Vaccine Progress, Approval, and Deployment

[hwl]

That depends on how effective the 3 month strategy actually is. There is as far as I am aware no published evidence to support this use of either vaccine. AstraZeneca leaks are not science. Of course we all hope the vaccines will end the current situation, but we need to be careful about what we actually expect to achieve. People have hooked on to the Pfizer and Moderna promises of 90%+ effective vaccines, but we are now mostly reliant on a vaccine found to be 62% effective in clinical trials (first dose alone effectiveness ???), and leaving people for three months with just the first dose of the Pfizer vaccine (52% effectiveness for the first dose, but wasn't tested for the full three months), with no evidence any of these figures hold up when the government has decided to invent it's own completely untested vaccination schedule.

Try the Lancet earlier this month for the Oxford-AZ vaccine:

DEFINE_ME

Effectiveness was measured differently in each trial with Oxford-AZ having a much lower threshold for an infection hence effectiveness will be lower than Pfizer or Moderna the other because of that but the difference is in minor or asymptomatic infections not serious ones.

One other key measure of effectiveness of the Oxford-AZ (and Moderna too but not Pfizer-BioNTech) is that there were 0 hospitalisations from Covid after 3 weeks of first dose.

 

[Dave1987]

I really don’t understand why British people are saying that the Oxford vaccine is the “game changer“ it really really isn’t. The BioNTech vaccine isn‘t grown on eggs like the Oxford one is. The BioNTech one is cutting edge. Can be mass produced and changed within a week. BioNTech had their vaccine ready to go in late Feb/early March but it’s such cutting edge tech there were lots of regulatory hurdles to go through. The Oxford vaccine is great as it is cheap and doesn’t need to be stored so cold but it takes a long time to mass produce and isn’t so easily changed as the BioNTech one is. The BioNTech vaccine has the potential to revolutionise medicine!

 

[158756]

Try the Lancet earlier this month for the Oxford-AZ vaccine:

DEFINE_ME

Effectiveness was measured differently in each trial with Oxford-AZ having a much lower threshold for an infection hence effectiveness will be lower than Pfizer or Moderna the other because of that but the difference is in minor or asymptomatic infections not serious ones.

One other key measure of effectiveness of the Oxford-AZ (and Moderna too but not Pfizer-BioNTech) is that there were 0 hospitalisations from Covid after 3 weeks of first dose.

I see the trial in Brazil gave the second jab 4-12 weeks after the first (which I've read elsewhere was not the original intention of the study), but is there a more detailed section on how effective if was after 12 weeks, or even if there was any robust data on that?

Pfizer have issued a statement on their vaccine: "There are no data to demonstrate that protection after the first dose is sustained after 21 days."

I really don’t understand why British people are saying that the Oxford vaccine is the “game changer“ it really really isn’t. The BioNTech vaccine isn‘t grown on eggs like the Oxford one is. The BioNTech one is cutting edge. Can be mass produced and changed within a week. BioNTech had their vaccine ready to go in late Feb/early March but it’s such cutting edge tech there were lots of regulatory hurdles to go through. The Oxford vaccine is great as it is cheap and doesn’t need to be stored so cold but it takes a long time to mass produce and isn’t so easily changed as the BioNTech one is. The BioNTech vaccine has the potential to revolutionise medicine!

Because to most people the 'game' is ending the disruption caused by the virus. BioNTech may have the more interesting technology, but it isn't going to be delivered fast enough to make a big difference in the next few months (in the UK at least).

 

[Yew]

That depends on how effective the 3 month strategy actually is. There is as far as I am aware no published evidence to support this use of either vaccine. AstraZeneca leaks are not science. Of course we all hope the vaccines will end the current situation, but we need to be careful about what we actually expect to achieve. People have hooked on to the Pfizer and Moderna promises of 90%+ effective vaccines, but we are now mostly reliant on a vaccine found to be 62% effective in clinical trials (first dose alone effectiveness ???), and leaving people for three months with just the first dose of the Pfizer vaccine (52% effectiveness for the first dose, but wasn't tested for the full three months), with no evidence any of these figures hold up when the government has decided to invent it's own completely untested vaccination schedule.

The numbers for Oxford and Pfizer/Modena were calculated differently, Oxford took regular PCR tests, whereas the others only tested when symptoms were shown.

