Sciencemadness Discussion Board

Covid vaccine results

Dr.Bob - 9-11-2020 at 10:10

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...

macckone - 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.

OldNubbins - 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!

macckone - 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.

Dr.Bob - 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]

Tsjerk - 9-11-2020 at 12:54

Nice, not the first mRNA drug, but it will be the first mRNA vaccin.

Dr.Bob - 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.

cyanureeves - 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.

macckone - 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.

Dr.Bob - 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.

Twospoons - 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.

macckone - 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.

woelen - 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]

Texium - 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...

Dr.Bob - 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...

Twospoons - 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.

Dr.Bob - 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.

macckone - 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.

Dr.Bob - 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."

Tsjerk - 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?

macckone - 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.

Dr.Bob - 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...

karlos³ - 18-11-2020 at 13:01

Can somebody explain to me why they put luciferase in some of these vaccines?

Tsjerk - 18-11-2020 at 13:17

Where did you read that?

paulll - 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.

Dr.Bob - 26-11-2020 at 11:29

I just entered a vaccine study to test a vaccine in the clinic, so I may or may not have a vaccine shot, don't know yet. The best part is that once the study is done, I get a real vaccine shot anyway if not already done. So that will still be fairly fast, and help get fast study results for the new vaccines. If anyone wants to enter a trial, just google "covid vaccine trials" and your city. It was easy to register, and they are moving fast now, so quick to get a call back it seems. It is an even faster way to get a vaccine or at least a chance at it.

Mush - 12-12-2020 at 08:41

Australia has become the first country to abandon a vaccine attempt, scrapping a $750 million project after the shot wrongly gave some people positive HIV test results

https://www.businessinsider.com/coronavirus-vaccine-australi...

outer_limits - 12-12-2020 at 09:18

I hope the vaccination using those products will be worth it.

I am against of all anti-vaccine bullshit but...
coupled with economic ruin and efforts of governments to make it even worse - that looks scary.

karlos³ - 12-12-2020 at 15:38

I am really not convinced that pushing those vaccines so heavily and quick on the market is not causing more harm than benefit.
Like here, on page 6: https://www.fda.gov/media/144245/download
Quote:
there was a numerical imbalance of four cases of Bell’s palsy in the vaccine group compared with no cases in the placebo group


Calling that a numerical imbalance sounds to me like intentionally making it seem less of a problem than it really is.
I get immediately reminded of the desaster with the swine-flu vaccine "pandemrix" which caused many cases of irreversible narcolepsia in mostly young people who got vaccinated.

If I can say that without being attacked in turn for, me and neither anyone I spoke with about this, would want to get the vaccine, most said never, and the others, if they decide to get it, said definitely not at this very early stage.
The potential harm and possible benefits are, so to say, "numerical imbalanced" in my opinion, to use their mode of language.
Lets not forget that thalidomide was well researched and tested in animals before it hit the market, over years, and not rushed at all.... and it still resulted in such a desastrous scenario.

Honestly, that those vaccines are not only of a differently acting kind is one thing.
But that they rush their release so much to the extent of taking shortcuts instead of what was for a long time the common practice, this simply makes me uncomfortable.

Dr.Bob - 12-12-2020 at 17:05

Vaccine trials are well known in general, and Pfizer's has been tested on 20,000+ people so far, and works great, and shows few major side effects so far. Doing a much longer trial would not provide much more data, as there is a deminishing return with more people. If there was no hurry, it would be worth it, but given that 3000 people are dying each day, I think a certain amount of speed is indicated. And while I know that it mostly kills older and sicker people, it is both making a number of younger people sick or dead, plus the economic pain of people being afraid of going out of their house is creating massive stress for small and large businesses over the entire world, creating unemployment, cancelling events, etc.

So I can't imagine not giving people the chance of taking it if they want it. Given that healthcare workers and older/sicker people are the main priority now, I think that there will plenty of data from vaccinating them before it will be readily available for otherwise healthy and younger people. So there will be plenty of time to see how it does in others if you want to wait and see. But given that about 300,000 people have already died of this, their is very little chance of any serious side effects coming close to that number. If you look at the numbers, data, medical knowledge, taking the vaccine is really a simple decision to do. I've read almost every bit of data available, and even the worst vaccine (which I am in the trial for) still appears to prevent serious covid in most cases, have few serious side effects, and work well within about 2 weeks.

