COVID-19 Vaccine Progress: Are We Ready for Rollout in Australia?

[berkeman]

Sorry if this has been asked and answered already, but what has to happen for each of the COVID vaccines to progress from the Emergency Use Authorization (EUA) stage to full approval? It seems like that is one of the most frequent reasons give by (fairly reasonable) people for not getting vaccinated yet. They don't like getting a vaccine under an EUA and would only consider it if fully approved. Probably getting full approval would help to boost the numbers of folks getting vaccinated and help us get closer to herd immunity...

 

[Vanadium 50]

I don't know the details of the process, but in the past it has taken years.

The argument you might use is "Once it's approved, they can start charging for it. I wonder how many hundreds of dollars the co-pay will be."

 

[Astronuc]

Apparently, CVS, Walgreens have wasted hundreds of thousands of Covid vaccine doses, data show
https://www.nbcnews.com/health/heal...s-thousands-covid-vaccine-doses-data-n1266032

There were logistical issues early on.

 

[Vanadium 50]

I have to say that article is very confused as to which numbers go where, and what is ordinary loss and what is Deaths We Can Blame on Trump. Walgreens, as far as I can tell has been able to get 99.5% of vaccines into people's arms, and most of the loss happened at the beginning. That 0.5% is compared to governmental numbers which are spotty at best.

To me, 0.5% sounds pretty good. Especially with no-shows. Out of 8 million doses, Walgreens is responsible for the US vaccination effort to fall behind by a grand total of 15 minutes. (i.e. 1% of a day) In project management terms, that's an SPI of about 0.99994.

 

[berkeman]

Sorry if this has been asked and answered already, but what has to happen for each of the COVID vaccines to progress from the Emergency Use Authorization (EUA) stage to full approval? It seems like that is one of the most frequent reasons give by (fairly reasonable) people for not getting vaccinated yet. They don't like getting a vaccine under an EUA and would only consider it if fully approved. Probably getting full approval would help to boost the numbers of folks getting vaccinated and help us get closer to herd immunity...

Looks like Pfizer just applied for full approval:

https://www.cnn.com/2021/05/07/health/pfizer-biontech-fda-approval-bla-vaccine/index.html

Pfizer/BioNTech seek full FDA approval for their Covid-19 vaccine​

 

[Ygggdrasil]

Promising news on the vaccine front: Researchers working to develop a more universal Coronavirus vaccine have shown in animal experiments that their vaccine candidate is broadly protective across a number of bat coronaviruses including the original SARS, SARS-CoV-2 and the major SARS-CoV-2 variants.

Neutralizing antibody vaccine for pandemic and pre-emergent coronaviruses
Saunders et al. Nature 2021
https://www.nature.com/articles/s41586-021-03594-0

Abstract:

Betacoronaviruses (betaCoVs) caused the severe acute respiratory syndrome (SARS) and Middle East Respiratory Syndrome (MERS) outbreaks, and the SARS-CoV-2 pandemic1–4. Vaccines that elicit protective immunity against SARS-CoV-2 and betaCoVs circulating in animals have the potential to prevent future betaCoV pandemics. Here, we show that macaque immunization with a multimeric SARS-CoV-2 receptor binding domain (RBD) nanoparticle adjuvanted with 3M-052/Alum elicited cross-neutralizing antibody (cross-nAb) responses against batCoVs, SARS-CoV-1, SARS-CoV-2, and SARS-CoV-2 variants B.1.1.7, P.1, and B.1.351. Nanoparticle vaccination resulted in a SARS-CoV-2 reciprocal geometric mean neutralization ID50 titer of 47,216, and protection against SARS-CoV-2 in macaque upper and lower respiratory tracts. Importantly, nucleoside-modified mRNA encoding a stabilized transmembrane spike or monomeric RBD also induced SARS-CoV-1 and batCoV cross-nAbs, albeit at lower titers. These results demonstrate current mRNA vaccines may provide some protection from future zoonotic betaCoV outbreaks, and provide a platform for further development of pan-betaCoV vaccines.

