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Vaccine Progress, Approval, and Deployment

Domh245

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To be honest that was what I expected to happen! When I booked it this evening, there was no mention of the second dose only after 8 weeks but I agree that most likely I will have to wait which is a shame!

If you don't mind a potentially wasted journey and want to try and get your second dose early, it may be worth turning up towards the end of the day. Whilst centres are under orders not to give second doses before 8 weeks, at the end of the day if they've got stock to use they might be less picky!
 
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yorkie

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Also, why does the CDC (US) say Pfizer should be given 21 days after the first dose...
Probably because that's generally accepted to be the minimum you can get away with to be effective, hence what the trials were based on. If the initial trials had been based on a longer gap, the vaccines would have been approved later and we'd not be so far down the road of vaccinations as we are.

and we have been pushing for 12 weeks in the UK? Is this due to the supply of vaccines?
Because this is better for long term efficacy:


Professor Anthony Harnden says the "sweet spot" is eight weeks and any earlier means you won't be protected for as long.

He says: "The data suggests very strongly that the longer you leave that second dose, the better longer term protection you will have.

"There is a sort of sweet spot from about eight weeks onwards, and we wouldn't advise anybody to really have the second dose before then."...

The gap between initial and booster shots for various vaccines does vary considerably and we are a long way from knowing for sure what the best gap is for Sars-CoV-2, but in general a longer gap results in a longer lasting immune memory. But of course you don't want to leave it too long either, hence the 8 to 12 week gap being deemed the most effective based on various factors.

If you really want to boost efficacy, a different type of vaccine is likely to be even better for your second shot (e.g. mRNA followed by viral vector, or vice-versa) but you are unlikely to be able to request this.

Further boosters may not be required and/or may not be deemed politically acceptable in the short term (due to the global situation) though this isn't clear yet; many people believe that natural infection will act as a booster, as already happens with existing endemic human coronaviruses, such as OC43 which is now believed to have caused a pandemic in 1889/90.
 

DelayRepay

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Further boosters may not be required and/or may not be deemed politically acceptable in the short term (due to the global situation) though this isn't clear yet; many people believe that natural infection will act as a booster, as already happens with existing endemic human coronaviruses, such as OC43 which is now believed to have caused a pandemic in 1889/90.

What is your view on the Autumn booster plans?

When the prospect of booster jabs was originally raised, I think the rationale was that the manufactures would be 'tweaking' the vaccines to be more effective against new variants. But this doesn't seem necessary at the moment, and as far as I know hasn't happened.

I wonder if there is evidence from those who were involved in the original trials that a booster is needed after 12 months?

This becomes a bit more important now given that we have a two tier set of rules around isolation, with those who have been jabbed not having to isolate if they are close contacts or return from amber countries.

At some point we also need to think about what to do with the current 17 year olds, who will turn 18 and therefore want jabs in order to avoid being subjected to isolation.
 

yorksrob

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I recieved a text message from my GP inviting me to book up at the local vaccination centre for my second jab via a website. The website kept on saying "no places available, please try again tomorrow"

After a week of this nonsense, I went down the vaccination centre anyway (which was pretty much empty anyway for some reason) and asked whether they were doing walk-in's. They promptly did it there and then without further fuss.

"The squeaky wheel gets the grease" as they say.
 

DelayRepay

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I recieved a text message from my GP inviting me to book up at the local vaccination centre for my second jab via a website. The website kept on saying "no places available, please try again tomorrow"

After a week of this nonsense, I went down the vaccination centre anyway (which was pretty much empty anyway for some reason) and asked whether they were doing walk-in's. They promptly did it there and then without further fuss.

"The squeaky wheel gets the grease" as they say.

I am surprised we've continued with the booking system to be honest.

My local GP posted on Facebook that they are running a Pfizer second dose clinic next week. They didn't mention that the mass vaccine centre a few miles away is running a walk in Pfizer clinic for first and second doses every day. So I don't know why anyone would specifically wait for the GP's clinic. It's actually taking place at a surgery in another village, so access to transport wouldn't be a reason.

Then someone replied to the Facebook post saying they were 62 and still waiting for their first dose. They did not realise they could book an appointment, and had been patiently waiting for a letter from the NHS, which for some reason had never arrived.
 