People do need to be aware that in any clinical trial on 44,000 people, there will be some issues, just like studying any group of 44,000 people for months. And since they tried to recruit people with existing health issues, older people, and essential workers likely to get Covid, there are almost certain to be people who get sick, die, or catch covid. Same way when they vaccinate people in bursing homes, there will be some who get sick or die, just like people do almost every day in nursing homes, where the average stay is about 6 months. So the media is likely to make a fuss, but the real data is looking for excess deathes, which there are a lot of these days.

Morgan - 12-12-2020 at 19:36

I saw something in the news on TV about India and some people there complaining the big corporations use their people for drug testing, maybe because it's less liability who knows ...
Whatever the case, it's sometimes true drug companies hide side effects or under report them and overstate their effectiveness while downplaying the dangers. When something too deleterious becomes apparent, it's taken off the market. i'm chagrined sometimes watching drug commercials in the US where serious side effects include death as they ramble on about liver and kidney failure, seizures, or other bizarre life threatening situations, the cure worse than the disease.

https://www.sciencemag.org/news/2020/11/india-needs-more-tra...

https://www.sciencemag.org/news/2020/12/malicious-and-miscon...

outer_limits - 12-12-2020 at 21:05
Quote:

So I can't imagine not giving people the chance of taking it if they want it.



The problem is that many people will be probably forced to do it, as vaccination will become mandatory and some services will be not available for those who refused.

Karlos mentioned "Pandemrix" which totally changed life of some young people.
At the time when this vaccine was released Health Minister of my country refused to use it as the clinical trials were not completed and the producer can't guarantee that using it is safe. And this is the case with Pfizer vaccine now. It's completely new, there is almost no safety information (as the research is not completed yet) and what's worse - if you will encounter any serious side effects you will be alone and nobody will help you (at least in my country).
So, from the perspective of mid 30s healthy man - when I will get infected (I am not sure if I didn't already...) the risk of complications is not very significant and probably I wouldn't need even any medical help. When I would take the vaccine which is not really tested I can develop some serious problems which could probably ruin my life and the only one who takes all the responsibility is me.
Those are not only my thoughts, there are many medical professionals who think in a same way.
If they will introduce any kind of discrimination for all that refused this one particular vaccination I would rather find the doctor who will dump it down the drain and give me (as well as my family) the certification.



karlos³ - 13-12-2020 at 10:42

Quote: Originally posted by outer_limits  

Those are not only my thoughts, there are many medical professionals who think in a same way.
If they will introduce any kind of discrimination for all that refused this one particular vaccination I would rather find the doctor who will dump it down the drain and give me (as well as my family) the certification.

My thoughts exactly too.
They are already discussing to keep people without a vaccination ID from entering supermarkets...
I am thinking of either having luck with my personal doctor who is a very integer person, or going to some shady doctor, maybe even offering money :o
I never thought that such a situation would ever occur in my life but suddenly it is all dystopian to an extent I never would have imagined.

Tsjerk - 13-12-2020 at 10:56

Quote: Originally posted by karlos³  

Lets not forget that thalidomide was well researched and tested in animals before it hit the market, over years, and not rushed at all.... and it still resulted in such a desastrous scenario.


Testing procedures have changed drastically since and because of the thalidomide disaster. I can't recall the details but they were enclosed in a college I was given in my biology years. The testing of thalidomide was done on many species but one, which would have showed the side effects before any human trails.

The thalidomide disaster gave a huge amount of insight in both biological mechanisms and testing procedures.

Let's not forget the thalidomide testing was done about 70 years ago.

[Edited on 13-12-2020 by Tsjerk]

Tsjerk - 13-12-2020 at 11:05

Please also remind all that the vaccine puts into your body is either something the (any) virus would put into your body, but without the pathogenic parts, or something that is part of any vaccin already tested on millions and millions of people.

