Vaccine Progress, Approval, and Deployment

[yorkie]

I'd expect a booster jab this autumn/ winter and then annual jabs for a few years after that at least,...
Why?

I think at least one 'annual booster' will be needed, maybe two (I'll say definitely two in the longer term, if the first one is rushed out for this autumn).

But annual for a few years? Really?

The virus doesn't mutate that much and even the SA variant does not completely evade the antibody response, as some people falsely try to claim.

The variants are not able to evade the T cell response (which appears to be the biggest factor in avoiding severe symptoms). If you want to hear this directly from Vincent Racaniello, a leading virologist, check this out:

1hr 9min 40sec:

The B cell epitopes are different to the T cell epitopes.

The spike protein has B cell epitopes which are recognised by antibodies and T cell epitopes which are recognised by T cells. The T cell epitopes are not changing. That's why the T cells still protect against the variants

My understanding is that an annual booster is not currently predicted to make much, if any, difference to severe symptoms, hospitalisations and deaths, and is more about trying to eliminate transmission.

Unless something really unexpected happens, the only reason we would do an annual booster for several years is if the aim is to actually eliminate transmission altogether, if that's even possible.

I'm not sure if the AZ vaccine can be altered to be prefusion stabilised but if so that is a potential improvement to that vaccine (I've heard several reports indicate that this is a reason why the AZ vaccine does not perform quite as well against the SA variant but I've not heard if this is an easy fix or not). Then there are adaptations for the known variants and potential adaptations for predicted future variants (there are only so many ways the virus can mutate and be viable, so it may be possible to predict these) and also, it may be possible to include other viral proteins so we get more T cell epitopes, to induce an even better T cell response.

So, without knowing what the timeframe for any such improvements may be, it's difficult to predict, but I don't see it as an annual thing, at least not beyond the next year or two.

Edit: I'll add that if it becomes necessary to have an annual booster, it would make sense to combine it with the annual influenza shot.

 

[LAX54]

Haven’t heard much about Novavax but I’d noticed some sort of backlash against J&J in recent days being talked about online. Not sure why!

J&J backlash is due to it is said, the Baby Powder causing cancer in some people, think it was said there are minute particles of asbestos in the mix, so there is a 'class action' in the USA, although it only seems to affect the USA as well.

 

[TravelDream]

Finally, Britain is going to start using a third vaccine this coming week. The Moderna vaccine was licensed in January, but only now are we receiving the first deliveries. The UK government haven't said how many we are going to get, but the Scottish government have said around 4000 doses per week for Scotland which means around 50,000 per week for the UK. Tiny numbers, but better than nothing.

https://twitter.com/SkyNewsPolitics/status/1376152511078354947

Dolly Parton invested in, received and sang a song about it...

 

[hwl]

J&J backlash is due to it is said, the Baby Powder causing cancer in some people, think it was said there are minute particles of asbestos in the mix, so there is a 'class action' in the USA, although it only seems to affect the USA as well.

J&J are currently doing trials in the US to move to a 2 dose regime like the similar Ox/AZ vaccine, hence some of this may be due to lower efficacy with a single dose compared to 2 dose vaccines especially the mRNA vaccines and it being viewed as second class compared to others until they move to 2 dose.

 

[TravelDream]

J&J are currently doing trials in the US to move to a 2 dose regime like the similar Ox/AZ vaccine, hence some of this may be due to lower efficacy with a single dose compared to 2 dose vaccines especially the mRNA vaccines and it being viewed as second class compared to others until they move to 2 dose.

I think everyone knows the US has a big issue with race at the moment and there was the perception among some that the JnJ vaccine was being sent to inner-cities and the Pfizer and Moderna ones to whiter areas.

TBF to the JnJ vaccine, its efficacy as a single-dose vaccine in not that different from the two dose Oxford/AZ one. Though you're right the two dose trial is well underway. I think last year they got cold feet with the single dose schedule and decided to start the two-dose one as an insurance policy.

