The vaccine

[UncleEbenezer]

Does that imply the vaccine itself is shipped in a big barrel or keg from which doses are drawn? So what's the role of those glass vials that some reports suggest have been a supply bottleneck?

The report I listened to said the different syringe got something like 6 doses from a vial while the original one only got 5.

Scott.

Actually that raises another question: what counts as a dose? And is it the same for a 20-stone rugger player as for an 8-stone lady?

[Bouleversee]

Sounds suspiciously like more thinking along the lines of the completely-untested 12-week gap that the rest of the world (and it seems doctors here) seem to regard as a Trump-like solution.

No this is just very sensible practical advice. The smaller needle/syringe means less wasted vaccine left in the used syringe after each dose.

I'm surprised that "normal" syringe design was so wasteful! It would seem such an obvious thing to have optimised in the early days of the NHS, if not before.

Does that imply the vaccine itself is shipped in a big barrel or keg from which doses are drawn? So what's the role of those glass vials that some reports suggest have been a supply bottleneck?

My reaction was the same as yours. Bearing in mind that shortage of vaccine is compromising the rate of inoculation, wouldn't you think the size of vial and size of needle would have been co-ordinated long before now in order to avoid waste, especially since the Pfizer one is quite expensive? That's assuming the recipients are getting the right amount of vaccine with the thinner needle; can we be sure of that? One would have thought that each vial would specify the number of doses and the correct needle to achieve this. From the manufacturer's p.o.v. the more vaccine wasted and required the better, of course.

As regards the 12 week gap, Lord Warner who writes in a letter to The Times today as "a former minister responsible for the regulation of medicines to ensure their safety and efficacy" and at the age of 80 has already had both jabs of the Pfizer-B. vaccine (I wonder how he managed that) refers to the manufacturer's info., the WHO's statement and other scientists' comments objecting to the shift from 21 days to 12 weeks for the 2nd dose and says he would have resigned if, as a minister, he had been instructed to delay the 2nd jab in this way.

[swill453]

As regards the 12 week gap, Lord Warner who writes in a letter to The Times today as "a former minister responsible for the regulation of medicines to ensure their safety and efficacy" and at the age of 80 has already had both jabs of the Pfizer-B. vaccine (I wonder how he managed that) refers to the manufacturer's info., the WHO's statement and other scientists' comments objecting to the shift from 21 days to 12 weeks for the 2nd dose and says he would have resigned if, as a minister, he had been instructed to delay the 2nd jab in this way.

Regarding the Oxford AstraZeneca one, Sir Mene Pangalos, executive vice-president of biopharmaceuticals research and development at AstraZeneca, said

What we’re seeing with our data so far is that as you go to the eight- to 12-week interval, you actually increase vaccine efficacy. People are protected enough with the first dose, to around 70%, but we see that within that eight- to 12-week interval is actually the sweet spot

https://www.theguardian.com/world/2021/ ... in-england

Scott.

[redsturgeon]

No this is just very sensible practical advice. The smaller needle/syringe means less wasted vaccine left in the used syringe after each dose.

I'm surprised that "normal" syringe design was so wasteful! It would seem such an obvious thing to have optimised in the early days of the NHS, if not before.

Does that imply the vaccine itself is shipped in a big barrel or keg from which doses are drawn? So what's the role of those glass vials that some reports suggest have been a supply bottleneck?

My reaction was the same as yours. Bearing in mind that shortage of vaccine is compromising the rate of inoculation, wouldn't you think the size of vial and size of needle would have been co-ordinated long before now in order to avoid waste, especially since the Pfizer one is quite expensive? That's assuming the recipients are getting the right amount of vaccine with the thinner needle; can we be sure of that? One would have thought that each vial would specify the number of doses and the correct needle to achieve this. From the manufacturer's p.o.v. the more vaccine wasted and required the better, of course.

As regards the 12 week gap, Lord Warner who writes in a letter to The Times today as "a former minister responsible for the regulation of medicines to ensure their safety and efficacy" and at the age of 80 has already had both jabs of the Pfizer-B. vaccine (I wonder how he managed that) refers to the manufacturer's info., the WHO's statement and other scientists' comments objecting to the shift from 21 days to 12 weeks for the 2nd dose and says he would have resigned if, as a minister, he had been instructed to delay the 2nd jab in this way.

