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

[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

 

[berkeman]

Novavax COVID shot effective but carries heart risk, FDA says

I didn't see the incidence rate of myocarditis and periocarditis in these studies (but I could have missed it). What were the rates? If it's 1/million vaccinations like some of the other risks with the mRNA vaccines, that's one thing. if it's 1/100,000 or greater, that's different, IMO.

 

[Astronuc]

I didn't see the incidence rate of myocarditis and periocarditis in these studies (but I could have missed it). What were the rates? If it's 1/million vaccinations like some of the other risks with the mRNA vaccines, that's one thing. if it's 1/100,000 or greater, that's different, IMO.

In their June 3 press release, Novavax states, "The data from our placebo-controlled studies show that overall, in our clinical development program, the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%)." or 7/100k and 5/100k, respectively, which seems about statistically the same.

 

[berkeman]

Interesting. Then why the FDA headline?

 

[Astronuc]

Interesting. Then why the FDA headline?

One would have to find the person responsible for authorizing the statement and have that person explain the motivation. Maybe, it's to avoid criticism from the public in the event that a person receives the vaccine and develops myocarditis.

If I recall correctly, there is a risk of myocarditis with each of the vaccines. However, I wonder if that is a consequence of injecting the vaccine solution directly into a blood vessel (vein) as opposed to the muscle. Perhaps that occurs in 1 in 100k to 1 in 10k cases?

 

[Godot_]

One would have to find the person responsible for authorizing the statement and have that person explain the motivation. Maybe, it's to avoid criticism from the public in the event that a person receives the vaccine and develops myocarditis.[...]

There probably is a statistical threshold. Once incoming possible adversary reaction reports exceed that threshold, a warning is issued. At least here in Europe that's the principle with "normal" medications...

If I recall correctly, there is a risk of myocarditis with each of the vaccines. However, I wonder if that is a consequence of injecting the vaccine solution directly into a blood vessel (vein) as opposed to the muscle. Perhaps that occurs in 1 in 100k to 1 in 10k cases?

This called "accidential intravasal injection", and is a plausible cause for myocarditis with the mRNA-vaccines, because...
a) the usual safety measure - aspiring before infection, and aborting if blood is drawn - must not be done with microsomal preparations. "Explicit instructions" was what I've been told when chatting up the lady giving me the third shot.
b) the next "damageable" organ the vaccine then hits is the heart. Most of it would be absorbed in the lung, but after that, the heart is the place to go. Other organs have more reserves and / or better protection.
c) the higher frequency of myocarditis in young males also hints at that. Young men have - on average - the best vascularization in their deltoids, bodybuilding or not.

But... ...Novavax is a protein vaccine. Doh.

 

[atyy]

There probably is a statistical threshold. Once incoming possible adversary reaction reports exceed that threshold, a warning is issued. At least here in Europe that's the principle with "normal" medications...This called "accidential intravasal injection", and is a plausible cause for myocarditis with the mRNA-vaccines, because...
a) the usual safety measure - aspiring before infection, and aborting if blood is drawn - must not be done with microsomal preparations. "Explicit instructions" was what I've been told when chatting up the lady giving me the third shot.
b) the next "damageable" organ the vaccine then hits is the heart. Most of it would be absorbed in the lung, but after that, the heart is the place to go. Other organs have more reserves and / or better protection.
c) the higher frequency of myocarditis in young males also hints at that. Young men have - on average - the best vascularization in their deltoids, bodybuilding or not.

But... ...Novavax is a protein vaccine. Doh.

https://www.cdc.gov/vaccines/covid-19/hcp/faq.html
"You should not aspirate before giving any vaccine, including COVID-19 vaccines. Aspiration can increase pain because of the combined effects of a longer needle-dwelling time in the tissues and shearing action (wiggling) of the needle. A discussion of vaccine administration best practices can be found in the Vaccine Administration chapter of Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book)."

https://covid.immune.org.nz/faq/there-need-aspirate-giving-covid-vaccine
"We are aware that occasionally consumers are requesting that the vaccinators aspirate the needle [pull back slightly to check for any minor blood vessels] prior to administration of the COVID vaccine. While this is currently not best practice and may be more uncomfortable for the patient, there is no danger associated with accommodating the consumer's requests."

 

[kyphysics]

https://www.yahoo.com/news/moderna-says-updated-covid-shot-110657596.html

Moderna's experimental COVID-19 vaccine that combines its original shot with protection against the omicron variant appears to work, the company announced Wednesday.

COVID-19 vaccine makers are studying updated boosters that might be offered in the fall to better protect people against future Coronavirus surges.