Domh245

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What is your view on the Autumn booster plans?

When the prospect of booster jabs was originally raised, I think the rationale was that the manufactures would be 'tweaking' the vaccines to be more effective against new variants. But this doesn't seem necessary at the moment, and as far as I know hasn't happened.

I wonder if there is evidence from those who were involved in the original trials that a booster is needed after 12 months?

This becomes a bit more important now given that we have a two tier set of rules around isolation, with those who have been jabbed not having to isolate if they are close contacts or return from amber countries.

At some point we also need to think about what to do with the current 17 year olds, who will turn 18 and therefore want jabs in order to avoid being subjected to isolation.

As I understand it, the plan (noting it is just a plan, not a guaranteed action unless I've missed some news) for boosters is very much a precautionary approach. We can't say for certain whether immunity from the vaccines reduces over time, but if it does then we want to be able to give boosters to continue to give protection to the most vulnerable.

As for the 17 year olds (and younger), surely they simply become able to book themselves in for jabs as soon as they turn 18? It won't be as good an offering as currently (all the mass vaccination centres will shutdown eventually, and it'll be limited to hospitals/larger GPs). It may also be (as Pfizer is approved for ages as low as 12 currently, but not recommended below 18) that they open it up in blocks - ie anyone turning 18 before xx/yy date, just as we saw with the main rollout where 1/7 was the date for age cutoffs
 

yorksrob

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I am surprised we've continued with the booking system to be honest.

My local GP posted on Facebook that they are running a Pfizer second dose clinic next week. They didn't mention that the mass vaccine centre a few miles away is running a walk in Pfizer clinic for first and second doses every day. So I don't know why anyone would specifically wait for the GP's clinic. It's actually taking place at a surgery in another village, so access to transport wouldn't be a reason.

Then someone replied to the Facebook post saying they were 62 and still waiting for their first dose. They did not realise they could book an appointment, and had been patiently waiting for a letter from the NHS, which for some reason had never arrived.

Yes, I perservered with the system because the first jab was so quick and efficient - but then that was arranged over the phone with a human being.
 

Peter Mugridge

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They did not realise they could book an appointment, and had been patiently waiting for a letter from the NHS, which for some reason had never arrived.
Given the huge amount of mail which gets lost in the post, I cannot say I am surprised at this. He's probably not the only one either.
 

DelayRepay

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Given the huge amount of mail which gets lost in the post, I cannot say I am surprised at this. He's probably not the only one either.
I hope there aren't too many people like him. The local GP hasn't helped because they've regularly posted that people shouldn't call them about vaccines, they should wait for their letter or text message. And never once have they mentioned that there are other ways to arrange a vaccine and there's no need to wait for the GP's letter.
 

YorkshireBear

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Pfizer reporting to be looking to gain approval for a third dose of the vaccine with medical regulators as information from Israel shows that it's effectiveness drops to around 64% after around 6 months. I had hoped protection would stay higher than that for longer to be honest.

Struggling to post the quote but it is on the BBC news live feed. Will try again.
 

Bantamzen

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Pfizer reporting to be looking to gain approval for a third dose of the vaccine with medical regulators as information from Israel shows that it's effectiveness drops to around 64% after around 6 months. I had hoped protection would stay higher than that for longer to be honest.

Struggling to post the quote but it is on the BBC news live feed. Will try again.
I saw this just a few minutes ago. However elsewhere it is being reported that they are seeing a drop in antibody levels. This is not uncommon, if previously produced antibodies are not needed then they are produced less over time. It doesn't necessarilea people have no resistance to the virus, this will continue to exist in B & T cells and if required antibodies can be reproduced once another infection occurs.

I do hope this is taken into consideration, and doesn't just become an excuse to delay normality and a cash cow for pharmaceuticals.
 

yorkie

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Covid vaccines are highly effective in people with underlying health conditions who were advised to shield earlier in the pandemic, real-world UK data reveals.
The study of more than a million people in at-risk groups shows two doses of the Pfizer or AstraZeneca vaccines are needed for this protection.
Being double-jabbed reduced the risk of symptomatic Covid-19 by around 90%.
One dose cut it by about 60%, says Public Health England (PHE).
Protection against hospitalisation and death in at-risk groups is expected to be greater than protection against symptomatic disease, as has been seen in studies of the general population, although more data is needed to confirm this.