Press release from Duke University: https://www.eurekalert.org/pub_releases/2021-05/dumc-nvb051021.php

 

[Ygggdrasil]

Novavax released data from its phase 3 trial of ~30k people in the US and Mexico, showing 90% effectiveness in preventing symptomatic infection. This effectiveness is in line with data released earlier from a smaller trial done in the UK and South Africa, and is similar to the effectiveness reported for the mRNA vaccines. Unlike the mRNA vaccines, which need to be stored and shipped frozen, the Novavax vaccine is a protein subunit vaccine that can be stored and shipped at normal refrigerator temperatures, which may make it easier to distribute. It's unlikely to help in the vaccination efforts in the US, but will likely be important for expanding vaccination efforts worldwide, especially in developing countries.

the vaccine did show effectiveness against the alpha variant (B.1.1.7), but because the trial was conducted in North America where the other variants are not as prevalent, the trial could not assess the effectiveness against the other variants (beta/B.1.351, gamma/P.1 or delta/B.1.617.2). Data from the earlier trial in South Africa suggested lower effectiveness of the vaccine in preventing symptomatic disease from the beta variant (B.1.351), though it was still highly effective at preventing severe disease, hospitalization and death.

The data have not yet been published in a peer-reviewed scientific journal and have only been released via press release from the company.

Novavax press release: https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-90-overall-efficacy-and

Popular press summary: https://www.statnews.com/2021/06/14/novavax-covid-19-vaccine-highly-effective-in-late-stage-trial/

 

[bhobba]

It's unlikely to help in the vaccination efforts in the US, but will likely be important for expanding vaccination efforts worldwide, especially in developing countries.

Thanks for the post. It is a significant milestone for Aus because we have ordered 51 million doses. Some in Aus have gone mad with the AZ vaccine and its 1 in a million death rate. They only want Pfizer. I wonder how they feel about its possible heart issue? Our stockpile of Pfizer is limited, and rationing has started in some places like Victoria (or so it is reported anyway):
https://www.dailymail.co.uk/news/article-9646627/Covid-Australia-Fears-Victoria-RUN-Pfizer-jabs.html

If we actually get our ordered Novavax, that possibly will be a big help.

Thanks
Bill

 

[Ygggdrasil]

One cautionary note is that Novavax has been having issues with manufacturing and its supply chain (one reason why its trials took much longer than the other vaccines). For example, see:

https://endpts.com/as-fears-mount-over-jj-and-astrazeneca-novavax-enters-a-shaky-spotlight/
https://www.theatlantic.com/science...cies-may-hold-key-coronavirus-vaccine/616792/

In the Stat News article I referenced above, the company says it expects to make 100 million doses per month by the end of the third quarter of 2021 and 150 million doses per month by the end of the year. Showing efficacy and safety in phase 3 trials is an important step towards getting the vaccine to people worldwide, but it is not the final step as now the company must work on scaling its manufacture and distribution capabilities. Hopefully, it can meet these goals.

 

[Vanadium 50]

Some in Aus have gone mad with the AZ vaccine and its 1 in a million death rate. They only want Pfizer.

Why is this a problem? Australia is a free country. Shouldn't people have a choice?

It may not even be irrational. There are, what, 30 million people in Australia? So it's up to 30 deaths from the AZ vaccine. When was the last Covid death? Six months ago? If you're under 75 or 80, it becomes even more rational. If you don't live in the cool and trendy (and infected) southeast of the country, it's even more rational.

 

[bhobba]

Why is this a problem? Australia is a free country. Shouldn't people have a choice?

And they do. We are, of course, a free country. Most certainly, it is not an irrational position to take in Aus at the moment. The issue is eventually, what we are doing to stay safe must come to an end.

The problem is we keep having lockdowns while waiting for most to be vaccinated (I think 80% is the magic number - but do not hold me to it). These lockdowns cause economic havoc. Generally, the government does what it can to reduce that impact. But it is expensive. At the beginning of the pandemic, of the main industrialised countries, Aus was spending the most on Covid. I hadn't checked it of late and, during a discussion here, had egg on my face, still thinking we were at the top. We are now 6th at 14.7% of GDP:
https://www.theguardian.com/busines...-spending-compares-with-the-rest-of-the-world

Still, 14.7% of our GDP is a lot. How long it can be maintained, who knows - but it can't be forever.