 

[kristiang85]

Certainly the impetus to innovate caused by COVID has meant great strides have been taken in a short space of time in vaccine technology. That is good news, especially as it will be transferable to actual serious diseases (eg TB).

It's a bit like how the Space Race meant almost impossible technoglical advancements in such a short time, which we still benefit from today.

 

[Yew]

I really don’t understand why British people are saying that the Oxford vaccine is the “game changer“ it really really isn’t. The BioNTech vaccine isn‘t grown on eggs like the Oxford one is. The BioNTech one is cutting edge. Can be mass produced and changed within a week. BioNTech had their vaccine ready to go in late Feb/early March but it’s such cutting edge tech there were lots of regulatory hurdles to go through. The Oxford vaccine is great as it is cheap and doesn’t need to be stored so cold but it takes a long time to mass produce and isn’t so easily changed as the BioNTech one is. The BioNTech vaccine has the potential to revolutionise medicine!

Perhaps BioNTech will have more use in the future, as it is changed for future diseases. But to get out of this situation, the Oxford Vaccine is a game changer, as we have a lot of it.

It's also cheap and easy to distribute, which is a godsend for developing countries.

 

[yorksrob]

I really don’t understand why British people are saying that the Oxford vaccine is the “game changer“ it really really isn’t. The BioNTech vaccine isn‘t grown on eggs like the Oxford one is. The BioNTech one is cutting edge. Can be mass produced and changed within a week. BioNTech had their vaccine ready to go in late Feb/early March but it’s such cutting edge tech there were lots of regulatory hurdles to go through. The Oxford vaccine is great as it is cheap and doesn’t need to be stored so cold but it takes a long time to mass produce and isn’t so easily changed as the BioNTech one is. The BioNTech vaccine has the potential to revolutionise medicine!

I don't mind which one is game changing, as long as one of them is.

 

[hwl]

I really don’t understand why British people are saying that the Oxford vaccine is the “game changer“ it really really isn’t. The BioNTech vaccine isn‘t grown on eggs like the Oxford one is. The BioNTech one is cutting edge. Can be mass produced and changed within a week. BioNTech had their vaccine ready to go in late Feb/early March but it’s such cutting edge tech there were lots of regulatory hurdles to go through. The Oxford vaccine is great as it is cheap and doesn’t need to be stored so cold but it takes a long time to mass produce and isn’t so easily changed as the BioNTech one is. The BioNTech vaccine has the potential to revolutionise medicine!

The Oxford-AZ vaccine is actually rated as the easiest to mass produce and is expected to be the most produced overall.
Most manufacturers are having issues ramping up production rates.

The Oxford vaccine can also be changed relatively easily and as like the Pfizer vaccine was created in matter of days.

 

[Bertie the bus]

I really don’t understand why British people are saying that the Oxford vaccine is the “game changer“ it really really isn’t. The BioNTech vaccine isn‘t grown on eggs like the Oxford one is. The BioNTech one is cutting edge. Can be mass produced and changed within a week. BioNTech had their vaccine ready to go in late Feb/early March but it’s such cutting edge tech there were lots of regulatory hurdles to go through. The Oxford vaccine is great as it is cheap and doesn’t need to be stored so cold but it takes a long time to mass produce and isn’t so easily changed as the BioNTech one is. The BioNTech vaccine has the potential to revolutionise medicine!

It isn't just British people and one of the reasons is because they can see beyond Britain. What many are saying is it is a "game changer" because it is cheap, easier to transport and easier to store and is therefore of much more use and importance to poorer countries. Despite what you seem to be implying they're not saying it because it was developed in Britain and they don't think Dover is the edge of the known world.

 

[HSTEd]

The most important thing about the Astra Zeneca vaccine is that we are in possession of a manufacturing plant.

 

[kez19]

Just to give you all an idea after first one, feels like I’m hungover, tired (excessively) hope tomorrow feeling more myself but today feel more lost than ever (know my routine)

 

[yorksrob]

Just to give you all an idea after first one, feels like I’m hungover, tired (excessively) hope tomorrow feeling more myself but today feel more lost than ever (know my routine)

Sounds like my average Sunday then.

 

[kez19]

Sounds like my average Sunday then.

