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

Sat Nov 14, 2020 4:43 am

dragon-wings wrote:
Did anyone catch his presser this afternoon where he actually said that The vaccine will be available to the entire general population with the exception of places like New York state for political reason. I am so glad he will not be around when it is time to distribute the vaccine!


Unfortunately, he will still be in office around Christmas when I expect the first doses to go in the first arms.

He only has some control. The fact is that Pfizer, Optum, and other companies are private companies and they will distribute as they see fit. Also, apparently Pfizer is a bit miffed at this Administration for attempting to take credit for Pfizer's work.
-Doc Lightning-

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

Sat Nov 14, 2020 5:22 am

dragon-wings wrote:
Did anyone catch his presser this afternoon where he actually said that The vaccine will be available to the entire general population with the exception of places like New York state for political reason. I am so glad he will not be around when it is time to distribute the vaccine!


I forgot to attach the link to the story

https://www.msn.com/en-us/news/politics ... d=msedgdhp
Don't give up don't ever give up - Jim Valvano
 
flyguy89
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Re: Updated: A COVID-19 vaccine candidate works!

Sat Nov 14, 2020 7:14 pm

dragon-wings wrote:
dragon-wings wrote:
Did anyone catch his presser this afternoon where he actually said that The vaccine will be available to the entire general population with the exception of places like New York state for political reason. I am so glad he will not be around when it is time to distribute the vaccine!


I forgot to attach the link to the story

https://www.msn.com/en-us/news/politics ... d=msedgdhp


To be fair, the actual quote was:

Cuomo "will have to let us know when he's ready for it because otherwise, we can't be delivering it to a state that won't be giving it to its people immediately."

A cheap political swipe to be sure...but then Cuomo did say he would potentially hold up distribution of the vaccine in New York so his own experts could validate it...an equally counterproductive and harmful outcome if indeed the Pfizer vaccine gets sign off from the FDA and other top scientists.
 
StarAC17
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Re: Updated: A COVID-19 vaccine candidate works!

Sat Nov 14, 2020 7:19 pm

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.


Doc I would assume the long term success of this type of vaccine will be a huge game changer for vaccine technology going forward and gives us a head start for the next pandemic (provided the infection is viral)?

From what I have read you need need to know the RNA sequence of the virus and do not need to learn how to manufacture the protein structure of the virus and either make the virus weakened or inert which is how vaccines were manufactured traditionally.

Also from what I have read the mRNA vaccine gets the the body's cells to manufacture the proteins similar to a real infection and then the immune system fights the proteins this with antibodies and T-cells. Is this correct?
Engineers Rule The World!!!!!
 
StarAC17
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Re: Updated: A COVID-19 vaccine candidate works!

Sat Nov 14, 2020 7:59 pm

flyguy89 wrote:
dragon-wings wrote:
dragon-wings wrote:
Did anyone catch his presser this afternoon where he actually said that The vaccine will be available to the entire general population with the exception of places like New York state for political reason. I am so glad he will not be around when it is time to distribute the vaccine!


I forgot to attach the link to the story

https://www.msn.com/en-us/news/politics ... d=msedgdhp


To be fair, the actual quote was:

Cuomo "will have to let us know when he's ready for it because otherwise, we can't be delivering it to a state that won't be giving it to its people immediately."

A cheap political swipe to be sure...but then Cuomo did say he would potentially hold up distribution of the vaccine in New York so his own experts could validate it...an equally counterproductive and harmful outcome if indeed the Pfizer vaccine gets sign off from the FDA and other top scientists.


I saw the operation warp speed segment on 60 minutes and those guys are not listening to Trump in any capacity.
Engineers Rule The World!!!!!
 
Sokes
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 15, 2020 2:41 pm

flyguy89 wrote:
A cheap political swipe to be sure...but then Cuomo did say he would potentially hold up distribution of the vaccine in New York so his own experts could validate it...an equally counterproductive and harmful outcome if indeed the Pfizer vaccine gets sign off from the FDA and other top scientists.

Thanks for the explanation. The news article was so busy criticizing Trump it forgot to give the required background information.

So who tries to gain politically from the vaccine, Trump or the NY governor?
Why can't the world be a little bit more autistic?
 
ltbewr
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 15, 2020 4:34 pm

I hope that the Pfizer/BNT and other vaccines do work for good of humanity and economy.

