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13 minutes ago, Corraleno said:

So Astra Zeneca just released some data, and it's... weird. Since the trial with an initial half-dose seems to have been much more effective, they are going to try to test that further in new trials.

The preliminary results on the AstraZeneca vaccine were based on a total of 131 Covid-19 cases in a study involving 11,363 participants. The findings were perplexing. Two full doses of the vaccine appeared to be only 62% effective at preventing disease, while a half dose, followed by a full dose, was about 90% effective. That latter analysis was conducted on a small subset of the study participants, only 2,741.

https://www.statnews.com/2020/11/23/astrazeneca-covid-19-vaccine-is-70-effective-on-average-early-data-show/

Yeah, I saw that and I was wondering if there was a typo somewhere!!! It's bizarre. 

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23 minutes ago, Corraleno said:

So Astra Zeneca just released some data, and it's... weird. Since the trial with an initial half-dose seems to have been much more effective, they are going to try to test that further in new trials.

The preliminary results on the AstraZeneca vaccine were based on a total of 131 Covid-19 cases in a study involving 11,363 participants. The findings were perplexing. Two full doses of the vaccine appeared to be only 62% effective at preventing disease, while a half dose, followed by a full dose, was about 90% effective. That latter analysis was conducted on a small subset of the study participants, only 2,741.

https://www.statnews.com/2020/11/23/astrazeneca-covid-19-vaccine-is-70-effective-on-average-early-data-show/

The Asian Boss video I linked above talks about how vaccine developers will be able to tweak the efficacy numbers higher with some fine tuning of dosing, boosters, and timing after the initial safety trials are over. 

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4 hours ago, PeterPan said:

I thought part of the gig with Trump's fast tracking was that he has PRE-BOUGHT millions of doses. I don't see how the manufacturer is going to have any to ship around the world. Or maybe they have other branches? I don't know. I was just under the impression these vaccines are tedious to manufacture.

Australia is building a facility for manufacturing vaccine and has agreements with several of the vaccine companies to manufacture their vaccine under license.  I imagine other countries with the capacity will do similar.  

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This is one possible explanation of why an initial half dose may have worked much better than a full dose:

[The AZ vaccine] uses an adenovirus that has been modified to include genetic material from the SARS-CoV-2 virus so that it introduces the immune system to the spike protein, which sits on the exterior of the virus. Some experts had feared that if viral-vectored vaccines required a priming and then a boosting dose, the immune system might recognize the viral vector — in this case the adenovirus — and shut down the immune response before the vaccine has a chance to boost the response to the spike protein. Fauci said the smaller initial dose may “tickle” the immune system enough to generate T cells, but not trigger development of antibodies that might work to suppress the response to the booster shot.

If further trials show that the half dose protocol is 90% effective, as the preliminary trial showed, then that would be awesome news, especially for poorer countries, because this vaccine can be stored at regular refrigerator temperatures for up to 6 months, and AZ is selling it at cost, which is $3-4 per dose. They can also produce far more of this vaccine than the mRNA ones — AZ says they can produce 3 billion doses in 2021, vs 1.3 billion of Pfizer's and "500 million to 1 billion" of Moderna's. 

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7 minutes ago, Corraleno said:

This is one possible explanation of why an initial half dose may have worked much better than a full dose:

[The AZ vaccine] uses an adenovirus that has been modified to include genetic material from the SARS-CoV-2 virus so that it introduces the immune system to the spike protein, which sits on the exterior of the virus. Some experts had feared that if viral-vectored vaccines required a priming and then a boosting dose, the immune system might recognize the viral vector — in this case the adenovirus — and shut down the immune response before the vaccine has a chance to boost the response to the spike protein. Fauci said the smaller initial dose may “tickle” the immune system enough to generate T cells, but not trigger development of antibodies that might work to suppress the response to the booster shot.

If further trials show that the half dose protocol is 90% effective, as the preliminary trial showed, then that would be awesome news, especially for poorer countries, because this vaccine can be stored at regular refrigerator temperatures for up to 6 months, and AZ is selling it at cost, which is $3-4 per dose. They can also produce far more of this vaccine than the mRNA ones — AZ says they can produce 3 billion doses in 2021, vs 1.3 billion of Pfizer's and "500 million to 1 billion" of Moderna's. 

That would make sense.  The lower cost would be a huge benefit and hopefully make it much more affordable.  Good on Astra Zeneca.

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8 minutes ago, Corraleno said:

This is one possible explanation of why an initial half dose may have worked much better than a full dose:

[The AZ vaccine] uses an adenovirus that has been modified to include genetic material from the SARS-CoV-2 virus so that it introduces the immune system to the spike protein, which sits on the exterior of the virus. Some experts had feared that if viral-vectored vaccines required a priming and then a boosting dose, the immune system might recognize the viral vector — in this case the adenovirus — and shut down the immune response before the vaccine has a chance to boost the response to the spike protein. Fauci said the smaller initial dose may “tickle” the immune system enough to generate T cells, but not trigger development of antibodies that might work to suppress the response to the booster shot.