 

[hwl]

I'd expect a booster jab this autumn/ winter and then annual jabs for a few years after that at least,...
Why?

I think at least one 'annual booster' will be needed, maybe two (I'll say definitely two in the longer term, if the first one is rushed out for this autumn).

But annual for a few years? Really?

The virus doesn't mutate that much and even the SA variant does not completely evade the antibody response, as some people falsely try to claim.

The variants are not able to evade the T cell response (which appears to be the biggest factor in avoiding severe symptoms). If you want to hear this directly from Vincent Racaniello, a leading virologist, check this out:

1hr 9min 40sec:




My understanding is that an annual booster is not currently predicted to make much, if any, difference to severe symptoms, hospitalisations and deaths, and is more about trying to eliminate transmission.

Unless something really unexpected happens, the only reason we would do an annual booster for several years is if the aim is to actually eliminate transmission altogether, if that's even possible.

I'm not sure if the AZ vaccine can be altered to be prefusion stabilised but if so that is a potential improvement to that vaccine (I've heard several reports indicate that this is a reason why the AZ vaccine does not perform quite as well against the SA variant but I've not heard if this is an easy fix or not). Then there are adaptations for the known variants and potential adaptations for predicted future variants (there are only so many ways the virus can mutate and be viable, so it may be possible to predict these) and also, it may be possible to include other viral proteins so we get more T cell epitopes, to induce an even better T cell response.

So, without knowing what the timeframe for any such improvements may be, it's difficult to predict, but I don't see it as an annual thing, at least not beyond the next year or two.

Edit: I'll add that if it becomes necessary to have an annual booster, it would make sense to combine it with the annual influenza shot.

Very unlikely to need an annual booster. With other Beta-coronaviruses the majority of those who have been infected maintain good T-Cell response well beyond 5 years, hence a 5 year interval with maybe 3 year for 70+ age group? The two dose vaccine T-cell responses measured so far seem better than for those infected with Covid, so positive for a good long term vaccine effectiveness.

A booster this autumn would be to improve the speed of the B-cell/antibody response to new variants (with 501 & 484 mutations) and reduce the ability of those infected (often with low level infections kept under control by T-cell response) to spread it? So possibly best focused in health, care and other sectors with higher spread risk /impact initially. The reality is that most jabs form this autumn could include 501 & 484 mutations by default.
An improved /faster B-cell / antibody response might help reduce a few of the residual serious cases but not that many hence targeting the over 65/70/75 where this effect would be most noticeable.

In terms of reducing spread, getting as many adults as possible vaccinated is far more useful given the transmission reductions being shown in real world studies both here and in Israel.

Pre-fusion should be an easy fix.

There was some work a few weeks ago showing that there are only a limited number of mutations that theoretically "enhance" the virus (we have already seen a number of these in practice), most have minimal effect or degrade its effectiveness.

The Ox/AZ and J&J T cell responses have been better than the mRNA ones and this may be more useful in the medium and long term.

I think everyone knows the US has a big issue with race at the moment and there was the perception among some that the JnJ vaccine was being sent to inner-cities and the Pfizer and Moderna ones to whiter areas.

TBF to the JnJ vaccine, its efficacy as a single-dose vaccine in not that different from the two dose Oxford/AZ one. Though you're right the two dose trial is well underway. I think last year they got cold feet with the single dose schedule and decided to start the two-dose one as an insurance policy.

[All the trials measure things slightly differently so best not read to much into individual numbers or comparisons]
The excellent effectiveness for the mRNA vaccines has moved the goal posts a bit.
All the serology work indicates that 2 doses would be best for long term vaccine effectiveness but it will be a while before this can be measured in practice but this will be part of J&J's thinking.

 

[TravelDream]

[All the trials measure things slightly differently so best not read to much into individual numbers or comparisons]
The excellent effectiveness for the mRNA vaccines has moved the goal posts a bit.
All the serology work indicates that 2 doses would be best for long term vaccine effectiveness but it will be a while before this can be measured in practice but this will be part of J&J's thinking.

