[Spellbound454]

Not unusual in vaccine development......It may restart in a few days.

Just goes to show the importance of making sure these things are safe.

[chiver78]

very true. it may not even be related to the vaccine itself, but as an adverse effect, it HAS to be investigated. 

my point in sharing the link was to show that while we're hearing amazing things about the progress made in vax development (and the promises made by 45 that a vax will be available Nov 1) that the industry is still doing things the way they should and shutting down as appropriate when problems pop up. 

[djAdvocate]

80% of phase three trials are eventually approved for use.

that means that of the dozen or so that have reached phase three for CV19, 2-3 will fail.

this might be one of them.

[Deleted]

I'm just happy we're at phase three trials. 

[justme]

So my friend is in another trial. He got his second shot last weekend. Doesn't have another follow up until Oct. And then 6 months later, and then 12 after that, then 12 after that. If it's approved he'll the find out if he was on the placebo - if he's on the placebo he'll stop the follow ups but get the real shot. 


Which is why this whole Nov stuff seems ludicrous to me. That's just 1 month after the first follow up - and I'm guessing he wasn't the last one to get the second shot so others who got it after him wouldn't have even had a follow up until later in Oct. 

But this is out of my wheelhouse - maybe they only need one follow up to get approved? 

[pulmonarymd]

If things are overwhelming positive, one follow up may be enough. But this is why early next year has always been a more reasonable timeframe if everything went perfectly, and why next summer would be the earliest to see significant supply even in the most optimistic scenario

[djAdvocate]

Sept 11, 2020 17:52:34 GMT -5 justme said:

So my friend is in another trial. He got his second shot last weekend. Doesn't have another follow up until Oct. And then 6 months later, and then 12 after that, then 12 after that. If it's approved he'll the find out if he was on the placebo - if he's on the placebo he'll stop the follow ups but get the real shot. 


Which is why this whole Nov stuff seems ludicrous to me. That's just 1 month after the first follow up - and I'm guessing he wasn't the last one to get the second shot so others who got it after him wouldn't have even had a follow up until later in Oct. 

But this is out of my wheelhouse - maybe they only need one follow up to get approved? 

it IS ludicrous, if you know anything about clinical testing. the only way we see a vaccine early next year is if we bypass some of the post study.  and maybe that is prudent, given the nature of the virus. but it really depends on how unusual the vaccine is.

[Spellbound454]

A person became ill....... but they have decided that it wasn't caused by the trial so it has restarted. Better be safe than sorry.

[justme]

Friend is positive for antibodies. So I guess he probably didn't get the placebo lol.

[pulmonarymd]

Sept 12, 2020 14:47:57 GMT -5 justme said:

Friend is positive for antibodies. So I guess he probably didn't get the placebo lol.

Don’t be so sure. Lots of people who were asymptotic even though they were infected. Only way to know is to break the code

[justme]

Sept 12, 2020 15:52:03 GMT -5 pulmonarymd said:

Sept 12, 2020 14:47:57 GMT -5 justme said:

Friend is positive for antibodies. So I guess he probably didn't get the placebo lol.

Don’t be so sure. Lots of people who were asymptotic even though they were infected. Only way to know is to break the code

I believe they tested him before the first shot. So it's possible he got it in the month from his first shot but not from the shot itself, though he doesn't go out much. He also was tested a in July and was negative for both covid and antibodies. And he did the drive thru test at least once before then.

Not definitive, but seems likely. 🤷‍♀️

ETA: Chatted with him. They did covid/antibody when he went in for his first shot - both negative. Had his second shot on Sun and they tested him for covid then and was negative. The antibody test was for both IgM and IgG. They took another PCR test today - I guess to find out if the antibodies are from infection or not (pure speculation on my part). Being along for the ride is fascinating - plus it's fun to ask him if he still has all his limbs attached or if we need to quarantine him.