There could be some 'flu' like side affects from the vaccines, with some variance from person to person including elevated temperatures, muscle aches, and others, that may mean people will not be able to go back to work. As most vaccines will require 2 doses, it means 2 times at risk of side affects. We need some financial help for those who cannot work and don't get paid sick days or enough of them mandated by local governments, if so affected by the side affects are not forced to go back to work too early.. https://www.nbcnews.com/health/health-n ... s-n1247485
 
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DocLightning
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 15, 2020 7:55 pm

StarAC17 wrote:
Doc I would assume the long term success of this type of vaccine will be a huge game changer for vaccine technology going forward and gives us a head start for the next pandemic (provided the infection is viral)?

From what I have read you need need to know the RNA sequence of the virus and do not need to learn how to manufacture the protein structure of the virus and either make the virus weakened or inert which is how vaccines were manufactured traditionally.


You do need to know the genetic sequence of the virus (some viruses are RNA, some are DNA, but in mammals most are RNA and there are some fascinating virological/evolutionary reasons why this is likely the case). Some understanding of protein structure is going to be necessary. For example, in the case of SARS-CoV-2, the spike is actually clipped into two sections by the infected host cell before the virus leaves. This "pre-perforation" primes the spike protein to undergo an enormous change in structure needed to enter the next cell. But the "post-fusion" spike is a worthless immune target and, worse, having antibodies against it might actually make the disease worse. So to design the vaccines, they eliminated that section of the protein that gets pre-perforated (called a polybasic furin cleavage site) so that the protein would hold together in its pre-fusion state (the state that we want antibodies against). Now, the antibodies will form against the spike protein in its form that it takes before it infects a cell and so the antibodies will prevent infection.

For different kinds of viruses, understanding the structure of the surface proteins will help to design these mRNA vaccines so that they are appropriate. For non-enveloped viruses, like picornaviruses (polio, enteroviruses, common cold viruses, etc.) we could program cells to assemble what we call virus-like particles. These virus-like particles generate a potent immune response, which is how the HPV vaccine works (and the new shingles vaccine, and also the Hepatitis B and Hepatitis A vaccines.) So there is a role for structural understanding.

However, we have new tools for structure, too. Magnetic resonance spectroscopy can be used to assemble structures of proteins in solution and cryoelectron microscopy, which assembles thousands of images of a given protein taken from different angles can also build up very good structures. These methods use older techniques of gathering data (nuclear magnetic resonance, electron microscopy) but leverage our enormous progress in computer design and information processing to assemble these structures from absurdly large datasets of information. These tools allowed us to solve the structure of the SARS-CoV-2 spike to atomic resolution within weeks of discovering the virus, a feat that might have taken a few years 20 years ago.

So we can do a lot with sequence alone, but it really helps to have the structure, and modern techniques can give us that information very quickly.
-Doc Lightning-

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

Mon Nov 16, 2020 8:25 am

#Doc

Illuminating. Thank you.
 
art
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 16, 2020 12:06 pm

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

Mon Nov 16, 2020 12:35 pm

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

Mon Nov 16, 2020 12:51 pm

Early data shows that Moderna's vaccine candidate is at least 94% effective. And unlike the Pfizer vaccine, it does not need to be stored in -70 degrees C freezers.

https://www.npr.org/sections/health-sho ... ical-trial

Just my thoughts:
Assuming that both of these get approved, I have a feeling that the Pfizer vaccine will be given to healthcare workers, and those in "well-off" urban and suburban areas as they will likely be trusted with handling the special storage freezers. Whereas, the Moderna vaccine will likely be given to "every-day" folks as it does not have stringent storage requirements.
 
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Braybuddy
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 16, 2020 1:39 pm

art wrote:
Moderna report their vaccine is 94.5% effective!

Russia will have to update its figures . . . :D
 
UpNAWAy
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 16, 2020 2:55 pm

Anyone notice how small the infection rate is for the placebo groups?
 
PPVRA
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 16, 2020 3:05 pm

UpNAWAy wrote:
Anyone notice how small the infection rate is for the placebo groups?


