Have you been vaccinated?

[dazza65]

2 x Pfizer, no issues at all with either dose

 

[jirskyr]

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.

I'm not quite sure what you mean. They certainly finished the Phase 3 in Nov 2020. They don't "have to make it out of Phase 3". Phase 3 will do, you don't actually have to do Phase IVs unless directed by a regulatory agency, or you want to change the marketing approval you have received. Post-marketing surveillance will occur regardless of any further research undertaken by the pharma company.

I'm pretty sure the EUA did not waive the need to report AEs, but changed the periodicity of such reporting. I'm not a US Regulatory expert, but it's likely that the FDA will require Pfizer to continue to report data either through more studies, or more analysis of the study they did. You can read the FDA's statement here:
https://www.fda.gov/media/150386/download

In fact you can see under Section III (F) and (G)
Pfizer Inc. will report to Vaccine Adverse Event Reporting System (VAERS):

>Pfizer Inc. must submit to Investigational New Drug application (IND) number 19736 periodic safety reports at monthly intervals in accordance with a due date agreed upon with the Office of Biostatistics and Epidemiology (OBE)/CBERbeginning after the first full calendar month after authorization. Each periodic safety report is required to contain descriptive information which includes:

They haven't waived AE reporting at all.

Also you are patently wrong about lack of control - they even posted the trial protocol online, you can read it yourself:
https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf

The title of the study alone tells you everything you need to know:
A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

Placebo-controlled. The control group didn't get real vaccine.

 

[tig_prmz]

. . . . Jirskyr, as a drug developer, I have a question for you. This probably isn't the best place to ask, but what the heck. I'll deal with the outfall . . . . so as a drug developer, you have been used to any new drug/treatment over the past 20+ years needing 8-10+ years of development, refinement and trials before it is "ready for the public". From memory, ( and I'm just a punter, not a drug developer), every single new drug you heard about on the news was some breakthrough for a university research team, and every single one would be available to the public in 8 or 10 years time. I don't recall even one that was ready in 2 years.
This jab was super fast-tracked, without the benefit of time to fully expose any problems with it.
What do you, as the professional, say ?
And to the rest of you, who aren't drug developers, happy to listen to rational and polite discussion. But I know how it will go.

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.

Thanks mate, that helps a lot.

What do you think about the FDA rejecting AZ and the entire manipulation of efficacy fiasco? Do you think AZ will be accepted eventually?

 

[jirskyr]

Thanks mate, that helps a lot.
What do you think about the FDA rejecting AZ and the entire manipulation of efficacy fiasco? Do you think AZ will be accepted eventually?

Honestly - I haven't read anything about it. Do you have a link?

I only ever saw something about a delay to approval, not an outright rejection.

Thing for the US is - they possibly don't need the AZ vaccine and may be in no rush to expedite it's approval. Most of the approved or near-approval vaccine companies are American - Pfizer, Moderna, Novavax etc.

They already have HQ and manufacturing for Pfizer, Moderna, Novavax. I think Pfizer does the bulk of its vaccine manufacturing in the EU, but Moderna are almost entirely US-based.

 

[Tiger5150]

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.

I'm not quite sure what you mean. They certainly finished the Phase 3 in Nov 2020. They don't "have to make it out of Phase 3". Phase 3 will do, you don't actually have to do Phase IVs unless directed by a regulatory agency, or you want to change the marketing approval you have received. Post-marketing surveillance will occur regardless of any further research undertaken by the pharma company.

I'm pretty sure the EUA did not waive the need to report AEs, but changed the periodicity of such reporting. I'm not a US Regulatory expert, but it's likely that the FDA will require Pfizer to continue to report data either through more studies, or more analysis of the study they did. You can read the FDA's statement here:
https://www.fda.gov/media/150386/download

In fact you can see under Section III (F) and (G)
Pfizer Inc. will report to Vaccine Adverse Event Reporting System (VAERS):

>Pfizer Inc. must submit to Investigational New Drug application (IND) number 19736 periodic safety reports at monthly intervals in accordance with a due date agreed upon with the Office of Biostatistics and Epidemiology (OBE)/CBERbeginning after the first full calendar month after authorization. Each periodic safety report is required to contain descriptive information which includes:

They haven't waived AE reporting at all.

Good solid information. I appreciate it. It contradicts what I had read elsewhere and its good to get correct information. Thank you.

Also you are patently wrong about lack of control - they even posted the trial protocol online, you can read it yourself:
https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf

The title of the study alone tells you everything you need to know:
A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

Placebo-controlled. The control group didn't get real vaccine.