If we get enough vaccinated voluntarily, fine - nothing needs to happen. If not, there is precedent here in Aus with Whooping Cough. When I was growing up, everyone got vaccinated. I do not even think it was mandatory; everyone just knew that you got it done as part of getting general checkups of your children. Vaccinations were also done at school - you could opt-out, but I never knew anyone that did. Vaccination basically eradicated Whooping Cough - I never heard of anyone getting it. But then, for some reason, not as many got vaccinated, and outbreaks began occurring. The government did not mandate it but introduced no jab, no pay:
https://www.aph.gov.au/about_parlia...ibrary/pubs/rp/budgetreview201516/vaccination

Outbreaks of Whooping Cough are still occurring occasionally, but it has helped. It needs to be mentioned Whooping Cough vaccine hesitancy is not the only reason we are now getting outbreaks. The older vaccine was phased out in the late 1990s. It carried a risk of temporary minor side effects like pain and swelling at the injection site, but also more serious complications such as febrile convulsions, sometimes even leading to loss of consciousness. So scientists developed a new vaccine. While safer and with fewer side effects, it is not as effective. Of course, researchers are working on the issue:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5748610/

Just a personal opinion, before being that 'drastic', if we need to, simply requiring people to consult a doctor before vaccine refusal would IMHO likely solve it. While a small violation of rights, this is serious stuff and not much of a requirement. Again just my view. Living in a democracy, it really comes down to what the majority think.

Thanks
Bill

 

[Vanadium 50]

The problem is we keep having lockdowns

That's a matter of choice, though.

First, as we previously discussed, there is an aspect of Kabuki to the Australian event-driven lockdowns. "Something must be done!" is an important, perhaps even driving, factor.

Next, as we have also previously discussed, the lockdowns don't distribute the burden equally. They are different for the important soy-latte-drinking members of the Zoom class in Sydney or Melbourne than for the unimportant hinterlands-residing Pauline Hanson-sympathizing deplorable, disgusting and diseased.

Almost finally, it's not true (and I know you don't believe it either) that at 80.000% vaccination everybody is perfectly safe, but at 79.999% "We're All Gonna Die!" I dislike the term "herd immunity" because it implies a very sharp line that just isn't there. It also implies we all form just one herd, which is nonsense. (Do conditions in Puerto Rico influence conditions in Guam more than conditions in Derby Line, Vermont influence conditions in Rock Island, Quebec?) Deciding when and how much to open is a decision balancing competing interests, and as such is political. It would be within the scope of the politicals to say "On XX/XX/XX date, everyone who could have been vaccinated will have had their chance, so we're opening everything up. If you chose not to get vaccinated and get sick, well, it's on you."

And finally finally, people should be free to make their choices. I got Moderna because it was the first one available to me. Would it have been worse to have chosen Moderna because I liked the name? It sounds all...modern. I found out after the fact that had I waited six days, I could have gotten Pfizer. That would have made me fully vaccinated one day sooner. Was this a bad choice? Due to a data entry error, the University thought I was older than I am and placed me on the fast track. I waited my turn. Was this irrational? Was it moral? I think we need to let people make these decisions for themselves, even if the State could potentially make "better" decisions. It's not really freedom if we are free to decide for ourselves, but only if we make the correct decision.

 

[bhobba]

Almost finally, it's not true (and I know you don't believe it either) that at 80.000% vaccination everybody is perfectly safe, but at 79.999% "We're All Gonna Die!" I dislike the term "herd immunity" because it implies a very sharp line that just isn't there.

As always, an excellent comment. Of course, the path to getting back to 'normal', is a continuum. Exactly how it will happen is being debated, but like most things gets tied up in political views. That is one of my pet turn off's. Why not simply look at the facts without putting a political spin on it? I guess, though, it seems part of human nature.

Thanks
Bill

 

[russ_watters]

Why is this a problem? Australia is a free country. Shouldn't people have a choice?

[separate post]That's a matter of choice, though.

They are related choices, and because of that if government is going to decide or weigh in on one, it has to weigh in on the other as well.

It may not even be irrational. There are, what, 30 million people in Australia? So it's up to 30 deaths from the AZ vaccine. When was the last Covid death? Six months ago? If you're under 75 or 80, it becomes even more rational. If you don't live in the cool and trendy (and infected) southeast of the country, it's even more rational.

