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Dr.Bob
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[*] posted on 9-11-2020 at 10:10
Covid vaccine results


The initial results for the Pfizer vaccine are very good, looks like at least 90+% effective. Other vaccines are likely to present interim results shortly, so we should have multiple products available shortly. Pfizer hopes to get approval in Dec, and will have 50 million does by then ready. I am very happy to hear that, this mess is a pain in the...

https://news.yahoo.com/coronavirus-updates-president-elect-j...

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macckone
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[*] posted on 9-11-2020 at 10:47


They can start the safety portion 60 days after the last person got the second shot.
But a more realistic estimate is 90 days because they have to contact all of the recipients.
The limit on the number of people getting covid in the trial is preset and they are only a third of the way there.
More realistic is sometime in january or february. Since it requires two doses 28 days apart, 50 million does is not even enough to vaccinate 10% of the US population and the doses are going around the world. However there are other vaccines in the pipeline.
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[*] posted on 9-11-2020 at 11:12


From what I understand, there have been no vaccines for other types of coronavirus (HCoV-229E and OC43 for example) but there are for the types that infect animals. I wasn't optimistic about a vaccine being available quickly since none are licensed for any other human coronavirus so what gives? Is it simply the scale of the pandemic that motivated the industry to pull out all the stops or are they throwing everything at the wall and seeing what sticks?

I'll admit, I was (and still am) quite ignorant when it comes to vaccine development but now I have just enough information to be scared of challenges like antibody-dependent enhancement when we are seeing chronic conditions related to scarring and clotting long after the virus is apparently gone. Just a year ago I thought vaccines were essentially just weakened or neutralized virus particles but the reality is like trying to get a drink of water from a firehose. I am amazed they could have something so effective so soon - fingers crossed!
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[*] posted on 9-11-2020 at 11:40


OldNubbins,
They threw everything at the wall and are seeing what sticks.
They started with several hundred candidates.
There are now a dozen.
Some will likely fail testing.
The pfizer vaccine is looking promising.
There are a lot of caveats though.
It was developed using expedited testing, it won't be certified for pregnant women, children or those that are already ill with this or any other disease.
This is not that uncommon. For example the flu vaccine is never approved for those that have respiratory infections and you can't get it if you have one.
This has delayed my annual flu vaccination. I have an upper respiratory virus but it isn't covid.
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[*] posted on 9-11-2020 at 12:44


The Pfizer vaccine will likely be available by Dec according to the medical people I know, and Moderna may be shortly behind it. They already have 50 million doses ready to ship, and are making about 130,000 more a month, so that would be enough to handle 50 million people for both doses starting immediately, and then the rest of the US in a couple of months. People seem to think that making 300,000,000 doses is impossible, but they make more flu vaccine every year than that, in less than 6 months.

https://seekingalpha.com/news/3633509-pfizer-biontech-covidm...

I have little doubt that we can vaccinate most of the people who need and want it within 2-3 months. If some people don't want it that just makes the rest of the population able to get it faster, and eventually most of the others will either get the vaccine or get sick, either of which will leave them immune for some time period. Early estimates are that the Pfizer vaccine will last at least a year, likely several years. which will be enough to get the worst of the pandemic over, after that we can figure out how long it lasts and if we need boosters eventually.

But know we know at least one good way how to make a vaccine and that should allow us to deal with any future outbreaks more easily. The amount of virus/vaccine research done in the last 8-10 months may be more than done in the last 20 years, and should help us with making better vaccines for other diseases as well. I think we should be able to start getting back to normal by March or April next year. And I am usually a pessimist, but I have great respect for the bulk of the scientists making the vaccines.

[Edited on 9-11-2020 by Dr.Bob]
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[*] posted on 9-11-2020 at 12:54


Nice, not the first mRNA drug, but it will be the first mRNA vaccin.
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Dr.Bob
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[*] posted on 9-11-2020 at 12:59


From Pfizer's release:

Pfizer Inc. (NYSE: PFE) and BioNTech SE (BNTX) (Nasdaq: BNTX) today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study. After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.

The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at seven days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continues to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”

“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech Co-founder and CEO. “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from seven days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms. The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus.

