Swerd

Swerd

Audioholic Warlord
@TLS Guy – Thanks for the summaries.

A long-held adage concerning large-scale Phase 3 clinical trials is that you should try your best to nail down the dosage & schedule before starting that trial. Otherwise it can cause confusion and delay. That's what has happened with the SARS-CoV-2 vaccines. During the earlier smaller clinical trials, there was not time enough to realize we needed to answer such questions about vaccine doses or one vs. two injections. If that's the only price we pay for the extremely rapid clinical development of these vaccines, we will be very lucky.

It's also very lucky that the corona virus Spike protein has been so potent at stimulating an immune response.

Of course, the harder you work, the luckier you become. High praise goes to the Jenner Institute at Oxford University in the UK, as well as the National Institute of Allergies and Infectious Diseases (NIAID) in the USA. Their decades-long efforts to develop new scientific discoveries, leading to new technologies, made possible the rapid development of these effective vaccines. The NIAID's efforts go back to the mid 1990s when a Vaccine Development Lab was created (at the direction of Anthony Faucci) to perform research on new ways to create vaccines. Their direct work, as well as the research they sponsored in other labs around the country, led to the formation of both Moderna and BioNTech as new start up R&D companies. The senior scientists behind these companies started their careers because of the NIAID research grant support 20-30 years ago.

This kind of R&D took many years before we could see any pay-off. That's how scientific progress happens. Short-sighted politicians take note!
 
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TLS Guy

TLS Guy

Seriously, I have no life.
@TLS Guy – Thanks for the summaries.

A long-held adage concerning large-scale Phase 3 clinical trials is that you should try your best to nail down the dosage & schedule before starting that trial. Otherwise it can cause confusion and delay. That's what has happened with the SARS-CoV-2 vaccines. During the earlier smaller clinical trials, there was not time enough to realize we needed to answer such questions about vaccine doses or one vs. two injections. If that's the only price we pay for the extremely rapid clinical development of these vaccines, we will be very lucky.

It's also very lucky that the corona virus Spike protein has been so potent at stimulating an immune response.

Of course, the harder you work, the luckier you become. High praise goes to the Jenner Institute at Oxford University in the UK, as well as the National Institute of Allergies and Infectious Diseases (NIAID) in the USA. Their decades-long efforts to develop new scientific discoveries, leading to new technologies, made possible the rapid development of these effective vaccines. The NIAID's efforts go back to the mid 1990s when a Vaccine Development Lab was created (at the direction of Anthony Faucci) to perform research on new ways to create vaccines. Their direct work, as well as the research they sponsored in other labs around the country, led to the formation of both Moderna and BioNTech as new start up R&D companies. The senior scientists behind these companies started their careers because of the NIAID research grant support 20-30 years ago.

This kind of R&D took many years before we could see any pay-off. That's how scientific progress happens. Short-sighted politicians take note!
Thank you for your kind words. I hope I did manage to condense a lot of data succinctly and pull out the chestnuts.

You are correct, without a lot of work over years from scientists in the US and UK mainly, we would not be where we are now with these vaccines. This really can not be over emphasized to our rulers, who like the captains of industry are focused on short term goals, and not the long haul.

This pandemic should be a wake up call in so many ways.

This means reducing the way we share air, as Mike Osterholm puts it. That means as job one every building needs Energy Recovery Ventilation. That means installing ERV units in ALL buildings, not just new ones. It is code here and I have one. I have it set to exchange all the air in the house every hour. I can go to 130%. The units heat incoming air with the exhausting air in the winter and reverse it in summer. My unit is 85% efficient. The ultra quiet air handler fan never shuts off. You never hear it. Also maintaining around 40% humidity year round helps. I have it 38% in the winter and 42% in the summer. The Aprilaire units, humidifier for the winter and dehumidifier for the summer keep those parameters rock steady. Dehumidifiers really help off load the AC systems and make them more efficient.

The other thing we need is skilled virus hunters stationed around the world for an early warning systems. We have a new strange evolving illness in India right now, but no International teams to do rapid analysis. The cause has not been nailed down after several days. They are not all in one town but a region around Andhra Pradesh.
546 people have been ill enough to be hospitalized and one has died. It affects people of all ages, including children. This is the sort of thing WHO needs to be nimble enough to be all over. All countries must allow access or pay severe consequences. We also need to lock down areas like that hard until the cause is found.