Are you talking about the number of cases these companies were waiting for to publish preliminary results? I think those are bare minimum numbers, probably determined by some minimum statistics significance. In other words, they’re not insignificant given the size and stage of the trials.
"If goods do not cross borders, soldiers will" - Frederic Bastiat
 
UpNAWAy
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 16, 2020 3:42 pm

0.075% in the Moderna trial got COVID with the placebo.
 
ltbewr
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 16, 2020 3:45 pm

acavpics wrote:
Early data shows that Moderna's vaccine candidate is at least 94% effective. And unlike the Pfizer vaccine, it does not need to be stored in -70 degrees C freezers.

https://www.npr.org/sections/health-sho ... ical-trial

Just my thoughts:
Assuming that both of these get approved, I have a feeling that the Pfizer vaccine will be given to healthcare workers, and those in "well-off" urban and suburban areas as they will likely be trusted with handling the special storage freezers. Whereas, the Moderna vaccine will likely be given to "every-day" folks as it does not have stringent storage requirements.


I agree that the different vaccines may by distributed in that way as no one of them can cover the overall need quickly enough and do so with the least risk of distribution issues.The ones with less stringent storage issues could be directed to local health boards, doctor's offices, even pharmacies. There is also the J&J 'one-shot' vaccine that may may want for convenience but also may mean more getting vaccinated faster overall. Perhaps too the 'less' effective ones would be targeted to lower risk persons and children pending testing and approvals, the more effective ones to older and higher risk persons.
 
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Tugger
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 16, 2020 4:21 pm

UpNAWAy wrote:
0.075% in the Moderna trial got COVID with the placebo.

Can you please provide a link? I searched for information based on what you posted and can find nothing supporting your assertion. I don't have time for a deeper dive. Thanks.

Tugg
I don’t know that I am unafraid to be myself, but it is hard to be somebody else. - W. Shatner
There are many kinds of sentences that we think state facts about the world but that are really just expressions of our attitudes. - F. Ramsey
 
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Tugger
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 16, 2020 4:25 pm

Has anyone published information on when "non-shot" delivered variants will be available? There is a population of people who need the vaccine but react badly, their body over reacts to direct-to-bloodstream/injection vaccines. Nasal vaccination processes tend to be the best for these people with auto-immune deficiencies.

Tugg
I don’t know that I am unafraid to be myself, but it is hard to be somebody else. - W. Shatner
There are many kinds of sentences that we think state facts about the world but that are really just expressions of our attitudes. - F. Ramsey
 
luckyone
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 16, 2020 4:26 pm

UpNAWAy wrote:
Anyone notice how small the infection rate is for the placebo groups?

If I read it correctly, it's 90/15,000. Considering states where hospitals are getting overwhelmed like the Dakotas, which are seeing numbers of 150-180/100,000 and other states like Wisconsin, Wyoming, and Iowa are seeing 100+/100,000, I would say that 90/15,000 is not a small infection rate.
 
PPVRA
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 16, 2020 8:16 pm

"Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study"

"As more cases accrue leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change."

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


This study isn't done. Might not be appropriate to divide the placebo cases by the total placebo participants just yet.
"If goods do not cross borders, soldiers will" - Frederic Bastiat
 
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DocLightning
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Re: Updated: A COVID-19 vaccine candidate works!

Mon Nov 16, 2020 10:15 pm

UpNAWAy wrote:
Anyone notice how small the infection rate is for the placebo groups?


Yes, it's a feature, not a bug. You can't have been infected to start and the trial has only been going since summertime. Also, all of the participants get education in how to stay safe.

But that's why there is a control group. So there were 95 infections. Five were in the study arm and 90 were in the placebo arm.

Hypothesis (null hypothesis): the vaccine doesn't work and this difference in infection rate was solely due to chance. OK, so we run the statistics (there are well-established methods to run these statistics) and we find out that there is a 1:1,000,000 chance that an ineffective vaccine could produce this result, or a p value of 0.0001. By convention, it is accepted that the null hypothesis is "disproven" if the p value is lower than 5. So we have now disproven the null hypothesis.

So how effective is the vaccine really given these numbers? Well, there is a 95% chance that the actual efficacy is somewhere between 82% and 99%. Now, given what we saw from Pfizer, which uses similar technology, I think we can exclude anything below the high 80s.

Now, how about severe cases? There were 11 severe cases, all in the placebo group. Does this prove that the vaccine is 100% effective at preventing severe COVID-19? No. When you run the statistics, it shows that it probably doesn't make people more likely to have a severe case, but if you get COVID-19 after having been vaccinated, we don't have enough data to say for sure that it will protect you from severe disease. However, given the way that vaccines work, my prediction is that we will see eventually that even if you do get COVID-19 after having been vaccinated, that you will be much less likely to get severe disease.