If further trials show that the half dose protocol is 90% effective, as the preliminary trial showed, then that would be awesome news, especially for poorer countries, because this vaccine can be stored at regular refrigerator temperatures for up to 6 months, and AZ is selling it at cost, which is $3-4 per dose. They can also produce far more of this vaccine than the mRNA ones — AZ says they can produce 3 billion doses in 2021, vs 1.3 billion of Pfizer's and "500 million to 1 billion" of Moderna's. 

Interesting. I'd want more data to know whether the 90% is a fluke, though. It's a little suspicious, although the explanation makes it more plausible. 

 

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I believe there is at least one other candidate well along with the testing.  I read on the web site of the local newspaper (Cali, Colombia) a few weeks ago that about 500 people in Cali are participating in a trial. Total number of worldwide participants is about 30 K or 40 K people as I recall. I think that's the Johnson and Johnson vaccine. Those trials will continue for 2 or 3 years now.

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6 minutes ago, Lanny said:

I believe there is at least one other candidate well along with the testing.  I read on the web site of the local newspaper (Cali, Colombia) a few weeks ago that about 500 people in Cali are participating in a trial. Total number of worldwide participants is about 30 K or 40 K people as I recall. I think that's the Johnson and Johnson vaccine. Those trials will continue for 2 or 3 years now.

Novovax is in Phase 3.  I’ve seen several people posting about receiving first dose as part of the trial last week.  If they do preliminary analysis as early in the piece as others there might be data out fairly quickly.

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My son is in the Pfizer/BioNtech trial. It requires two shots about 21-28 days apart. It needs to be kept at -112 and takes 30 minutes to thaw. DS had to be on site and wait the 30 minutes. It was *not* the trial that had an issue and shut down for a short time. The second dose was the one that caused short term Covid-like side effects in some participants, although DS did not have any. He may have had the placebo though, since it's double blind. They are hoping to be able to start vaccinations by mid-December and planning to make it widely available by April and they applied for emergency FDA approval last Friday.

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2 minutes ago, mom2scouts said:

My son is in the Pfizer/BioNtech trial. It requires two shots about 21-28 days apart. It needs to be kept at -112 and takes 30 minutes to thaw. DS had to be on site and wait the 30 minutes. It was *not* the trial that had an issue and shut down for a short time. The second dose was the one that caused short term Covid-like side effects in some participants, although DS did not have any. He may have had the placebo though, since it's double blind. They are hoping to be able to start vaccinations by mid-December and planning to make it widely available by April and they applied for emergency FDA approval last Friday.

Thx to your son for participating!

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@Lanny

https://www.health.gov.au/news/health-alerts/novel-coronavirus-2019-ncov-health-alert/vaccines-and-treatments/australias-vaccine-agreements

I found a summary of the various vaccine agreements the Australian government has.  I wonder if there’s anything similar for Colombia?

It looks like Astra Zeneca is the only one we currently have an agreement for local manufacture.  

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2 hours ago, Corraleno said:

Moderna and Pfizer have pre-sold most of their doses already. Which vaccines Colombia gets, and when, depends on which companies the government there placed preorders with and what the timeframe is in their contract. The US pre-ordered 100 million doses of each, with an option to buy an additional 400 million doses of Moderna and I think another 500 million from Pfizer. They also preordered 300 million doses of Astra Zeneca. If the AZ vaccine is as effective as the mRNA vaccines, then it's possible that the US won't exercise the options on the additional Moderna and Pfizer doses, since the AZ vaccine is vastly cheaper. 

And just to work my little brain, you think this is doses, as in divide by 2 or 3 to get the number of people it will actually treat, right?

2 hours ago, Corraleno said:

Moderna and Pfizer will each have 20 million doses available in the US by the end of December, which is enough to vaccinate 20 million people. Alex Azar said he expects to have enough vaccine to cover everyone in the US who wants it by the end of the 2nd quarter.

Which may be why the cruise restrictions go till Nov...

 

 

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Article in NYT today on vaccine distribution — FDA will be meeting to appprove the Pfizer vaccine on December 10th, and there are 6.4 million doses ready to go out immediately upon approval. Vaccine will be allocated to states based on adult population size, and states will then determine who gets it. First doses expected to go to HCW and possibly others who are especially vulnerable. After the initial distribution, there will be weekly shipments after that, and they hope to have 40 million doses by the end of December (so enough for 20 million people). Half of those doses will be coming from Moderna, who are expected to file for approval shortly. There are around 18 million HCWs, so that should (theoretically) cover them plus a couple million others. 

https://www.nytimes.com/2020/11/24/world/pfizer-vaccine-distribution.html

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I talked with a friend who is a doctor and thus will be among the first in line for the mRNA vaccines, and she said she'll take it because of her exposure at work, but wants to wait for a non-mRNA vaccine for her children. 

mRNA technology is brand new, right? And it's not DNA, but it's still genetic material/instructions injected into the body. The theory is it will only replicate in a limited number of cells, but we don't really know that for sure with a few months' data. And the risks for young people with their reproductive years ahead of them, and more years to develop cancer, are different than for older people for whom Covid is a much greater risk. 

There are dozens of vaccines in the works. Availability will vary by region and population, but personally I'd like to wait for a vaccine using tried-and-true technology, rather than something brand new that's superfast-tracked due to pandemic. If my family included health care workers or high risk individuals my risk/benefit calculation might look different, and I might jump at any chance for vaccination asap. 