"May not even be irrational" doesn't necessarily make it rational. The logic you are outlining requires an assumption that the future will look something like the past. But that past also included a variety of containment efforts, which people don't want to continue. So the future is unlikely to look like the past, and people don't want it to. The question is, can the future death rates look like past death rates even if the containment efforts are dropped? And how? Qualitatively the answer is clear: almost certainly yes it can, if enough people get vaccinated. "How many?" is the tough part. Thresholds are established, because they have to be, even if they are a bit silly in how they are characterized.

 

[Vanadium 50]

The logic you are outlining requires an assumption that the future will look something like the past.

Sure, but only as far as it needs to. What's the wait time for Pfizer relative to AZ in Australia? A month? Two?

As I found out here, the Moderna-Pfizer wait time was 6 days. Or -1, depending on how you count.

 

[bhobba]

Sure, but only as far as it needs to. What's the wait time for Pfizer relative to AZ in Australia? A month? Two?

Nobody, at least publically, knows. All that is known is the link I gave about Victoria, where stocks are running low:
https://www.9news.com.au/national/c...reported/73d1011c-b234-4373-92e1-d439e6f73b69

My disability worker came over today for some shopping. Being a front line aged care worker, she should have been jabbed early on, before me, in phase 1a with Pfizer so she is vaccinated as quickly as possible and can safely help her clients sooner. The AZ requires 12 weeks before you get the second dose - 3 weeks for Pfizer. She can't get it. It turns out a lot of early information we got about vaccines was wrong. We were told CSL in Melbourne had been producing vaccines and were producing over 1 million AZ doses a week. We now find out it was 400,000 per week and there were distribution problems. We are now producing over 1 million a week, but distribution problems remain, as I think I did a post about. IMHO Aus will have to wait to find out what is really going on as far as Pfizer and eventually Novavax goes.

The total vaccination numbers still seem to be going well:
https://www.abc.net.au/news/2021-03-02/charting-australias-covid-vaccine-rollout/13197518

A public holiday probably caused the falloff over the last few days. If it keeps up, we will likely be all vaccinated by years end - at least those that want it anyway. As more get fully vaccinated, the government will have to decide how we will transition to our next phase - whatever that is.

Thanks
Bill

 

[russ_watters]

Sure, but only as far as it needs to. What's the wait time for Pfizer relative to AZ in Australia? A month? Two?

As I found out here, the Moderna-Pfizer wait time was 6 days. Or -1, depending on how you count.

Fair enough, if we're just talking about the choice of which vaccine to get. If we're also talking about having a choice of whether to get vaccinated or not, Australia and the other isolated island nations may have a worse hesitancy problem than others. And perhaps counter-intuitively, their isolation and success to date makes the risk of not achieving as high a vaccination rate higher for them, not lower.

 

[bhobba]

And perhaps counter-intuitively, their isolation and success to date makes the risk of not achieving as high a vaccination rate higher for them, not lower.

Indeed. But take my word for it, a lot of people do not see the danger. The very rare danger of dying from the AZ vaccine (2 dead out of about 4 million vaccinations in Aus) has made many people say - I want Pfizer. The government has recently recommended the AZ only for those 60 and over - although, of course, you can get the AZ if you wish. You can still get the Phizer if over 60, of course, but those under 60 have priority, so do not hold your breath. This is despite the possible low-risk heart issues with Pfizer. They do not seem to understand should Australia have a third wave, then the AZ risk is nothing compared to getting Covid. I constantly point this out on forums in Aus, but nobody seems to agree.

Thanks
Bill

 

[Ygggdrasil]

CureVac published a press release providing an interim update on the Phase 3 trial of its mRNA vaccine. the study is of ~40,000 individuals in ten countries across Latin America and Europe. The results unfortunately showed only a 47% efficacy against COVID-19 disease of any severity, which is well bellow most health agencies' threshold for emergency use authorization.

Unlike the Pfizer and Moderna mRNA vaccines, which clinical trials and real world data have shown to be highly effective at preventing COVID-19, the CureVac vaccine does not add modified RNA nucleotides into its mRNA vaccine. This would seem to confirm previous research that the modified RNA nucleotides, which help prevent the mRNA from being attacked by cells' innate immune responses and improves the translation of the mRNA into protein, are key to making the mRNA vaccine technology work.

