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Waterbomber2
Posts: 1445
Joined: Mon Feb 04, 2019 3:44 am

Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 7:53 am

I'm not an anti-vaxxer but I want to see more and much stronger data on these vaccine candidates because I strongly doubt these high effectiveness data based on their methods to measure effectiveness. I could be wrong but to me it sounds like these pharmaceuticals are trying to earn big bucks by advertising their vaccines and governments are playing along to get as many people as possible vaccinated.

How good is it?
The trial involved 30,000 people in the US with half being given two doses of the vaccine, four weeks apart. The rest had dummy injections.

The analysis was based on the first 95 to develop Covid-19 symptoms.

Only five of the Covid cases were in people given the vaccine, 90 were in those given the dummy treatment. The company says the vaccine is protecting 94.5% of people.


https://www.bbc.com/news/health-54902908

So it looks to me like this company is basing their analysis of effectiveness only on symptomatic individuals.


IMO the only measure of real effectiveness is to PCR test all test subjects at 7 day intervals so you can also count all asymptomatic individuals.
Because a vaccine that makes you asymptomatic in 95% of cases weeks after application but still a spreader, is asking for trouble.

In addition, these vaccines have quite serious short-term side effects and we won't find out the whole picture of side effects for a while.


Fever, aches from Pfizer, Moderna jabs aren’t dangerous but may be intense for some

This summer, Luke Hutchison, a Massachusetts Institute of Technology–educated computational biologist, volunteered for a trial of Moderna’s COVID-19 vaccine. After he got the second injection, his arm immediately swelled up to the size of a “goose egg,” Hutchison says. He can’t be sure he got the vaccine and not a placebo, but within a few hours, the healthy then-43-year-old was beset by bone and muscle aches and a 38.9°C fever that felt, he says, “unbearable.” “I started shaking. I had cold and hot rushes,” he says. “I was sitting by the phone all night long thinking: ‘Should I call 911?’”


https://www.sciencemag.org/news/2020/11 ... tense-some

For instance, this test subject developed Covid symptoms hours after the injection. Was he counted as a symptomatic individual? How can Moderna know that it was a side-effect of the vaccine shot and not an actual infection?

Again, not an anti-vaxxer but I don't fancy how these pharmaceuticals are spreading convenient truths on these high effectiveness, while negotiating mutli-billion dollar contracts.

The United States paid Moderna $15 per dose to secure 100 million vaccines in a $1.5 billion deal in August. That was on top of $1 billion in funding for Moderna’s vaccine, effectively bringing the combined price to $25, according to the publicly released terms of the deal.


https://www.reuters.com/article/health- ... NKBN27W256
 
Tiredofhumanity
Posts: 63
Joined: Sat Sep 19, 2020 9:27 pm

Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 8:26 am

Waterbomber2 wrote:
I'm not an anti-vaxxer but I want to see more and much stronger data on these vaccine candidates because I strongly doubt these high effectiveness data based on their methods to measure effectiveness. I could be wrong but to me it sounds like these pharmaceuticals are trying to earn big bucks by advertising their vaccines and governments are playing along to get as many people as possible vaccinated.

How good is it?
The trial involved 30,000 people in the US with half being given two doses of the vaccine, four weeks apart. The rest had dummy injections.

The analysis was based on the first 95 to develop Covid-19 symptoms.

Only five of the Covid cases were in people given the vaccine, 90 were in those given the dummy treatment. The company says the vaccine is protecting 94.5% of people.


https://www.bbc.com/news/health-54902908

So it looks to me like this company is basing their analysis of effectiveness only on symptomatic individuals.


IMO the only measure of real effectiveness is to PCR test all test subjects at 7 day intervals so you can also count all asymptomatic individuals.
Because a vaccine that makes you asymptomatic in 95% of cases weeks after application but still a spreader, is asking for trouble.

In addition, these vaccines have quite serious short-term side effects and we won't find out the whole picture of side effects for a while.


Fever, aches from Pfizer, Moderna jabs aren’t dangerous but may be intense for some

This summer, Luke Hutchison, a Massachusetts Institute of Technology–educated computational biologist, volunteered for a trial of Moderna’s COVID-19 vaccine. After he got the second injection, his arm immediately swelled up to the size of a “goose egg,” Hutchison says. He can’t be sure he got the vaccine and not a placebo, but within a few hours, the healthy then-43-year-old was beset by bone and muscle aches and a 38.9°C fever that felt, he says, “unbearable.” “I started shaking. I had cold and hot rushes,” he says. “I was sitting by the phone all night long thinking: ‘Should I call 911?’”


https://www.sciencemag.org/news/2020/11 ... tense-some

For instance, this test subject developed Covid symptoms hours after the injection. Was he counted as a symptomatic individual? How can Moderna know that it was a side-effect of the vaccine shot and not an actual infection?

Again, not an anti-vaxxer but I don't fancy how these pharmaceuticals are spreading convenient truths on these high effectiveness, while negotiating mutli-billion dollar contracts.

The United States paid Moderna $15 per dose to secure 100 million vaccines in a $1.5 billion deal in August. That was on top of $1 billion in funding for Moderna’s vaccine, effectively bringing the combined price to $25, according to the publicly released terms of the deal.


https://www.reuters.com/article/health- ... NKBN27W256


You sound like an anti-vaxxer. How are these vaccines any different from ones approved 30-40 years ago that we now take for granted?

Where is the evidence that corners have been cut? Please explain?

Another 5 years of this I might just start selling my organs...
 
art
Posts: 3768
Joined: Tue Feb 08, 2005 11:46 am

Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 9:47 am

EA CO AS wrote:
DocLightning wrote:
Let's go with flu x4. If 40% of Americans get their flu shot every year, then let's assume 80% will do this. For two shots per person, then that's 4x the jabs we'd see in a typical flu season. This is a lot, but it's not impossible.


Assuming the preliminary info of about 20-30M doses available immediately, coupled with about that amount monthly thereafter between the Pfizer and Moderna vaccines, would you agree with Dr. Fauci's assessment that we're looking at herd immunity, or something close to it, in the U.S. by 3Q21?


I think it will be difficult to estimate when herd immunity will be reached (say 2/3 of the population being immune) because while it can be predicted how many are immune through vaccination (say 90% of vaccinees), the incidence of recovered asymptomatic/mildly affected infectees who did not get tested is an imponderable as is how many of those are imbued with immunity.

While about 12 million COVID-19 cases have been confirmed in the US so far, how many additional 'invisible' cases have there been so far - 10, 20, 30, 40 million?

I guess that herd immunity will be reached sooner than expected.
 
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DocLightning
Posts: 21966
Joined: Wed Nov 16, 2005 8:51 am

Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 4:05 pm

EA CO AS wrote:
Assuming the preliminary info of about 20-30M doses available immediately, coupled with about that amount monthly thereafter between the Pfizer and Moderna vaccines, would you agree with Dr. Fauci's assessment that we're looking at herd immunity, or something close to it, in the U.S. by 3Q21?


I wouldn't be shocked. Although one thing I will say about Dr. Fauci is that his prognostications are usually a bit on the pessimistic side. He didn't think we'd have a vaccine for another year. I predicted one around Christmas.

The big unknown here is to what degree immunity against SARS-CoV-2 reduces transmission. In the vast majority of antiviral vaccines, strong antiviral adaptive immunity (antibodies) prevents both illness and transmission. It is reasonable to predict that protective immunity against SARS-CoV-2 will prevent or at least reduce transmission. But that isn't necessarily always the case. The rotavirus vaccine does not do a good job of preventing rotavirus transmission in vaccinated subjects although even then, there is some role for herd immunity there.(1)

But with such a high vaccine efficacy, I suspect that we will see very few cases in people who have been vaccinated, and so if it does provide sterilizing immunity, then the population threshold for eliminating transmission might be pretty low, around 70%.