Given our health status and ability to distance, we're going to hold out a few months and see how things shake out.

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9 minutes ago, Acadie said:

I talked with a friend who is a doctor and thus will be among the first in line for the mRNA vaccines, and she said she'll take it because of her exposure at work, but wants to wait for a non-mRNA vaccine for her children. 

mRNA technology is brand new, right? And it's not DNA, but it's still genetic material/instructions injected into the body. The theory is it will only replicate in a limited number of cells, but we don't really know that for sure with a few months' data. And the risks for young people with their reproductive years ahead of them, and more years to develop cancer, are different than for older people for whom Covid is a much greater risk. 

There are dozens of vaccines in the works. Availability will vary by region and population, but personally I'd like to wait for a vaccine using tried-and-true technology, rather than something brand new that's superfast-tracked due to pandemic. If my family included health care workers or high risk individuals my risk/benefit calculation might look different, and I might jump at any chance for vaccination asap. 

Given our health status and ability to distance, we're going to hold out a few months and see how things shake out.

I might be misunderstanding here, but ANY virus is genetic material inserted into the body, no? Viruses have genetic material. 

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10 minutes ago, Not_a_Number said:

I might be misunderstanding here, but ANY virus is genetic material inserted into the body, no? Viruses have genetic material. 

This is a new way of doing so. I'm not totally reassured by this JAMA update that says the "chance of integration into human DNA is believed to be very low."

I'd like to wait and see how this plays out. And again, if work exposure or risk factors were different in my family I might make a different risk-benefit calculation. 

https://jamanetwork.com/journals/jama/fullarticle/2770485

"Gene-based vaccines take a different tack. They carry the genetic instructions for the host’s cells to make the antigen, which more closely mimics a natural infection. In the case of coronaviruses, the antigen of interest is the surface spike protein the virus uses to bind and fuse with human cells. “You’re not giving them the protein—you’re giving them the genetic material that then instructs them how to make that spike protein, to which they make an antibody response that hopefully is protective,” University of Pennsylvania vaccinology professor Paul Offit, MD, explained in a JAMA livestream in June...

Speaking at the July 27 media briefing, Collins addressed concerns: “Yes, we’re going fast. But, no, we are not going to compromise safety or efficacy.” Experts say several factors argue for mRNA vaccines’ safety. For one, mRNA can’t cause an infection. It also doesn’t enter the cell’s nucleus, so the chance of its integration into human DNA is believed to be very low. In addition, the body breaks down mRNA and its lipid carrier within a matter of hours, assuaging some concerns about long-term risks."

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Just now, Acadie said:

This is a new way of doing so. I'm not totally reassured by this JAMA update that says the "chance of integration into human DNA is believed to be very low."

Right, but is there any reason to assume that this is worse than viruses, who themselves inject their genetic material into your cells? How is it actually different in terms of how your cells interact with it? 

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15 minutes ago, Not_a_Number said:

Right, but is there any reason to assume that this is worse than viruses, who themselves inject their genetic material into your cells? How is it actually different in terms of how your cells interact with it? 

I don't think the question is which is worse, mRNA vaccine or COVID, because many other vaccines are in the pipeline and will be available soon. And I'm not making assumptions mRNA is worse, simply that it's unknown.

We can't all get the first round of mRNA vaccines, and I'm willing to wait. 

 

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1 minute ago, Acadie said:

I don't think the question is which is worse, mRNA vaccine or COVID, because many other vaccines are in the pipeline and will be available soon. And I'm not making assumptions mRNA is worse, simply that it's unknown.

We can't all get the first round of mRNA vaccines, and I'm willing to wait. 

I'm not arguing about COVID... I just thought that the only difference was the delivery. Isn't it the case that a virus-based vaccine just uses a different virus to inject the same genetic material into our cells? 

Here's a relevant article:

https://cen.acs.org/pharmaceuticals/vaccines/Adenoviral-vectors-new-COVID-19/98/i19#:~:text=The engineered viruses%2C called adenoviral,into thinking it's been infected.

And a quote: 

"The engineered viruses, called adenoviral vectors, are designed to shuttle a gene from SARS-CoV-2, the novel coronavirus that causes COVID-19, into our bodies where our cells will read it and make coronavirus spike proteins." 

I'm really not seeing a difference between different entities inserting the same genetic material into our cells. Am I misunderstanding something? 

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 This is a terrific article on the history of mRNA vaccines.  And here is a Nature article from 2018 on the technology.  

I share some of Acadie's initial concerns about the mRNA vaccines but am definitely looking forward to learning more about them, as I'm sure we all will in the coming months.  I doubt that these particular vaccines are going to wind up being offered to kids, at least, anyway, and maybe not even to the general public.  The vaccine landscape is going to look quite different by next summer.

Oh, I also recommend the interview with virologist Shane Crotty at about the hour point here, about a very large study on immune persistence.  Gist of it is that so far there seems to be very good evidence for a long-lasting immune response to the virus, and he had the clearest explanation I've heard for why vaccines can and often do produce a much better immune response than does natural infection.  

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1 minute ago, JennyD said:

 This is a terrific article on the history of mRNA vaccines.  And here is a Nature article from 2018 on the technology.  