In any case, this is fantastic news. I think it's time to get to work on distribution. Over 600 people in the USA died yesterday alone.
-Doc Lightning-

"The sky calls to us. If we do not destroy ourselves, we will one day venture to the stars."
-Carl Sagan
 
StarAC17
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Re: Updated: A COVID-19 vaccine candidate works!

Tue Nov 17, 2020 4:57 am

In any case, this is fantastic news. I think it's time to get to work on distribution. Over 600 people in the USA died yesterday alone.


You are the expert but I agree and I think both companies will secure an Emergency use Authorization by the end of the month. Health Canada has been asked to start reviewing these vaccines for similar up here as we have contracts for both. I am awaiting an announcement from AstraZenica to see what the results of their trials are also.


I do have a question. Why do these and some other vaccines need two shots where some even other covid19 ones don't? Also is there any protection after one?

The only one that I think I needed multiple ones were Hep A and Hep B. I got measles when I was 12 and then got MMR 3 years ago because I was going to Kenya and the travel doctor said for your age MMR wouldn't have been standard when you were younger and I would have had the risk risk of contracting Mumps and Rubella.
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DocLightning
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Re: Updated: A COVID-19 vaccine candidate works!

Tue Nov 17, 2020 5:32 am

StarAC17 wrote:
I do have a question. Why do these and some other vaccines need two shots where some even other covid19 ones don't? Also is there any protection after one?


So because vaccines don't make us really sick, they often don't trigger the kind of intense memory immunity that truly damaging viruses do. Another way to get a really good long-term memory immune response is to expose the patient repeatedly to the same antigen. Here is a classic textbook graph of how the antibody levels respond over time:

Image

After a single dose, I'd predict that you'd get some protection against severe disease, but it usually takes at least two doses to give a long-term memory response. This is actually pretty typical. We get two MMRs (one at 1yo and one at 4yo) and three doses of HBV, four of polio, two of hepatitis A, and either two or three for HPV among others.

The J&J/Janssen candidate uses an enormous dose to get a good response at one dose, but I do have questions about whether it will last as long. They are now investigating a two-dose series.

I will be utterly unsurprised when it turns out that a third dose of either of these mRNA vaccines given six months after the first dose results in decades-long immunity. The issue is that we are in too much of a rush right now to be trialling 6mo dosing regimens. That can wait. The first two doses seem to work well enough for now.
-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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SQ22
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Re: Updated: A COVID-19 vaccine candidate works!

Tue Nov 17, 2020 5:58 am

Please remember to provide a link to every image your are posting, this applies for charts as well. Thanks.
 
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DocLightning
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Re: Updated: A COVID-19 vaccine candidate works!

Tue Nov 17, 2020 8:28 pm

Tugger wrote:
Has anyone published information on when "non-shot" delivered variants will be available? There is a population of people who need the vaccine but react badly, their body over reacts to direct-to-bloodstream/injection vaccines. Nasal vaccination processes tend to be the best for these people with auto-immune deficiencies.

Tugg


No vaccines are injected directly into the blood. However, I do agree that insisting on injections is a problematic approach. People hate needles and also, for a virus that enters at a mucosal surface, I think that approaching from the mucosa makes more sense. Moreover, having non-needle approaches makes it easier to deliver vaccines to resource-poor areas where sterilization is not readily available.

There are two approaches that would work well for this. The first would be to use a "live-attenuated" vaccine (a term that bugs me because viruses are not alive). Attenuating a virus is a process that takes time and a lot of trial and error. However, more modern molecular genetic techniques may come into play. There are a number of targets within SARS-CoV-2 that could be mutated so as to provide a good vaccine strain. Examples of these targets are a protein called NSP1, which is involved in immune evasion, a protein called E, which is involved in producing new particles, and some of the viral ORFs such as ORF7. However, these must be developed with great care. In addition, the four most prevalent attenuated vaccines, measles, mumps, rubella, and varicella, are given by injection and work best that way. So it isn't clear that an attenuated version will actually work best by nasal administration. In addition, such an approach would not be suitable for patients with compromised immune systems.