As far as I know there is no vaccine that has ever caused serious side effects.

[Edited on 13-12-2020 by Tsjerk]

karlos³ - 13-12-2020 at 12:34

Quote: Originally posted by Tsjerk  

As far as I know there is no vaccine that has ever caused serious side effects.

Yet, but mRNA vaccines are something completely new.
I wouldn't trust them until they are widespread in use and shown to be harmless.
After a period of like, at least two years.
Nobody wants a second pandemrix-like accident happening.
Quote: Originally posted by Tsjerk  

As far as I know there is no vaccine that has ever caused serious side effects.

I really don't know, as someone being affected by narcolepsia I wouldn't sort this under non-serious side effects :/
And how many swedes got affected, was it 7.000 people who reported those side effects?
I would really call this a serious issue... a life disturbing one, and I hope not to step any boundaries, but possibly life ruining one even.
And those who suffer from that suddenly first require to get a specific treatment and doctors who accept this are rare.
Being tired and never feeling like getting enough sleep on EVERY morning is really not something I would call not serious :/

[Edited on 13-12-2020 by karlos³]

outer_limits - 13-12-2020 at 12:59

Quote: Originally posted by karlos³  
Quote: Originally posted by Tsjerk  

As far as I know there is no vaccine that has ever caused serious side effects.

Yet, but mRNA vaccines are something completely new.
I wouldn't trust them until they are widespread in use and shown to be harmless.


Using a well known IT words - they will do the tests on production.
Which means literally that the whole vaccinated population will be their test group, despite those who participated in clinical trials.
2 or 3 years minimum, I totally agree with karlos.

Tsjerk - 13-12-2020 at 13:44

I didn't know about the pandemrix side effects yet... They suck. Apparently the real flu would give the same narcolepsy side effect.

Although mRNA vaccins are new, mRNA drugs aren't.

macckone - 13-12-2020 at 16:39

Tsjerk,
The statement that no vaccine has ever caused serious side effects is clearly false.

Live weakened viruses can cause disease and the polio vaccine has caused outbreaks.
Vaccines primarily cause immune over response.
The dengue fever vaccine in particular can only be given after the person has had dengue fever once or it can lead to a life threating reaction when exposed to the live virus.
Some vaccines contain things that cause allergic reactions in some people. anaphalaxis and death are pretty serious.
The ebola vaccine can cause fetal abnormalities in pregnant women.

The list of potential problems that can happen with a vaccine is endless.
The new covid vaccines have shown the potential for triggering autoimmune syndrome.
Of course the virus has shown that potential as well as have many other viruses.

But that means some people will be very negatively impacted.
The real question is if it is safer for the vast majority of people.
The pfizer covid vaccine is not yet approved for pregnant women or children in the US.
It has shown a lower incident of immune issues than the moderna vaccine.

Considering the virus kills upwards of 4% of people, and only a handful of serious side effects out of 30+ thousand people, both vaccines are considerably safer than the virus.
The misconception that children don't die or that only people with risk factors die is clearly false.
Additionally a large percentage of covid victims experience life threating long term issues.
A coworker that had the virus now has both kidney and liver damage.
The kidney damage is recovering but his liver issues are worsening 4 months later.



[Edited on 14-12-2020 by macckone]

[Edited on 14-12-2020 by macckone]

paulll - 13-12-2020 at 17:12

"The misconception that children don't die or that only people with risk factors die is clearly false."
I'd add to that, that,"young, perfectly healthy," people would be well-advised not to get in a vehicle accident or tangle with gravity or be the victim of violent crime for the foreseeable future, because the safety net that you're used to having available to you is fouled-up and unavailable.

outer_limits - 16-12-2020 at 07:18

https://www.cnbc.com/2020/12/14/pfizers-ceo-hasnt-gotten-his...

He claims he's healthy 59 and doesn't need the vaccine. The governments and airlines want to vaccinate everyone.
He could say that he got it or get the vaccine in public, even if it will be sodium chloride solution (assuming that he's so honest and really don't want to cut the line).
It be a risky move as it could be compromised.
Now he made a great move - he won't get the vaccine because of other people's needs.
I don't trust people, especially when there is a lot of money

wg48temp9 - 17-12-2020 at 05:31

What is in the vaccine that causes an allergic reaction in some people?