I know yet I rarely drink! Not looking forward to next one though

 

[yorksrob]

I know yet I rarely drink! Not looking forward to next one though

At least it's only one more then you're done with it !

 

[kez19]

At least it's only one more then you're done with it !

That’s true but god knows how the second one will be, believe I have been told it’s a full dose next time, if this after the first one I’ll probably be floored on the next!

 

[Domh245]

That’s true but god knows how the second one will be, believe I have been told it’s a full dose next time, if this after the first one I’ll probably be floored on the next!

It would have been a full dose on the first jab - the only one being currently given is the Pfizer BioNtech one, which was (like Ox/AZ) approved on the basis of 2 full doses. It'll be interesting to see when you are called for your second jab now, it should have been 3 weeks from the first jab but this may be pushed out to 12 weeks following the announcement today

 

[778]

Will previously booked 2nd appointments (for the pfizer jabs 2nd dose), now be cancelled?

 

[Class 317]

Will previously booked 2nd appointments (for the pfizer jabs 2nd dose), now be cancelled?

I'm fairly certain the 12 week's is only the Oxford vaccine.

 

[Domh245]

I'm fairly certain the 12 week's is only the Oxford vaccine.

It's for both. The MHRA announcement today had this line:

Dosage interval - the advice has been updated to say that the second dose of the Pfizer/BioNTech vaccine should be given at least 21 days after the first dose.

(my emphasis - it was previously "You should receive two doses (each 0.3mL) given 21 days apart.")

however, the 'slam-dunk' is in the CMOs' press release

The Joint Committee on Vaccination and Immunisation (JCVI) has subsequently recommended that as many people on the JCVI priority list as possible should sequentially be offered a first vaccine dose as the initial priority. They have advised that the second dose of the Pfizer/BioNTech vaccine may be given between 3 to 12 weeks following the first dose, and that the second dose of the AstraZeneca (Oxford) vaccine may be given between 4 to 12 weeks following the first dose. The clinical risk priority order for deployment of the vaccines remains unchanged and applies to both vaccines. Both are very effective vaccines.

Although worth noting that in both cases, 12 weeks is the upper limit of the time between doses, and the interval between them will depend on the supply available and the number of phase 1 patients still to be vaccinated, I would think it unlikely that they'll push it all the way to 12 weeks for people who've already received the Pfizer vaccine

 

[kez19]

It would have been a full dose on the first jab - the only one being currently given is the Pfizer BioNtech one, which was (like Ox/AZ) approved on the basis of 2 full doses. It'll be interesting to see when you are called for your second jab now, it should have been 3 weeks from the first jab but this may be pushed out to 12 weeks following the announcement today

I was wondering that as I read it on the news app earlier, I rather just get it over with.

 

[birchesgreen]

Side-effects seem to vary, my uncle (83 yo) just had a bit of arm numbness for a bit after his jab. My best friend (50, US based medical professional) didn't report anything much at all after it.

 

[kez19]

It would have been a full dose on the first jab - the only one being currently given is the Pfizer BioNtech one, which was (like Ox/AZ) approved on the basis of 2 full doses. It'll be interesting to see when you are called for your second jab now, it should have been 3 weeks from the first jab but this may be pushed out to 12 weeks following the announcement today

I read that yesterday before going into work but hopefully the 12 weeks wait is passed on but god knows, seems like no one knows!

Update: took paracetamol this morning just as a bit of backup, but managed to sleep it off last night (headache), usually if I have headache I usually let my body naturally sleep it off if I can than take paracetamol immediately

 

[Darandio]

It's for both. The MHRA announcement today had this line:

And Pfizer have apparently told the Guardian that there was no data to demonstrate that protection after the initial dose was sustained after 21 days.

Seems to me like the government are continuing their amazing track record of poor decision making. Call me cynical but to me this just smacks of another dose of their love for announcing huge figures. In 8 weeks time they can make an amazing claim of vaccinating a large number of people even it is at the potential detriment to the effectiveness of the vaccine itself.

 

[kez19]

And Pfizer have apparently told the Guardian that there was no data to demonstrate that protection after the initial dose was sustained after 21 days.

Seems to me like the government are continuing their amazing track record of poor decision making. Call me cynical but to me this just smacks of another dose of their love for announcing huge figures. In 8 weeks time they can make an amazing claim of vaccinating a large number of people even it is at the potential detriment to the effectiveness of the vaccine itself.