(1)https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5967271/
-Doc Lightning-

"The sky calls to us. If we do not destroy ourselves, we will one day venture to the stars."
-Carl Sagan
 
StarAC17
Posts: 3908
Joined: Thu Aug 07, 2003 11:54 am

Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 5:04 pm

Because a vaccine that makes you asymptomatic in 95% of cases weeks after application but still a spreader, is asking for trouble.


Even if your are immune to an infection (via vaccine or previous exposure) a successive encounter will involve some replication of the virus in your body.

The immune system will squash it long before it gets to the point of being contagious and making the infected person feel sick. As more an more people get the vaccine the even if it could spread its getting less and less people sick as they will be immune and not be harmed from exposure to Covid19.

All vaccines state they prevent the disease and not the infection and I was reading articles regarding infections like Chickenpox that the antibodies half-life does not correspond to lifetime immunity but people usually are immune for most of their life (getting shingles later excluded) and it seemed to theorize that you get exposed to past pathogens more often than you think but don't realize because the immune system is doing its job an then the antibodies are back. I have to run but will try to find the article later.

Measles which is far more contagious than Covid still infects you somewhat but if you have had the vaccine the immune system calls in the troops basically immediately.
Engineers Rule The World!!!!!
 
Waterbomber2
Posts: 1445
Joined: Mon Feb 04, 2019 3:44 am

Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 6:54 pm

StarAC17 wrote:
Because a vaccine that makes you asymptomatic in 95% of cases weeks after application but still a spreader, is asking for trouble.


Even if your are immune to an infection (via vaccine or previous exposure) a successive encounter will involve some replication of the virus in your body.

The immune system will squash it long before it gets to the point of being contagious and making the infected person feel sick. As more an more people get the vaccine the even if it could spread its getting less and less people sick as they will be immune and not be harmed from exposure to Covid19.

All vaccines state they prevent the disease and not the infection and I was reading articles regarding infections like Chickenpox that the antibodies half-life does not correspond to lifetime immunity but people usually are immune for most of their life (getting shingles later excluded) and it seemed to theorize that you get exposed to past pathogens more often than you think but don't realize because the immune system is doing its job an then the antibodies are back. I have to run but will try to find the article later.

Measles which is far more contagious than Covid still infects you somewhat but if you have had the vaccine the immune system calls in the troops basically immediately.


What I'm saying is that Moderna's interim analysis does not seem to indicate the rate of infection prevention but the rate of symptom prevention, a few weeks after the injections.
The 95 individuals who tested positive at the point of analysis did so after presenting symptoms.
All leading candidates' phase 3 studies do not seem to be sweep-testing all individuals for infections but only symptomatic individuals.

Image

https://pbs.twimg.com/media/EiTYc8oU0AA ... name=large

So their analysis may not be uncovering all the asymptomatic people that could be infected.


I'm not an anti-vaxxer, I'm an anti-idiocy person.
What is happening here is idiocy, of the same level as the previous months.
It is irresponsible for the pharma companies to make such forward-looking statements without adding words of caution. This can cause early abandonment of fireproof strategies that are in effect and working after which they will say, "oh, actually the real life effectiveness (not efficacy) seems to be only 40%. We opened up too soon, we are seeing a 3rd wave."


A personal anecdote.
I'm convinced that I had Covid-19 in early December 2019.
A couple of days after a majority got vaccinated for the flu at work, the people who got the shot called in sick en masse, like 70%. Some of them were out for a full week.
A week later, the rest of us who did not get the flu shot got sick.
I had 38.5 degree fever, muscle pain, extreme fatigue and lost the sense of smell and taste, something that I had never experienced before. My boss convinced me to stay home for a day even though I was essential at that time, and I'm someone who very rarely gets sick. I got better after a day but I was freaked out because it felt different from a flu.
Several weeks later, my mother whom I had come in contact with, was hospitalised with a lung infection, on the chest X-ray. She was one of the first in our country to have been subjected to PCR testing but we were never told the result and the doctor sent her home to sick it out.

The conspiracy theory around the office is that those flu shots may have contained Covid and that we were shot with it intentionally. We dismissed it as just a conspiracy theory until Italy started reporting Covid presence as early as September 2019.


The study - published by NCI's scientific magazine Tumori Journal - found that 11.6% of blood samples from 959 healthy volunteers, who were enrolled in a lung cancer screening trial between September 2019 and March 2020, had developed antibodies well before February.


https://news.sky.com/story/covid-19-cir ... m-12133825

It could be just a conspiracy theory, but the same guys who produce those flu vaccines are the ones producing this vaccine, so it makes one wonder what will be written in the history books.


In any case, show me a vaccine that works at 95% for 2 or 3 months and I will be the first to take it.
But test everybody in the clinical trial at regular intervals, otherwise it's a pile of BS.
 
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Thunderboltdrgn
Posts: 2165
Joined: Wed Jan 18, 2012 5:39 pm

Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 8:08 pm

I think there will be many Swedes who will be sceptical about the new vaccines because of what happened with the side effects Pandemrix swine flue influenza (A(H1N1)) vaccine.

An increased risk of narcolepsy was found following vaccination with Pandemrix, a monovalent 2009 H1N1 influenza vaccine that was used in several European
countries during the H1N1 influenza pandemic. This risk was initially found in Finland, and then other European countries also detected an association.


https://www.cdc.gov/vaccinesafety/conce ... y-flu.html
https://www.socialstyrelsen.se/stod-i-a ... arkolepsi/
https://vaccinationer.se/nyhetsinlagg/n ... av-vaccin/

Hopefully the Sars-Cov-2 vaccines won't have any severe side effects (like narcolepsy) and some of those being sceptical will come around.
Like a thunderbolt of lightning the Dragon roars across the sky. Il Drago Ruggente
 
StarAC17
Posts: 3908
Joined: Thu Aug 07, 2003 11:54 am

Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 8:28 pm

What I'm saying is that Moderna's interim analysis does not seem to indicate the rate of infection prevention but the rate of symptom prevention, a few weeks after the injections.


As I said before. Either achieving immunity through infection or vaccination does not prevent infection. It prevents illness and disease. The immune system ramps up the response before the virus makes you sick and before it can gain a foothold to spread.

Even if it did and enough people are vaccinated they aren't doing to get seriously sick and the amount of people getting sick will easily be manageable by society.

In any case, show me a vaccine that works at 95% for 2 or 3 months and I will be the first to take it.
But test everybody in the clinical trial at regular intervals, otherwise it's a pile of BS.


As Doc posted. MMR has a 97% efficiency. No one (that is taken seriously) complains about that one.

Although constant monitoring and testing for Covid is likely going to continue for years so we will know more once the vaccine is deployed to more people.

It could be just a conspiracy theory, but the same guys who produce those flu vaccines are the ones producing this vaccine, so it makes one wonder what will be written in the history books.


Doc can correct me but the reason that the Flu Vaccine had limited efficiency is that there are so many strains of that virus our there and it constantly mutates. Covid19 does not appear to mutate at that rate.

The annual flu vaccine does the best to predict what strains will be prevelant. Even so it has partial effectiveness and in a high risk person that can be the difference between life and death.

mRNA can revolutionalize the flu shot because they can adapt the mRNA much faster to the prevelant strains of the flu in a given year.
Engineers Rule The World!!!!!
 
Waterbomber2
Posts: 1445
Joined: Mon Feb 04, 2019 3:44 am

Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 10:06 pm

StarAC17 wrote:
What I'm saying is that Moderna's interim analysis does not seem to indicate the rate of infection prevention but the rate of symptom prevention, a few weeks after the injections.