The second approach would be a viral vector approach. This is already being used with the adenovirus vectors, which are being developed by J&J and Oxford/AstraZenica in the West and also the Sinovac and Gambelaya approaches. Adenoviruses in humans are spread in the same way as other common cold viruses and from the beginning, I wondered why the ChAdOx1 and Ad26 vectored vaccines weren't being tried in a nasal route. They should be able to infect the nasal mucosa and generate an immune response. However, it seems like the nasal mucosa isn't fantastic at driving systemic adaptive responses. An oral route might make more sense, as GI mucosal immunity appears to be much more robust. At least one researcher in China has reported some favorable results with using a chimpanzee adenovirus (not Y25 or ChAdOx1) by a nasal route in a mouse model. As long as these viral vectors are replication-incompetent, they should be safe for use in those with compromised immune systems (although they may not work as well).

But it's important to understand that even if not injected, these vaccines will activate the immune response and so they may have their own side effects that might be quite unpleasant, too.
-Doc Lightning-

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

Wed Nov 18, 2020 3:30 am

UpNAWAy wrote:
Anyone notice how small the infection rate is for the placebo groups?

That is entirely by design. The threshold for publishing the interim report for the Pfizer vaccine was 64 cases. By the time report was published they had hit 90 cases. If you have 50,000 people in the trial, then the infection rate will always be very low.
 
Sokes
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 11:24 am

UpNAWAy wrote:
0.075% in the Moderna trial got COVID with the placebo.

90/ 15.000 = 0,006 = 0,6%
Why can't the world be a little bit more autistic?
 
PPVRA
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 2:16 pm

Are there any estimates of how long it would take to get all healthcare workers in the US vaccinated?
"If goods do not cross borders, soldiers will" - Frederic Bastiat
 
ltbewr
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 3:09 pm

Dolly Parton, the well known country entertainer, was a funding contributor, with $1 Million, via Vanderbilt University of research of the Madema vaccine. She became friends with a lead doctor in the research who treated her after a 2014 car accident. The doctor is an immigrant from Lebanon. Her name was included publication of the vaccine in the New England Journal of Medicine as requires disclosures for ethical reasons. https://www.theguardian.com/music/2020/ ... e-research
 
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DocLightning
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 4:12 pm

BOOM!

We have a complete Phase III clinical trial!

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
From the press release (emphasis mine):
•Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
•Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
•Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
•Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
•Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
•The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021
•Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world


Some comparative antiviral vaccine efficacies (CDC data):
•Measles: 97% after both doses
*Mumps: 88% after both doses
*Rubella: 97% after one or both doses
*Polio: 98-99% after three doses
*Chickenpox: 90% after both doses
*Smallpox: 95%
*Rotavirus: 88-92% effective after completion of the course (two or three doses depending on manufacturer)
*Hepatitis B: 94% after all three doses
*Hepatitis A: 95% after both doses

So this is right up there. And if they're all this good (and I'll bet they will be) then this pandemic is going to be over very quickly as soon as we start distributing this vaccine.

Now get in my arm and bring me some of that sweet, sweet immunity.
-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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casinterest
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 4:16 pm

DocLightning wrote:
BOOM!

We have a complete Phase III clinical trial!

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
From the press release (emphasis mine):
•Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
•Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
•Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
•Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
•Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
•The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021
•Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world


Some comparative antiviral vaccine efficacies (CDC data):
•Measles: 97% after both doses
*Mumps: 88% after both doses
*Rubella: 97% after one or both doses
*Polio: 98-99% after three doses
*Chickenpox: 90% after both doses
*Smallpox: 95%
*Rotavirus: 88-92% effective after completion of the course (two or three doses depending on manufacturer)
*Hepatitis B: 94% after all three doses
*Hepatitis A: 95% after both doses

So this is right up there. And if they're all this good (and I'll bet they will be) then this pandemic is going to be over very quickly as soon as we start distributing this vaccine.

Now get in my arm and bring me some of that sweet, sweet immunity.



Good news. But now we have the logistics nightmare to work out.
Twenty years from now you will be more disappointed by the things you didn't do than by the ones you did..So throw off the bowlines. Sail away from the safe harbor. Catch the trade winds in your sails. Explore. Dream. Discover.--Mark Twain
 
T4thH
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 4:19 pm

Source in German.
https://www.welt.de/wirtschaft/article220431400/Corona-Biontech-Impfstoff-erreicht-Wirksamkeit-von-95-Prozent.html

Update/final result of the Pfizer/Biontech Vaccine tests: With new updated results, efficacy is now up to 95%.
So we have now already two vaccines with proven excellent and much better than expected efficacy above 90%.
For both, as I have till now seen/heard of in all news e.g., safety seems to be OK, side effects are according expectation for vaccines, comparable to flue vaccines.
 