Moderna's preliminary study results show people given the combination shot experienced an eight-fold increase in virus-fighting antibodies capable of targeting the omicron mutant, the company announced.

 

[Laroxe]

For people who are members of Medscape (you can join for free) this is an interesting review of Novavax and another new vaccine, Covaxin.
https://www.medscape.com/viewarticle/975110

I think we are now at the stage that the main issues in vaccine appraisal will be the incidence of adverse events and the "breadth" of the antibody response. It does seem that in the future, mixing vaccines is the way to go rather than continually developing variant specific vaccines. Many, if not most, of the vaccines in development, that have been shown to be effective have been discontinued. For these vaccines to be economically viable they need to offer advantages beyond their effectiveness, the first vaccines set a very high bar.

It is still difficult to estimate the risks involved in vaccination, any sort of activation of the immune system may increase some risks and it seems to be the case that the immune response to some specific pathogens can be associated with some specific problems. However, the fact that interactions with our environment mean we are constantly exposed to a range of antigens means that there is usually a constant background rate of many of the suggested adverse events.

Only vaccines that can be associated with low rates of possible adverse events are widely used, in many cases it can be difficult to identify any increased rate as the frequency is so low it can be difficult to identify different rates of occurrence. This was an issue with the Astra Zenica / viral vector vaccines and is considered in the review of Novavax. Many of the adverse events identified are frequently seen in actual infections and at a much higher rate.

A great deal of attention is paid to the possibility of adverse events to vaccines, and the global monitoring systems mean that information about individual cases is widely available and influences uptake. This is a prime example of how human stories influence behaviour when good quality information doesn't. If we looked at measles vaccination about which we have detailed information over many years, its clear it is very safe, there are very few cases of serious side effects that can be attributed to the vaccine, and it provides lifelong protection. At the same time vaccine refusal, often in areas of high risk is very common, despite vaccination campaigns leading to an 80% reduction in deaths between 2000 and 2017, the WHO still reported around 110,000 deaths over this same period.

With Covid we saw widespread campaigns to ensure equal distribution of vaccine stocks to African countries and the development of vaccine production facilities. Unfortunately, and for a variety of reasons, despite the vaccines being made widely available, vaccine uptake remains very low, a new production facility in South Africa was in fact closed for lack of orders. I suspect that the idea that new vaccines that use different technologies will reassure people who were suspicious of mRNA vaccines and increase uptake, may be a triumph of hope over experience.

 

[Sagittarius A-Star]

NEW YORK (Reuters) - The U.S. Food and Drug Administration will not require companies to submit clinical trial data on COVID-19 vaccines modified to protect against the BA.4 and BA.5 versions of Omicron in order to authorize those shots, a top FDA official said on Thursday.

Source:
https://www.reuters.com/legal/gover...thorize-redesigned-covid-boosters-2022-06-30/

 

[morrobay]

Source:
https://www.reuters.com/legal/gover...thorize-redesigned-covid-boosters-2022-06-30/

Not familiar with protocols but is it common and appropriate to omit clinical data. Clinical data that may show adverse effects ?

 

[Sagittarius A-Star]

Not familiar with protocols but is it common and appropriate to omit clinical data. Clinical data that may show adverse effects ?

I am not an expert for this. But I read something similar for (inactivated) influenza vaccines:

In the United States, licensed influenza vaccine manufacturers must submit a supplement to their license for review and obtain FDA approval before the updated version of the influenza vaccine containing new virus antigens can be distributed. Such supplements to inactivated and recombinant protein seasonal influenza vaccines do not require additional clinical data specific for the new strain.

Source:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947948/

 

[morrobay]

I am not an expert for this. But I read something similar for (inactivated) influenza vaccines:

Source:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947948/

However does this apply to mRNA boosters too ? Because from quick search some of the new BA. 4,5 boosters are mRNA based.

 

[Sagittarius A-Star]

However does this apply to mRNA boosters too ? Because from quick search some of the new BA. 4,5 boosters are mRNA based.

As I understand, for fall 2022 that is not yet decided. If they decide for an mRNA booster containing Omicron BA.1 genes, then clinical data will be available. If they jump directly to Omicron BA.4/BA.5 genes for better efficiency of the vaccine against BA.4/BA.5, then they will rely for authorization on the clinical data created for BA.1.

The future strategy seems to be, that they rely for authorization of variant "n" on the data for variant "n-1".

Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses
...
Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an omicron BA.4/5 component. Manufacturers will also be asked to begin clinical trials with modified vaccines containing an omicron BA.4/5 component, as these data will be of use as the pandemic further evolves.