As I said before. Either achieving immunity through infection or vaccination does not prevent infection. It prevents illness and disease. The immune system ramps up the response before the virus makes you sick and before it can gain a foothold to spread.

Even if it did and enough people are vaccinated they aren't doing to get seriously sick and the amount of people getting sick will easily be manageable by society.

In any case, show me a vaccine that works at 95% for 2 or 3 months and I will be the first to take it.
But test everybody in the clinical trial at regular intervals, otherwise it's a pile of BS.


As Doc posted. MMR has a 97% efficiency. No one (that is taken seriously) complains about that one.

Although constant monitoring and testing for Covid is likely going to continue for years so we will know more once the vaccine is deployed to more people.

It could be just a conspiracy theory, but the same guys who produce those flu vaccines are the ones producing this vaccine, so it makes one wonder what will be written in the history books.


Doc can correct me but the reason that the Flu Vaccine had limited efficiency is that there are so many strains of that virus our there and it constantly mutates. Covid19 does not appear to mutate at that rate.

The annual flu vaccine does the best to predict what strains will be prevelant. Even so it has partial effectiveness and in a high risk person that can be the difference between life and death.

mRNA can revolutionalize the flu shot because they can adapt the mRNA much faster to the prevelant strains of the flu in a given year.



The MMR vaccine was developed by a selfless researcher with a true passion for his job, who wasn't trying to get rich or famous, and over a long period of several years.

https://en.wikipedia.org/wiki/Maurice_Hilleman


Unlike the guy at the head of Pfizer for instance:

Pfizer CEO Albert Bourla raked in more than three times his base salary when he sold about 60% of his stock on Monday, shortly after trumpeting the stellar performance of his company's COVID-19 vaccine in a late-stage trial.


https://markets.businessinsider.com/new ... 1029798146


We live in an era of greed, fraud, lack of responsibility and ethics, don't forget that.



The way these companies are fanfaring this one after the other is suspicious, while their testing regimes are chaotic.
The studies all missed their analysis endpoints they had set for their studies, it seems to be very poorly organised.

AstraZeneca’s trial, unlike the ones from counterparts, only plans for one interim analysis that could allow the company to stop the trial early and petition for an emergency use authorization. That analysis is expected to occur at 75 infections. Moderna expects two analyses, at 53 and 106 events, while Pfizer penciled in four — at 32, 62, 92 and 120 cases.


https://endpts.com/astrazeneca-publishe ... different/

Did Pfizer really miss their 32 and 62 endpoints and go straight to 92 or were the results inconvenient at the earlier endpoints?

How independent are these self-regulating studies really?
How much can the companies influence the outcome?
Who chooses who gets the placebo and who gets the vaccine?


If you bother to read the small writing in the press releases:

As more cases accrue leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change. The Company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication.

(...)

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine (mRNA-1273) against the novel coronavirus, mRNA-1273's efficacy and its ability to prevent infection or mitigate symptoms of COVID-19, the safety profile for mRNA-1273, further changes to mRNA-1273’s efficacy as the study continues




https://investors.modernatx.com/news-re ... y-efficacy


My concern is that we're going to get burned relying too much on vaccines, causing more death and economic hardship than if we extend the lockdowns or semi-lockdowns we are already in until Covid is eradicated.
 
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DocLightning
Posts: 21966
Joined: Wed Nov 16, 2005 8:51 am

Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 11:40 pm

Waterbomber2 wrote:
IMO the only measure of real effectiveness is to PCR test all test subjects at 7 day intervals so you can also count all asymptomatic individuals.
Because a vaccine that makes you asymptomatic in 95% of cases weeks after application but still a spreader, is asking for trouble.


No vaccine has ever been developed under such conditions. Why suddenly change the rules?

Waterbomber2 wrote:
Did Pfizer really miss their 32 and 62 endpoints and go straight to 92 or were the results inconvenient at the earlier endpoints?


They missed them because they were in discussions with the FDA. By the time they agreed to drop the 32-event endpoint and proceed to 64, they had already passed 64. Believe it or not, Pfizer does not get to do the unblinding. A Data Monitoring Board does it. The folks at Pfizer did not know the results before the DMB met. This is standard practice. So if you're going to have strong opinions, then you should at least know how the process works. All of this information is publicly available.

Waterbomber2 wrote:
A personal anecdote.
I'm convinced that I had Covid-19 in early December 2019.


Were you in Wuhan at the time? If not, then no you did not.
-Doc Lightning-

"The sky calls to us. If we do not destroy ourselves, we will one day venture to the stars."
-Carl Sagan
 
Waterbomber2
Posts: 1445
Joined: Mon Feb 04, 2019 3:44 am

Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 23, 2020 6:48 am

DocLightning wrote:
Waterbomber2 wrote:
IMO the only measure of real effectiveness is to PCR test all test subjects at 7 day intervals so you can also count all asymptomatic individuals.
Because a vaccine that makes you asymptomatic in 95% of cases weeks after application but still a spreader, is asking for trouble.


No vaccine has ever been developed under such conditions. Why suddenly change the rules?


As I see it, there are no rules set in stone.
The framework is determined by the characteristics of the diseases, by the companies pursuing the vaccines.

In other diseases, the infection may be symptomatic in all cases, asymptomatic spread could have been rare and chances of reinfection low.
Covid-19 is proportionally deadly and survivable with lasting disability, highly infectious, has chances of reinfection and spreads asymptomatically.
The studies should hence reflect those characteristics.

As shown in earlier posts, interim or final analysis of the ongoing vaccine studies has so far measured efficacy within 4 weeks on a very small part of the test population, and some of the test population haven't even gotten to their second shot of the vaccine.
4 weeks is a period just double the incubation period. Some test subjects may have been infected from before the trial began.
Did they take a PCR test of the individuals before they started the trial at all?
At the current rate, the placebo group may have unknowingly been infected from before the trial began.
Also, testing within the study population seems to be triggered only by mild symptoms or a combination of symptoms, while symptoms soon after the shots are being ignored. So the vaccines may be effective enough to avoid triggering PCR tests, but not enough to stop lasting light infections.

As we get more data, and the studies get longer, I expect the efficacy and effectiveness within actual populations to be much lower.
However, as shown in the above post and link, these studies have endpoints too short to measure the long-term efficacy of the vaccines, while efficacy may reduce significantly after 3 months or several exposures to the virus.

As a result, the vaccines may be creating a false sense of security for the vaccinated individuals.

Doctors should also pay particular attention to the side effects of the vaccines as they are not mild.
High risk groups may be particularly sensitive to them, with many sensitive enough that taking the vaccine and getting out of sheltering may not be warranted over sheltering and avoiding exposure.



DocLightning wrote:
Waterbomber2 wrote:
Did Pfizer really miss their 32 and 62 endpoints and go straight to 92 or were the results inconvenient at the earlier endpoints?


They missed them because they were in discussions with the FDA. By the time they agreed to drop the 32-event endpoint and proceed to 64, they had already passed 64. Believe it or not, Pfizer does not get to do the unblinding. A Data Monitoring Board does it. The folks at Pfizer did not know the results before the DMB met. This is standard practice. So if you're going to have strong opinions, then you should at least know how the process works. All of this information is publicly available.



As said earlier, it is apparent that the studies didn't start with a PCR test. So they most certainly have started with infected individuals in the test population. So the vaccine may be triggering a response sufficient to subside the symptoms enough that they are avoiding the criteria set to trigger PCR testing, skewing the efficacy.
With the virus confirmed in 1.5% of the US population, and the studies triaging PCR testing based on pre-determined and (by company) different sets of symptoms, we are getting a very poor picture of efficacy. This fits the definition of a rushed process and does not give me confidence at all.