I share some of Acadie's initial concerns about the mRNA vaccines but am definitely looking forward to learning more about them, as I'm sure we all will in the coming months.  I doubt that these particular vaccines are going to wind up being offered to kids, at least, anyway, and maybe not even to the general public.  The vaccine landscape is going to look quite different by next summer.

Oh, I also recommend the interview with virologist Shane Crotty at about the hour point here, about a very large study on immune persistence.  Gist of it is that so far there seems to be very good evidence for a long-lasting immune response to the virus, and he had the clearest explanation I've heard for why vaccines can and often do produce a much better immune response than does natural infection.  

A quote: 

"The use of mRNA has several beneficial features over subunit, killed and live attenuated virus, as well as DNA-based vaccines. First, safety: as mRNA is a non-infectious, non-integrating platform, there is no potential risk of infection or insertional mutagenesis."

If I'm not misunderstanding, this is saying that an mRNA vaccine is LESS likely to integrate into our genes than a different kind of vaccine. And that makes sense, since we carry insertions from viruses in our DNA already -- viruses DO integrate into our genes. 

@maize, is this your area of expertise or no? I may be misunderstanding something here, because I'm not an expert, but I'm not understanding the concern. 

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8 hours ago, Acadie said:

I talked with a friend who is a doctor and thus will be among the first in line for the mRNA vaccines, and she said she'll take it because of her exposure at work, but wants to wait for a non-mRNA vaccine for her children. 

mRNA technology is brand new, right? And it's not DNA, but it's still genetic material/instructions injected into the body. The theory is it will only replicate in a limited number of cells, but we don't really know that for sure with a few months' data. And the risks for young people with their reproductive years ahead of them, and more years to develop cancer, are different than for older people for whom Covid is a much greater risk. 

There are dozens of vaccines in the works. Availability will vary by region and population, but personally I'd like to wait for a vaccine using tried-and-true technology, rather than something brand new that's superfast-tracked due to pandemic. If my family included health care workers or high risk individuals my risk/benefit calculation might look different, and I might jump at any chance for vaccination asap. 

Given our health status and ability to distance, we're going to hold out a few months and see how things shake out.

Yes it’s new.  I think the adenovirus vaccine tech is pretty new as well.  None of the older style vaccines have come through yet.  Most likely they will be safe but I’m in the same position where I may wait for the kids.  Low risk for now here, low risk for them anyway and it’s not yet proven that any of these vaccines prevent the spread so no certain benefit in terms of protecting parents etc.  But I think by the time any of them become available to us who will be well down the line in terms of risk we will have a lot more data anyway.

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https://www.abc.net.au/radio/programs/coronacast/is-the-oxford-vaccine-worse-than-the-other-ones/12916230
 

coronacast had some good discussion comparing the vaccines today, mostly focussed on Astra Zeneca.  I think there’s a transcript for anyone who like me prefers to skim read.

 

“So this is the problem, releasing by press release. And what they did in this press release was really naughty. They gave an average of 70% but it was an average over two separate trials. You can't do that, you cannot average two separate trials with different objectives, different doses and so on and say your average was 70%, and you can only assume that what they were trying to hide was that the full dose trial which was the larger of the two was actually quite disappointing compared to the 90%, 95% results that Pfizer and Moderna have been reporting for the mRNA vaccine. 
Where they get the average coming up a bit is actually what at first sight seems counterintuitive. So you've got one trial which is a big one, which is two full doses, and you've got a smaller trial where they did a half dose to begin with and then a full dose about a month later. And what they got with that one was 90%”

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On 11/23/2020 at 1:20 PM, Corraleno said:

Moderna and Pfizer will each have 20 million doses available in the US by the end of December, which is enough to vaccinate 20 million people. Alex Azar said he expects to have enough vaccine to cover everyone in the US who wants it by the end of the 2nd quarter.

 

Moderna and Pfizer have pre-sold most of their doses already. Which vaccines Colombia gets, and when, depends on which companies the government there placed preorders with and what the timeframe is in their contract. The US pre-ordered 100 million doses of each, with an option to buy an additional 400 million doses of Moderna and I think another 500 million from Pfizer. They also preordered 300 million doses of Astra Zeneca. If the AZ vaccine is as effective as the mRNA vaccines, then it's possible that the US won't exercise the options on the additional Moderna and Pfizer doses, since the AZ vaccine is vastly cheaper. 

This morning, on the web site of the largest newspaper in Cali, Colombia (El Pais), today is 25 November 2020, there is an article. Colombia expects to begin receiving the vaccines during the 2nd quarter of 2021.  They have contracted with COVAX (possibly Spanish acronym) for 20 million dosis and they have contracts for or options or negotiations with 6 companies at this time, for another 10 million dosis. Total is for 15 million people. They expect to get 20 million dosis from COVAX and buy the other 10 million dosis from the labs. The Colombian government will pay for the vaccines. The first priority will be for people over 60, health care workers, etc.  This link is in Spanish:

https://www.elpais.com.co/colombia/ya-tenemos-aseguradas-20-millones-de-dosis-de-vacuna-contra-covid-19-minsalud.html

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5 hours ago, Lanny said:

This morning, on the web site of the largest newspaper in Cali, Colombia (El Pais), today is 25 November 2020, there is an article. Colombia expects to begin receiving the vaccines during the 2nd quarter of 2021.  They have contracted with COVAX (possibly Spanish acronym) for 20 million dosis and they have contracts for or options or negotiations with 6 companies at this time, for another 10 million dosis. Total is for 15 million people. They expect to get 20 million dosis from COVAX and buy the other 10 million dosis from the labs. The Colombian government will pay for the vaccines. The first priority will be for people over 60, health care workers, etc.  This link is in Spanish:

https://www.elpais.com.co/colombia/ya-tenemos-aseguradas-20-millones-de-dosis-de-vacuna-contra-covid-19-minsalud.html

COVAX is a joint program of WHO and GAVI (Global Alliance for Vaccines and Immunizations), partly funded by the Gates Foundation, to manufacture and distribute vaccines to lower income countries. They have a deal with Astra Zeneca for 1 billion doses, which will be manufactured by the Serum Institute in India.

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I am hoping each recipient who considers taking a SARS-CoV-2 vaccine is told that it has been licensed under emergency approval, understands how the PREP Act effects any problems that may arise from taking the vaccine, and given information on VAERS.  Harvard was given a grant from HHS and found that VAERS normally only captures a very small percentage of adverse reactions: "Adverse events from vaccines are common but underreported, with less than one percent reported to the Food and Drug Administration (FDA). Low reporting rates preclude or delay the identification of 'problem' vaccines, potentially endangering the health of the public." https://digital.ahrq.gov/ahrq-funded-projects/electronic-support-public-health-vaccine-adverse-event-reporting-system  If people (doctors, nurses, patients, pharmacists) don't report adverse reactions from these new vaccines because they are told they are safe and only mild side effects occur, it could lead to problems that were avoidable.  Does anyone know if any of the manufacturers are planning on conducting a further study of their vaccine after the FDA has given emergency approval?  Or will the vaccines just be monitored through VAERS?

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1 hour ago, hopeallgoeswell said:

I am hoping each recipient who considers taking a SARS-CoV-2 vaccine is told that it has been licensed under emergency approval, understands how the PREP Act effects any problems that may arise from taking the vaccine, and given information on VAERS.  Harvard was given a grant from HHS and found that VAERS normally only captures a very small percentage of adverse reactions: "Adverse events from vaccines are common but underreported, with less than one percent reported to the Food and Drug Administration (FDA). Low reporting rates preclude or delay the identification of 'problem' vaccines, potentially endangering the health of the public." https://digital.ahrq.gov/ahrq-funded-projects/electronic-support-public-health-vaccine-adverse-event-reporting-system  If people (doctors, nurses, patients, pharmacists) don't report adverse reactions from these new vaccines because they are told they are safe and only mild side effects occur, it could lead to problems that were avoidable.  Does anyone know if any of the manufacturers are planning on conducting a further study of their vaccine after the FDA has given emergency approval?  Or will the vaccines just be monitored through VAERS?

As VAERS is a self reported database that has no information on actual causality, I assume that the vaccine will be monitored in the usual ways. 
Most medications that are granted emergency approval have continued studies.

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1 hour ago, hopeallgoeswell said:

I am hoping each recipient who considers taking a SARS-CoV-2 vaccine is told that it has been licensed under emergency approval, understands how the PREP Act effects any problems that may arise from taking the vaccine, and given information on VAERS.  Harvard was given a grant from HHS and found that VAERS normally only captures a very small percentage of adverse reactions: "Adverse events from vaccines are common but underreported, with less than one percent reported to the Food and Drug Administration (FDA). Low reporting rates preclude or delay the identification of 'problem' vaccines, potentially endangering the health of the public." https://digital.ahrq.gov/ahrq-funded-projects/electronic-support-public-health-vaccine-adverse-event-reporting-system  If people (doctors, nurses, patients, pharmacists) don't report adverse reactions from these new vaccines because they are told they are safe and only mild side effects occur, it could lead to problems that were avoidable.  Does anyone know if any of the manufacturers are planning on conducting a further study of their vaccine after the FDA has given emergency approval?  Or will the vaccines just be monitored through VAERS?

Vaccine companies are required to continue monitoring all study participants for two years in order to get full FDA approval. The EUA is not permanent and does not replace the regular approval process, it just allows the vaccines to be distributed prior to full approval due to the pandemic. My son's university was soliciting college students for one of the AZ trials, and one of the conditions of participation is that you have to agree to further monitoring for two years afterwards.

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So one thought on the Astra Zeneca results is that with the full dose the body developed antibodies to the adenovirus vector after the first dose meaning the coronavirus spike bit couldn’t be carried into the cell with the second dose because the body reacted to the adenovirus.  Apparently the Russian vaccine actually uses two different adenoviruses - one for the first dose and one for the second dose that may effectively prevent that problem.

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3 hours ago, Mrs Tiggywinkle said:

As VAERS is a self reported database that has no information on actual causality, I assume that the vaccine will be monitored in the usual ways. 
Most medications that are granted emergency approval have continued studies.

 

3 hours ago, Corraleno said:

Vaccine companies are required to continue monitoring all study participants for two years in order to get full FDA approval. The EUA is not permanent and does not replace the regular approval process, it just allows the vaccines to be distributed prior to full approval due to the pandemic. My son's university was soliciting college students for one of the AZ trials, and one of the conditions of participation is that you have to agree to further monitoring for two years afterwards.