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 4:26 pm

Thanks Doc for the consistent information (actual information! Who'da thunk it possible?!?) and clear responses to questions. You are a credit to your profession and to this community. Know your efforts are appreciated.

OK so enough of the fawning praise... :spin:

Doc, it looks like we'll have two vaccine heading for distribution in the coming month(s) and with each requiring two doses and distribution being appropriately done across the world, it looks like about 25 million will be able to receive the vaccine in the USA between the Pfizer/Biontech and Moderna initial production?

With many other vaccines in the pipeline and the remarkable (I think) success we are seeing in the trials 2021 is looking to have an exciting and busy first few months. (A decent list of all the vaccines in development can be found here: https://www.nationalgeographic.com/scie ... ments-cvd/ )

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

Wed Nov 18, 2020 4:29 pm

casinterest wrote:
Good news. But now we have the logistics nightmare to work out.

Fortunately the world is getting really good at logistics!

But yes, the logistics and distribution part is the real key to getting this into real world action.

Tugg
I don’t know that I am unafraid to be myself, but it is hard to be somebody else. - W. Shatner
There are many kinds of sentences that we think state facts about the world but that are really just expressions of our attitudes. - F. Ramsey
 
frmrCapCadet
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 4:52 pm

Questions. The primary Chinese vaccine appears not as effective as the two tested in the US. Would it make sense to use it anyway, and later get the more effective series. And the Pfizer appears effective even after the first dose, so would it be better to give one shot to twice as many people now, and the second shot after manufacturing catches up to enough vaccines for about everyone?
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art
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 4:55 pm

Tugger wrote:
casinterest wrote:
Good news. But now we have the logistics nightmare to work out.

Fortunately the world is getting really good at logistics!

But yes, the logistics and distribution part is the real key to getting this into real world action.

Tugg


I wonder how many jabs are administered each year 'normally' and what percentage increase in rate would be required to vaccinate everyone against COVID-19.
 
ThePointblank
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 7:57 pm

Tugger wrote:
casinterest wrote:
Good news. But now we have the logistics nightmare to work out.

Fortunately the world is getting really good at logistics!

But yes, the logistics and distribution part is the real key to getting this into real world action.

Tugg

We're discussing the logistics side of things on this thread there:

viewtopic.php?f=10&t=1454033

But the gist of it is that Pfizer's vaccine is the more problematic of the two vaccines because of its storage and shipping requirements, which would severely limit its distribution. Moderna's vaccine will be the easier vaccine to handle logistically.
 
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 8:49 pm

DocLightning wrote:
BOOM!

We have a complete Phase III clinical trial!

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
From the press release (emphasis mine):
•Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
•Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
•Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
•Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
•Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
•The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021
•Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world


Some comparative antiviral vaccine efficacies (CDC data):
•Measles: 97% after both doses
*Mumps: 88% after both doses
*Rubella: 97% after one or both doses
*Polio: 98-99% after three doses
*Chickenpox: 90% after both doses
*Smallpox: 95%
*Rotavirus: 88-92% effective after completion of the course (two or three doses depending on manufacturer)
*Hepatitis B: 94% after all three doses
*Hepatitis A: 95% after both doses

So this is right up there. And if they're all this good (and I'll bet they will be) then this pandemic is going to be over very quickly as soon as we start distributing this vaccine.

Now get in my arm and bring me some of that sweet, sweet immunity.


So what is the next step? I assume they will send requests to government agencies around the world, like the Swedish Medical Products Agency (läkemedelsverket) for approval of their vaccine trial results?
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Re: Updated: A COVID-19 vaccine candidate works!

Wed Nov 18, 2020 8:56 pm

frmrCapCadet wrote:
Questions. The primary Chinese vaccine appears not as effective as the two tested in the US. Would it make sense to use it anyway, and later get the more effective series. And the Pfizer appears effective even after the first dose, so would it be better to give one shot to twice as many people now, and the second shot after manufacturing catches up to enough vaccines for about everyone?


In some vaccines, getting a less effective version first can reduce the efficacy of a later more effective version. So I would go with a slam-dunk vaccine. Then again, we're in a pandemic, so I'd be fine with China using theirs to start before we can bring more effective ones online. Theirs is a pretty quick-and-dirty inactivated vaccine using beta propiolactone (which is toxic, but evaporates really quickly). I was skeptical of this approach, but it works better than I would have expected (based on the preclinical data).