Source:
https://www.fda.gov/news-events/pre...icron-ba45-component-covid-19-vaccine-booster

 

[bhobba]

However does this apply to mRNA boosters too ? Because from quick search some of the new BA. 4,5 boosters are mRNA based.

It's a risk vs reward thing. We have enough experience with inactivated virus vaccines which is the main technology used to make the Flu vaccine - the virus is often grown in eggs. But recently other technologies have started to be used. Anyway because of that experience they don't go through the full gamut of phases 1, 2, 3, 4 etc since for certain groups the flu can be very dangerous indeed. We are now seeing a bad flu season because the lockdowns etc have reduced natural immunity. Even so every now and then you hear of an otherwise healthy young person dying of the flu. In 2017 I seem to recall where I live (Queensland) about 300 died so it is not something to take lightly.

Anyway, we are now getting a lot of experience with MRNA vaccines and the new Omicron variants 4 and 5 are causing havoc in a number of places (where I am in Brisbane for example) that it may be judged the reward is worth the risk. We are seeing 12 deaths a day although it must be said the majority have not had their 3rd booster. The 4th booster is now recommended for everyone. Reports in the media say Omicron 4 and 5 vaccines likely will be in use sometime toward the end of the year. But the companies have announced they will be ready for mass distribution in August. Evidently, they can be produced and manufactured that fast. IMHO this is the most potent weapon we have. We should fast-track it as much as possible. Unfortunately, public servants are legendary for their process rather than results-oriented practices so I am betting on more likely at year's end - sadly.

In the interim please get the 4th dose, wear a mask while inside, wash hands etc. It's not to be taken lightly. Even the Flu should not be taken lightly and unfortunately, the 4 and 5 variants, which will become the dominant strains, are worse than the flu. Although it is not known if widespread use of the current vaccine's 4th dose will bring it back to flu levels - we can only hope.

Thanks
Bill

 

[Tom.G]

Researchers at Caltech (California Institute of Technology) have come up with a vaccine against multiple Corona Viruses, even those that are not specifically included in the vaccine.

So far it works in mice and monkeys, and they have been funded with USD $30 million ($3×10⁷) for Phase 1 human trial (safety evaluation). Trial expected to start late 2022 - early 2023 and take about a year.

Scientific report:
https://www.science.org/doi/10.1126....1578319343.1656969987-1539684278.1656679986&

Popular article:
https://www.latimes.com/science/sto...-multiple-coronaviruses-to-begin-human-trials

Successful or not, it looks like major progress to me!

Cheers,
Tom

 

[bhobba]

Trial expected to start late 2022 - early 2023 and take about a year.

I don't get this. It does not have to take that long. You do phase 1, then halfway through start phase 2, and halfway through that start phase 3. In parallel with phase 3, you start mass production so it is ready to go when phase 3 is completed. The only people put at risk are the volunteers who participated in phase 2 before phase 1 finished, and those that participated in phase 3 before phase 2 finished. Once ready to be used it has been through all the phases and is as safe as doing it sequentially. Why can't we compress it? I don't get it? Perhaps those more knowledgeable can shed some light on it. At the moment I am confounded. Vaccines are our most potent weapon - we must get them out there ASAP. It will save countless lives.

Thanks
Bill

 

[Tom.G]

I don't get this. It does not have to take that long. You do phase 1, then halfway through start phase 2, and halfway through that start phase 3. In parallel with phase 3, you start mass production so it is ready to go when phase 3 is completed. The only people put at risk are the volunteers...

And which overlapping phase are YOU volunteering for?

Other than that question, there is something known as The Hippocratic Oath that doctors are (supposedly) bound by.

Compressed version: "First, Do No Harm."

For longer versions, see:
https://www.google.com/search?&q=hippocratic+oath+text

 

[bhobba]

And which overlapping phase are YOU volunteering for?

Well, it was how the first-generation vaccines were developed so fast. I would volunteer for any, although being immunocompromised it is doubtful they would accept me except for phase 3. In phase 3 they would want vulnerable people because they are the group that the vaccine would help the most. But you bring up a valid point - it will fail without sufficient volunteers. That applies to the usual method as well. It's just that in practice it has not proved to be a problem. Challenge trials speed it up even more, and they had no shortage of volunteers:
https://www.vox.com/future-perfect/2020/11/17/21540773/covid-19-vaccine-human-challenge-trial-ethics.

I am unsure though if the situation is so dire challenge trials are the way to go, but it is good to know it is there if required. And yes, there are difficult ethical issues involved which is why I gave your post a like.