I understand that, but they are the best comparison between vaccines that we have.

Arguably, the JnJ vaccine had a tougher job as part of its initial phase 3 trial was completed in South Africa when their variant was becoming widespread. This wasn't the case for the Oxford/AZ one.

Of course, the phase three trials are continuing and will report on the longer term efficacy when such results become available. Pfizer just reported a few days ago with 91% after 6 months.

Ongoing trial shows Pfizer Covid-19 vaccine remains highly effective after six months | CNN

The ongoing Phase 3 clinical trial of Pfizer/BioNTech's coronavirus vaccine confirms its protection lasts at least six months after the second dose, the companies said Thursday. The trial continues and protection is expected to last longer than six months.

edition.cnn.com

 

[yorksrob]

It seems from Radio 4 that the blood clot issue is being studied in this country in relation to the Astra Zenecka vaccine.

As a forty something, I personally will be very angry if my vaccination, or indeed the rolling back of lockdown is delayed because of the 30 or so cases of blood clots.

Professor Adam Finn currently being interviewed on Today has spoken a lot about "walking a tightrope between saving lives and preventing their loss" and he said to get the balance right "we need clear evidence to understand what's going on and not guesswork". He also mentioned the differing risk/benefit ratio of vacination according to age.

I only wish that SAGE and other policy formers would demand clear evidence for lockdown measures (including keeping them in place) and would look at risk/benefit ratio of lockdown. However I expect that they will be demanding a much higher standard of safety and efficacy from the vaccines than they do from lockdown measures.

It's notable that he said that the release from lockdown was dependant on a successful vaccine rollout (no consideration of the safety and efficacy of lockdown in itself, needless to say).

The interview is at 7:08.

 

[YorkshireBear]

It seems from Radio 4 that the blood clot issue is being studied in this country in relation to the Astra Zenecka vaccine.

As a forty something, I personally will be very angry if my vaccination, or indeed the rolling back of lockdown is delayed because of the 30 or so cases of blood clots.

Professor Adam Finn currently being interviewed on Today has spoken a lot about "walking a tightrope between saving lives and preventing their loss" and he said to get the balance right "we need clear evidence to understand what's going on and not guesswork". He also mentioned the differing risk/benefit ratio of vacination according to age.

I only wish that SAGE and other policy formers would demand clear evidence for lockdown measures (including keeping them in place) and would look at risk/benefit ratio of lockdown. However I expect that they will be demanding a much higher standard of safety and efficacy from the vaccines than they do from lockdown measures.

It's notable that he said that the release from lockdown was dependant on a successful vaccine rollout (no consideration of the safety and efficacy of lockdown in itself, needless to say).

The interview is at 7:08.

I agree to an extent. But the blood clots seem to be killing otherwise healthy under 50s.

If their risk of dying from the vaccine is higher than covid? Is that fair? Considering the chances of dying if healthy and under 50 I am not surprised they are taking a good luck at the figures.

If say my wife died (I wouldn't care if I died obviously as I'd be dead) as a late 20s woman taking a vaccine for something that was so unlikely to kill her that would feel so beyond futile.

The key is that it doesn't appear to affect those over 50 so we can get all groups 1-9 vaccinated and should then be fine... But I agree goalposts now seem to be being moved regarding how much vaccination we need.

 

[VauxhallandI]

It seems from Radio 4 that the blood clot issue is being studied in this country in relation to the Astra Zenecka vaccine.

As a forty something, I personally will be very angry if my vaccination, or indeed the rolling back of lockdown is delayed because of the 30 or so cases of blood clots.

Professor Adam Finn currently being interviewed on Today has spoken a lot about "walking a tightrope between saving lives and preventing their loss" and he said to get the balance right "we need clear evidence to understand what's going on and not guesswork". He also mentioned the differing risk/benefit ratio of vacination according to age.

