Fantastic Vaccine Results in US

[JoeWras]

And take into account that mRNA drugs/vaccines are an entirely new class of medications, with the potential to revolutionize pharmacologic treatment of many diseases, and their track record looks even better.

And to get technical, the 3 vaccines in the USA are not "officially" approved. They are being distributed under emergency authorization.

 

[Chuckanut]

This is not the US, but I didn't want to start a whole new thread for it.

Israel is reporting that the infection rate for children under 12 (who are not yet being vaccinated) is falling in line with the infection rate for adults (who are being vaccinated). As we adults get vaccinated we are also helping the young ones who are not yet vaccinated.

More good news..... Pfizer is reporting their vaccine works well down to 12 years old.

 

[ExFlyBoy5]

What does the group think about this scenario? I apparently was infected in March 2020 in New York right as the outbreaks started, right before the City went into shutdown mode, but was never symptomatic.

Since June 2020 I have donated convalescent plasma every 4 weeks and my blood has been tested for the antibodies 13 times that I am aware of, testing positive for the antibodies each time. I am A+ and feel that donating the plasma is my way of helping those who haven’t been as fortunate in fighting COVID off. My understanding is A+ people usually have more problems with COVID.

Being over 50, I am now eligible to get the vaccine. I am not against getting it, but once I get the vaccine I am ineligible to donate convalescent plasma and provide this help to others. To be clear, I get flu shots most years, have my Shingrix shots and am current on every vaccine for my age.

I have planned to get the vaccine all along, but am stymied as to what to do right now. Should I:
1. Get vaccinated as soon as I can get an appointment?
2. Delay my shots until many more people get theirs so my plasma can still help the hospitalized? If so, how to best decide how long to wait?

I would vote to get the vax as soon as you can. The number of hospitalizations has been declining (and hopefully will stay that way) so the need for the convalescent plasma has decreased markedly. I think you have gone above and beyond.

 

[ExFlyBoy5]

I can't donate blood because of military deployments to Europe during mad cow. lol)[/U], I'd probably wait to get it until I needed it for travel or other reasons...

Most of those restrictions have been done away with for mil members. I also wasn't able to donate for YEARS because of my travels and adventures across the globe but became eligible again a few months ago.

https://blogs.va.gov/VAntage/83743/...0, the U.S. Food,and 1996 from donating blood.

 

[dirtbiker]

Most of those restrictions have been done away with for mil members. I also wasn't able to donate for YEARS because of my travels and adventures across the globe but became eligible again a few months ago.

https://blogs.va.gov/VAntage/83743/...0, the U.S. Food,and 1996 from donating blood.

Great to know! Time to get back to donating blood.

Thanks!

 

[ExFlyBoy5]

Great to know! Time to get back to donating blood.

Thanks!

Woohoo! Guess that can count as my good deed of the day. It was great donating for the 1st time after being told NO for so long. Sure, it's not a heroic thing, but it's SOMETHING!

 

[ls99]

Curious, when will these vaccine experiments conclude? And become officially "approved"?


Edit add, Formatting did not transfer to post:

Found one study on NIH website:
https://clinicaltrials.gov/ct2/show/NCT04368728

BioNTech SE

"Study Design
Go to
January 31, 2023 Study Type : Interventional (Clinical Trial) Estimated Enrollment : 43998 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention Official Title: A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS Actual Study Start Date : April 29, 2020 Estimated Primary Completion Date : August 3, 2021 Estimated Study Completion Date :
Condition or disease Intervention/treatment Phase SARS-CoV-2 Infection COVID-19 Biological: BNT162b1 Biological: BNT162b2 Other: Placebo Phase 2 Phase 3

 

[stepford]

Not particularly unexpected given the large population now vaccinated, but more COVID infections are now turning up despite vaccination:

https://abcnews.go.com/Health/100-f...ontract-covid-19-washington/story?id=76784838

 

[Another Reader]

What does the group think about this scenario? I apparently was infected in March 2020 in New York right as the outbreaks started, right before the City went into shutdown mode, but was never symptomatic.