Thanks
Bill

 

[Laroxe]

I think people have to remember that to carry out large scale clinical trials usually involves comparing the outcomes between vaccinated and unvaccinated groups, the starting point would be identifying people without antibodies. Currently, with the high level of vaccination and infection this is almost impossible. It's not unusual for a vaccine that uses well established technologies not to undergo the full evaluation process, this doesn't mean that evidence of effectiveness or adverse events is ignored, in fact these are the things that the process focusses on.
A major issue at the moment is that virtually all the studies use antibody measures as a proxy measure of effectiveness, the various sub variants of SARS-CoV-2, which show considerable differences in the effectiveness of antibody protection, this isn't really very helpful. Unfortunately, few people have tried to evaluate the effectiveness of other parts of the immune response. It appears that regardless of the variant involved in infection, the original vaccines continue to provide significant protection against serious illness and death. So despite the current surge in infections, we are not seeing a significant increase in mortality. As far as I'm aware there is no good evidence that a fourth dose given to people without other risk factors offers significant benefits.
I would still recommend the virology blog TWiV on you tube is a good way to keep up to date with Covid 19 research though the video's can be a bit long.

 

[bhobba]

It appears that regardless of the variant involved in infection, the original vaccines continue to provide significant protection against serious illness and death.

Yes. We now know that here in Australia sadly 40 people are dying each day of Covid or 14,600 a year. But on a more positive note, only 3% have the 4th dose and of those, the majority are in aged care facilities and over 85. That would be 438 if everyone had the 4th dose as is now being recommended in Australia. During the 2017 flu pandemic in Queensland (the state where I live) 300 died of the flu - of course, many more would have died in the whole of Australia. The flu/cold season is only halfway through here in Aus so a few back-of-the-envelope calculations show with current vaccines we can bring it down to about the death rate of a bad flew season. While I personally would like to see accelerated development of second-generation vaccines and antivirals if that is required is arguable. But we must convince people to use the tools we currently have - that seems the most urgent issue.

Thanks
Bill

 

[Laroxe]

This is an interesting discussion and shows how complex the issue is. The panel includes Paul Offit who took part in the review of the Omicron specific vaccines, interestingly he voted against their use.

 

[Delta2]

Not sure if this is the right thread to post but I got a question which I tried to look up myself but couldn't find data.
What's the percentage of people that catch the corona virus and don't recover, i.e. they die? An average from all variants if possible..

 

[Tom.G]

In Greece (where @Delta2 is):

There have been 3,963,142 infections and 30,476 coronavirus-related deaths reported in the country since the pandemic began.

(above from:
https://graphics.reuters.com/world-coronavirus-tracker-and-maps/countries-and-territories/greece/)

(above found with:
https://www.google.com/search?&q=how+many+covid+infections+in+Greece)

Cheers,
Tom

 

[bhobba]

What's the percentage of people that catch the corona virus and don't recover, i.e. they die? An average from all variants if possible..

It varies a bit from country to country and even within the same country from state to state. Where I am in Queensland 1.41 million got it, 1442 died. That is a death rate of about .1%. It must be mentioned the vast majority of those that died have not been vaccinated. And just 3% of those that do die have had the 4th booster. So another plug - GET THE FOURTH BOOSTER. Actually for those with the fourth booster flu seems a bigger worry. If you book in for a booter at my doctor's, you also get a flu shot - no ifs or buts. This is why there is debate on the urgency of an Omicron-specific vaccine. But it must be said while some countries like Israel are going ahead with a 5th booster, some immunlogists are getting worried there must be a light at the end of the tunnel to the number of boosters we should get. Work is progressing on a universal Covid vaccine:
https://www.abc.net.au/news/2022-07-18/how-far-off-is-a-universal-vaccine/101247184

I am a bit perturbed by the mention of a lack of funding - this should be the number one priority IMHO. With the current vaccine, if people get the 4th dose and the new antivirals, I think we have the death rate under control; at least for those that have a few brains and avail themselves of the massive glut in vaccines we now have. While any death is a tragedy, it's even worse when it is the result of being ill-informed.

Here in Queensland, the main issue is not the death rate, it is the number getting it and important services like hospitals, the police etc are drastically understaffed with people off on sick leave. But people no longer want to even take the most basic of measures like wearing masks indoors in confined spaces. It reduces transmission by 20%. Even explaining that makes no difference. To be fair, a decent advertising campaign with actual numbers would likely help.

Thanks
Bill

 

[Rive]

What's the percentage of people that catch the corona virus and don't recover, i.e. they die?

Originally it was around 1-2%, depending on many local variables. By now, it's really hard to say: the immunity from previous waves and vaccines is changing/waning slowly, just as the virus is mutating. Likely it'll stay significantly lower than the original value, but not known yet that how much lower.