No surprises here, though it's good to get this news at a time when some people are falsely claiming that vaccines are not effective for vulnerable people, so that we can debunk their vaccine efficacy denying claims.
 

Dent

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No surprises here, though it's good to get this news at a time when some people are falsely claiming that vaccines are not effective for vulnerable people, so that we can debunk their vaccine efficacy denying claims.

Does that not depend entirely on what the underlying condition is? "Underlying condition" can mean such a wide range of things that it is impossible to generalise in this way.
 

yorkie

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Does that not depend entirely on what the underlying condition is? "Underlying condition" can mean such a wide range of things that it is impossible to generalise in this way.
The study goes into more detail if you'd like to read it:

When considering all risk groups together or when focussing on the shielding group, there was generally no reduction in VE compared to those not in risk groups. In some cases, VE was higher in the shielding group after 2 doses, though confidence intervals were very wide. When stratifying into groups of specific conditions the only group where VE was notably diminished was the immunocompromised group. In the cohort analysis, VE after one dose of any vaccine was just 4.0% (95% CI -31.5% to 29.9%). However, this increased to 74.1% (95% CI 48.8% to 87.0%) after 2 doses. In the TNCC, dose 2 effects were similar but dose 1 VE was 18.3% (95% CI -18.4% to 43.7%). Dose 2 effects were similar for the Pfizer and AstraZeneca vaccines. Among other risk groups, VE estimates do not differ significantly from those in non-risk groups.
So even in the most affected cohort, effectiveness is around 74% "against symptomatic medically attended COVID-19".

It is widely accepted that the effectiveness of vaccines against serious symptoms is much greater than the effectiveness against symptomatic Covid.
 

TravelDream

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Pfizer reporting to be looking to gain approval for a third dose of the vaccine with medical regulators as information from Israel shows that it's effectiveness drops to around 64% after around 6 months. I had hoped protection would stay higher than that for longer to be honest.

Struggling to post the quote but it is on the BBC news live feed. Will try again.

On the study from Israel, 64% is for Delta specifically rather than the original/ alpha variant. It is for symptomatic infection and they found it was 93% effective against Delta hospitalisation.

And Public Health England says the vaccine remains 96% effective against hospitalisation versus Delta. Similar to Israel's 93%.


It appears the FDA and CDC have slapped Pfizer down saying the vaccines remain effective enough.
''Pfizer said it would soon publish data about a third dose of vaccine and submit it to the US Food and Drug Administration, European Medicines Agency and other regulators. The company specified it would seek FDA emergency use authorization for a booster dose in August.
But in an unusual move, two top federal agencies said Americans don't need boosters yet and said it was not up to companies alone to decide when they might be needed.
Hours after Pfizer issued its statement, the FDA and Centers for Disease and Control issued a joint statement saying Americans do not need booster shots yet.''
 

yorkie

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Pfizer definitely won't want two doses to be enough; they will want people to have annual boosters, in order to boost their profits.

But I've heard virologists say they think natural infections could replace the need for boosters.

I wouldn't trust anything Pfizer say unless it is backed up by independent virologists or immunologists.

.... So I don't know why anyone would specifically wait for the GP's clinic.....
This won't apply to many people, but one example where this could apply is people who may be at risk of anaphylaxis
 

Silver Cobra

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As of today, Myocarditis and Pericarditis are both to be recognised as possible side-effects of the mRNA-based vaccines (Pfizer and Moderna) in the UK and Europe:


Heart inflammation is a "very rare" side-effect of the Covid vaccines made by Pfizer and Moderna, according to regulators in Europe.

The European Medicines Agency said the side-effects were more common in younger men.

The medicines safety body said the benefits of Covid vaccines continue to far outweigh any risks.

But doctors and patients have been advised to be aware of the symptoms of heart inflammation.

These include chest pain, a feeling of breathlessness and a pounding or fluttering heartbeat. Anyone with these symptoms should see a doctor.