Pfizer and BioNTech (NTGN) are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. Based on supply projections, we expect to supply globally up to 50 million vaccine doses in 2020 and manufacture up to 1.3 billion doses in 2021. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.
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[*] posted on 9-11-2020 at 13:13


Quote: Originally posted by OldNubbins  
From what I understand, there have been no vaccines for other types of coronavirus (HCoV-229E and OC43 for example) but there are for the types that infect animals. I wasn't optimistic about a vaccine being available quickly since none are licensed for any other human coronavirus so what gives? Is it simply the scale of the pandemic that motivated the industry to pull out all the stops or are they throwing everything at the wall and seeing what sticks?

I'll admit, I was (and still am) quite ignorant when it comes to vaccine development but now I have just enough information to be scared of challenges like antibody-dependent enhancement when we are seeing chronic conditions related to scarring and clotting long after the virus is apparently gone. Just a year ago I thought vaccines were essentially just weakened or neutralized virus particles but the reality is like trying to get a drink of water from a firehose. I am amazed they could have something so effective so soon - fingers crossed!
for 2 billion+ dollars for the first couple of million doses no wonder trump was giving it a shot.BLEACH! windex,brake fluid.
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macckone
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[*] posted on 9-11-2020 at 20:52


Dr. Bob,
The forward looking statements are overly optimistic. I would not expect approval until early january.
The infection rate in the trial subjects is just over half of required and it has been going on since July.
That 100 million doses is not just for the US. And that estimate is high by my calculations there are only going to be 74 million doses.
Moderna is only scheduled to have 20 million doses by the end of december.
The Jannsen trial is behind the others and likely will not complete until February.
The astrazeneca trial is behind and they will only deliver 4 million doses this year.
Let's assume the US gets 30% of those doses. That is only enough for 11 million full vaccinations.
Yes once production is fully ramped up they can produce something in excess of a billion doses a year but we need over 14 billion, lets say 85% vaccination rate, that is still over 12 billion. Even with four companies producing vaccines at a billion doses a year (assuming all trials are successful) it will take 3 years to vaccinate everyone.

And by everyone, I mean everyone, not just the US because if it is in africa and mutates, we start over.
Mutation pressure is low as long as most people are not resistant.
As immunity rises so does mutation pressure.
So it is very important to vaccinate as many people as possible as quickly as possible to avoid catastrophic mutation occuring before we can drop R0 below 1.
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Dr.Bob
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[*] posted on 10-11-2020 at 13:34


I agree that I am optimistic, but even Faucci said it should be available in the US before the end of Dec.

Remember that China and Russia and a number of other countries are all making vaccine, China has already dosed many thousands, if not already into the millions under their emergency use, including people in other countries who have bought the vaccine from China. They will each make billions of doses.

And BioNTech has their own facility in Europe I believe, which they purchased from Novartis a while back.

The nice part about the MRNA vaccine is that it can be modified trivially to cope with any mutations, but so far no major mutations have been found that should not be covered by this vaccine. I expect that scientists will be watching for that all over the world, so we will know pretty quickly if that happens, and the vaccine could be reformulated for any major changes much quicker once it has been fully tested and the manufacturing is well known. While it may not be easy, I have personally made multiple grams of customs DNA pieces, and RNA is not that different to make, I do think these vaccines may have some non-natural pieces in them, but not sure.

But the scale up of mRNA is quite simple, compared to the production of some older vaccines and the antibodies (Lilly's was approved and Regeneron's will be shortly, I suspect). The REGN-COV2 antibody will likely be used at 2g or 1.5 g doses, and other than the huge cost and need for early administration to work, it may allow some reduction in deaths if given soon enough for the highest risk people. But if we can cut the sheer number of cases with the vaccine, that will leave doctors much more time to deal with the remaining cases.

My point is that they can start dosing in Dec. with 10 to 50 million doses and I think by early 2021 the majority of the healthcare and "essential" workers will be covered, and Pfizer can make 130 million doses per month after that, so in one month we can dose most of the remaining people who want to be vaccinated, by the time they need the second shot, another 130 million does will be available. And they say that within a week of the second shot, most people show good antibodies, so only about a month after the start they will be mostly safe.

I don't expect the vaccine to be perfect, or everyone to respond. Older people and immuno-compromised people likely won't respond as well, but if most others get it, that will help protect them. And the vaccine may not be approved for people under 18 at first, which is fine, since few of them will get very ill, which cuts the population to vaccinate by about 25%. I think if we vaccinate half the people between 20 and 80, skipping the ~10 million people who have already had Covid at first (since they should be already somewhat protected), that would only be about 100 million people, which is quite doable in a few months, and that will slow it down enough that we can then figure out the rest of the population over the next few months.