DocLightning wrote:
Waterbomber2 wrote:
A personal anecdote.
I'm convinced that I had Covid-19 in early December 2019.


Were you in Wuhan at the time? If not, then no you did not.


The Italian National Cancer Institute has found Covid-19 antibodies in blood samples from September 2019 collected for a cancer research study.
My symptoms fit with covid-19 and I remember thinking "What the heck was that?" after getting better. Plus my mother's subsequent confirmed lung infection for which she was briefly hospitalised does seem to confirm. My mother underwent a nasal swab around Jan 20th 2020 but the result was never returned, they may not have had the reagents to check it or they may have voluntarily obscured the result.
I remember seeing about 15% of the hospital room doors of the geriatric department taped up with nurses in hazmat suits entering them when I went to see my mother, and the doctor suggesting my mother to sick it out at home due to a high volume of highly infectious lung infections in the hospital. "Staying here may be worse for her".
Something was going on back then for sure.
Less than 2 months later, we were in full lockdown.

ROME (Reuters) - The new coronavirus was circulating in Italy since September 2019, a study by the National Cancer Institute (INT) of the Italian city of Milan shows, signaling that COVID-19 might have spread beyond China earlier than previously thought.

(...)

Italian researchers told Reuters in March that they reported a higher than usual number of cases of severe pneumonia and flu in Lombardy in the last quarter of 2019 in a sign that the new coronavirus might have circulated earlier than previously thought.


https://www.reuters.com/article/health- ... NKBN27V0KH


Regardless of disagreements, I don't know what kind of doctor you are, but if you are coming in contact with (potential) Covid-19 patients, I pray for your staying safe and healthy.
 
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Francoflier
Posts: 5589
Joined: Wed Oct 31, 2001 12:27 pm

Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 23, 2020 2:33 pm

Oxford's vaccine trials results are showing fairly good efficacy, with preliminary figures showing around 70% protection, though it may be more.
It uses a completely different approach to the other two, as this one is a genetically modified common cold virus.

While that may seem a bit lackluster compared to the 90-95% demonstrated in trials by Pfizer and Moderna, this vaccine is cheaper to produce and does not suffer from the restrictive storage conditions required for the latter. This will make it easier to produce in very large quantities and distribute around the World and will likely make it a better solution for developing/warm countries with younger overall populations in my view.

https://www.bbc.com/news/health-55040635
I'll do my own airline. With Blackjack. And hookers. In fact, forget the airline.
 
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DocLightning
Posts: 21966
Joined: Wed Nov 16, 2005 8:51 am

Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 25, 2020 4:12 pm

Waterbomber2 wrote:

As I see it, there are no rules set in stone.
The framework is determined by the characteristics of the diseases, by the companies pursuing the vaccines.

In other diseases, the infection may be symptomatic in all cases, asymptomatic spread could have been rare and chances of reinfection low.
Covid-19 is proportionally deadly and survivable with lasting disability, highly infectious, has chances of reinfection and spreads asymptomatically.
The studies should hence reflect those characteristics.


Well, you got your wish. The Oxford/AZ study did test a portion of participants weekly by PCR and did find a reduction in both symptomatic and asymptomatic positive test rate. I submit that such results would only be useful if mean Ct values are also reported across the groups.

As shown in earlier posts, interim or final analysis of the ongoing vaccine studies has so far measured efficacy within 4 weeks on a very small part of the test population, and some of the test population haven't even gotten to their second shot of the vaccine.


You have misread the study. The analysis does not begin until a given subject is 7 days after the second dose. Data accrual began in the summer and has been ongoing. The primary endpoint was set at a given number of total infections, at which point the data were unblinded by an independent data monitoring board and interpretation was performed.

Did they take a PCR test of the individuals before they started the trial at all?
At the current rate, the placebo group may have unknowingly been infected from before the trial began.
Also, testing within the study population seems to be triggered only by mild symptoms or a combination of symptoms, while symptoms soon after the shots are being ignored. So the vaccines may be effective enough to avoid triggering PCR tests, but not enough to stop lasting light infections.


The clinical trial protocols are available here: https://www.bmj.com/content/371/bmj.m4058. As for your last question, the PCR test is sensitive enough to detect a single virus copy. That is also its weakness; it can be so sensitive that contaminants can set it off.

As we get more data, and the studies get longer, I expect the efficacy and effectiveness within actual populations to be much lower.
However, as shown in the above post and link, these studies have endpoints too short to measure the long-term efficacy of the vaccines, while efficacy may reduce significantly after 3 months or several exposures to the virus.


So far Pfizer/BNT's values went up from their initial estimates, the Russian value (if you can believe them) stayed the same, and we will see what happens with Oxcford/AZ. They seem to have a puzzle on their hands. Theirs is currently the candidate that I'd likely not want to receive. As for efficacy, because this is a rapidly-replicating virus, it is likely more relatedto memory CD-4/8+ T and B cell memory levels than circulating immunoglobulin levels. For the vast majority of viral infections, antibody levels are a predictive measure of protection, but may be negative in persons who have an adequate memory immunity. In those persons, re-exposure to a given viral pathogen will trigger a very rapid rise in memory immune cell replication and antibody and CD-4/8+ T cells. This kind of immunity can last for decades.

Doctors should also pay particular attention to the side effects of the vaccines as they are not mild.
So far no serious side-effects that can't be managed with a strong dose of ibuprofen have been identified. We will continue to monitor.


The Italian National Cancer Institute has found Covid-19 antibodies in blood samples from September 2019 collected for a cancer research study.
My symptoms fit with covid-19 and I remember thinking "What the heck was that?" after getting better. Plus my mother's subsequent confirmed lung infection for which she was briefly hospitalised does seem to confirm. My mother underwent a nasal swab around Jan 20th 2020 but the result was never returned, they may not have had the reagents to check it or they may have voluntarily obscured the result.
I remember seeing about 15% of the hospital room doors of the geriatric department taped up with nurses in hazmat suits entering them when I went to see my mother, and the doctor suggesting my mother to sick it out at home due to a high volume of highly infectious lung infections in the hospital. "Staying here may be worse for her".
Something was going on back then for sure.
Less than 2 months later, we were in full lockdown.

ROME (Reuters) - The new coronavirus was circulating in Italy since September 2019, a study by the National Cancer Institute (INT) of the Italian city of Milan shows, signaling that COVID-19 might have spread beyond China earlier than previously thought.

(...)

Italian researchers told Reuters in March that they reported a higher than usual number of cases of severe pneumonia and flu in Lombardy in the last quarter of 2019 in a sign that the new coronavirus might have circulated earlier than previously thought.


Last year was a terrible Flu year. If you were in Italy, then there is a minuscule chance you had symptoms in very late December when it was first detected. Otherwise, you did not. The virus did not emerge out of China until that time.

I am staying safe, and I will b evaccinated
-Doc Lightning-

"The sky calls to us. If we do not destroy ourselves, we will one day venture to the stars."
-Carl Sagan
 
bgm
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 25, 2020 4:42 pm

DocLightning wrote:
I am staying safe, and I will be vaccinated


Me, too.

I've been vaccinated my entire life without anything other than very mild side effects (I once had 4 vaccines at once so felt a bit yucky for the rest of the day but nothing serious).

Even with some mild side effects, surely that is better than catching Covid? I will be first in line to take the vaccine when it's available to me. If it allows us to return to any semblance of normality, I'm 110% for it.
 
stratosphere
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 25, 2020 5:28 pm

bgm wrote:
DocLightning wrote:
I am staying safe, and I will be vaccinated


Me, too.

I've been vaccinated my entire life without anything other than very mild side effects (I once had 4 vaccines at once so felt a bit yucky for the rest of the day but nothing serious).

