General COVID vaccination thread

Quote:

---

Originally Posted by dan_bgblue

Wikipedia is not allowed to publish the recent meta-analysis on Ivermectin authored by Dr. Andrew Hill. Furthermore, it is not allowed to say anything concerning www.ivmmeta.com showing the 61 studies comprising 23,000 patients which reveal up to a 96% reduction in death [prophylaxis] with Ivermectin.

---

I am going to ignore Ivermectin for a moment to say that Wikipedia's editors have been a problem for a long time. They are a VERY necessary bullwark against misinformation but are also prone to having known bias problems which, in essence, cause the exact thing they are there to prevent. It isn't nearly as bad as many critics make it seem but it does exist and it is more of a problem than Wikipedia thinks.

When it comes to Ivermectin, Wikipedia is not in the wrong here (and even Dr. Hill agrees but I will get to that in a bit). The authors of the article to which you link attempt to use n-values to bolster their argument, n-value is only important when BOTH the input studies and meta-analyses are done properly. Meta-analysis in particular is extremely susceptible to flawed input studies, data massaging, flawed procedures, and outright manipulation.

To quote the British Medical Journal:

Quote:

---

Different websites (such as https://ivmmeta.com/, https://c19ivermectin.com/, https://tratamientotemprano.org/estudios-ivermectina/, among others) have conducted meta-analyses with ivermectin studies, showing unpublished colourful forest plots which rapidly gained public acknowledgement and were disseminated via social media, without following any methodological or report guidelines. These websites do not include protocol registration with methods, search strategies, inclusion criteria, quality assessment of the included studies nor the certainty of the evidence of the pooled estimates. Prospective registration of systematic reviews with or without meta-analysis protocols is a key feature for providing transparency in the review process and ensuring protection against reporting biases, by revealing differences between the methods or outcomes reported in the published review and those planned in the registered protocol. These websites show pooled estimates suggesting significant benefits with ivermectin, which has resulted in confusion for clinicians, patients and even decision-makers. This is usually a problem when performing meta-analyses which are not based in rigorous systematic reviews, often leading to spread spurious or fallacious findings.

---

For example, two of the largest studies around Ivermectin which showed a benefit have had MAJOR problems: Elgazzar et al. was retracted due to potential scientific fraud and breach of ethical conduct by the researchers while the other study Niaee et al, has been roundly criticized for failing to randomize the cohorts leading to biased results. This lead to Dr. Hill retracting his own meta-analysis . Quite simply, Wikipedia VERY RIGHTLY refuses to accept their data because they not only refuse to comply with the accepted protocol standards which have been developed to prevent bias, data manipulation, and outright fraudulent analysis but their data has multiple known major flaws. As stated before, Dr. Hill (the author of said retracted study) states that Wikipedia is correct in not citing them:

Quote:

---

Our meta-analysis of survival for ivermectin had to be retracted after one of the main studies was suspected of medical fraud. With the revised version, there is no statistically significant survival benefit for ivermectin. So the original version should not be quoted

---

Source

I have been following these studies pretty intently and most of the well-detailed testing shows AT BEST a very slight improvement in the reduction of outcomes for Ivermectin with most showing no statistically significant difference. This potential slight benefit is offset by the fact that Ivermectin has an extremely notable "toxic shelf". This means it is relatively easy to exceed the toxic threshold for Ivermectin and when that happens the side effects can be extremely severe (nerve damage, sensory damage, etc.).

Quote:

---

Originally Posted by dan_bgblue

What does this mean? Does it mean that the vaccines available in the USA are wonder drugs as they have a 98.2% survival rate, or does it mean that that the overall health care in India is 2.2% worse than it is in the USA, and survival rates in the USA would be around 98.2% with no Vaccine as Ivermectin used as a treatment of Covid 19 is a hoax?

---

You missed some other far more likely options:

One, as discussed above, the data in the meta-analysis had multiple problems, was retracted by the author, and subsequent analysis shows no benefit.

Two, the data from India is extremely unreliable and inaccurate. Quite simply, parts of India suffer from extreme corruption and a lack of infrastructure. In particular, northern states like Bihar and Uttar Pradesh are EXTREMELY impoverished and lack many basic necessities let alone any sort of reasonable health care. As such, much of the outbreak was not even quantified in these regions. There were no doctors to go to, no testing, and certainly no treatment. People just contracted COVID, died, and were cremated.