If you think about how a syringe works you will understand that there will always be a little fluid left in the needle and the spout after the plunger has been pushed all the way down. A bit like the last bit of toothpaste in the tube. If you have a thinner spout and needle you draw up less vaccine from the vial but the same dose is still delivered because there is less waste. Also since you will recall that half the recommended dose of the AZ vaccine is actually better than the full dose then there is a bit of leeway and the dosing is not super critical for the vaccine. NB the same dose will be given to a 20 year old, 6 stone woman as to an 80 year old, 25 stone man.

John

[UncleEbenezer]

If you have a thinner spout and needle you draw up less vaccine from the vial but the same dose is still delivered because there is less waste.

As I said, I find it very surprising that hasn't long-since been optimised. It seemed blindingly obvious to my 1970s schoolboy self when I had a syringe associated with some chemistry set.

Also since you will recall that half the recommended dose of the AZ vaccine is actually better than the full dose

Isn't that an accidental (not tested as such) observation, and therefore no better than anecdotal?

then there is a bit of leeway and the dosing is not super critical for the vaccine. NB the same dose will be given to a 20 year old, 6 stone woman as to an 80 year old, 25 stone man.

John

That may be the case, but we're now into handwaving "looks fine, just do it" logic, under which we might as well have started vaccinating nine months earlier.

[redsturgeon]

If you have a thinner spout and needle you draw up less vaccine from the vial but the same dose is still delivered because there is less waste.

As I said, I find it very surprising that hasn't long-since been optimised. It seemed blindingly obvious to my 1970s schoolboy self when I had a syringe associated with some chemistry set.

Also since you will recall that half the recommended dose of the AZ vaccine is actually better than the full dose

Isn't that an accidental (not tested as such) observation, and therefore no better than anecdotal?

then there is a bit of leeway and the dosing is not super critical for the vaccine. NB the same dose will be given to a 20 year old, 6 stone woman as to an 80 year old, 25 stone man.

John

That may be the case, but we're now into handwaving "looks fine, just do it" logic, under which we might as well have started vaccinating nine months earlier.

You may have noticed we are in the middle of a pandemic...

John

[Bouleversee]

No this is just very sensible practical advice. The smaller needle/syringe means less wasted vaccine left in the used syringe after each dose.

https://www.ema.europa.eu/en/news/extra ... 19-vaccine

EMA advice but the same principle applies.

John

Your link is all about a COVID-19 vaccine called "Comirnaty". I've never heard of this! Is it another name for a vaccine we have already discussed on this board or has the EMA slipped one through with nobody noticing?

It is the Pfizer Biontec vaccine.

John

How interesting. Why give a drug a (rather strange) name if nobody uses it? The ticket I was given to take with me if I am still alive by the time I get my 2nd jab merely gives (handwritten) Pfizer-BioNTech as name of vaccine, followed by a batch no. I presume this firm makes a lot of drugs. I hope there aren't any mix-ups. Nothing would surprise me any more.

redsturgeon said "If you think about how a syringe works you will understand that there will always be a little fluid left in the needle and the spout after the plunger has been pushed all the way down. A bit like the last bit of toothpaste in the tube. If you have a thinner spout and needle you draw up less vaccine from the vial but the same dose is still delivered because there is less waste. Also since you will recall that half the recommended dose of the AZ vaccine is actually better than the full dose then there is a bit of leeway and the dosing is not super critical for the vaccine. NB the same dose will be given to a 20 year old, 6 stone woman as to an 80 year old, 25 stone man."

I am afraid your response makes no sense to me at all. I must be very dim. We were talking about the Pfizer B. vaccine not AZN but what you said about the latter doesn't seem to correspond with what is being dished out in any case because aiui the half dose was only trialled by accident on a small number of people, all under 55, and in any case I remain to be convinced that one can assume they are interchangeable.

[Bouleversee]

redsturgeon said:

You may have noticed we are in the middle of a pandemic...

Are you sure you spelled that correctly? Shouldn't it be PANIC?

[redsturgeon]

Your link is all about a COVID-19 vaccine called "Comirnaty". I've never heard of this! Is it another name for a vaccine we have already discussed on this board or has the EMA slipped one through with nobody noticing?

It is the Pfizer Biontec vaccine.

John

How interesting. Why give a drug a (rather strange) name if nobody uses it? The ticket I was given to take with me if I am still alive by the time I get my 2nd jab merely gives (handwritten) Pfizer-BioNTech as name of vaccine, followed by a batch no. I presume this firm makes a lot of drugs. I hope there aren't any mix-ups. Nothing would surprise me any more.