We will eventually have more doses than people on earth (based on the number of companies making it, and early government orders) so we can eventually even give some people extra shots if they need. It may turn out that one companies vaccine is better than the others, and if so, I suspect that eventually that one will be offered to the rest of the population. I don;t expect that there won't be glitches, mistakes, or screw-ups, but I do know that there are enough shots on goal here to get a few or more vaccines to work, and we will find a way to ramp them up faster than ever imagined just a few years ago.
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[*] posted on 10-11-2020 at 17:47


The -70C storage temperature is a bit of a stumbling block though. Its going to make large scale distribution more difficult, especially in third world countries. -70C freezers are a bit specialized.



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[*] posted on 10-11-2020 at 21:33


The russian vaccine does not appear to have been through sufficient testing for most countries to allow it.
China is ordering the Moderna vaccine as their capability to produce over a billion doses in a reasonable amount of time is not there.
Not that they cannot upgrade capacity but it will take a while.

The myth that young people do not get ill is dangerous.
We are starting to find that they are suffering the same types of organ damage that adults do including brain damage.
That damage can occur in asymptomatic people.

The pfizer agreement is to deliver 300 million does to the US in 2021 .. that means by the end of 2021.
They have agreements with numerous other countries to deliver doses as well.
Including UK, canada, japan, germany, italy, france, isreal just to name a few.
Do not assume the US is going to get a substantial amount of vaccine first.
Pfizer is vaccinating its employees first. With world wide distribution for health care workers in the first quarter. No plans have yet been formulated for 'essential workers', but vulnerable populations are ahead of them. Initial release of the vaccine in the US is going to be healthcare workers only, pfizer considers its employees to be healthcare workers.
Then expanding to people over 55 (I just miss the cutoff). But I may be eligible on the basis of risk factors.

The excluded groups that have been announced so far are pregnant women and anyone with a viral infection.
Children may be excluded initially as well since none were included in the trial and they are not generally healthcare workers or a vulnerable population.
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[*] posted on 11-11-2020 at 00:44


Let's hope that the so-called 'cluster 5' mutated strain does not get out of Denmark. There is strong evidence that this new mutated virus does not (or at least much less so than the current virus) respond to the currently developed vaccines. If this new strain is going over the world, then we might be set back to where we were at the start of this year.

https://www.bbc.com/news/world-europe-54890229

In Denmark they decided to kill al 17 million minks they have in the country, but now there is a lot of protest and it seems that after killing part of these animals, the remaining ones are not culled.

In the Netherlands we also have quite a few mink-farms, albeit not so many as in Denmark. Nearly half of these farms were shut down in the last few months and in early 2021 the last mink-farm in the Netherlands will be shut down.

[Edited on 11-11-20 by woelen]




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[*] posted on 11-11-2020 at 10:11


Quote: Originally posted by macckone  
The myth that young people do not get ill is dangerous.
We are starting to find that they are suffering the same types of organ damage that adults do including brain damage.
That damage can occur in asymptomatic people.
Indeed. That myth has been widely spread by universities that are trying their hardest to avoid another move to online-only. I am only 22, but I don't want to take any chances with a disease that could potentially shorten my lifespan even if there aren't noticeable acute effects. I teach in-person organic chemistry lab and have had many students who have had to miss labs because of exposure and one student who actually tested positive. They wanted that student to come back to lab this week after only a ten day quarantine since the day that they tested positive. I wouldn't have it, and told the student that they could come to my other lab section next week instead. I'm still uncomfortable with that, but I don't have any say beyond that. They say they're taking the most stringent precautions, but it's still not enough in my opinion. It may suck for the handful students who have their graduation delayed because of it, but they can wait a year to take o chem lab...



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[*] posted on 11-11-2020 at 11:01


The Pfizer vaccine is being made in at least three places, 2 in Europe, and one or more in the US, with several more coming on board shortly.

"The European supply will come from BioNTech's manufacturing sites in Germany and Pfizer's site in Belgium. The EU deal follows agreements for 100 million doses in the U.S., 120 million doses in Japan and an undisclosed number of doses in Canada.