CureVac press release: https://www.curevac.com/en/2021/06/...generation-covid-19-vaccine-candidate-cvncov/
Popular press summary: https://blogs.sciencemag.org/pipeline/archives/2021/06/17/curevac-comes-up-short

 

[Astronuc]

I was listening to a discussion of the Serum Institute of India and India's response to the second wave of SARS-Cov-2, which happened after the Modi's government declared the outbreak under control - when it certainly wasn't. SII made commitments and received payments to deliver vaccines to underdeveloped nations, but then the Indian government blocked exports.

The Serum Institute’s manufacturing capacity is at the heart of Covax, run by a global alliance that includes the World Health Organization. The institute received hundreds of millions of dollars to expand its facilities and manufacture the Oxford-AstraZeneca vaccine, licensed to it with the commitment that a large share would go to poor nations.

As part of its plan to have two billion doses by the end of the year, Covax has been counting on hundreds of millions of the Oxford-AstraZeneca vaccine produced by Serum Institute, as well as hundreds of millions of a second vaccine being developed with an American company, Novavax.

After India’s devastating second wave of Coronavirus infections, the institute diverted all its manufacturing powers to domestic needs, falling behind on commitments to the Covax partnership as well as on bilateral commercial deals with many countries. The institute played down each delay as temporary. But Tuesday’s statement makes clear it is unlikely to meet commitments before the end of the year.

https://www.nytimes.com/2021/05/19/world/india-serum-institute-vaccines.html

https://www.nytimes.com/2021/05/07/world/india-serum-institute-covid19.html

 

[Laroxe]

India wasn't of course the only country to believe they had controlled the virus, and so didn't start the mass vaccination program when it could. I suspect we may see similar things played out in other countries, I'm a bit worried about some of the countries that so far have had few cases, people seem disinclined to learn, and some politicians seem incapable of it.
Really, in restricting exports of vaccines from India, they are only following the example of other vaccine producers. In fact, it might reasonably be argued that the limited supplies of vaccine available should be used in the areas with high levels of spread, whether the distribution is fair shouldn't be a criterion, that's a political decision rather than a medical one. In India, they have already significantly increased production, SII producing Covishield, a licenced version of the AS vaccine and the Russian Sputnik V is also used, but there are lots of other things happening, the company Bharat Biotech is just starting to ramp up production of Covaxin, a locally developed vaccine given emergency approval in January. A vaccine developed by Biological E, an Indian private vaccine-making company, is expected to be available in a few months, other vaccines approved in other countries have been approved, enlarging the portfolio. Novovax is expected to be available by the end of the year and will be produced locally, as will the J and J vaccine. The vaccination program despite supply problems has started to look impressive with some 5.91 million doses administered in a single day (June 24th).
At the same time, several countries are getting to the position of being able to start supplying vaccine to Covax and to areas with particular problems. The USA has already distributed a large proportion of their Astra Zenica stockpile, which they are not using, with more to come, and the G7 countries have committed to supply a billion doses over the next year. It is likely that several countries will have production facilities operating before then, and there are several locally developed vaccines close to approval.
Of course vaccines on their own will not totally control this pandemic, but it still looks as if they remain very effective in preventing serious illness and deaths even among the variants causing so much anxiety.

 

[bhobba]

Of course vaccines on their own will not totally control this pandemic, but it still looks as if they remain very effective in preventing serious illness and deaths even among the variants causing so much anxiety.

Indeed. To make posting easier, I will introduce the term micromort:
https://en.wikipedia.org/wiki/Micromort

The CDC says the current vaccines have a 7 micromort chance of hospitalisation and a 1 micromort chance of dying.
https://medicalxpress.com/news/2021-05-tiny-vaccine-breakthrough-covid-cases.html

Compare that with the probabilities in the article of many daily activities - like just surviving a day (about 20 micromorts), and the odds are rather good. But like you, I do not believe the first generation vaccines alone will totally control it.

That said, fingers crossed, the next generation, and how quickly they can be made to respond to variants, could have a chance:
https://www.abc.net.au/news/2021-06...trials-in-australia-variant-booster/100229294

Thanks
Bil

 

[Rive]

I suspect we may see similar things played out in other countries, I'm a bit worried about some of the countries that so far have had few cases

You are most likely right with that worry. And with these new variants coming from places with sudden outbreaks, the whole world might get unwanted further trouble.

Fortunately, this is still within the scope of 'drift', so cross-immunity works. The first generation vaccines might not be able to control it completely, but they maybe able to suppress it to the point where the rate it coming up with new variants became limited.