Thought the vaccine was an oil emulsion with the oil containing the RNA. I guess the allergic reaction could be to the RNA or oil but that seems unlikely.

Dr.Bob - 17-12-2020 at 19:59

If you are allergic to mRNA you would be very sick, as your body makes it comstantly. Likely there is some compoent of the liquid that the mRNA is dissolved in. There are risks to every single thing you do or don't do. A meteor could come kill you any time, a drunk could run you down, etc. But scientificly evaluating risk is something that people do very poorly.

For older people or people with health issues, Covid can be very serious. For children or young people, it is pretty rare to cause serious issues, which is why they avoided testing it in children at first. (This is the opposite of many childhood diseases that can kill children but are not so bad for adults.) So people under 16 won't be vaccinated for a while. And pregnent women are rarely tested for anything, so they just need to get a shot before getting pregnent or wait until after the baby is born. But if the people around them vaccinate, then they will be much safer, since most covid come from friends and family.

I'm perfectly happy to let people opt out of vaccination, at least until everyone who wants it gets it. After that, it will be a while before the vaccine gets full approval, and it is doubtful that companies and schools can mandate any vaccine under emergency use, other then a few small groups. But I do think that in the future, if you want to travel internationally, take a cruise, or many other activities, you may eventually need to get it, at least until it gets under control. Also, about 20% of the US has likely been exposed to Covid already, so we may find that herd immuinity comes easier now, since they will have some immunity already.

ordenblitz - 17-12-2020 at 21:16

I appreciate the folks that are wary of taking this new unproven vaccine because for every one of you, I get moved up a little farther in the line. Thank you!

wg48temp9 - 18-12-2020 at 00:13

I have found the list of excipients in the vaccine. From www.gov.uk:

ALC-0315 = (4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate)
ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
1,2-Distearoyl-sn-glycero-3-phosphocholine
cholesterol
potassium chloride
potassium dihydrogen phosphate
sodium chloride
disodium hydrogen phosphate dihydrate
sucrose
water

Apparently the ALC-0315 and ALC-1559 are synthetic lipids (oil) so I guess it could be the oil that that triggers the allergic reaction in a few (<1 in 1,000) people.

Dr Bob@ yes I have lots of RNA in my body but I doubt and hope the sequence is not the same as the RNA in the vaccine. I also know a woman who is allergic to her own mitocondria. As most of her mitochondria are inside her cells and therefore hidden from her immune system its not a big problem for her.

I will be taking the vaccine unfortunately it will probably not be available to me for a several months.

Tsjerk - 18-12-2020 at 01:15

Those are some special lipids, they allow for fusion of the lipid bilayer of the nano-particles (liposomes) the mRNA is packaged in and the lipid bilayer of our cells. Only that way you can get the mRNA into the cell.

I now also understand the question Karlos asked somewhere around here, he asked why there was luciferase in these vaccins. There indeed was luciferase and luciferase encoding mRNA used in experiments around the lipids to be used. Luciferase is a nice marker protein, as it catalyses a light emitting reaction, and there are very specific antibodies against luciferase, allowing for northern blots. I can also imaging there are luciferase antibody antibodies.


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zed - 9-4-2021 at 23:39

Covid vaccine? Yeah, I got a shot, and I'm damned glad I did.

My State in the USA, has had less COVID deaths than a lot of other States, but we have had just plenty of hospitalizations and deaths. Moreover, plenty of people have suffered from permanent lung damage, and other complications.

Currently, the State is reporting about 500 new infections per day. Everyday, approximately 20 people die.

Usually, about half of the reported new cases and deaths, are in Portland, and I live in Portland.

I also have a lot of miles on me. Meaning.... I'm not young. And, not being privy to the kind of care members of congress get, if I got really sick, it could go very badly.

Do I like getting vaccinations? F*** NO!

Did I get one? F*** YES!

Nothing to it. Put on a mask. Drive through the vaccination site with your paperwork.