We need to continue research on Vaccines and certify them mainly by the technology they use. We do this with flu vaccines every year. We do not trial each new yearly batch. If we did, the way influenza undergoes antigenic mutation, they would be useless.

If we do not do this we will be going though this all over again.

Remember just because it is 102 years since the last pandemic it does not mean it will be 100 years until the next one. The chance of a new pandemic is the same one year to the next, and actually the risk is more likely than not on the increase. Changes need to be made and promptly. We can not let this happen again.

Before closing there have been two severe allergic reactions to the Pfizer vaccine in two NHS staff in the UK. Both had to be given adrenalin. So this sounds like an anaphylactic reaction. Both subjects have a known propensity for this, and both routinely carry adrenalin. There is a lesson here, as an allergic history was an exclusion criterion for entering the Pfizer study. So be careful not to have your exclusions too broad. This should have been known before release in my view. So the UK have made a history of severe allergies an exclusion to receiving the vaccine. So what other shoes will drop?
 
D

Dude#1279435

Audioholic Spartan
Msnbc are reporting Pfizer gave the US the *option* to buy a second distribution of vaccine that would have totaled up to 500 million doses. They declined.
 
Swerd

Swerd

Audioholic Warlord
Maybe if you ask nicely...
Said politely, like a true Canadian.

Speaking of Canada, yesterday Canada became the 3rd nation to approve use of the Pfizer vaccine. Previously the UK and Bahrain had approved it. I hope the USA soon becomes the 4th nation to do so.
 
M

Mr._Clark

Audioholic Samurai
It looks like India is preparing to really gear up production of vaccines. Hopefully these other vaccines also prove to be effective.

 
D

Dude#1279435

Audioholic Spartan
Wally: Golly gee, Beaver! That's a $1000 gift card to Amazon!!!

[The Beav gives Uncle Donny a great big bear hug.]
[nostalgic 50s audience track: awwwww]

Ward: June, it was a good thing Donny brought you flowers. I'd forgot on my way home from work.

[audience: hahahaha]

June: Yanno Ward, if I'd had a daughter I'd want her to marry someone just like Uncle Donny.

Ward: He's such a swell guy, a patriot, and a true American. Why anyone would want to criticize him --- w-w-w-well they must have TDS (Trump Derangement Syndrome)!

[Family laughs]
[audience: hahahaha]

---------------

Me: [punches paper bag full of hot air]

Do I think we need to keep our emotions in check for the greater good of getting the vaccines to America regardless of where the problem lies? Yes.

Do I care if along the way Trump's blamed for it and his base cries about it? Uh no. :rolleyes:
 
Swerd

Swerd

Audioholic Warlord
At 6 pm I read online that the FDA's Vaccine Advisory Committee recommended approval of the Pfizer vaccine on an emergency use basis. I've been waiting all day to be able to post that :D:D:D:D!

The vote was 17-4 with 1 member abstaining. Now all the FDA has to do is act on that recommendation as soon as possible – if not sooner. I want to hear by tomorrow that the FDA has approved.

Emergency Use means that the public may receive the Pfizer vaccine now even though the clinical trial of the Pfizer vaccine will continue until there is safety data 6-months after vaccination. That requires that the trial participants must not know if they received the vaccine or placebo for at least another 4 months.

It is possible that some of the NO votes were from those who thought it's unethical to not offer the vaccine to the placebo recipients now, instead of waiting until the FDA has 6-month safety data. Once that data is collected, and the FDA has given full approval to the vaccine, those on the placebo arm can get the vaccine.
 
Swerd

Swerd

Audioholic Warlord
well with several Canadien members amongst us, what say you ............

It's a hoax alright. But the claim in the audio recording is the hoax, not PCR tests. PCR tests results are the most reliable way to detect the presence of SARS-CoV-2 virus in patient samples.
 
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KEW

KEW

Audioholic Overlord
At 6 pm I read online that the FDA's Vaccine Advisory Committee recommended approval of the Pfizer vaccine on an emergency use basis. I've been waiting all day to be able to post that :D:D:D:D!

The vote was 17-4 with 1 member abstaining. Now all the FDA has to do is act on that recommendation as soon as possible – if not sooner. I want to hear by tomorrow that the FDA has approved.

Emergency Use means that the public may receive the Pfizer vaccine now even though the clinical trial of the Pfizer vaccine will continue until there is safety data 6-months after vaccination. That requires that the trial participants must not know if they received the vaccine or placebo for at least another 4 months.