Lack of control was specifically in regards to Phase 4.

 

[jirskyr]

Lack of control was specifically in regards to Phase 4.

I don't follow. They haven't done a Phase 4. Like I said they actually don't have to. It's common not to do a Phase 4.

They probably will do other studies on COVID though, I expect it's inevitable. Firstly in case of COVID variants, they may change the formulation to drive efficacy.

Secondly they may seek to combine the COVID jab with something like flu, make it an annual product. I know 100% Novavax are looking at this now.

If they change the vaccine up or combine with another product, that won't be Phase 4, it will be a new earlier phase of what is technically a new product.

 

[NT_Tiger]

Yes, but am not able to due to health complications.

Same here. My Dr has advised me not to get AZ. As I'm 62 I'm not eligible for Pfizer.

I would happily get Pfizer now, or AZ if the Dr said it was OK. It's not very reassuring that I can't get vaccinated when I live in a 'hot-zone'.

I've emailed him today to see if any of the recent changes to policy may change his views.

Keep your ear to the ground and mention it when talking to people. I was 62 and didn't want the AZ. The only thing available at my local clinic was AZ but I heard on the grapevine that the hospital (2 hours away) had an oversupply of Pfizer and were worried it would pass its use by date. I booked in there and when filling out the agreement form I ticked the Pfizer box and got through that way.
More importantly, If your doctor has advised against AZ, get your doctor to write a note regarding your health reasons for not getting AZ but Pfizer. The nurses administering the shots have to take that into account.

 

[innsaneink]

This shows that there are a lot of oldies on the forum. :grin:

It's been goin for nearly 2 decades so yeh some of us are getting on

What?

 

[cochise]

This shows that there are a lot of oldies on the forum. :grin:

It's been goin for nearly 2 decades so yeh some of us are getting on

What?

I was in my early 20's when I started on here, not so much any more.

 

[Radoush]

Im still baffled how this isnt ripping through children.

Apparently kids don't have lungs go figure

 

[mike]

. . . . Jirskyr, as a drug developer, I have a question for you. This probably isn't the best place to ask, but what the heck. I'll deal with the outfall . . . . so as a drug developer, you have been used to any new drug/treatment over the past 20+ years needing 8-10+ years of development, refinement and trials before it is "ready for the public". From memory, ( and I'm just a punter, not a drug developer), every single new drug you heard about on the news was some breakthrough for a university research team, and every single one would be available to the public in 8 or 10 years time. I don't recall even one that was ready in 2 years.
This jab was super fast-tracked, without the benefit of time to fully expose any problems with it.
What do you, as the professional, say ?
And to the rest of you, who aren't drug developers, happy to listen to rational and polite discussion. But I know how it will go.

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.

Great post. I also think there is some confusion about what the %efficacy is. Eg AZ is 92% after second shot. All that means is that some people still caught Covid19 and might report a symptom, which could be as trivial as runny nose, sore throat, cough or headache etc.

The vaccine however is 100% effective against death or severe infection from Covid19. 100% protects against death from the Delta Variant, with a slight lowing in severity effectiveness.

To put it simply there have been no deaths from Covid19 for people that have been vaccinated.
————————-
COVID-19 Vaccine AstraZeneca confirms 100% protection against severe disease, hospitalisation and death in the primary analysis of Phase III trials
————————
I would think Pfizer is slightly better.

 

[TrueTiger]

Getting my first shot of AZ this Wednesday. Only booked it in on Sunday too

They can’t get rid of it quick enough..
Good luck JC

Thanks mate, I'm sure I'll be all goods ?? Just want to get it out of the way

Bunnings or maccas should’ve done the vaccine rollout..

That's actually genius haha, get it done at Bunnings and get a snag. We'd be fully vaccinated already

60 day wait for the Pfizer vaccine..?

I think it depends on location. I chose RPA and got it next day.

I live in jurrasic park ?
No vaccine hub up here ..
60 day wait at Nepean hospital ..

If scomo throws more cash out I’ll grab it , go hard at Dan Murphy’s and bunker down .

That is only since the outbreak, I could have booked in the next day when I got mine 6 weeks ago.

I’ll just have to bunker down and wait

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.

The mrs is panicking a bit ?

Funnily enough so was mine tonight with the locations popping up around Penrith.

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

Harvey Norman and the Home Maker Centre plus quite a few more as well now.

Close the bridges

I'll come weld your door shut.