Roll down your car window, present your shoulder, and Bingo! You're vaccinated!

You are sent to a waiting area, for observation, and provided you don't have an allergic reaction, thirty minutes later, you are back on the road.

There was a sore spot on my shoulder for a few days. I experienced no other problems, and no observable side-effects.

In a few weeks, I'm going back for a second shot. World, here I come!

I've had enough of being cooped up.

P.S....... Oh yeah. I was the Pfizer Vaccine.

[Edited on 10-4-2021 by zed]

Pfizer

MadHatter - 10-4-2021 at 06:46

Zed, got my 2nd shot of Pfizer vaccine
yesterday. Like the 1st shot my shoulder
is a little tender but that'll pass.

WGTR - 10-4-2021 at 09:55

I got the Janssen single shot, and I’m glad that is over with. My parents also got it, and in a couple of weeks we can spend more time together without worrying about things.

I had more side effects than the usual person, I think. I felt pretty good for a few hours, then became extremely tired, like I was on antihistamines. This lasted a few days. The day after the shot, I developed body aches and mild fever that lasted for a day or so. I slept 24 hours that day.

It’s possible that I already had COVID before and was asymptomatic. I spent time with a neighbor one month ago who tested positive that next morning. We spent maybe a hour sitting next to each other about 2 feet apart. I never had any symptoms and tested negative at the time. Either I was asymptomatic and had a false negative test, or already had the illness before and was immune.

I wonder if you have already had the illness, if you get the vaccine are you more likely to get side effects? Like anything else, I imagine that the answer is, “it depends”.

violet sin - 11-4-2021 at 11:37

My second shot of moderna was on Wednesday.

My shoulder hurt, but it was on lunch time and there were more warehouse duties before the day was over. Each time I had 4 hrs of stacking and packing boxes from pallets. No headache etc. beyond my allergies with the field grass drying out here.

I'd say ouch if you pushed the spot of the shot.. really, no complaints here.

My mother doesn't want the shot and my son it going back to school in person. He started 1st grade online and fingers crossed, never has to deal with this again. One can hope anyhow.

Texium - 11-4-2021 at 11:59

Quote: Originally posted by WGTR  
I wonder if you have already had the illness, if you get the vaccine are you more likely to get side effects? Like anything else, I imagine that the answer is, “it depends”.
I have read that that is a likely trend, and it is backed up by the anecdotes that I have heard. People I know who had covid have all seemed to have the more unpleasant side effects while those who didn't have been fine.

I am curious to see how I fare with the vaccine (I am scheduled for next week, though I don't know yet which one I'll be getting). Early last March I was sick for a few days after coming home from visiting Utah for a recruitment weekend. It was before mask-wearing was widely accepted, and it wasn't even known to the public at that time that the virus was already spreading in the US. Thus I had flown on a plane, and gone to restaurants and bars with virtually no precautions taken. Since testing wasn't available yet at that time, I have no idea whether I had it or if it was just a common cold.

pantone159 - 11-4-2021 at 12:22

I got my second Pfizer shot last Thursday. For both, I had a sore arm and felt a little off for a day or so, but nothing that stopped me from doing anything. I now have both an old and new school vaccine card, first the Yellow Card for yellow fever (which has been required for some international travel for a long time), and now the new USA CDC COVID card (not necessarily accepted internationally).

It is very nice to have a fixed date on the calendar when I can treat life normally. I just had a campout with a big group of friends, we had not seen many of them in person for the past year, and most everybody had at least partial vaccination, and with being outdoors, it was possible to act normal again in a group for the first time since last March. It will be good to wear masks indoors until everybody has a chance to get the shot, to set a good example if nothing else, but I am used to that part now.

Elemental Phosphorus - 11-4-2021 at 12:24

While this is only tangentially related, one thing that worries me about current vaccines is the focus on the spike protein, because when the spike protein mutates, the vaccines may be less effective. As I understand it, the mRNA sequence in Pfizer and Moderna vaccines codes for the coronavirus spike protein, and then the immune system learns to recognize it. The viral vector vaccines like J&J and Sputnik V also seem to code for the spike protein, but using an adenovirus to deliver that genetic code instead.