It is possible that some of the NO votes were from those who thought it's unethical to not offer the vaccine to the placebo recipients now, instead of waiting until the FDA has 6-month safety data. Once that data is collected, and the FDA has given full approval to the vaccine, those on the placebo arm can get the vaccine.
I heard from an NPR interview (wish I remembered the rather important point of who was providing the info) that the debate was over the administering of the vaccine to anyone over 16 years old. I guess that was Pfizer's proposal and there was some question among the FDA of whether the vaccine should be categorically given to someone that young. I think if the age had been 21 (or, maybe 18) it would have been a quick slam dunk!
Here it is:
3 minutes:
 
Swerd

Swerd

Audioholic Warlord
I heard from an NPR interview (wish I remembered the rather important point of who was providing the info) that the debate was over the administering of the vaccine to anyone over 16 years old. I guess that was Pfizer's proposal and there was some question among the FDA of whether the vaccine should be categorically given to someone that young. I think if the age had been 21 (or, maybe 18) it would have been a quick slam dunk!
I think you're correct.

The question of giving the vaccine to those aged 16 or 17 is about statistics. There were not enough people of those ages on the trial to estimate the vaccine's efficacy & safety with statisticall reliability. The no votes came from people who wanted to see greater accrual in those age groups before they could feel comfortable with approving the vaccine for those age groups. They were outnumbered by the 17 who believe the pandemic requires emergency use now.
 
D

Dude#1279435

Audioholic Spartan
CDC director says 3000 deaths per day for the next 60-90 days. 400K around February, 500K by April. Is it the holiday surge combined with colder weather? I don't really get it though. This has been common place for 9 months now. It seems to me you just Zoom it.
 
M

Mr._Clark

Audioholic Samurai
The Sanofi/GSK vaccine has not been shown to be effective in older groups, and they are planning to start another round of trials:

>>>Sanofi and GSK delay COVID-19 vaccine, marking setback for global fight

Sanofi and GlaxoSmithKline said clinical trials of their COVID-19 vaccine showed an insufficient immune response in older people, delaying its launch to late next year and marking a setback in the global fight against the pandemic.<<<

 
GO-NAD!

GO-NAD!

Audioholic Spartan
So yesterday, after work, I attended a "pop-up" rapid COVID-19 testing clinic in my neighbourhood. I had no reason to suspect that I might be infected, but the clinic was a 5-minute walk from my house. And, I figure even negative results are good data to have. When they say the testing probe causes "some discomfort", they ain't kidding. It made my eyes water. Anyway, I tested negative.

These clinics started in November and were initiated by a Dalhousie University infectious disease researcher, Dr. Lisa Barrett*. As I understand it, the purpose of these clinics is to catch COVID infections in asymptomatic people who have not knowingly been exposed to the virus as well as to get a better picture of the virus' presence in the community. Anyone who wants to be tested is able to be tested. Right now, the more accurate PCR testing is only being administered to people who have been pre-screened - presenting symptoms, exposed to an infected person, etc.

The pop-up clinics run for a day or two in various locations, primarily in the Halifax area where most of our cases are located. I haven't been able to find more recent data, but as of Dec 2nd, they had tested 5,500 people (it's many more now) and got 21 positives, 12 of which were confirmed by the follow-up PCR test. That's 12 people who could have infected many others before they became symptomatic. Fantastic!

So far this month, Nova Scotia has had 88 new cases, but the running average is steadily falling along with the number of active cases (64).

I realize that this is of little comfort to anyone living in a high infection rate area, but it shows that with some determination, the virus can be kept at bay. It requires buy-in from government, health authorities, business and the wider community. We certainly have our share of feckless ya-hoos, but so far, they have been unable to ruin it for the rest of us.


*She spent two and a half years doing clinical trials and lab work with another person you may have heard about in recent months - a certain Dr. Anthony Fauci.
 
Trell

Trell

Audioholic Spartan
I have been involved in competitive shooting sports for over 50 years going back to when I was in high school and I can honestly say the number of times I've experienced unsafe gun handling with other shooters I can count on one hand with fingers left over. Firearms safety and responsible ownership not only should start early but reinforcement of those practices shall remain forever vigilant.
Then some of us reads statistic and "news" not exclusively from NRA and Fox News ;)
 
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