I think that this mRNA vaccine is going to be the future. And if that's the case, then maybe we can transition our yearly flu shots to mRNA vaccines and get some *real* protection.
-Doc Lightning-

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

Wed Nov 18, 2020 9:30 pm

casinterest wrote:

Good news. But now we have the logistics nightmare to work out.


"Challenge."

The guy in charge of the Warp Speed logistics is [url="https://www.npr.org/sections/health-shots/2020/11/09/933060635/operation-warp-speeds-logistics-chief-weighs-in-on-vaccine-progress"]Gen. Gustave Perna[/url], who has been in charge of the Army's Materiel Command, so just the kind of guy you want in charge of these things. And Pfizer has been hard at work on sorting the logistical issues, too.

art wrote:
I wonder how many jabs are administered each year 'normally' and what percentage increase in rate would be required to vaccinate everyone against COVID-19.


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.
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StarAC17
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Re: Updated: A COVID-19 vaccine candidate works!

Thu Nov 19, 2020 3:46 pm

DocLightning wrote:
frmrCapCadet wrote:
Questions. The primary Chinese vaccine appears not as effective as the two tested in the US. Would it make sense to use it anyway, and later get the more effective series. And the Pfizer appears effective even after the first dose, so would it be better to give one shot to twice as many people now, and the second shot after manufacturing catches up to enough vaccines for about everyone?


In some vaccines, getting a less effective version first can reduce the efficacy of a later more effective version. So I would go with a slam-dunk vaccine. Then again, we're in a pandemic, so I'd be fine with China using theirs to start before we can bring more effective ones online. Theirs is a pretty quick-and-dirty inactivated vaccine using beta propiolactone (which is toxic, but evaporates really quickly). I was skeptical of this approach, but it works better than I would have expected (based on the preclinical data).

I think that this mRNA vaccine is going to be the future. And if that's the case, then maybe we can transition our yearly flu shots to mRNA vaccines and get some *real* protection.


I agree and if they prove safe and they likely are and only give minor side effects it gives us an opportunity to create a vaccine much quicker, in weeks and not years from what I have read.
If there are any significant mutations to Covid19 or any other virus they can get another vaccine out relatively quickly to deal with the mutation.
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Re: Updated: A COVID-19 vaccine candidate works!

Fri Nov 20, 2020 5:20 am

StarAC17 wrote:
If there are any significant mutations to Covid19 or any other virus they can get another vaccine out relatively quickly to deal with the mutation.


Most RNA viruses mutate quite quickly because the enzyme that copies the RNA to make more RNA, the RNA-directed RNA polymerase (RdRp) doesn't have a "spell check" function built in like the DNA polymerases in our own cells. However, coronavirus RdRp has an ExoN (exonuclease) function that does allow it to "backspace" and replace errors made in replicating the viral RNA. For that reason, coronaviruses have a much lower mutation rate than other RNA viruses. So I think that the idea that this virus will mutate around the vaccine is pretty outlandish. Besides, measles virus doesn't even have ExoN and the same measles vaccine that was approved almost a half century ago still works just fine. All viruses have to have a way to stay present in a population. For measles, it was its insane reproductive number. For flu, it's constantly changing the surface proteins. For coronaviruses, we think they trigger a kind of waning immunity, but that's not clear. If that is the case, the vaccine will probably not trigger a waning immunity.

However, the RNA vaccines could be adapted to influenza. Imagine an annual flu shot that works 95% of the time rather than 30-60%. And when (not if) there is another pandemic coronavirus, the experience working with this one will allow us to come up with a vaccine even more quickly.
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Re: Updated: A COVID-19 vaccine candidate works!

Fri Nov 20, 2020 7:28 am

DocLightning wrote:
StarAC17 wrote:
If there are any significant mutations to Covid19 or any other virus they can get another vaccine out relatively quickly to deal with the mutation.