Even with some mild side effects, surely that is better than catching Covid? I will be first in line to take the vaccine when it's available to me. If it allows us to return to any semblance of normality, I'm 110% for it.


Ditto I am high risk and tired of living as a prisoner of my house. I have always tolerated vaccines well and while I would like to see longer term trials I think at least it's worth the risk.
 
santi319
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 25, 2020 7:59 pm

I am someone with several family members hospitalized with covid. My friends family in a completely different country also hospitalized. The literal idiots that think covid is fake and the vaccine is a control method etc, definetly need a brain scan. Its real and when its in your doorstep its the most devastating thing ever. I will be the first one to get a vaccine asap and the ones that dont want to get a vaccine need to stay away from me and my family as far as possible.
 
ThePointblank
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Re: Updated: A COVID-19 vaccine candidate works!

Thu Nov 26, 2020 8:13 pm

AstraZeneca is likely going to run an additional global test of their vaccine after some anomalies were noticed in their testing data:

https://www.bloomberg.com/amp/news/arti ... ssion=true

AstraZeneca Plc is likely to conduct an additional global trial to assess the efficacy of its Covid-19 vaccine, according to the company’s chief executive officer, after current studies raised questions over its level of protection.

The new trial would be run instead of adding an arm to an ongoing U.S. trial and would evaluate a lower dosage that performed better than a full amount in Astra’s studies. The company’s acknowledgment that the lower level was given in error fueled concerns, and the new trial would be used to confirm whether or not the higher 90% efficacy rate stands.


This after a manufacturing error was also discovered that is also causing concern about the efficacy of their vaccine:

https://abc30.com/amp/astrazeneca-vacci ... ssion=true

LONDON -- AstraZeneca and Oxford University on Wednesday acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine.

A statement describing the error came days after the company and the university described the shots as "highly effective" and made no mention of why some study participants didn't receive as much vaccine in the first of two shots as expected.
 
Waterbomber2
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Re: Updated: A COVID-19 vaccine candidate works!

Fri Nov 27, 2020 4:01 am

Astra Zeneca has been very transparent about their issues in the development process.
These are the types of issues that one should expect to see in a vaccine trial done on a global scale and at a short notice.
This transparency gives me more trust in the Astra Zeneca vaccine than the other two leading ones.

My family and I will be in the wait and see camp for vaccination.
We're not going to take a vaccine that may only be effective for 1 or 2 months and whose mid-to longterm side effects are not known. If other don't mind being guinea pigs, we don't have a problem with that.

I also want to see Fauci put his seal of approval on the vaccines. That could boost confidence.
So far, he is optimistic about a vaccine becoming available soon, but is refraining from commenting on individual vaccines.

https://www.cbsnews.com/news/anthony-fa ... 020-11-22/

I think that by mid-2021, we will know more about real life short to mid-term effectiveness of vaccines and their safety. I predict that real-life effectiveness after 2 months will be about 40% as vaccinated individuals will come out more and get more exposed than those who keep sheltering.
 
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Francoflier
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Re: Updated: A COVID-19 vaccine candidate works!

Fri Nov 27, 2020 4:05 am

ThePointblank wrote:
AstraZeneca is likely going to run an additional global test of their vaccine after some anomalies were noticed in their testing data:

https://www.bloomberg.com/amp/news/arti ... ssion=true

AstraZeneca Plc is likely to conduct an additional global trial to assess the efficacy of its Covid-19 vaccine, according to the company’s chief executive officer, after current studies raised questions over its level of protection.

The new trial would be run instead of adding an arm to an ongoing U.S. trial and would evaluate a lower dosage that performed better than a full amount in Astra’s studies. The company’s acknowledgment that the lower level was given in error fueled concerns, and the new trial would be used to confirm whether or not the higher 90% efficacy rate stands.


This after a manufacturing error was also discovered that is also causing concern about the efficacy of their vaccine:

https://abc30.com/amp/astrazeneca-vacci ... ssion=true

LONDON -- AstraZeneca and Oxford University on Wednesday acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine.

A statement describing the error came days after the company and the university described the shots as "highly effective" and made no mention of why some study participants didn't receive as much vaccine in the first of two shots as expected.


What's interesting about that is that those who received the lower initial dose seemed to have been better protected.

https://www.bbc.com/news/health-55086927

Even in the worst case, they still meet the threshold for effectiveness for FDA approval, so hopefully they can still work towards approval while they fine tune their testing and dosage and get more accurate results.
I'll do my own airline. With Blackjack. And hookers. In fact, forget the airline.
 
StarAC17
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Re: Updated: A COVID-19 vaccine candidate works!

Fri Nov 27, 2020 4:41 pm

I also want to see Fauci put his seal of approval on the vaccines. That could boost confidence.
So far, he is optimistic about a vaccine becoming available soon, but is refraining from commenting on individual vaccines.


He says he would take the Pfizer one upon the FDA approving it which an EUA is probably weeks away in the states.

https://www.forbes.com/sites/carlieport ... 0382201a7f
Engineers Rule The World!!!!!
 
WIederling
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Re: Updated: A COVID-19 vaccine candidate works!

Fri Nov 27, 2020 5:42 pm

Braybuddy wrote:
I love the way the Russian Sputnik V vacciine was rolled out ahead of all the others, but nothing was said about its efficacy. Now that that the Pfizer vaccine has been claimed to be 90 per cent effective, the Russians suddenly come out with figures:

https://www.themoscowtimes.com/2020/11/ ... ata-a72012
:lol: :roll:


IMU it was "rolled out" like all the other vaccines that got the nod for public testing.
50:50 distribution of vaccine and placebo: 20 infections in a group of 16k ( or 8k not clear )
infections in the placebo group must be around 480 for "96% effective"?

i.e. some targeted misrepresentation in news propagation.

with 96% effective for the limited group of volunteers it sits near the top of offers around, doesn't it?

the other vaccines that presented numbers did this earlier at <100 infected over both groups.
Obviously an information of lesser preciseness.
Murphy is an optimist
 
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casinterest
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Re: Updated: A COVID-19 vaccine candidate works!

Fri Nov 27, 2020 9:43 pm

https://www.cnn.com/world/live-news/cor ... 89f5617c32

Advisers to the Centers for Disease Control and Prevention will vote Tuesday on the very first people to get a coronavirus vaccine once one gets emergency authorization.

The CDC’s Advisory Committee for Immunization Practices has scheduled an emergency meeting for Tuesday to discuss allocation of Covid-19 vaccines, according to a document obtained by CNN.

Members of the committee will discuss who should be in the first group, and clinical considerations for the group. Draft recommendations have suggested that health care workers should be in the 1a vaccine allocation group. Other possible members of the group: people most likely to catch, spread and develop severe disease from the virus such as nursing home residents.




The virus approvals must be on Track in the US.
Where ever you go, there you are.
 
dobilan
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Re: Updated: A COVID-19 vaccine candidate works!

Sat Nov 28, 2020 6:29 am

1. Normally I would like to see the States endorse and enforce the rigurous testing for these vaccines and not simply let the companies use their own procedures. AstraZeneca already counted a (pretty major) blunder regarding the testing. Bad dosage is an elementar and grave mistake. Things like Dieselgate and Boeing 737 Max are a bad precedent and people deserve explanations.
2. I don't understand the heated debate between pro-mandatory-vaxxers and antivaxxers at this moment. They are fighting over a vaccine that for the time being is not available for the general population anyway. I'm understanding that the vaccines will be freely available for the general population at the end of next summer and priority will be given first to essential workers (medical, army, police) and vulnerable categories (elderly, etc). Until end of summer we'll have plenty of time to gather additional data regarding the use of these vaccines and the virus itself.
 