 

[Astronuc]

COVID-19 Vaccine Breakthrough Infections Reported to CDC — United States, January 1–April 30, 2021
https://www.cdc.gov/mmwr/volumes/70/wr/mm7021e3.htm

https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html

 

[Laroxe]

COVID-19 Vaccine Breakthrough Infections Reported to CDC — United States, January 1–April 30, 2021
https://www.cdc.gov/mmwr/volumes/70/wr/mm7021e3.htm

https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html

There are always breakthrough infections, there are just to many variables involved in infection, disease and immunity. The current vaccines are in fact very efficient and there are few none responders to two dose regimes. The risk of breakthrough infections is often associated with falling antibody levels, and we know that some variants are less sensitive to antibodies. The current view is that the T cell response, which is rather more general than the specific antibodies, does continue to provide significant longer term protection, but this response tend to be slower than the available circulating antibodies.

We are now starting to see studies that clearly show the differences in risk of developing symptomatic disease, though remember some studies use evidence of infection from PCR tests not symptomatic disease. Many infectious diseases will start multiplying even in immune individuals, but the immune system kicks in and clears the body before symptoms appear, these would still be counted as infections in some studies. If we just look at symptomatic disease comparisons between vaccinated and unvaccinated, make the reductions in risk following vaccination clear. However, the often stated original aim of the vaccination program was to prevent deaths and to protect the health services by preventing serious illness that required hospital care. This would leave a situation in which the SARS-CoV 2 becomes rather like the other coronavirus's that infect humans, that also jumped species in the not to distant past, an inconvenient cold like disease. The two dangerous coronavirus's didn't really hack it. Really, the only measures that are meaningful are the rates of serious disease and deaths, and in this the vaccines have been hugely effective. While the anxiety about reinfection sells papers, more than 90% of these will be asymptomatic or mild disease, people are invited to panic about the risk of getting a cold. The linked study gives some information around effectiveness and seems to present a very different picture to the number of re-infections with no context.
I think it would be great if we could effectively eliminate the virus, if this does happen, it certainly won't be in the immediate future.

https://www.bmj.com/content/373/bmj.n1088

 

[Astronuc]

Interesting article in the Atlantic - The mRNA Vaccines Are Extraordinary, but Novavax Is Even Better
"Persistent hype around mRNA vaccine technology is now distracting us from other ways to end the pandemic. "
https://www.theatlantic.com/health/archive/2021/06/novavax-now-best-covid-19-vaccine/619276/

(The mRNA vaccines [Pfizer and Moderna] delivered efficacy rates of 95 and 94 percent against the original Coronavirus strain in Phase 3 trials, as compared with 96 percent for Novavax in its first trial, and now 90 percent against a mixture of variants.

Edit/update: Also -

The Novavax vaccine also has a substantially lower rate of side effects than the authorized mRNA vaccines. Last week’s data showed that about 40 percent of people who receive Novavax report fatigue after the second dose, as compared with 65 percent for Moderna and more than 55 percent for Pfizer. Based on the results of Novavax’s first efficacy trial in the U.K., side effects (including but not limited to fatigue) aren’t just less frequent; they’re milder too.

I didn't experience fatigue with Pfizer, as most people who got that vaccine did not. My son did take a day of following his second Moderna, and that seems more common among those who got that vaccine.

 

[Vanadium 50]

The difference between 95% vs 96% is really hard to spot.

The difference in serious hospitalizations and deaths is even smaller, since it's a tiny subsample of the 4 or 5%. It's even harder to spot. (And it's not clear which direction it will go)

Passing on a 95% efficient vaccine in hopes of a 96% efficient vaccine in a few months or a year is likely not the best strategy.

 

[Ygggdrasil]

The FDA warns that the Johnson & Johnson vaccine is associated with Guillain-Barre syndrome:

The Johnson & Johnson Coronavirus vaccine has been linked to an extremely rare neurological disorder, according to the Centers for Disease Control and Prevention. Of the more than 12 million vaccine doses administered in the U.S., there have been around 100 reports of people developing Guillain-Barré syndrome.

In light of the newly documented risk, the Food and Drug Administration has updated the label of the vaccine to include a new warning: "Guillain-Barré Syndrome Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination."

https://www.npr.org/sections/corona...o-neurological-disorder-in-extremely-rare-cas

Given ~ 100 events from 12M vaccine doses, the incidence is very low at ~ 1 per 100,000 vaccinated.