I only wish that SAGE and other policy formers would demand clear evidence for lockdown measures (including keeping them in place) and would look at risk/benefit ratio of lockdown. However I expect that they will be demanding a much higher standard of safety and efficacy from the vaccines than they do from lockdown measures.

It's notable that he said that the release from lockdown was dependant on a successful vaccine rollout (no consideration of the safety and efficacy of lockdown in itself, needless to say).

The interview is at 7:08.

As the Son of a Mother that got blood clots on her lungs after taking it my opinion isn’t so blasé about it.

 

[Huntergreed]

If it turns out that it does cause clots, what are the repercussions for this? (speaking as someone who has already had it)

 

[birchesgreen]

I seem to recall something about vaccine manufacturers not being liable? Compensation will be covered by the state though only in severe cases:

Britain to cover COVID-19 vaccine side-effects under damages scheme

Britain will pay individuals who suffer any severe side-effects from COVID-19 vaccines under an existing programme, the government said on Thursday, ahead of a rollout of Pfizer and BioNTech's vaccine in the country following emergency approval.

www.reuters.com

Britain will pay individuals who suffer any severe side-effects from COVID-19 vaccines under an existing programme, the government said on Thursday, ahead of a rollout of Pfizer and BioNTech’s vaccine in the country following emergency approval.

COVID-19 will be added as a "precautionary step" to the list of diseases covered for potential liabilities under the Vaccine Damage Payments Scheme (VDPS), the Department of Health and Social Care said. It added that vaccines would be deployed only after stringent checks. (bit.ly/3mEuZ3I)

Compensation for any possible side-effects from a COVID-19 vaccine has been the subject of much debate in recent months, as drugmakers and governments around the world have worked in record time to develop and approve vaccines against the illness which has created havoc worldwide.

Britain's VDPS was set up in 1979 and covers victims of side-effects caused by common vaccines, such as those against measles, influenza, smallpox and tetanus. In 2009 the vaccine against the H1N1 swine flu was also briefly added to the list. (bit.ly/2KZCB2N) (bit.ly/33GyIXa)

Under the scheme, individuals are entitled to a lump sum capped at 120,000 pounds ($161,676) if they can prove to have been seriously disabled as a result of a vaccination.

The scheme is meant to dissuade people from seeking compensation through lengthy and costly court proceedings, but has been criticised for the cap and its restrictive conditions.

“The current scheme is not really adequate for the current situation. If adverse events occur, the route to compensation is too complicated. It would be much better if the government set up a bespoke scheme for COVID-19,” said Duncan Fairgrieve, of the British Institute of International and Comparative Law.

 

[DustyBin]

This latest development with the AZ vaccine surely puts us at risk of failing one of the four roadmap “tests”. How convenient....

Assuming the efficacy of the vaccines in the over 50s (or even over 60s) is indeed as high as thought, I see no reason why it needs to be forced onto younger people who will acquire natural herd immunity in due course. With the progress made to date there’s no reason to delay any stage of the roadmap. Sorry to sound so pessimistic but I don’t like where this appears to be heading.

 

[Yew]

This latest development with the AZ vaccine surely puts us at risk of failing one of the four roadmap “tests”. How convenient....

Assuming the efficacy of the vaccines in the over 50s (or even over 60s) is indeed as high as thought, I see no reason why it needs to be forced onto younger people who will acquire natural herd immunity in due course. With the progress made to date there’s no reason to delay any stage of the roadmap. Sorry to sound so pessimistic but I don’t like where this appears to be heading.

Indeed, I understand that we're at the 'Cry Freedom' stage, according to the health secretary.

 

[VauxhallandI]

Why we are trialing children I don’t know, has this been explained and justified anywhere?

 

[Richard Scott]

Why we are trialing children I don’t know, has this been explained and justified anywhere?

Paranoid politicians is likely to be the answer.

 

[DustyBin]

Why we are trialing children I don’t know, has this been explained and justified anywhere?