Waterbomber2
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Re: Updated: A COVID-19 vaccine candidate works!

Sat Nov 28, 2020 10:44 pm

dobilan wrote:
1. Normally I would like to see the States endorse and enforce the rigurous testing for these vaccines and not simply let the companies use their own procedures. AstraZeneca already counted a (pretty major) blunder regarding the testing. Bad dosage is an elementar and grave mistake. Things like Dieselgate and Boeing 737 Max are a bad precedent and people deserve explanations.
2. I don't understand the heated debate between pro-mandatory-vaxxers and antivaxxers at this moment. They are fighting over a vaccine that for the time being is not available for the general population anyway. I'm understanding that the vaccines will be freely available for the general population at the end of next summer and priority will be given first to essential workers (medical, army, police) and vulnerable categories (elderly, etc). Until end of summer we'll have plenty of time to gather additional data regarding the use of these vaccines and the virus itself.


Agreed.
By the end of the summer of 2021 we should have a pretty good idea of whether these vaccines are working, how well they are working and how safe they are.

I will be in the wait and see camp, applaud the blissful people who have the gift of trusting anything and anyone, and probably go for a shot in the fall of 2021 if all pans out.
 
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Braybuddy
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 29, 2020 8:19 am

WIederling wrote:
Braybuddy wrote:
with 96% effective for the limited group of volunteers it sits near the top of offers around, doesn't it?

That's if you can believe anything coming out of Russia. Initially, there were no claims about the Sputnik V's efficacy. When Pfizer announced a rate of 90%, they suddenly claimed that Sputnik V's rate was 92%. When Pfizer revised their figures up to 95% and Moderna announced the same, the Russian figure suddenly went up to 95%. :scratchchin: :roll:
 
WIederling
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 29, 2020 10:30 am

Braybuddy wrote:
WIederling wrote:
Braybuddy wrote:
with 96% effective for the limited group of volunteers it sits near the top of offers around, doesn't it?

That's if you can believe anything coming out of Russia. Initially, there were no claims about the Sputnik V's efficacy. When Pfizer announced a rate of 90%, they suddenly claimed that Sputnik V's rate was 92%. When Pfizer revised their figures up to 95% and Moderna announced the same, the Russian figure suddenly went up to 95%. :scratchchin: :roll:


common feature: all test runs are revising their data during the tests progression
( unsurprising given how effectivity numbers are computed on the run).
your allegation of data manipulations fits all or none.

( you are assuming something and work from there. That probably is the wrong methodology.)
Murphy is an optimist
 
art
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 29, 2020 11:27 am

i am very disappointed that Astra Zeneca should make a mistake in their trial - not giving the specified first dose of vaccine to trial participants. Sure, serendipity kicked in (higher immunity found in participants incorrectly dosed), but it brings into question Astra Zeneca's competence to trial drugs/vaccines.

I was hoping to receive their vaccine soon. I will not be surprised if their failure to conduct tests accurately results in a significant delay in their vaccine being licensed for use in the UK. Or have I got this wrong?
 
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Braybuddy
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 29, 2020 4:22 pm

WIederling wrote:
common feature: all test runs are revising their data during the tests progression
( unsurprising given how effectivity numbers are computed on the run).
your allegation of data manipulations fits all or none.

( you are assuming something and work from there. That probably is the wrong methodology.)


I'm not the only one:
https://www.sciencemag.org/news/2020/11 ... ritics-say

https://www.sciencenews.org/article/cor ... ccine-test
 
frmrCapCadet
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 29, 2020 5:17 pm

https://southseattleemerald.com/2020/11 ... -covid-19/

A very provisional article quoting some research. The MMR vaccine in the studies seems to be involved with a much lower death rate from COVID-19. The writers hastens to add that this is not actionable information, just some intriguing correlations.
Buffet: the airline business...has eaten up capital...like..no other (business)
 
WIederling
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 29, 2020 5:45 pm

Braybuddy wrote:
WIederling wrote:
common feature: all test runs are revising their data during the tests progression
( unsurprising given how effectivity numbers are computed on the run).
your allegation of data manipulations fits all or none.

( you are assuming something and work from there. That probably is the wrong methodology.)


I'm not the only one:
https://www.sciencemag.org/news/2020/11 ... ritics-say

This is from Nov 11. i.e. reasonably current.

This article assumes that 20 infections overall occured. i.e. ( 1 - ( 1 / 19.) ) * 100 = 94.74%
Not sure that is the proper interpretation of the original data.
that text seemed to say that they had 20 infections in the innoculated group.
going to look into this.
( they seem to have started earlier. expectations are that they had much more infections in the reference group.)

this is from Aug. 11

Yet it also noted the review covered just 20 total COVID-19 cases

no further infections from Aug.11 to Nov.11 ?
you've got a story there!

Whatever quality Russian media releases may have.
these articles seem to carefully aim below that level. :-)
Murphy is an optimist
 
T4thH
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 29, 2020 6:03 pm

art wrote:
i am very disappointed that Astra Zeneca should make a mistake in their trial - not giving the specified first dose of vaccine to trial participants. Sure, serendipity kicked in (higher immunity found in participants incorrectly dosed), but it brings into question Astra Zeneca's competence to trial drugs/vaccines.

I was hoping to receive their vaccine soon. I will not be surprised if their failure to conduct tests accurately results in a significant delay in their vaccine being licensed for use in the UK. Or have I got this wrong?


Astra Zeneca has really messed up the clinical trial. And it is inappropriate to calculate the results of both parts together, this is not science. Regarding as the first and these were the "young" patients, have received the incorrect dosing, the whole efficacy and part of the safety data are now for the bin/low value.
Do it again with an additional clinical trial or an amendment to the running.

Also it seems, the efficacy results are...in comparison to Pfizer/Biontec and Modena...with 60 % in the correct dosed arm really bad to the overall around 95% for the other two.
OK, 60 %, if this number is really reliable is still more than the expected minimum requested 50% of the WHO.
And do they have finally prepared for COVID. Not that the special cooling containers were sent one way to UK, as they are not able to perform the recommended sterilization, as nor accordingly certified, to send them back into the EU.

By luck the EU has ordered already 300 million and 300 million + 100 million option from the Pfizer/Biontec and Modena vaccines, so this shall be OK.
I am not any more following up regarding IK, as on the way of the backside of the moon, landing on 01-Jan-2021. Do they have already made some contracts with other companies?

And do they have finally prepared for the 01-Jan-2021? Not that the rare special cooling containers go one way from Europe to the island and will never come back, as they have no certified companies for sterilization to send them back to the EU?
 
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Braybuddy
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 29, 2020 9:50 pm

WIederling wrote:
Whatever quality Russian media releases may have.
these articles seem to carefully aim below that level. :-)

I think I'd take the opinion of two respected science organisations above anything coming out of Russia. Their coronavirus figures are highly suspect too.
 
M564038
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 29, 2020 10:50 pm

Although official Russia is completely and utterly unreliable, and initial information was presented as a propaganda attempt, information through medical and science circles does indeed suggest that all conventional procedures has been completed, that Sputnik is a very conventional vaccine, made with the dame traditional vaccine methods as the oxford vaccine, that it works, that it is safe and probably will be perfectly acceptable as one of the now 4 options for maximum vaccine proliferation in the comming months.