 

[PeroK]

The UK appears to be near to the end of our vaccination programme. We only did half a million first time jabs last week and the numbers are down again this week. We've vaccinated 46 million people, which is over 85% of the adult population (which is 67% of the total population). We may squeeze another million, perhaps, but we are largely down to the (8 million) people who don't want the vaccine now.

 

[pinball1970]

The UK appears to be near to the end of our vaccination programme. We only did half a million first time jabs last week and the numbers are down again this week. We've vaccinated 46 million people, which is over 85% of the adult population (which is 67% of the total population). We may squeeze another million, perhaps, but we are largely down to the (8 million) people who don't want the vaccine now.

What is the demographic for that 8 million?
Age/ethnicity?

If they are over 50 that will translate to significant deaths.

 

[PeroK]

What is the demographic for that 8 million?
Age/ethnicity?

If they are over 50 that will translate to significant deaths.

The figures must be online somewhere. The projection I saw was up to 200 deaths per day. We are at 50 at the moment.

 

[bhobba]

Given ~ 100 events from 12M vaccine doses, the incidence is very low at ~ 1 per 100,000 vaccinated.

Eerily about the same as the 1976 flu vaccine:
https://www.smithsonianmag.com/smart-news/long-shadow-1976-swine-flu-vaccine-fiasco-180961994/

The recovery period for Guillain-Barré syndrome can be long, but most people recover. It is not as common as the 1976 vaccine but even today still occurs with the flu vaccine.

Thanks
Bill

 

[bhobba]

Things are on a knife-edge in Aus right now:
https://www.couriermail.com.au/coronavirus/nsw-covid-updates-sydney-bracing-for-case-spike/live-coverage/6fad7c928caf1ea95d7f542d8622c621?utm_source=CourierMail&utm_medium=email&utm_campaign=Editorial&utm_content=CM_LATESTNEWS_BREAKING-CUR_01&net_sub_id=285783538&type=curated&position=1&overallPos=1

The vaccine rollout must be accelerated.

Thanks
Bill

 

[Laroxe]

The FDA warns that the Johnson & Johnson vaccine is associated with Guillain-Barre syndrome:

https://www.npr.org/sections/corona...o-neurological-disorder-in-extremely-rare-cas

Given ~ 100 events from 12M vaccine doses, the incidence is very low at ~ 1 per 100,000 vaccinated.

To be honest, I didn't find this surprising. In the USA it occurs in a wide range of estimates of incidence from 1 per 3000 individuals, to 1 per 100,000, usually following a respiratory or gastrointestinal viral infection. The pathology is still not well understood but its generally thought to be either an autoimmune response or a more general T cell activation that targets myelin. It seems the pathology can vary depending on the activating infection, quite a number of infections have been incriminated as triggers, usually by temporal association's.
Based on this evidence, infections with the gram negative enteropathogen Campylobacter jejuni, cytomegalovirus (CMV), Epstein-Barr virus, and Mycoplasma pneumoniae are precipitants of GBS whereas other infections occur no more often in this neuropathy than in controls. It does seem to follow some sort of general immune activation rather than something specific. More recently Zika virus, Lassa fever and Covid 19 have been added to the list.
It does suffer from the same problems as other rare conditions, in that the evidence is generally poor quality.
This becomes even more of an issue when trying to make associations with vaccination against some of these diseases, where the disease is seen as rarer still. This means that there is still some debate about these associations and as the risk with this vaccine appears to be at the same level as the background rate its difficult to make sense of this association.
https://www.medscape.com/answers/31...n-proven-to-cause-guillain-barre-syndrome-gbs

 

[Astronuc]

Novavax COVID shot effective but carries heart risk, FDA says​

https://www.axios.com/2022/06/03/novavax-covid-vaccine-heart-risk-fda

June 3 - https://ir.novavax.com/Novavax-Stat...-Document-Related-to-Myocarditis-Pericarditis

May 31 - https://ir.novavax.com/Novavax-Init...-COVID-19-Omicron-Strain-Vaccine-as-a-Booster

More statements on vaccine for SARS-Cov-2
https://ir.novavax.com/press-releases?category=2