Most vaccines have reported a significantly reduced efficacy against the B.1.351 variant (South African variant), most likely because antibodies that are made to bind the original 'wild type' spike protein are less effective at binding these mutated spike proteins.
AstraZeneca reported much lower efficacy against the variant, J&J reported efficacy of 57% as opposed to 72% against wild type virus, Novavax reported 60% against B.1.351 as opposed to 96% against wild type. In a 'in vitro' trial, Pfizer reported antibodies as having about 10x less neutralizing activity against B.1.351, although their human trial in South Africa so far seems to be reporting positive results.

It seems like some scientists think that because of the focus on antibody production against the spike protein, even a minor change in the spike decreases antibody neutralizing activity, and these vaccines (mRNA vaccines and viral vector vaccines that code for the spike, and the Novavax vaccine which contains spike proteins attached to nanoparticles) tend to focus on teaching the immune system to recognize and destroy the spike protein rather than other parts of the virus or the virus as a whole, and this approach gives lots of antibodies (which seem to protect pretty well) and relatively less of a response from T cells and other immune cells. This worries me a bit since antibody neutralizing activity seems to decrease significantly against certain variants of Covid-19 but apparently T cells still recognize all of the variants quite well (https://www.reuters.com/article/idUSKBN2BM3B1)

All of the vaccines still seem to be quite good at preventing hospitalization and death, even from the variants, but I would worry that eventually a variant may emerge which escapes immune protection more thoroughly, because all of the vaccines available in the West currently seem to target the spike protein.

One piece of good news though, is that the inactivated virus vaccine made by Sinopharm appears to retain pretty good efficacy against the B.1.351 variant in vitro, they claim that neutralizing activity only decreased by 1.6 times in a study:

https://www.biorxiv.org/content/10.1101/2021.02.01.429069v1....

Also good news, is that possibly more vaccines are being developed for COVID-19 than for any other disease ever (except maybe the flu?) and other vaccines which claim to be able to induce better immunity against parts of the virus other than just the spike are in the pipeline, some are using viral vectors that code for multiple pieces of the virus, some are directly injecting other viral proteins, etc.

One vaccine that interested me was this one that contains 11 different viral proteins that are apparently less likely to mutate (I don't know enough about virology to comment on that) and supposedly produces good T cell responses as well:
https://www.biospace.com/article/releases/ose-immunotherapeu...

The Pasteur institute and a company called TheraVectys are developing a nasal spray viral vector vaccine, rationale being that since the SARS-CoV-2 virus tends to infect through the respiratory tract, the best place to produce an immune response would be the respiratory tract. They claim that it was almost completely protective in monkeys, so that's another exciting development. The press release is here, if anyone is interested:
https://www.pasteur.fr/en/all-sars-cov-2-covid-19-institut-p...


On an unrelated note, I received my first shot recently (Pfizer). I am pretty young, but I got a message saying that I was eligible (I had previously pre-registered) so I went ahead and got it. Noticed no ill effects other than a sore arm and maybe a little tiredness, but it could have been because I was not sleeping well.
Sharp contrast with a meningitis vaccine that I received about a month ago, which had my arm extremely sore for most of a week, and gave me about a day and a half of fever and chills. I guess a lot of it is up to chance.

I wonder if the risk of a live attenuated virus vaccine (which usually tend to produce a robust T cell and good all-around immune response) would be low enough in already-vaccinated people to justify the slight risk of an infection.



Pfizer Covid-19 Vaccine

MadHatter - 12-4-2021 at 14:12

3 days after my 2nd shot and no ill effects.
Even my shoulder stopped hurting. :D

zed - 13-4-2021 at 06:22

Well, I slept and slept, after my vaccination. Wasn't really tired or anything. Just felt good to sleep.

I just felt relaxed and good. De-stressed. Sleeping from relief?

I'm expecting to need some boosters bye and bye.

Perhaps we were lucky that this pandemic has been relatively mild.

As terrible as it has been; it could have been a lot worse.

Good preparation for the next one. A learning experience.

I've learned a lot about protective gear. Not to mention, keeping some food in reserve.