Braybuddy wrote:
WIederling wrote:
Whatever quality Russian media releases may have.
these articles seem to carefully aim below that level. :-)

I think I'd take the opinion of two respected science organisations above anything coming out of Russia. Their coronavirus figures are highly suspect too.
 
airtechy
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 29, 2020 11:23 pm

Well, for a lot of us who are retired and like to travel .. especially international .. this last year has been almost a total loss. If you are in good health and in your late 70's waiting around a year to see if the vaccine will be 100 percent safe and not kill you is really not a good option. Especially since I suspect that many countries are going to require a vaccination to enter .. and maybe airlines to fly. I'll gladly take my chances. Maybe if I was 20 I would have a different plan. ;)
 
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DocLightning
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 5:14 am

art wrote:
i am very disappointed that Astra Zeneca should make a mistake in their trial - not giving the specified first dose of vaccine to trial participants. Sure, serendipity kicked in (higher immunity found in participants incorrectly dosed), but it brings into question Astra Zeneca's competence to trial drugs/vaccines.

I was hoping to receive their vaccine soon. I will not be surprised if their failure to conduct tests accurately results in a significant delay in their vaccine being licensed for use in the UK. Or have I got this wrong?


While I am also disappointed, let's look at what DIDN'T happen. They DIDN'T try to bury their findings. They DIDN'T try to deflect blame. They DIDN'T massage the numbers. They came out and were transparent.

In 2018, a Sanofi candidate vaccine for Clostridioides difficile flopped in Phase III clinical trials after showing excellent immunogenicity in Phases I/II. You probably never heard about it because it wasn't a major news item or public discussion. These things happen. Fortunately, we have at least two excellent candidates and I am confident that a few of the others will work.
-Doc Lightning-

"The sky calls to us. If we do not destroy ourselves, we will one day venture to the stars."
-Carl Sagan
 
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Braybuddy
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 7:49 am

M564038 wrote:
Although official Russia is completely and utterly unreliable, and initial information was presented as a propaganda attempt, information through medical and science circles does indeed suggest that all conventional procedures has been completed, that Sputnik is a very conventional vaccine, made with the dame traditional vaccine methods as the oxford vaccine, that it works, that it is safe and probably will be perfectly acceptable as one of the now 4 options for maximum vaccine proliferation in the comming months.

I doubt anyone denies the Russians have developed a vaccine that works, but there are questions over their methodology and duplication of data, and its accuracy:

https://www.biocentury.com/article/6301 ... o-question

https://www.nature.com/articles/d41586-020-02619-4

https://www.euractiv.com/section/corona ... cine-data/
 
WIederling
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 8:35 am

Braybuddy wrote:
M564038 wrote:
Although official Russia is completely and utterly unreliable, and initial information was presented as a propaganda attempt, information through medical and science circles does indeed suggest that all conventional procedures has been completed, that Sputnik is a very conventional vaccine, made with the dame traditional vaccine methods as the oxford vaccine, that it works, that it is safe and probably will be perfectly acceptable as one of the now 4 options for maximum vaccine proliferation in the coming months.

I doubt anyone denies the Russians have developed a vaccine that works, but there are questions over their methodology and duplication of data, and its accuracy:

https://www.biocentury.com/article/6301 ... o-question

https://www.nature.com/articles/d41586-020-02619-4

https://www.euractiv.com/section/corona ... cine-data/


published mid September referencing mid August (early) activities.
There should be quite a bit more information available now. (thumbs up or down, whatever )

I do have hold backs vs. these "open letter scientists".
There were so many similar campaigns published in recent years that all
seemed to have been orchestrated by some "leaders from behind".
i.e. monetary compensation driven synthetic opinion spouting.

I do note the balanced reaction from "the Lancet".
Murphy is an optimist
 
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Braybuddy
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 8:53 am

WIederling wrote:
published mid September referencing mid August (early) activities.
There should be quite a bit more information available now. (thumbs up or down, whatever )

I do have hold backs vs. these "open letter scientists".
There were so many similar campaigns published in recent years that all
seemed to have been orchestrated by some "leaders from behind".
i.e. monetary compensation driven synthetic opinion spouting.

I do note the balanced reaction from "the Lancet".

St Petersburg awake at last . . . :roll:
 
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flyingclrs727
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Re: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 8:55 am

DocLightning wrote:
The good news is that the list of people who cannot take the vaccine is pretty short. That would be: 1) Children (any approval will be for adults 18+ and then at some point later children 12+) 2) Anyone with allergies to the vaccine's components. The major components of the vaccine are RNA, and you can't be allergic to RNA, and lipids, and you can't be allergic to lipids. However, without a complete list of the other ingredients, there might be an odd ingredient to which a small number of people are allergic.

The vaccine will be safe for people with immunocompromising conditions (although it may not work as well). It also probably won't be approved for pregnant women, mostly out of an abundance of caution and not because this kind of vaccine would propose any specific risk to pregnant women or their pregnancy.


I am in the Moderna trial. I was told that not only do they not want women to get pregnant within the period between the first dose and one month after the second dose. They told me to use a condom plus spermicide with my wife till at least a month after the second injection. They said they are concerned that the fetus could be exposed to the mRNA.

Currently my wife and I have an 8 and a half month old son and are not interested in getting pregnant again within the next few months, but I definitely don't want her to get pregnant before she has an opportunity to get vaccinated. Considering pregnant women are likely to be more at risk from COVID-19 than women who are not, would the Oxford/Astrazenica vaccine be the vaccine likely to be recommended for pregnant women?
 
WIederling
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 9:44 am

Braybuddy wrote:
WIederling wrote:
I do note the balanced reaction from "the Lancet".

St Petersburg awake at last . . . :roll:


brilliant reply, really. Feel better now?
Murphy is an optimist
 
art
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 9:44 am

DocLightning wrote:
art wrote:
i am very disappointed that Astra Zeneca should make a mistake in their trial - not giving the specified first dose of vaccine to trial participants. Sure, serendipity kicked in (higher immunity found in participants incorrectly dosed), but it brings into question Astra Zeneca's competence to trial drugs/vaccines.

I was hoping to receive their vaccine soon. I will not be surprised if their failure to conduct tests accurately results in a significant delay in their vaccine being licensed for use in the UK. Or have I got this wrong?


While I am also disappointed, let's look at what DIDN'T happen. They DIDN'T try to bury their findings. They DIDN'T try to deflect blame. They DIDN'T massage the numbers. They came out and were transparent.


I don't have any idea as to the inner workings of the vaccine authorisation process. From memory, the lower initial dose was given to about 3.000 study subjects. Those subjects were all under 55 years old They manifested higher immunity. Would the vaccine be authorised for use using the lower initial dose or would it be necessary to gather test data on thousands more recipients first? Also, would it make sense to give millions of people jabs in doses that data showed to provide around 60% immunity if data (albeit a small amount) suggested that different dosing would provide about 90% immunity?
 
WIederling
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 10:05 am

art wrote:
Also, would it make sense to give millions of people jabs in doses that data showed to provide around 60% immunity if data (albeit a small amount) suggested that different dosing would provide about 90% immunity?


IS it a repeat jab or another jab with a different vaccine?
( imu depending on the product you get two different jabs .)
Murphy is an optimist
 
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Braybuddy
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 10:11 am

WIederling wrote:
Braybuddy wrote:
WIederling wrote:
I do note the balanced reaction from "the Lancet".

St Petersburg awake at last . . . :roll:


brilliant reply, really. Feel better now?

Only 95%, but I'll await verification before confirming . . . :D
 
art
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 12:20 pm

WIederling wrote:
art wrote:
Also, would it make sense to give millions of people jabs in doses that data showed to provide around 60% immunity if data (albeit a small amount) suggested that different dosing would provide about 90% immunity?


IS it a repeat jab or another jab with a different vaccine?
( imu depending on the product you get two different jabs .)


No idea if it is a smaller dose of the same vaccine but I have not heard/read anything to suggest otherwise.
 
