hobbo1
Well-known member
@cochise said in [Have you been vaccinated?](/post/1413433) said:
I’ll just have to bunker down and wait
Have you been vaccinated?
- Thread starter tig_prmz
- Start date
I’ll just have to bunker down and wait
T
Tiger5150
Guest
@jirskyr said in [Have you been vaccinated?](/post/1413281) said:
cochise
Well-known member
@hobbo1 said in [Have you been vaccinated?](/post/1413421) said:
Yeah I did.
cochise
Well-known member
@hobbo1 said in [Have you been vaccinated?](/post/1413435) said:
Yeah, I was lucky as a family member of a health care worker I was able to get mine early. We really needed greater numbers vaccinated to avoid the situation we are in now.
hobbo1
Well-known member
@cochise said in [Have you been vaccinated?](/post/1413440) said:
The mrs is panicking a bit ?
cochise
Well-known member
@hobbo1 said in [Have you been vaccinated?](/post/1413448) said:
Funnily enough so was mine tonight with the locations popping up around Penrith.
hobbo1
Well-known member
@cochise said in [Have you been vaccinated?](/post/1413449) said:
1 at Emu shopping centre and 1 at a cafe in Glenbrook ..
I shouldn’t have laughed @happy_tiger when he told me he was a doomsday prepper
cochise
Well-known member
@hobbo1 said in [Have you been vaccinated?](/post/1413454) said:
Harvey Norman and the Home Maker Centre plus quite a few more as well now.
voice_of_reason
Well-known member
@harvey said in [Have you been vaccinated?](/post/1413277) said:
I trust him and he knows my body well 🙂 To be honest I didn't question him when he told me - even if he gave me an explanation it would probably mean nothing to me as I'm not a Dr.
I don't believe it's his reason but I also have a long history of serious blood clots.
hobbo1
Well-known member
@cochise said in [Have you been vaccinated?](/post/1413457) said:
Close the bridges
cochise
Well-known member
@hobbo1 said in [Have you been vaccinated?](/post/1413463) said:
I'll come weld your door shut.
hobbo1
Well-known member
@cochise said in [Have you been vaccinated?](/post/1413465) said:
Hard to weld timber .. I’ll leave a tube of liquid nails in the mailbox
bathursttiger1
Well-known member
This shows that there are a lot of oldies on the forum. :grin:
jirskyr
Well-known member
@go_you_good_things said in [Have you been vaccinated?](/post/1413409) said:
You mean how did they get it done so fast?
Four reasons...
(1) Firstly the technology was already there, ready. The AZ vaccine is old technology, they just needed info on the COVID virus itself - the sequencing, samples to test, what proteins it expresses etc. For Pfizer, the mRNA vaccine was also based on existing technology that they hadn't put into many trials, but they'd been working on it for a while. You will note that AZ and Pfizer, two very big pharmaceutical corps, were able to mobilise very quickly to get the product into trial. The smaller companies - Moderna, Novavax, have taken longer.
My company ran the big Pfizer COVID vaccine study in 2020. Pfizer is a strategic partner of ours, so it's also very fast for us to convert a Pfizer study into action, especially because they don't have to waste time putting the work out to extensive tender.
(2) Second reason is all the regulatory agencies fast-tracked approvals of anything to do with COVID. Much of the time spent on trials is caught up in red-tape and resourcing challenges. For example the normal startup time for a hospital in a trial in the US is about 10-12 weeks (from selection to start of recruiting subjects). Under the COVID conditions we were getting sites ready to go in 2 weeks.
(3) Third reason: funding. Trump, who is a convicted Rapist and Felon actually did one good thing during the pandemic - signing off Operation Warp Speed poured millions and millions into the research coffers. Remember that drugs are horrendously expensive to research, somewhere in the vicinity of USD 500M-1B to bring one to market. Pharma companies can be quite rich but those costs are still very big and they need to approach studies conservatively in order not to blow the budget.
When governments start pouring money into research, big resources can be mobilised very quickly.
(4) Fourth reason: enrolment. Studies are typically difficult to enrol for, to find potential patients, get them to sign on, answer all their questions. It wasn't an issue for the COVID studies - patients were easy to find, very eager to participate. Many were already well-informed.
Your second comment
without the benefit of time to fully expose any problems with it
that isn't accurate to how clinical research is done.
Early-phase clinical trials are done in healthy volunteers (Phase 1), to assess safety and dose target, then in small amounts of target population for early safety and efficacy (Phase 2). After they pass these reviews you can open up to bigger populations, which is where the most robust data comes in (called Phase 3).
Phase 3 studies may run for several years, but typically they have a primary safety and efficacy target within about 6-12 months of starting, and that is really dependent on enrolment rather than "waiting". I.e. the faster you can enrol, the faster you can start looking at the data.
And that makes sense right? You should have some decent idea if a drug works or not, and if it's safe or not, reasonably quickly. Imagine you took a panadol but you couldn't tell if it worked for 12 months? This is particularly true if you can get lots of people to test the drug in a short amount of time, rather than having to wait years to enrol.
Most major safety effects will also show within months of treatment, and the more people you enrol, the more safety data you have. However typically Phase 3 is enrolling 50-1000 patients, which obviously is NOTHING close to the real population. They design the trials to be a good predictor of what would happen in the general population, statistically.
So once a drug passes Phase 3 - proven effective and sufficiently low risk (no such thing as zero risk), it can be approved by regulatory agencies. After that, any new studies are Phase 4, which is post-marketing surveillance. Every drug on the planet is still being monitored by its manufacturer for side effects, and occasionally you do get drugs pulled from market because of very long-term side effects observed across millions of users.
Vaccines however are less like this that other classes of drug, because they are a one or two time administration. You aren't taking them chronically over long periods of time, and they exist to generate immune responses, i.e. your own body does the heavy lifting, not a chemical you need to keep taking. Most vaccine-related reactions are observable within an hour or so, and they are mostly predictable.
Don't forget there are a very wide range of vaccines being administered globally by the billions every year, well before COVID, so researchers have become very very good at developing vaccines.
jirskyr
Well-known member
@tiger5150 said in [Have you been vaccinated?](/post/1413436) said:
I wish. I project manage studies, I basically never get my hands on actual drugs.
hobbo1
Well-known member
@truetiger said in [Have you been vaccinated?](/post/1413522) said:
Are you bad boy Bubby ?
?
T
Tiger5150
Guest
@jirskyr said in [Have you been vaccinated?](/post/1413524) said:
Jirsky, I don't doubt that you work in the field and most of what you have said is very accurate and great information, however the Pfizer did not make it out of Phase 3 and will never go through Phase 4 due to the Emergency Use Authorisation (EUA) signed that indemnified the manufacturers and removed the requirement for compulsory reporting of adverse reactions. Additionally, no control group. There will never be a Phase 4 trial for these vaccines.