Two conditions were linked to the vaccines - inflammation of the heart muscle itself, known as myocarditis, and inflammation of the fluid-filled sac the heart sits in, known as pericarditis.

The EMA analysis of cases found:

Pfizer-BioNTech - 145 cases of myocarditis and 138 cases of pericarditis out of 177m doses given
Moderna - 19 case of myocarditis and 19 cases of pericarditis out of 20 million doses given
Five people died. The review said they were all either elderly or had other health conditions.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has also been investigating the link.

It reported: "A consistent pattern of cases occurring more frequently in young males and shortly after the second dose of the vaccines.

"These reports are extremely rare, and the events are typically mild with individuals usually recovering within a short time with standard treatment and rest," it added.

Most cases are thought to be within 14 days of vaccination.

While the risk is very rare, it is more likely to develop in young people - who are currently the focus on the vaccination campaign in the UK.

Concerns about the side-effects have already played into the UK debate around vaccinating children, who are at lower risk of Covid.

Myocarditis and pericarditis will be officially listed as side-effects in the UK and Europe, mirroring a move by the regulators in the US last month.

Based on the description of the symptoms for these two conditions, they sound very similar to what I had several weeks ago, not long after my first dose of Pfizer. If I did indeed have either of these two conditions as a result of the Pfizer vaccine, it does make me somewhat concerned about getting my second dose on 12th August, in the sense of will I suffer from this again, and if so, will it be even worse the second time.
 

yorkie

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As of today, Myocarditis and Pericarditis are both to be recognised as possible side-effects of the mRNA-based vaccines (Pfizer and Moderna) in the UK and Europe:
It's interesting as several experts have been saying for many weeks now, there was a huge fuss over rare side effects of the Oxford AZ vaccine (which later transpired to be applicable to other viral vector vaccines) but hardly any mention of the fact that the side effects were seen predominantly in women, not men. Dr John Campbell pointed out that the side effects which affect the mRNA vaccines predominantly affect men.

So this idea that young people should get an mRNA vaccine rather than a viral vector vaccine was a bit silly; I agree with Dr Campbell on this; young men should actually have been recommended the Oxford AZ vaccine, while young women should have been offered Pfizer or Moderna. But this wasn't done. Maybe it will now...?

It is worth noting that negative side effects (other than simply feeling a little unwell) are very rare. No medical intervention has zero risk. Anyone who decides not to get a vaccine on this basis would have to also not take paracetamol or aspirin or many medicines if they were applying the same logic.

That said, for young children, who are naturally exposed to Coronaviruses from a young age, it probably doesn't make sense to vaccinate. The question is whether we vaccinate 12-17 year olds and stop there, or whether we stop at 18 and allow anyone under 18 to gain immunity through natural infection. My suspicion is that vaccinations will take place for 12-17 year olds, but not much - if any - younger than that, but other peoples' guesses are probably as good as mine on that.

The main thing to remember is that these vaccines are safe and robust measures are in place.
Based on the description of the symptoms for these two conditions, they sound very similar to what I had several weeks ago, not long after my first dose of Pfizer. If I did indeed have either of these two conditions as a result of the Pfizer vaccine, it does make me somewhat concerned about getting my second dose on 12th August, in the sense of will I suffer from this again, and if so, will it be even worse the second time.
Speak to your doctor.

If it was me, I'd be asking for a viral vector vaccine for my second dose.
 
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Yew

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Pfizer reporting to be looking to gain approval for a third dose of the vaccine with medical regulators as information from Israel shows that it's effectiveness drops to around 64% after around 6 months. I had hoped protection would stay higher than that for longer to be honest.

Struggling to post the quote but it is on the BBC news live feed. Will try again.
Against infection of against hospitalisation? We're not here to stop people from having a mild cough.
 

philosopher

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I saw this just a few minutes ago. However elsewhere it is being reported that they are seeing a drop in antibody levels. This is not uncommon, if previously produced antibodies are not needed then they are produced less over time. It doesn't necessarilea people have no resistance to the virus, this will continue to exist in B & T cells and if required antibodies can be reproduced once another infection occurs.