Hard to weld timber .. I’ll leave a tube of liquid nails in the mailbox

leave some gladwrap in the mailbox....we can wrap you up and keep you fresh....

Are you bad boy Bubby ?
?

No Im his brother ""bad,bad,boy Ziggy....:sunglasses: :muscle:

 

[yeti]

Haven't been vaccinated. No intention of being vaccinated.

 

[cochise]

Haven't been vaccinated. No intention of being vaccinated.

Why?

 

[westTAHger]

Yes, both Astro shots.

 

[happy_tiger]

Getting my first shot of AZ this Wednesday. Only booked it in on Sunday too

They can’t get rid of it quick enough..
Good luck JC

Thanks mate, I'm sure I'll be all goods ?? Just want to get it out of the way

Bunnings or maccas should’ve done the vaccine rollout..

That's actually genius haha, get it done at Bunnings and get a snag. We'd be fully vaccinated already

60 day wait for the Pfizer vaccine..?

I think it depends on location. I chose RPA and got it next day.

I live in jurrasic park ?
No vaccine hub up here ..
60 day wait at Nepean hospital ..

If scomo throws more cash out I’ll grab it , go hard at Dan Murphy’s and bunker down .

That is only since the outbreak, I could have booked in the next day when I got mine 6 weeks ago.

I’ll just have to bunker down and wait

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.

The mrs is panicking a bit ?

Funnily enough so was mine tonight with the locations popping up around Penrith.

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

Harvey Norman and the Home Maker Centre plus quite a few more as well now.

Close the bridges

I'll come weld your door shut.

Hard to weld timber .. I’ll leave a tube of liquid nails in the mailbox

Freeze it shut ....is it much extra ....to freeze his tongue and fingers to something as .......

The Forum needs one days break ....PLEASE lol

 

[tig_prmz]

Thanks mate, that helps a lot.
What do you think about the FDA rejecting AZ and the entire manipulation of efficacy fiasco? Do you think AZ will be accepted eventually?

Honestly - I haven't read anything about it. Do you have a link?

I only ever saw something about a delay to approval, not an outright rejection.

Thing for the US is - they possibly don't need the AZ vaccine and may be in no rush to expedite it's approval. Most of the approved or near-approval vaccine companies are American - Pfizer, Moderna, Novavax etc.

They already have HQ and manufacturing for Pfizer, Moderna, Novavax. I think Pfizer does the bulk of its vaccine manufacturing in the EU, but Moderna are almost entirely US-based.

I'll link you tomorrow but I was wondering more about USA not considering AZ as legit vaccines. It has big ramifications for travelling there for UK people who are mainly AZ vaccinated.

 

[Blake]

Lack of control was specifically in regards to Phase 4.

I don't follow. They haven't done a Phase 4. Like I said they actually don't have to. It's common not to do a Phase 4.

They probably will do other studies on COVID though, I expect it's inevitable. Firstly in case of COVID variants, they may change the formulation to drive efficacy.

Secondly they may seek to combine the COVID jab with something like flu, make it an annual product. I know 100% Novavax are looking at this now.

If they change the vaccine up or combine with another product, that won't be Phase 4, it will be a new earlier phase of what is technically a new product.

Thanks for taking the time to explain all of that @jirskyr. There is information on the net but is of various ages and usually has some spin on it.

 

[jirskyr]

It's a very easy scenario peeps - free medicine. You are lucky enough to live in an era and country where they will give you free medicine, no tricks, no catch.

Without the free medicine, there is a reasonable chance you get very sick and/or risk death.

Makes your life and everyone else's lives easier, scientifically and economically proven.

If you are risk adverse, take solace in the FACT that the vaccine risks are extremely low and after literally hundreds of millions of doses now been given, the safety data pool is very very big. I can understand if you don't like risk, but if you are so risk intolerant: don't drive, ride in a commercial aircraft, swim in the ocean, golf in bad weather, operate heavy machinery, rock climb, ride a horse, run a marathon, handle a weapon, own a motorbike etc.

Also take heart that since vaccines were first invented, we've basically eradicated the threat in Australia from polio, smallpox, tetanus, measles, diptheria, rabies, TB, mumps, whooping cough, rubella, typhoid, cholera. Hoping to add COVID to that list.

No reason not to get vaccinated except for special health concerns. Nerves are also understandable, but if you gave into nerves you'd never kiss a girl/boy, get a job or ride a bike.

So go get your free medicine and let's everyone get our freedoms back.

 

[oldprop]

Had both AZ shots. I’m 70 and no side effects.