I saw an article summary today that mentioned these concerns and talks about the difference between EUA and "expanded access." Again, I didn't read the article yet, but that was in the summary I saw. Here is the article:

https://www.technologyreview.com/2020/11/13/1012098/covid-19-vaccines-fda-emergency-use-authorization-opinion?fbclid=IwAR2rwlPNcBe2FXUy9zwnwwod9yQ97qM5CzSdMI6Ii6Xf5RiBln9taTytAGo

It was posted on the Facebook page called COVID-19: Scientific Sources and Reputable News.

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15 minutes ago, kbutton said:

 

I saw an article summary today that mentioned these concerns and talks about the difference between EUA and "expanded access." Again, I didn't read the article yet, but that was in the summary I saw. Here is the article:

https://www.technologyreview.com/2020/11/13/1012098/covid-19-vaccines-fda-emergency-use-authorization-opinion?fbclid=IwAR2rwlPNcBe2FXUy9zwnwwod9yQ97qM5CzSdMI6Ii6Xf5RiBln9taTytAGo

It was posted on the Facebook page called COVID-19: Scientific Sources and Reputable News.

The author of that article makes 4 main arguments against EUAs for covid vaccines:

(1) If they approve a vaccine under EUA, that will hamper research into other vaccines and maybe a better one will come along later. This does not seem valid to me, since there are so many companies all over the world currently developing vaccines, and they aren't going to stop just because one country gave EUA to one (or more) vaccines. If better ones come along later, we can switch to those.

(2) Getting an EUA means companies won't follow up on their own research. Again this is not true, because they still need to collect data for the next two years to get full approval.

(3) Granting EUA makes people not trust the vaccine. I think this is more of a political issue than a scientific one, and not a reason to prevent people, esp. HCWs and high-risk individuals, from accessing a vaccine that could save their lives. Those who don't trust it can just not get it, they should not have the power to decide that no one else can get it either.

(4) The FDA should have used the Expanded Access program instead of Emergency Use Authorization, which apparently has way more hoops to jump through, requires ethics panel reviews to gain access, etc. I don't think this is really practical in the middle of a pandemic that has already killed 260,000 Americans, and which even the very conservative IHME model predicts will kill over 400,000 by March 1st. Given what a total cluster**** testing and tracing has been in this country, I think I adding lots of extra layers of bureaucracy to vaccine access would be a disaster — and would become very very political very quickly.

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4 hours ago, Mrs Tiggywinkle said:

As VAERS is a self reported database that has no information on actual causality, I assume that the vaccine will be monitored in the usual ways. 
Most medications that are granted emergency approval have continued studies.

VAERS reports are investigated.  The phase 3 participants will be followed, but the only way to capture adverse events for a vaccine in circulation is through VAERS.  Unless I am misunderstanding and all people who receive the vaccine dose after emergency approval will be followed long-term?  https://www.fda.gov/files/vaccines, blood & biologics/published/Understanding-the-Vaccine-Adverse-Event-Reporting-System-(VAERS).pdf

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1 minute ago, hopeallgoeswell said:

VAERS reports are investigated.  The phase 3 participants will be followed, but the only way to capture adverse events for a vaccine in circulation is through VAERS.  Unless I am misunderstanding and all people who receive the vaccine dose after emergency approval will be followed long-term?  https://www.fda.gov/files/vaccines, blood & biologics/published/Understanding-the-Vaccine-Adverse-Event-Reporting-System-(VAERS).pdf

It's basically impossible to capture every single reaction. That's why we follow the Phase 3 participants and do further studies -- to get a reasonable sample of people. 

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Just now, Not_a_Number said:

It's basically impossible to capture every single reaction. That's why we follow the Phase 3 participants and do further studies -- to get a reasonable sample of people. 

Do you have a link handy for the further studies any company is going to do?  Or do you mean that the manufacturers will continue to study the phase 3 participants?

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1 minute ago, hopeallgoeswell said:

Do you have a link handy for the further studies any company is going to do?  Or do you mean that the manufacturers will continue to study the phase 3 participants?

I don't have a link, sorry. And I'd guess other people know more than me about the nitty-gritty of this process. However, I believe it's common to have Phase 4 trials. 

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27 minutes ago, hopeallgoeswell said:

VAERS reports are investigated.  The phase 3 participants will be followed, but the only way to capture adverse events for a vaccine in circulation is through VAERS.  Unless I am misunderstanding and all people who receive the vaccine dose after emergency approval will be followed long-term?  https://www.fda.gov/files/vaccines, blood & biologics/published/Understanding-the-Vaccine-Adverse-Event-Reporting-System-(VAERS).pdf

VAERS is watched for patterns and those patterns are investigated. But single VAERS reports are not investigated for causality and can be inaccurate or incomplete.
https://vaers.hhs.gov/data/dataguide.html

VAERS is good for identifying patterns. But it is not a good measure of vaccine safety. I frankly have a hard time taking it seriously.  You can get a vaccine and get hit by a car walking out of the building and get that listed in VAERS as an adverse effect.