I do hope this is taken into consideration, and doesn't just become an excuse to delay normality and a cash cow for pharmaceuticals.
The UK has been giving out second does between 8 and 12 weeks instead of 3 or 4 weeks. A longer interval is meant to boost antibody levels, so perhaps it will extend immunity against infection too.
 

yorkie

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Antibody levels aren't really that relevant.

People who had mild infections tended to have lower antibody levels than people who had severe symptoms. A strong T cell response is linked with milder symptoms, while a weaker T cell response is linked with more severe symptoms.

What really matters is the body's ability to make memory B and T cells.

B cells will produce antibodies when they are needed.

This idea that we should all have loads of antibodies circulating constantly is completely absurd, but many ill-informed people seem to believe it (especially hysterical people on social media)
 

Domh245

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My suspicion is that vaccinations will take place for 12-17 year olds, but not much - if any - younger than that, but other peoples' guesses are probably as good as mine on that.

I think we can only really expect to see the more vulnerable given it, at least short term*. We don't have the Pfizer necessary to do that age group, and Moderna is not approved for under 18s. We could do more of that age group as/when our second order starts to come online in the autumn, but that feels a bit "too little too late" in a sense, as we should be on the way down from the exit wave by then.

AIUI, pfizer are looking for a separate approval for under 12s using a reduced dose, so it's eminently possible that we buy into that if we're still obsessively vaccinating everyone when that comes to market

*more so than we already have seen

(edited to remove reference to edited post)
 

MattA7

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Pfizer is reportedly seeking approval to allow a third booster dose (presumably due to the UK government considering offering the most vulnerable a third dose in September) if this happens I wonder if the vaccine will then be given every year to vulnerable patients in the same way as the annual flu vaccine (possibly altered to confer immunity against new variants)
 

yorkie

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I assume that was a typo - it's the vaccines that are safe (though the virus is not exactly a massive deal for younger people)
I have corrected the post; you're right my point was the vaccines are safe. But yes it's also true that the risk from natural infection reduces drastically in kids, so it may be that we don't go down that path.
Pfizer is reportedly seeking approval to allow a third booster dose (presumably due to the UK government considering offering the most vulnerable a third dose in September)
If we are going to do boosters, it really ought to be a different type of vaccine to the original vaccine given, in my opinion as this seems more likely to enable a broader immune response. Also if the boosters have been tweaked, based on the latest research and the latest iterations of the virus, then that's another aspect to consider.

I'm not convinced boosters are actually needed though.

if this happens I wonder if the vaccine will then be given every year to vulnerable patients in the same way as the annual flu vaccine
I would be extremely surprised to see this happen for several reasons.

Coronaviruses mutate at a much slower rate than influenza viruses.

Also, do bear in mind there is only one strain of Sars-CoV-2, which is in stark contrast to influenza, which has multiple strains.

The first strain of influenza which you encounter will remain the strain against which you are best protected. Each strain is constantly mutating at a fast rate and it is difficult to predict which strain may dominate in any given flu season.

I think one or two boosters may be needed, but possibly only in more vulnerable/older groups, but the extent to which this is desirable depends on all sorts of factors which we may not know the answer to at present.

(possibly altered to confer immunity against new variants)
Vaccines remain highly effective in protecting against severe symptoms with all variants.

The immune response attacks multiple parts of the spike protein. The idea that the spike protein can mutate so much as to to evade this response is not deemed credible by any of the virologists or immunologists I've been listening to (I take no notice of fear-mongers such as Eric Ding).

The media likes to talk about a particular amino acid change in a variant that "evades" antibodies, but this isn't going to stop the vaccines working. Indeed T-cells are widely believed to be key to fighting this virus, and I've seen no evidence to suggest the T-cell epitopes are changing.

Variants are hyped up, and vaccines are put down, by people who want indefinite restrictions.
 

david1212

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...

The question is whether we vaccinate 12-17 year olds and stop there, or whether we stop at 18 and allow anyone under 18 to gain immunity through natural infection. My suspicion is that vaccinations will take place for 12-17 year olds, but not much - if any - younger than that, but other peoples' guesses are probably as good as mine on that.