.

Drugs are always given Trade names for patent protection. Once out of patent then the generic forms can be manufactured and sold under different names.
Tozinameran[12] (INN), commonly known as the Pfizer–BioNTech COVID-19 vaccine and sold under the brand name Comirnaty, is a COVID-19 vaccine developed by BioNTech in cooperation with Pfizer. It is both the first COVID-19 vaccine to be authorized by a stringent regulatory authority for emergency use[13][14] and the first cleared for regular use.[11]

[UncleEbenezer]

How interesting. Why give a drug a (rather strange) name if nobody uses it?

Evidently someone uses it.

Maybe it's just the British press that don't use it? Maybe it's linguistically meaningful to Germans of Turkish origin?

[redsturgeon]

redsturgeon said "If you think about how a syringe works you will understand that there will always be a little fluid left in the needle and the spout after the plunger has been pushed all the way down. A bit like the last bit of toothpaste in the tube. If you have a thinner spout and needle you draw up less vaccine from the vial but the same dose is still delivered because there is less waste. Also since you will recall that half the recommended dose of the AZ vaccine is actually better than the full dose then there is a bit of leeway and the dosing is not super critical for the vaccine. NB the same dose will be given to a 20 year old, 6 stone woman as to an 80 year old, 25 stone man."

I am afraid your response makes no sense to me at all. I must be very dim. We were talking about the Pfizer B. vaccine not AZN but what you said about the latter doesn't seem to correspond with what is being dished out in any case because aiui the half dose was only trialled by accident on a small number of people, all under 55, and in any case I remain to be convinced that one can assume they are interchangeable.

Sorry for the confusion. They are not interchangeable they are two very different vaccines. I was using the half dosage story as a general illustration that as far as vaccines are concerned the dosage is not super critical as would be the case with many medicines eg. warfarin.

HTH
John

[UncleEbenezer]

that as far as vaccines are concerned the dosage is not super critical as would be the case with many medicines eg. warfarin.

HTH
John

Is there an evidence base for that, from real trials addressing differences such as body weight? If so, is there also an evidence base for generalising from trialled examples to all vaccines?

Or is it just received wisdom: we've always done it that way?

Remind me: where's the medical evidence for my 14 or 21 or 28 units of alcohol a week, and which is it this week?

[redsturgeon]

How interesting. Why give a drug a (rather strange) name if nobody uses it? The ticket I was given to take with me if I am still alive by the time I get my 2nd jab merely gives (handwritten) Pfizer-BioNTech as name of vaccine, followed by a batch no. I presume this firm makes a lot of drugs. I hope there aren't any mix-ups. Nothing would surprise me any more.

.

You will be fine. The hand written ticket confirms that you had the Pfizer-BioNTech covid vaccine and the batch number will enable them to identify exactly what batch you were given your dose from. Useful in case of an issues. Pfizer make a lot of drugs but the covid vaccine is the only thing that have made in collaboration with BioNTech AFAIK.

John

[dealtn]

As regards the 12 week gap, Lord Warner who writes in a letter to The Times today as "a former minister responsible for the regulation of medicines to ensure their safety and efficacy" and at the age of 80 has already had both jabs of the Pfizer-B. vaccine (I wonder how he managed that) refers to the manufacturer's info., the WHO's statement and other scientists' comments objecting to the shift from 21 days to 12 weeks for the 2nd dose and says he would have resigned if, as a minister, he had been instructed to delay the 2nd jab in this way.

Regarding the Oxford AstraZeneca one, Sir Mene Pangalos, executive vice-president of biopharmaceuticals research and development at AstraZeneca, said

What we’re seeing with our data so far is that as you go to the eight- to 12-week interval, you actually increase vaccine efficacy. People are protected enough with the first dose, to around 70%, but we see that within that eight- to 12-week interval is actually the sweet spot

https://www.theguardian.com/world/2021/ ... in-england

Scott.

Which is precisely why it is annoying, and no doubt even more frustrating to those close to the process, to hear words such as "completely untested" used by detractors about this decision.

[redsturgeon]

that as far as vaccines are concerned the dosage is not super critical as would be the case with many medicines eg. warfarin.

HTH
John

Is there an evidence base for that, from real trials addressing differences such as body weight? If so, is there also an evidence base for generalising from trialled examples to all vaccines?

Or is it just received wisdom: we've always done it that way?