I’ve tried to find an answer to this myself, but failed to do so. It’s starting to feel like a vanity project with Johnson and Hancock wanting to be able to announce that every single person in the UK has been offered the vaccine. I certainly don’t think there’s a medical need to vaccinate everybody, others may think differently though.

 

[bengley]

And it's situations just like this one which are why I won't be having the vaccine.

We're now just months into the vaccination programme and potentially fatal side effects are being seen in young people, around my age.

I am not willing to risk it - I'll take my chances with COVID.

 

[cuccir]

Why we are trialing children I don’t know, has this been explained and justified anywhere?

Because without innoculation, children will act as a reservoir through which the disease will circulate. Few children will be seriously ill but the virus would spread to and kill vaccinated people, and it there is a high chance of mutating into vaccine resistant strains.

And it's situations just like this one which are why I won't be having the vaccine.

We're now just months into the vaccination programme and potentially fatal side effects are being seen in young people, around my age.

I am not willing to risk it - I'll take my chances with COVID.

That's your choice, but you should be clear to yourself when making it that you're risking other people's lives too.

Ideally, the Moderns vaccine would be more readily available by May and under-40s can receive that. I don't know if ordered numbers are sufficient though.

 

[Simon11]

Why we are trialing children I don’t know, has this been explained and justified anywhere?

Because evidence supports that the vaccine reduces the chances of people spreading the virus and for people unable to have the jab, this provides more safety.

As it will take a while to carry out this testing phase, it is worth them kicking this off now and in a few months with some data, SAGA can make a decision if needed on whether to roll this out.

 

[VauxhallandI]

So when’s the roll out to babies?

When’s the roll out for the flu vaccination?

 

[bengley]

Because without innoculation, children will act as a reservoir through which the disease will circulate. Few children will be seriously ill but the virus would spread to and kill vaccinated people, and it there is a high chance of mutating into vaccine resistant strains.


That's your choice, but you should be clear to yourself when making it that you're risking other people's lives too.

I'm not risking anyone else's lives at all. You've fallen for the hysteria.

The vulnerable who are likely to have severe cases of COVID have been vaccinated and they are proven to be almost 100% protected against death or serious illness.

Why should I risk my health by taking a vaccine which will most likely not prevent me from getting serious illness but may give me serious side effects?

Additionally, our PM only a couple of days ago was telling people not to meet indoors at Easter even if vaccinated, so again, why risk my health for something which isn't even going to protect the people I'm being coerced into taking a vaccine to protect?

Covid-19: Boris Johnson warns against mixing indoors as Easter weekend begins

The Easter weekend warning comes as latest figures show the lowest number of daily cases since mid-September.

www.bbc.co.uk

 

[roversfan2001]

Because without innoculation, children will act as a reservoir through which the disease will circulate. Few children will be seriously ill but the virus would spread to and kill vaccinated people, and it there is a high chance of mutating into vaccine resistant strains.


That's your choice, but you should be clear to yourself when making it that you're risking other people's lives too.

The vaccines both reduce both transmissibilty of the virus and risk of illness by orders of magnitude - no one is risking anyone else's life by not getting vaccinated. Try to guilt trip people who (for whatever reason) don't want the vaccine is a sure fire way to ensure their viewpoint stays that way.

Suppressing the virus is far more likely to lead to vaccine resistant strains developing but you keep regurgitating what SAGE tell you.

 

[Bantamzen]

And it's situations just like this one which are why I won't be having the vaccine.

We're now just months into the vaccination programme and potentially fatal side effects are being seen in young people, around my age.

I am not willing to risk it - I'll take my chances with COVID.

Well so far the numbers look a bit like this:

Germany have so far recorded 31 cerebral venous sinus thromboses and nine deaths out of 2.7 million people vaccinated, that is a risk of clotting of around 0.001%, and risk of death as a result of of clots at less than a quarter of that. In this country there have been reports of 30 clotting incidents out of 18 million vaccinations, giving a risk level nearly 7 times less than seen in Germany.