To keep infection levels in schools to a minimum I think this will happen.

Now that realistically the vast majority of 18+ that wish to be vaccinated have had their first injection been there needs to be a decision ASAP so vaccination of 12-17 year olds can be started so most can have one vaccination by around 20 August 2 - 3 weeks ahead of the school term commencing.
 

MattA7

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I would also suspect even if under 18s aren’t routinely vaccinated it may be available on request for those who request it.

Most countries appear to be making COVID vaccination a requirement for entry and different countries will have different rules regarding the age of travelers who are required to be vaccinated

I received my first jab 2 weeks ago (Pfizer) and was wondering how much protection you get between jabs. I should have got it months ago due to underlying health issues but was somehow overlooked.
 
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yorkie

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We are now up to two thirds of adults fully vaccinated, and we are not far off 90% with one dose. It may take a few weeks to get up to 90% but I am confident we will.

1st dose: 87.2%
2nd dose: 66.2%

Places like the US would do well to ever reach these figures!
 

MattA7

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We are now up to two thirds of adults fully vaccinated, and we are not far off 90% with one dose. It may take a few weeks to get up to 90% but I am confident we will.



Places like the US would do well to ever reach these figures!

If such high numbers are vaccinated shouldn’t we now begin to see the effect of heard immunity even those who have had the first dose still gain considerable immunity after 2 weeks. I received my first dose 2 weeks ago (Pfizer) and vaguely remember the nurse saying immunity starts after 2 weeks.

I doubt the US will ever reach that high as that is where a lot of the Anti-Vaxer movement comes from. There are also minority religious sects in the US that oppose any form of modern medicine.
 

yorkie

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If such high numbers are vaccinated shouldn’t we now begin to see the effect of heard immunity...
Be careful with that term, as people cannot agree on what it means (as discussed in numerous other threads), but for sure we've been seeing the effects of increased immunity in the population increasing over the past few months.

even those who have had the first dose still gain considerable immunity after 2 weeks. I received my first dose 2 weeks ago (Pfizer) and vaguely remember the nurse saying immunity starts after 2 weeks.
Yes it's generally accepted that 2 weeks onwards, the effects become measurable, though mRNA vaccines seem to take effect quicker than viral vector vaccines.

The status at which countries generally allow you to enter is from 2 weeks after the second dose; from this point onwards immunity will be very good.

Immunity is not a binary thing; the vaccines are highly effective at preventing serious illness (and of course deaths) but do not prevent infections occurring, though they do dramatically reduce the likelihood of becoming infectious (and anyone who is infectious is likely to be a lot less infectious and for a shorter duration of time)

It is widely accepted as being impossible to generate sufficient levels of sterilising immunity to reach a full 'herd immunity' threshold to eliminate the virus, as we did with smallpox; instead they circulate in a state of endemic equilibrium, and that's where most experts believe Sars-CoV-2 is headed.

I doubt the US will ever reach that high..
I'd be absolutely shocked if they do, at least least in terms of the 1st dose figure. It's theoretically possible they might eventually reach 66% of the population with two doses but it'll take a while to get there. A lot of people in the US are clearly going to have to get immunity exclusively through natural infection, as that is the path they have chosen.
 

The Ham

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If such high numbers are vaccinated shouldn’t we now begin to see the effect of heard immunity even those who have had the first dose still gain considerable immunity after 2 weeks. I received my first dose 2 weeks ago (Pfizer) and vaguely remember the nurse saying immunity starts after 2 weeks.

I doubt the US will ever reach that high as that is where a lot of the Anti-Vaxer movement comes from. There are also minority religious sects in the US that oppose any form of modern medicine.

It depends on how you measure it, but it could be argued that we are seeing the benefits of the vaccine.

Last summer we saw one week in which there were fewer than 150 deaths and that was when there were circa 5,000 cases per week. For 7 of the last 8 weeks there's data for we've seen fewer than 150 deaths per week, however cases per week have been significantly higher with about 25,000 cases a week about a month before the latest set of data.

Given that was late May for cases when we'd only really just started to vaccinate those aged about 40 I would expect that the risk for those getting the virus now would likely be fairly low, even though there's many more cases.
 

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