Since June 2020 I have donated convalescent plasma every 4 weeks and my blood has been tested for the antibodies 13 times that I am aware of, testing positive for the antibodies each time. I am A+ and feel that donating the plasma is my way of helping those who haven’t been as fortunate in fighting COVID off. My understanding is A+ people usually have more problems with COVID.

Being over 50, I am now eligible to get the vaccine. I am not against getting it, but once I get the vaccine I am ineligible to donate convalescent plasma and provide this help to others. To be clear, I get flu shots most years, have my Shingrix shots and am current on every vaccine for my age.

I have planned to get the vaccine all along, but am stymied as to what to do right now. Should I:
1. Get vaccinated as soon as I can get an appointment?
2. Delay my shots until many more people get theirs so my plasma can still help the hospitalized? If so, how to best decide how long to wait?

As an asymptomatic, there are some concerns. You may have residual undetected health problems, especially with your heart, that could cause problems. There is a remote possibility that undetected persistent virus could cause ADE, antibody dependent enhancement. I would talk to your doctor about the risks to asymptomatic Covid patients before getting the vaccine. In most cases, the benefits of vaccination far outweigh the risks.

 

[ivinsfan]

Not particularly unexpected given the large population now vaccinated, but more COVID infections are now turning up despite vaccination:

https://abcnews.go.com/Health/100-f...ontract-covid-19-washington/story?id=76784838

102 cases out of 1.2 million people vaccinated....in my book that's a resounding success.

 

[MuirWannabe]

102 cases out of 1.2 million people vaccinated....in my book that's a resounding success.

And those 102 were either no symptoms or very mild....dare I say it, cold like symptoms. That is a further resounding success.

 

[explanade]

I don’t think convalescent plasma has proved to be as useful as they hoped.

When it got EUA, it was controversial with the FDA accused of caving to political influence.

Not clear they’re using it that much for treatment these days.

 

[stepford]

And those 102 were either no symptoms or very mild....dare I say it, cold like symptoms.

Tell that to the 8 were were hospitalized and 2 who died.

Small numbers to be sure, but it just serves as a reminder: Immunity is not absolute - some of the vaccinated will still be infected and a smaller fraction will still get seriously ill. This just means that we still have to practice infection control measures in addition to vaccination until infection rates are knocked down to much lower levels.

 

[Amethyst]

Your thinking is heroic (and I'm A+!). Now's the time to do your part - for you, and everyone else - and get your vaccine.

]

Since June 2020 I have donated convalescent plasma every 4 weeks and my blood has been tested for the antibodies 13 times that I am aware of, testing positive for the antibodies each time. I am A+ and feel that donating the plasma is my way of helping those who haven’t been as fortunate in fighting COVID off. My understanding is A+ people usually have more problems with COVID.

Being over 50, I am now eligible to get the vaccine. I am not against getting it, but once I get the vaccine I am ineligible to donate convalescent plasma and provide this help to others. To be clear, I get flu shots most years, have my Shingrix shots and am current on every vaccine for my age.

I have planned to get the vaccine all along, but am stymied as to what to do right now. Should I:
1. Get vaccinated as soon as I can get an appointment?
2. Delay my shots until many more people get theirs so my plasma can still help the hospitalized? If so, how to best decide how long to wait?

 

[tulak]

Tell that to the 8 were were hospitalized and 2 who died.

The 2 were over 80 and had underlying health issues. It’s not clear that covid played any role in their death.

 

[MuirWannabe]

Tell that to the 8 were were hospitalized and 2 who died.

Small numbers to be sure, but it just serves as a reminder: Immunity is not absolute - some of the vaccinated will still be infected and a smaller fraction will still get seriously ill. This just means that we still have to practice infection control measures in addition to vaccination until infection rates are knocked down to much lower levels.

You raise a good point that I shouldn’t have skipped mention of this. But as has already been pointed out the 2 deaths were over 80 with other issues already existing. Still, if that’s you, it’s not what you hoped for clearly.