Now I will defend the right for anyone in this country to make their own choices on the vaccine, but its important to keep these numbers in context. As things stand the risk to younger people from the vaccine is very small to insignificant.

 

[Mintona]

I see vaccine shortages are expected until July now. Almost all dosages given until then will be second doses.

 

[bengley]

Well so far the numbers look a bit like this:

Germany have so far recorded 31 cerebral venous sinus thromboses and nine deaths out of 2.7 million people vaccinated, that is a risk of clotting of around 0.001%, and risk of death as a result of of clots at less than a quarter of that. In this country there have been reports of 30 clotting incidents out of 18 million vaccinations, giving a risk level nearly 7 times less than seen in Germany.

Now I will defend the right for anyone in this country to make their own choices on the vaccine, but its important to keep these numbers in context. As things stand the risk to younger people from the vaccine is very small to insignificant.

Listening to LBC this morning Nick Ferrari seemed to be implying the risk of clots increases as the age of the recipient of the vaccine decreases. Given that very few under 30s have so far been vaccinated, it's likely these numbers will rise.

The vaccines both reduce both transmissibilty of the virus and risk of illness by orders of magnitude - no one is risking anyone else's life by not getting vaccinated. Try to guilt trip people who (for whatever reason) don't want the vaccine is a sure fire way to ensure their viewpoint stays that way.

Suppressing the virus is far more likely to lead to vaccine resistant strains developing but you keep regurgitating what SAGE tell you.

Indeed, I'd compare the blackmail techniques being employed to that used by militant vegans. Their campaigning doesn't make me want to become a vegan.

 

[Richard Scott]

Because without innoculation, children will act as a reservoir through which the disease will circulate. Few children will be seriously ill but the virus would spread to and kill vaccinated people, and it there is a high chance of mutating into vaccine resistant strains.

No, there isn't a high chance it will mutate into vaccine resistant strains.

 

[YorkshireBear]

I see vaccine shortages are expected until July now. Almost all dosages given until then will be second doses.

Still predicting 2.5 million doses per week. Not too shabby!

 

[yorksrob]

I agree to an extent. But the blood clots seem to be killing otherwise healthy under 50s.

If their risk of dying from the vaccine is higher than covid? Is that fair? Considering the chances of dying if healthy and under 50 I am not surprised they are taking a good luck at the figures.

If say my wife died (I wouldn't care if I died obviously as I'd be dead) as a late 20s woman taking a vaccine for something that was so unlikely to kill her that would feel so beyond futile.

The key is that it doesn't appear to affect those over 50 so we can get all groups 1-9 vaccinated and should then be fine... But I agree goalposts now seem to be being moved regarding how much vaccination we need.

It's a question of numbers really. Given they've identified 30 cases out of 18 million, it certainly looks like the greater threat to me, as a forty-something male, is from the virus, therefore I would be very much against halting the roll out at this stage.

This might change for a twenty something female, for example, but they've got plenty of time to do their research before we get to them.

As the Son of a Mother that got blood clots on her lungs after taking it my opinion isn’t so blasé about it.

That's a fair point, but equally there are people on these forums who point out relatives who've had the virus.

I'm out and about regularly (I don't believe in lockdown) and want to get the vaccination sorted ASAP frankly.

 

[Bantamzen]

Listening to LBC this morning Nick Ferrari seemed to be implying the risk of clots increases as the age of the recipient of the vaccine decreases. Given that very few under 30s have so far been vaccinated, it's likely these numbers will rise.

Do we even know the proportion of those who developed clots were under 50 or 60? If not we would need to be careful to jump to conclusions based on the knee jerk responses from various governments. And to be quite honest I'd be surprised if younger people were more at risk than older people, covid disproportionally effects older people so on the face of it you'd expect a vaccine that uses protein fragments would equally be more risky for older people, given that it is designed to trigger the immune system in a similar manner as if a full infection had occured.