Another thing that was raised was if the COVID vaccine is going to be annually/yearly (again this is something that needs to be said but I guess it’s filed under the “we don’t know”)

As I said before there is more questions than answers which none of the governments seems to have an answer for but will happily play guesswork

 

[158756]

And Pfizer have apparently told the Guardian that there was no data to demonstrate that protection after the initial dose was sustained after 21 days.

Seems to me like the government are continuing their amazing track record of poor decision making. Call me cynical but to me this just smacks of another dose of their love for announcing huge figures. In 8 weeks time they can make an amazing claim of vaccinating a large number of people even it is at the potential detriment to the effectiveness of the vaccine itself.

The data to support it for the Oxford/AstraZeneca vaccine is also apparently unpublished, which doesn't inspire confidence, especially given the quality of their published work.

Expectations of the vaccination programme are far too high. The government have made this move because a realistic, science based approach would have had maybe only a million people done by the end of January, months, maybe most of the year to finish the vulnerable groups and much longer for everyone else, but no one wants to hear that. But the backlash would be nothing compared to that which will come in a few months or so if it turns out our 'strategy' has rendered every single dose completely ineffective.

 

[Yew]

But the backlash would be nothing compared to that which will come in a few months or so if it turns out our 'strategy' has rendered every single dose completely ineffective.

If it means restrictions can be lifted more quickly, then I support it. A 'few months' could is probably more likely to be 'in the summer', when respiratory illnesses are typically lower anyway, and we'll have more breathing room if we do need to re-vaccinate some individuals.

 

[hwl]

But the backlash would be nothing compared to that which will come in a few months or so if it turns out our 'strategy' has rendered every single dose completely ineffective.

Unlikely to completely ineffective e.g. likely to very effective at reducing hospitalisations but could well have impacts on how much transmission is reduced (which comes with a significant economic impact).

 

[Domh245]

And Pfizer have apparently told the Guardian that there was no data to demonstrate that protection after the initial dose was sustained after 21 days.

Seems to me like the government are continuing their amazing track record of poor decision making. Call me cynical but to me this just smacks of another dose of their love for announcing huge figures. In 8 weeks time they can make an amazing claim of vaccinating a large number of people even it is at the potential detriment to the effectiveness of the vaccine itself.

Don't mistake "no evidence that it does" for "evidence that it doesn't"

"No evidence that it does" means exactly that, they've no evidence that it protection is sustained after 21 days as they only studied what happens when you give people a second dose after 21 days. That doesn't mean that protection isn't sustained, and indeed based on our understanding of immunity it'd be quite surprising if it did suddenly drop away to the point of becoming ineffective, which is why I'm sure the UK CMOs felt comfortable taking this gamble.

It's like in the early days of the pandemic when the WHO was saying "there's no evidence that infection confers immunity" - it was entirely true at that point that we didn't know if infection conferred immunity as it hadn't been studied, but it'd have been a departure from the norm if it didn't, so it was an entirely reasonable thing to assume

 

[hwl]

If it means restrictions can be lifted more quickly, then I support it. A 'few months' could is probably more likely to be 'in the summer', when respiratory illnesses are typically lower anyway, and we'll have more breathing room if we do need to re-vaccinate some individuals.

It speeds up initial restriction lifting but prolongs lifting of later ones especially if the reduction in transmission is less good.
There is also no data on re-vaccinating. Can it be done with single dose - if so does this need to be larger that used for manufacturer planned double dose given the time that has passed? Or does it need a new double vaccination but with different doses? What types of immune response are missed because of not following the double dose as trialled (Pfizer and Oxford-AZ illicit very different responses). Does a huge time gap between the first 2 dose lead to a smaller time gap between eventual booster doses?

The government will be having to do (pay for) a lot of extra trials as a result.

 

[158756]

If it means restrictions can be lifted more quickly, then I support it. A 'few months' could is probably more likely to be 'in the summer', when respiratory illnesses are typically lower anyway, and we'll have more breathing room if we do need to re-vaccinate some individuals.

Restrictions will last much longer if the hospitals are full of half vaccinated people. Even if this gamble actually works the whole situation is a gift to anti-vaxxers, and may well harm trust in this and other vaccines and the level of take up.