Remind me: where's the medical evidence for my 14 or 21 or 28 units of alcohol a week, and which is it this week?

It really isn't my job to educate you on the mode of action of vaccines and how physical factors will affect a persons response to it or the rationale behind the design of clinical trials. Age is actually a definite factor in reaction to vaccines such a the flu vaccine which is why a different one is given to older patients. The fact that is not the case with the covid vaccines suggests either we have not had and opportunity to study it long enough or it is not an issue. If body weight is a significant issue in any medical product then guidelines can be given to use a dose per kilo of weight.

As to the alcohol question who knows...I stopped drinking six months ago so I don't really care.

John

[dealtn]

Also since you will recall that half the recommended dose of the AZ vaccine is actually better than the full dose

Isn't that an accidental (not tested as such) observation, and therefore no better than anecdotal?

No it was accidentally done, not accidentally observed, and was as tested as other variants. It was unintentional, not anecdotal.

[Arborbridge]

Also since you will recall that half the recommended dose of the AZ vaccine is actually better than the full dose

Isn't that an accidental (not tested as such) observation, and therefore no better than anecdotal?

No it was accidentally done, not accidentally observed, and was as tested as other variants. It was unintentional, not anecdotal.

A happy accident. I believe there have been many in the history of science.

[Bouleversee]

How interesting. Why give a drug a (rather strange) name if nobody uses it? The ticket I was given to take with me if I am still alive by the time I get my 2nd jab merely gives (handwritten) Pfizer-BioNTech as name of vaccine, followed by a batch no. I presume this firm makes a lot of drugs. I hope there aren't any mix-ups. Nothing would surprise me any more.

.

You will be fine. The hand written ticket confirms that you had the Pfizer-BioNTech covid vaccine and the batch number will enable them to identify exactly what batch you were given your dose from. Useful in case of an issues. Pfizer make a lot of drugs but the covid vaccine is the only thing that have made in collaboration with BioNTech AFAIK.

John

Thanks, John, but I wasn't worrying about myself insofar as getting the right drug was concerned. However, I'd like to see some evidence that increasing the interval and also reducing, albeit slightly, the dose administered won't have some effect on the degree and duration of immunity conferred by each jab. I'm with Lord Warner on this one. I must look him up.

[UncleEbenezer]

Also since you will recall that half the recommended dose of the AZ vaccine is actually better than the full dose

Isn't that an accidental (not tested as such) observation, and therefore no better than anecdotal?

No it was accidentally done, not accidentally observed, and was as tested as other variants. It was unintentional, not anecdotal.

I didn't say anecdotal, I said no better than anecdotal. Apologies for the wording.

Statistically speaking, a result that is observed without being explicitly tested may be entirely due to random variations. We then pose the hypothesis that the result is valid, and devise a test for it. Only if and when that test proves successful can we claim the result as statistically meaningful.

Now I'm not saying we should delay the vaccine while we conduct such a trial. But I would contrast quotes from Dr Pangloss (mediated by a journalist) with the many times since about April I've heard Sarah Gilbert on t'wireless speaking of very promising observational results but never suggesting we go ahead with a rollout before they had conducted a testing programme.

Why bother with the clinical trials in the first place if we then go ahead with an un-trialled regime? And yes, I am guilty of conflating different issues here: dosage and interval are not the same!

[Bouleversee]

As regards the 12 week gap, Lord Warner who writes in a letter to The Times today as "a former minister responsible for the regulation of medicines to ensure their safety and efficacy" and at the age of 80 has already had both jabs of the Pfizer-B. vaccine (I wonder how he managed that) refers to the manufacturer's info., the WHO's statement and other scientists' comments objecting to the shift from 21 days to 12 weeks for the 2nd dose and says he would have resigned if, as a minister, he had been instructed to delay the 2nd jab in this way.

Regarding the Oxford AstraZeneca one, Sir Mene Pangalos, executive vice-president of biopharmaceuticals research and development at AstraZeneca, said

What we’re seeing with our data so far is that as you go to the eight- to 12-week interval, you actually increase vaccine efficacy. People are protected enough with the first dose, to around 70%, but we see that within that eight- to 12-week interval is actually the sweet spot

https://www.theguardian.com/world/2021/ ... in-england

Scott.

Which is precisely why it is annoying, and no doubt even more frustrating to those close to the process, to hear words such as "completely untested" used by detractors about this decision.

Again, Lord Warner and I were talking about the Pfizer vaccine, the one both he and I have had, not the AZN one.