Pfizer aims to begin delivering doses of the experimental coronavirus vaccine before the end of the year. The pharma giant has scaled up manufacturing to do so, Chief Executive Albert Bourla said in a written statement."

https://www.investors.com/news/technology/coronavirus-vaccin...
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[*] posted on 11-11-2020 at 13:27


Quote: Originally posted by macckone  

The myth that young people do not get ill is dangerous.
We are starting to find that they are suffering the same types of organ damage that adults do including brain damage.
That damage can occur in asymptomatic people.


The media focus on deaths alone doesn't help either - if people were more aware of the long term effects on survivors, they might be more amenable to measures designed to slow or stop the spread of this virus.




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[*] posted on 11-11-2020 at 14:35


Sadly, the whole thing has been mired in politics, media crap, and stupidity. Clearly, until we have a vaccine and better treatments, the best solution is to stay away from crowds, wear a mask (over the mouth and nose) when near others, and try to keep some distance as best as possible. Some want to ignore it or claim it is a hoax, but unfortunately, other people think we should shut every business and stay in our house for a year. Neither is practical or reasonable, but using some sense would prevent the thing from going wild. I find it odd that some people who aree terrified of the virus are also terrified of the vaccine, you have to pick your battles, and I see the vaccine as safer than the virus, based on my experience.

The good news is that labs have got structures for most of the proteins in the virus, so finding small molecule treatments will eventually happen, but it usually takes 2 years to get a good lead and then 4-10 years to go through clinical trials, might be faster now, but hopefully the vaccine will buy us lots of time. I am optiomistic for it to work well due ot the data that I have seen on all of the various studies.
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[*] posted on 11-11-2020 at 21:38


Dr Bob,
I agree with the mired in politics.
The pfizer vaccine is really promising.
I just don't think they can meet the delivery timelines they are promising.
They may be able to get a EUA to speed things up but they previously said they would not apply for an EUA.

The safety results for moderna are a little more concerning due to the autoimmune response in at least one patient.
That could delay the vaccine and could even be a roadblock.
Although the vaccines are similar they are not identical which could mean different results.
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[*] posted on 13-11-2020 at 11:31


Pfizer said right in the release (see below) that it would file for a EUA, they are saying it will be available, ~12 million doses by early Dec. for healthcare workers. The news also said that most doses would be offered at a variety of drug stores and pharmacys in the US for free, but it implied that their would be some prioritization, and maybe a sign up appt. system, much like the one that the Covid tests are using. The plant in Kalamazoo is making most of the US and Canadian supply, the rest is coming from two plants in Europe for Europe, Asia, and other places. I agree that there are challenges, but I think they will be solved quickly given the enormous need for it to get out. Hopefully by Mar we can at least have vaccinated the highest priority people that want it.

'"Pfizer and BioNTech (NTGN) are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose."
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[*] posted on 13-11-2020 at 11:58


Does, in the USA, the manufacturer have anything to say about who can use the vaccine? For example Healthcare workers?
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[*] posted on 13-11-2020 at 14:12


Tsjerk,

To some extent they can. More importantly the government gets to decide.
For example the manufacturer can say we don't know if this is safe for pregnant women, children or those with viral infections.
The government won't allow the vaccine to be used in those groups.
The prioritization is controlled by the government as well.
Obviously the manufacturer is going to reserve doses for its employees.
They can't make the vaccine if there is an outbreak at the plant.
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[*] posted on 18-11-2020 at 11:01


Pfizer has already releazed their final data for the EUA request, it is stellar. 95% effective, works just as well in older people, only one person with the vaccine got seriously ill with covid verses 9 in the placebo group. That is enough to really stop the spread almost cold within a month of administration to anyone who can get it and wants it. They will have millions of doses ready to ship upon approval according to Pfizer, and claim that it will be at health care facilities within days of release by the FDA. SO hopefully the FDA people will work around the clock to get this approved, as thousands are dying a day just in the US, and this could stop it quickly.

https://www.pfizer.com/news/press-release/press-release-deta...
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[*] posted on 18-11-2020 at 13:01


Can somebody explain to me why they put luciferase in some of these vaccines?
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[*] posted on 18-11-2020 at 13:17


Where did you read that?
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[*] posted on 18-11-2020 at 14:41


It's used as a tracer in developing RNA vaccines; They put a segment encoding a luciferin in alongside the payload segment and any cell that takes up the payload should express a luciferin. I imagine the final vaccine won't contain the luciferin segment but I couldn't say that for sure.
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