WIederling
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 6:52 pm

art wrote:
WIederling wrote:
art wrote:
Also, would it make sense to give millions of people jabs in doses that data showed to provide around 60% immunity if data (albeit a small amount) suggested that different dosing would provide about 90% immunity?


IS it a repeat jab or another jab with a different vaccine?
( imu depending on the product you get two different jabs .)


No idea if it is a smaller dose of the same vaccine but I have not heard/read anything to suggest otherwise.


The links from Braybuddy suggest that some of the vaccine candidates are double jab for two distinct RNA sequences that
create a path to antibody answers.
Murphy is an optimist
 
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DocLightning
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Re: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 8:31 pm

flyingclrs727 wrote:
They said they are concerned that the fetus could be exposed to the mRNA.


I'd say that's an unrealistic and yet appropriately conservative concern. It would require the lipid nanoparticles to somehow make their way all the way from the deltoid muscle down to the placenta and then to be transported across the placenta. That is not a realistic possibility.

That said, one does not blithely test medicines on pregnant women with alacrity. Because vaccines necessarily stimulate the immune system, they do induce a temporary stress on the body. We would want to make very sure that there are no significant safety concerns in healthy, non-pregnant people before getting to pregnant women. I will point out that the MMR and varicella vaccines are still not approved in pregnant women, even though there have been many documented incidents in which pregnant women have accidentally received these vaccines without any harm to the fetus.

WIederling wrote:

The links from Braybuddy suggest that some of the vaccine candidates are double jab for two distinct RNA sequences that
create a path to antibody answers.


Not any of the vaccines with which I am familiar. A booster immunization needs to expose you to the same antigen as the prime. However, the Sputnik V candidate uses the same DNA sequence coded into two different adenovirus vectors to get around the problem of anti-vector immunity.

art wrote:
I don't have any idea as to the inner workings of the vaccine authorisation process. From memory, the lower initial dose was given to about 3.000 study subjects. Those subjects were all under 55 years old They manifested higher immunity. Would the vaccine be authorised for use using the lower initial dose or would it be necessary to gather test data on thousands more recipients first? Also, would it make sense to give millions of people jabs in doses that data showed to provide around 60% immunity if data (albeit a small amount) suggested that different dosing would provide about 90% immunity?


Their product is inferior to the two leading candidates. I would not recommend approval at this time. They need to go and have a good look into what went wrong and if there might be a different approach that works better. Perhaps they need to use two different vectors like the Russians did, ChAdOx1 and then ChAdOx2. The problem with such an approach is that it complicates the supply chain and workflow. For the Moderna and Pfizer products, the exact same product can be used for the prime and the boost. There is one NDC and to vaccinate 100 people you need 200 doses. But for Sputnik V or any other differential prime-boost strategy, you now need to use two different products with different NDCs and I can just forsee administration errors as a result.
-Doc Lightning-

"The sky calls to us. If we do not destroy ourselves, we will one day venture to the stars."
-Carl Sagan
 
LCDFlight
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 9:31 pm

T4thH wrote:
art wrote:
i am very disappointed that Astra Zeneca should make a mistake in their trial - not giving the specified first dose of vaccine to trial participants. Sure, serendipity kicked in (higher immunity found in participants incorrectly dosed), but it brings into question Astra Zeneca's competence to trial drugs/vaccines.

I was hoping to receive their vaccine soon. I will not be surprised if their failure to conduct tests accurately results in a significant delay in their vaccine being licensed for use in the UK. Or have I got this wrong?


Astra Zeneca has really messed up the clinical trial. And it is inappropriate to calculate the results of both parts together, this is not science. Regarding as the first and these were the "young" patients, have received the incorrect dosing, the whole efficacy and part of the safety data are now for the bin/low value.
Do it again with an additional clinical trial or an amendment to the running.

Also it seems, the efficacy results are...in comparison to Pfizer/Biontec and Modena...with 60 % in the correct dosed arm really bad to the overall around 95% for the other two.
OK, 60 %, if this number is really reliable is still more than the expected minimum requested 50% of the WHO.
And do they have finally prepared for COVID. Not that the special cooling containers were sent one way to UK, as they are not able to perform the recommended sterilization, as nor accordingly certified, to send them back into the EU.

By luck the EU has ordered already 300 million and 300 million + 100 million option from the Pfizer/Biontec and Modena vaccines, so this shall be OK.
I am not any more following up regarding IK, as on the way of the backside of the moon, landing on 01-Jan-2021. Do they have already made some contracts with other companies?

And do they have finally prepared for the 01-Jan-2021? Not that the rare special cooling containers go one way from Europe to the island and will never come back, as they have no certified companies for sterilization to send them back to the EU?


Depending on exactly what happened, they absolutely can calculate results without notable difficulty. Think of it as the Hubble telescope after its corrective lens was applied. Does the mirror defect mean that all the science from the Hubble after the correction was applied should not be used? No, it's not even a problem now. Nevertheless, the fact that a problem occurred needs investigation and correction.
 
art
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Re: A COVID-19 vaccine candidate works!

Mon Nov 30, 2020 11:24 pm

DocLightning wrote:
[
art wrote:
I don't have any idea as to the inner workings of the vaccine authorisation process. From memory, the lower initial dose was given to about 3.000 study subjects. Those subjects were all under 55 years old They manifested higher immunity. Would the vaccine be authorised for use using the lower initial dose or would it be necessary to gather test data on thousands more recipients first? Also, would it make sense to give millions of people jabs in doses that data showed to provide around 60% immunity if data (albeit a small amount) suggested that different dosing would provide about 90% immunity?


Their product is inferior to the two leading candidates. I would not recommend approval at this time. They need to go and have a good look into what went wrong and if there might be a different approach that works better. Perhaps they need to use two different vectors like the Russians did, ChAdOx1 and then ChAdOx2. The problem with such an approach is that it complicates the supply chain and workflow. For the Moderna and Pfizer products, the exact same product can be used for the prime and the boost. There is one NDC and to vaccinate 100 people you need 200 doses. But for Sputnik V or any other differential prime-boost strategy, you now need to use two different products with different NDCs and I can just forsee administration errors as a result.


Inferior in protective performance? Yes - 90% immunity demonstrated against around 95% demonstrated by Pfizer and Moderna.

Superior in cost terms to the end user? I think so - Astra Zeneca say they wiould sell their vaccine on a non-profit basis. The projected price is about $3 per shot. They plan to produce 3 billion doses at this price in 2021.

Source: https://www.firstpost.com/tech/science/ ... 46111.html
 
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DocLightning
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Re: A COVID-19 vaccine candidate works!

Tue Dec 01, 2020 4:09 am

art wrote:
Inferior in protective performance? Yes - 90% immunity demonstrated against around 95% demonstrated by Pfizer and Moderna.


That 90% number is a bit problematic given that it occurred in a small subset of patients under age 55 given a mistakenly small prime dose.
-Doc Lightning-

"The sky calls to us. If we do not destroy ourselves, we will one day venture to the stars."
-Carl Sagan
 
art
Posts: 3768
Joined: Tue Feb 08, 2005 11:46 am

Re: A COVID-19 vaccine candidate works!

Tue Dec 01, 2020 7:46 am

DocLightning wrote:
art wrote:
Inferior in protective performance? Yes - 90% immunity demonstrated against around 95% demonstrated by Pfizer and Moderna.


That 90% number is a bit problematic given that it occurred in a small subset of patients under age 55 given a mistakenly small prime dose.


Agreed, But if the test with the same small prime dose ts repeated in a larger number of candidates similar results (about 90% immunity) can be expected.

My main concern is that a refusal to license emergency use of the Astra Zeneca vaccine using the same small prime dose protocol will delay millions of people being vaccinated in a manner giving a high degree of protection. Is there any chance of it being approved for use in people under the age of 55 at this point?
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