Edited by Mrs Tiggywinkle
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https://www.npr.org/sections/health-shots/2020/11/24/938617836/initial-batch-of-covid-19-vaccines-will-go-to-states-based-on-population-not-ris?utm_source=facebook.com&utm_term=nprnews&utm_campaign=npr&utm_medium=social&fbclid=IwAR1DLtQ4crhrmqyV_A0OO_oo9-u3zwUqi-K2ThCYz8420SytrKSNZiYYYeg

Quote

At a briefing on October 23, top HHS official Paul Mango told reporters that Operation Warp Speed would send vaccines out to states based on the number of people in high-risk groups, such as health care workers, nursing home residents and factory workers, who had been identified by the CDC advisory committee.

The committee is currently working on guidelines for prioritizing these groups, which will be finalized once a vaccine is authorized by the FDA. Operation Warp Speed officials had previously said they would wait for these guidelines to be completed.

Now government officials say that's changed. Instead of waiting for the advisory committee's recommendations, they've gone ahead and allocated the first 6.4 million doses to states, based on overall population. "I finally made the decision, late Friday night," said Gen. Gustave Perna, head of logistics for Operation Warp Speed, at the briefing Tuesday. "So states could prioritize based on [their] amount," meaning how many doses of vaccine each state will receive.

I am still trying to figure out if this is a major or minor contradiction to the earlier plans considering that most of the US is facing serious increases in cases, and because the rest of the article seems to indicate that there will still be following some kind of risk guidelines.

Quote

Still, many states intend to follow the committee's guidance on how to prioritize limited doses, according to plans submitted to the CDC. States are currently enrolling local hospitals, doctors offices and pharmacies to be eligible to give COVID-19 shots when they're available — and providers are signing agreements saying they will follow the CDC's advisory committee guidelines.

 

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2 hours ago, Corraleno said:

The author of that article makes 4 main arguments against EUAs for covid vaccines:

(1) If they approve a vaccine under EUA, that will hamper research into other vaccines and maybe a better one will come along later. This does not seem valid to me, since there are so many companies all over the world currently developing vaccines, and they aren't going to stop just because one country gave EUA to one (or more) vaccines. If better ones come along later, we can switch to those.

...

(4) The FDA should have used the Expanded Access program instead of Emergency Use Authorization, which apparently has way more hoops to jump through, requires ethics panel reviews to gain access, etc. I don't think this is really practical in the middle of a pandemic that has already killed 260,000 Americans, and which even the very conservative IHME model predicts will kill over 400,000 by March 1st. Given what a total cluster**** testing and tracing has been in this country, I think I adding lots of extra layers of bureaucracy to vaccine access would be a disaster — and would become very very political very quickly.

I don't necessarily disagree, but I do think that the potential implications of an EUA on both these trials and trials of other vaccines are worth thinking through very carefully.  Here's an article on these issues from about a month ago. 

That said, these questions looked a lot harder a few weeks ago, when we didn't know yet how spectacularly effective these early vaccines would be.  If the first vaccines to come up had, say, 55% efficacy, we'd be far more worried about disrupting research into potentially more effective vaccines.  

Still, I'm glad that people in the field are debating this stuff. 

Edited by JennyD
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Apparently the Astra Zeneca trial that used the half dose and apparently showed higher efficacy had no over 55s


“He confirmed a few things about the 2,741 participants who got the promising half-strength initial dose in Monday's results:
🔹They were all in the UK trial & age 18-55.
🔹They got it at the beginning of the trial, over the course of weeks before the dosing error was discovered.”

https://www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html#click=https://t.co/94xkl1u5VK

 

(quietly taking back what I said yesterday about AZ seeming more transparent)
 

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On 11/21/2020 at 2:59 PM, Not_a_Number said:

So is the idea that ANYTHING derived from an aborted fetus is now off-limits? Because if anything that has involved loss of life in any previous point can't be used, we gotta clear out of this country, lol. I'm pretty sure we didn't get this land by peaceful means... 

Now, don't go expecting people to be consistent, because they will disappoint... 😉 

On 11/21/2020 at 3:05 PM, Not_a_Number said:

Got it. I really hope people don't decide to rile people up about this 😕 . That's all we need, for people to decide they can't get these treatments because of where they come from... 

(In general, I tend to assume that if I look "under the hood" of most processes, I'll be disturbed. Very few things are totally ethically sourced.

I agree with the bolded statement for sure. In principle, I am against animal testing as well as testing done on aborted human cell lines. I'm also against sweatshops and factory farms. I admire people who can avoid things from all of those processes and places (thinking of one member here in particular). I find it incredibly difficult. 

Here are my random thoughts on the use of aborted human stem cells in vaccines:

1. It is a sad thing when we hope people won't have information because they will do illogical and foolish things with it. Information should never be feared--but then, people aren't always logical or wise.

2. I seriously doubt all the people objecting to the use of aborted human stem cells also have objected to the many other vaccines that used those same cells in their development. (Also, I hope they object just as vehemently to murders by police, the slaughter of indigenous peoples, and deaths caused by unjust wars.)