As for your comments about needing to still practice infection control measures I’m not so sure. At least for those vaccinated it doesn’t seem really necessary based upon these numbers. The results are really that good. I’ll follow the rules and even the current social norms. But I hope both those rules and norms begin to change soon to reflect the reality of the results as they continue.

Regardless, I’m just happy for the results that are rightly being trumpeted in this thread. It’s truly wonderful.

 

[garyt]

I should have been more clear in my post, but drugs not going onto FDA approval while being studied is completely normal. On average, a drug takes 12 years to go from pre-clinical testing to FDA approval. Of drugs in the pre-clinical testing phase, only 1 in 1000 ever make it to human testing. Only 1 in 5 of those get FDA approval, which means that only 1 in 5000 drugs ever go from pre-clinical to FDA approval. And take into account that mRNA drugs/vaccines are an entirely new class of medications, with the potential to revolutionize pharmacologic treatment of many diseases, and their track record looks even better.

Still looking for the article but it stated that mRNA treatments had never made it past stage 1 testing before this vaccine. That's what I meant when I said rejected. Hopefully I'll find it.

 

[garyt]

Still looking for the article but it stated that mRNA treatments had never made it past stage 1 testing before this vaccine. That's what I meant when I said rejected. Hopefully I'll find it.

This isn't the article I first saw but :
https://www.the-scientist.com/news-opinion/the-promise-of-mrna-vaccines-68202

Scientists have clinically tested mRNA vaccines for a wide range of infectious diseases, including rabies, influenza, and Zika. Until now, none have made it past small, early-phase clinical trials. The two SARS-CoV-2 vaccines are “by far the most advanced,” Liu tells The Scientist. “None [of the others] were as promising as what we’ve seen.”

 

[USGrant1962]

The 2 were over 80 and had underlying health issues. It’s not clear that covid played any role in their death.

Yup, it is the old died with Covid versus died from Covid problem. These numbers are so low that one cannot discern the difference.

 

[JoeWras]

This isn't the article I first saw but :
https://www.the-scientist.com/news-opinion/the-promise-of-mrna-vaccines-68202

Scientists have clinically tested mRNA vaccines for a wide range of infectious diseases, including rabies, influenza, and Zika. Until now, none have made it past small, early-phase clinical trials. The two SARS-CoV-2 vaccines are “by far the most advanced,” Liu tells The Scientist. “None [of the others] were as promising as what we’ve seen.”

Thanks for the pointer. That was interesting reading, and the original article was fairly friendly to the non-specialist.

Part of the problem is that there is "no money" in vaccines. Well there was none, until the pandemic. We'll see what happens after the pandemic. Maybe society and medicine will have a different perspective, although reading sengsational's excellent posts about treatment options (and the money involved) give me less hope.

Back to the article. There are pointers to the studies. The important take-away is there were no significant adverse effects. The studies were also looking at other issues regarding delivery (needle or not). This was all part of the work involving the "fat blob" delivery, so I'd hardly say it was a failure. They were learning.

In summary:
- Rabies: From 2017. Safe and effective, but needle injection doesn't work effectively. [Joe: I guess they fixed this?]
- Influenza: direct quote - "The first mRNA vaccines against H10N8 and H7N9 influenza viruses were well tolerated and elicited robust humoral immune responses." [Joe: but is there money in it, considering the now well known issues with freezers, etc.]
- Zika: no results. This study was to conclude about now, with the main study time being in 2020. It looks like it might have been paused or aborted because, uh, "something else" came up. Or maybe not. Could still just be gathering results.

 

[garyt]

Thanks for the pointer. That was interesting reading, and the original article was fairly friendly to the non-specialist.

Part of the problem is that there is "no money" in vaccines. Well there was none, until the pandemic. We'll see what happens after the pandemic. Maybe society and medicine will have a different perspective, although reading sengsational's excellent posts about treatment options (and the money involved) give me less hope.