Most RNA viruses mutate quite quickly because the enzyme that copies the RNA to make more RNA, the RNA-directed RNA polymerase (RdRp) doesn't have a "spell check" function built in like the DNA polymerases in our own cells. However, coronavirus RdRp has an ExoN (exonuclease) function that does allow it to "backspace" and replace errors made in replicating the viral RNA. For that reason, coronaviruses have a much lower mutation rate than other RNA viruses. So I think that the idea that this virus will mutate around the vaccine is pretty outlandish. Besides, measles virus doesn't even have ExoN and the same measles vaccine that was approved almost a half century ago still works just fine. All viruses have to have a way to stay present in a population. For measles, it was its insane reproductive number. For flu, it's constantly changing the surface proteins. For coronaviruses, we think they trigger a kind of waning immunity, but that's not clear. If that is the case, the vaccine will probably not trigger a waning immunity.

However, the RNA vaccines could be adapted to influenza. Imagine an annual flu shot that works 95% of the time rather than 30-60%. And when (not if) there is another pandemic coronavirus, the experience working with this one will allow us to come up with a vaccine even more quickly.


Are we to understand that not only did researchers find a vaccine for the virus in record time, but also potentially revolutionized vaccine technology while they were at it?
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bennett123
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Re: Updated: A COVID-19 vaccine candidate works!

Fri Nov 20, 2020 9:52 am

My understanding, (sorry to be vague) is that a lot of the difference in timescale was due to two factors;

Immediate availability of research funding/resources

Different stages in the process overlapping, rather than one stage being fully completed before commencing planning of the next stage.
 
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Re: Updated: A COVID-19 vaccine candidate works!

Fri Nov 20, 2020 5:25 pm

Francoflier wrote:
Are we to understand that not only did researchers find a vaccine for the virus in record time, but also potentially revolutionized vaccine technology while they were at it?


Pretty much! RNA vaccines have been in the works for almost 30 years. I remember reading about them in "Popular Science" when I was a young teenager. But there were a whole slew of technical problems to get around. The technology only appeared ready for prime time about three or four years ago, just in time for the pandemic to hit. As for RNA vaccines, this was fortuitous because now that they have been developed, the barriers to being the first ones approved have fallen.

Now, I will point out that RNA vaccines are not the solution to all problems. We're not going to replace existing excellent vaccines like measles with RNA vaccines (if it ain't broke, don't fix it). Moreover, antibacterial vaccines often are directed against non-protein antigens (sugars found on the surface of the bacterium), so this technology won't work there. But for antiviral vaccines, this technology is amazingly promising. It can likely be used against almost any virus (except HIV, for which a protective immune response seems out of reach). So we could see flu shots being replaced with mRNA vaccines in the future and they'd be much more effective (assuming the flu doesn't shift under us).
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frmrCapCadet
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Re: Updated: A COVID-19 vaccine candidate works!

Fri Nov 20, 2020 5:49 pm

I occasionally subscribe to Popular Science, it is generally a reliable source. Their reports on science and science in the future are careful to lay out the limits of what is known.
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Re: Updated: A COVID-19 vaccine candidate works!

Sat Nov 21, 2020 2:55 am

DocLightning wrote:
Francoflier wrote:
Are we to understand that not only did researchers find a vaccine for the virus in record time, but also potentially revolutionized vaccine technology while they were at it?


Pretty much! RNA vaccines have been in the works for almost 30 years. I remember reading about them in "Popular Science" when I was a young teenager. But there were a whole slew of technical problems to get around. The technology only appeared ready for prime time about three or four years ago, just in time for the pandemic to hit. As for RNA vaccines, this was fortuitous because now that they have been developed, the barriers to being the first ones approved have fallen.

Now, I will point out that RNA vaccines are not the solution to all problems. We're not going to replace existing excellent vaccines like measles with RNA vaccines (if it ain't broke, don't fix it). Moreover, antibacterial vaccines often are directed against non-protein antigens (sugars found on the surface of the bacterium), so this technology won't work there. But for antiviral vaccines, this technology is amazingly promising. It can likely be used against almost any virus (except HIV, for which a protective immune response seems out of reach). So we could see flu shots being replaced with mRNA vaccines in the future and they'd be much more effective (assuming the flu doesn't shift under us).


Thanks, that's quite interesting.
I guess that could count as one of the few silver linings of this pandemic then.
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art
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 6:14 am

When Pfizer applied for an emergency use licence 20th November, I was surprised that it would not be until 10th December that the FDA would meet to issue its approval (iif forthcoming). Why so long - 20 days in the middle of an extreme health crisis?
 
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Re: Updated: A COVID-19 vaccine candidate works!

Sun Nov 22, 2020 6:34 am

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?
"In this present crisis, government is not the solution to our problem - government IS the problem." - Ronald Reagan

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