3. I am as pro-life and anti-abortion as they come. I agree, however, with the argument presented in the Southern Baptist article someone (kbutton, I think) linked above. If we would not, as pro-lifers, object to the organs of a victim of crime being donated, neither should we object using the cells of victims of abortion for research--provided that those victims were not killed specifically for their cells. We may strongly prefer they not be used, because those humans never should have been killed in the first place--I know I do. We may feel uncomfortable with it--again, I do. But we also have a duty to love and protect our neighbors and these vaccines will help us do that.

I hope to receive one of the vaccines as soon as possible, unless I see something in the next few months to convince me otherwise. 

ETA: According to the chart linked by PeterPan, neither Moderna or Pfizer used aborted human stem cell lines in their development or production of their vaccines. Both, however, used them for some of their testing.

Edited by MercyA
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18 hours ago, Corraleno said:

COVAX is a joint program of WHO and GAVI (Global Alliance for Vaccines and Immunizations), partly funded by the Gates Foundation, to manufacture and distribute vaccines to lower income countries. They have a deal with Astra Zeneca for 1 billion doses, which will be manufactured by the Serum Institute in India.

@Corraleno   A million thanks to you for the information above. Extremely interesting to me. I will begin to pay attention to the Astra Zeneca vaccine. I think that's the one that requires shipping and storage at -70 C?    Also is that the one they found strange results with, when they gave 1/2 doses and found them more effective than full doses?

Hoping that when the vaccine becomes available to me that I might be able to get the Moderna or another vaccine (Pfizer or Johnson & Johnson, etc.) mentioned in the article, hoping the Colombian government have them among the 6 companies they are apparently negotiating with for 5 million people here. The first 15 million people will be the beginning of the immunization here. I think the current population is approximately 45 million people, so they will need to buy for many more people, after the first 15 million.

Question: Do you have any knowledge or opinion of the vaccines produced by the Serum Institute of India and their quality?

Thank you again for the great explanation and Happy Thanksgiving to you and your family!  (DD arrived in the house about 1 A.M. on Thanksgiving Day 🙂 )

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1 hour ago, Lanny said:

@Corraleno   A million thanks to you for the information above. Extremely interesting to me. I will begin to pay attention to the Astra Zeneca vaccine. I think that's the one that requires shipping and storage at -70 C?    Also is that the one they found strange results with, when they gave 1/2 doses and found them more effective than full doses?

Hoping that when the vaccine becomes available to me that I might be able to get the Moderna or another vaccine (Pfizer or Johnson & Johnson, etc.) mentioned in the article, hoping the Colombian government have them among the 6 companies they are apparently negotiating with for 5 million people here. The first 15 million people will be the beginning of the immunization here. I think the current population is approximately 45 million people, so they will need to buy for many more people, after the first 15 million.

Question: Do you have any knowledge or opinion of the vaccines produced by the Serum Institute of India and their quality?

Thank you again for the great explanation and Happy Thanksgiving to you and your family!  (DD arrived in the house about 1 A.M. on Thanksgiving Day 🙂 )

Not corellano sorry but Pfizer is the one that needs really cold storage.  That and Moderna are both mRNA.  The Astra Zeneca is the one with the weird results with the half dose but cheaper and easier to store.  

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1 hour ago, Lanny said:

@Corraleno   A million thanks to you for the information above. Extremely interesting to me. I will begin to pay attention to the Astra Zeneca vaccine. I think that's the one that requires shipping and storage at -70 C?    Also is that the one they found strange results with, when they gave 1/2 doses and found them more effective than full doses?

Hoping that when the vaccine becomes available to me that I might be able to get the Moderna or another vaccine (Pfizer or Johnson & Johnson, etc.) mentioned in the article, hoping the Colombian government have them among the 6 companies they are apparently negotiating with for 5 million people here. The first 15 million people will be the beginning of the immunization here. I think the current population is approximately 45 million people, so they will need to buy for many more people, after the first 15 million.

Question: Do you have any knowledge or opinion of the vaccines produced by the Serum Institute of India and their quality?

Thank you again for the great explanation and Happy Thanksgiving to you and your family!  (DD arrived in the house about 1 A.M. on Thanksgiving Day 🙂 )

https://thecitypaperbogota.com/news/colombia-to-start-mass-covid-19-vaccination-by-early-2021/26373
 

This may be of interest if you haven’t already seen it.  

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4 hours ago, Ausmumof3 said:

https://thecitypaperbogota.com/news/colombia-to-start-mass-covid-19-vaccination-by-early-2021/26373
 

This may be of interest if you haven’t already seen it.  

Thank you for the link. This morning, there was another article on the web site of the largest newspaper here. Apparently, they are going to buy, from one or more of the 6 companies they are negotiating with now, vaccine for the first 5 million people (eldery above 60 years of age, medical people, vulnerable, etc.) and those 5 million people will be vaccinated with one or more of those 6 vaccines during the first quarter of 2021. Then during the 2nd quarter of 2021, they will get vaccine for another 10 million people from the COVAX and vaccinate them. Then with time, they will buy more vaccine and vaccinate more people. They are studying the 6 vaccines from the companies, and also the COVAX vaccine(s)

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Moderna's final results are in: 94% efficacy, with 11 symptomatic illnesses in the treatment group vs 185 in the placebo group. And none of the cases in the vaccine group were severe, vs 30 severe cases in the placebo group. (Total participants = 30K.)
Link: Science

(x-post from Wuhan thread)

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