Back to the article. There are pointers to the studies. The important take-away is there were no significant adverse effects. The studies were also looking at other issues regarding delivery (needle or not). This was all part of the work involving the "fat blob" delivery, so I'd hardly say it was a failure. They were learning.

In summary:
- Rabies: From 2017. Safe and effective, but needle injection doesn't work effectively. [Joe: I guess they fixed this?]
- Influenza: direct quote - "The first mRNA vaccines against H10N8 and H7N9 influenza viruses were well tolerated and elicited robust humoral immune responses." [Joe: but is there money in it, considering the now well known issues with freezers, etc.]
- Zika: no results. This study was to conclude about now, with the main study time being in 2020. It looks like it might have been paused or aborted because, uh, "something else" came up. Or maybe not. Could still just be gathering results.

Here's another article on mRNA, including safety concerns. And I'm not anti vax, like I said I got my first shot and get my second tomorrow. I'm just making the point that there is reason to be a little concerned, I guess.

https://www.medpagetoday.com/infectiousdisease/covid19/89998

For those who want more information on the history and science of mRNA vaccines and therapeutics before getting their jab, here's a primer.

[mod edit to ensure compliance with copyright. See here for detail

This is a little concerning to me: "promoted blood coagulation and pathological thrombus formation."

 

[donheff]

As for your comments about needing to still practice infection control measures I’m not so sure. At least for those vaccinated it doesn’t seem really necessary based upon these numbers. The results are really that good. I’ll follow the rules and even the current social norms. But I hope both those rules and norms begin to change soon to reflect the reality of the results as they continue.

Regardless, I’m just happy for the results that are rightly being trumpeted in this thread. It’s truly wonderful.

As I understand current CDC advice, vaccinated people are OK to socialize with other vaccinated people sans masks. Vaccinated people are also OK to include a non vaccinated household member (who is so inclined) to a social gathering (like a family dinner) sans masks. It is in public and in larger mixed groups that vaccinated people are asked to continue wearing masks. This makes sense to me. It protects the unvaccinated. Some vaccinated people feel like they should be able to wander about unmasked since they present little risk to others. But no one who has been unable to get a vaccine should be expected to rely on the good faith of these supposed safe folks given the anti-mask, anti-vax sentiments rampant in the country. Once the vaccine is available to anyone who wants it, it may be reasonable to start loosening up on public mask wearing.

 

[anethum]

The latest results from the Pfizer/BioNTech Phase 3 clinical trial are very encouraging, with the vaccine providing good protection against infection for at least 6 months following the 2nd dose, including protection against the South Africa variant:

https://www.cnn.com/2021/04/01/health/pfizer-covid-vaccine-efficacy-six-months-bn/index.html

"The vaccine remains more than 91% effective against disease with any symptoms for six months, the companies said. And it appeared to be fully effective against the worrying B.1.351 variant of the virus, which is the dominant strain circulating in South Africa and which researchers feared had evolved to evade the protection of vaccines, the companies said."

"The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug Administration (FDA)," Pfizer and BioNTech said in a joint statement."

 

[audreyh1]

Many experts believe that immunity/protection will turn out to last at least a year and probably longer.

Really good news about effectiveness against the South Africa variant. We already know that it is effective against the B117 variant because Israel had 80% B117 cases during its successful vaccination program.

 

[Sojourner]

Really good news about effectiveness against the South Africa variant.

Yes, absolutely, although the results are based on fairly small numbers.

The shot was 100 percent effective in preventing illness among trial participants in South Africa, where the new B.1.351 coronavirus variant is dominant, the companies said. The South Africa trial was relatively small, with 800 participants. Pfizer said the rate was derived from a relatively small number of nine infections observed, all in the placebo group.

Considering that a few other "variants of concern" share similar mutations with the B.1.351 strain (i.e., the E484K mutation, also found in the P.1 variant from Brazil and the B.1.526 variant from New York), this study provides hope that the Pfizer vaccine may turn out to be pretty broadly effective against many of the currently/widely circulating strains, including the very widespread B.1.1.7.