If we look at excess deaths during the COVID outbreak, there were somewhere between 3-4 million more deaths than normal but only a bit over 400,000 were ascribed to COVID. At this point, it is pretty well accepted that the death toll in India is in the millions. This is supported by government satellite images showing mass cremations across the country, shortages in medical equipment which far exceeds the official numbers ,etc. Add in the hyper-nationalistic Modi government, which tried to downplay COVID throughout, and you end up with heavily distorted data. The truth is, we will never know how high the death toll was in India but we know that it was FAR FAR higher than the official numbers which were reported.

In conclusion, this misinformation is the most insidious kind, it took a LOT of work on my part to explain why it is wrong and why Wikipedia is right to block this particular info.

Quote:

---

Originally Posted by Catfan73

My brother in law posted this on his Facebook page this morning. He’s an epidemiologist, works at East Carolina U.

I think I've heard every excuse and argument there is for not getting the vaccine. Bottom line - the vaccines available in the U.S. are very safe and highly effective at preventing severe illness. They are not 100% effective but I can't think of any vaccine that is. They work exactly as they should and depending on your viewpoint can be viewed as a fantastic scientific success story and/or a wonderful gift from God. Either way -- I'm ecstatic that they work so well. What I'm frustrated about is the fact that so many have dug their heels in simply to dig their heels in and refuse. Everybody who gets the current virus is giving it to about 7 others on average. So, each person is building their own "pyramid of infection". And even if the person at the top of the pyramid has a mild or asymptomatic infection, it's guaranteed that some people in their pyramid below them will need to be hospitalized and some will die. So even if you don't get the vaccine and have no problems with COVID in the future, you are still wrong. You can never say you were right just because you had an easy time with COVID. You will have spread the virus and your pyramid of infection will contain people who you may or may not know who became extremely ill and you will even be responsible for a few who died. In addition, every infected person gives the current virus strain a chance to mutate and get stronger so this whole mess can definitely get worse. So if you are not vaccinated yet, please stop being stubborn and just help fight this disease.

---

I blame it on the government, big tech and especially Fauci. People are always going to be suspicious of the pushing of a single agenda. At some point there will be investigations into why the US ratio of cases and deaths per million are much higher than similar sized countries that don’t have anywhere near the level of health care we have in the US.

Pedro, I thank you for your time and energy to do the research, and if you feel this article is not worth a flip, then ignoring it will not offend me one bit.

https://journals.lww.com/americanthe...ment_of.7.aspx

Quote:

---

Originally Posted by dan_bgblue

Pedro, I thank you for your time and energy to do the research, and if you feel this article is not worth a flip, then ignoring it will not offend me one bit.

https://journals.lww.com/americanthe...ment_of.7.aspx

---

I don't mind, this one is easy (since I already did the research on it). This meta-analysis includes the flawed Elgazzar et al and Niaee et al studies in their dataset which automatically makes the results very suspect. These are the same studies which Dr. Hill retracted his paper over. In fact, this letter in the BMJ discusses that only 4 of the 15 studies in the Bryant meta-analysis meet the necessary acceptance criteria for inclusion (along with other issues).

The Bryant meta-analysis also does not appear to include the more recent IVERCOR and TOGETHER studies. These are two of the largest and most rigorously designed studies into Ivermectin, both of which fail to show ANY impact. In fact, IVERCOR shows that patients on Ivermectin required mechanical ventilation 5 days SOONER than those on placebo (this result is statistically significant) though the overall rates of ventilation are not statistically different between the two cohorts. On a side note, the TOGETHER does show some positive potential benefit for Fluvoxamine treatment of COVID when it comes to preventing hospitalization but showed no impact on preventing death.

This article goes into detail on the multitude of issues found in the Elgazzar study and it is pretty damning:

Quote:

---

For example, the study reports getting ethical approval and beginning on the 8th of June, 2020, but in the data file uploaded by the authors onto the website of the preprint fully 1/3 of the people who died from COVID-19 were already dead when the researchers started to recruit their patients. Unless they were getting dead people to consent to participate in the trial, that’s not really possible.

Moreover, about 25% of the entire group of patients who were recruited for this supposedly prospective randomized trial appear to have been hospitalized before the study even started, which is either a mind-boggling breach of ethics or a very bad sign of potential fraud. Even worse, if you look at the values for different patients, it appears that most of group 4 are simply clones of each other, with the same or largely similar initials, comorbidities, lymphocyte scores, etc.

---

The same author in a different post on Medium discusses how around 1/3 Ivermectin research has significant issues/flaws.

Quote:

---

Originally Posted by PedroDaGr8

I don't mind, this one is easy (since I already did the research on it). This meta-analysis includes the flawed Elgazzar et al and Niaee et al studies in their dataset which automatically makes the results very suspect. These are the same studies which Dr. Hill retracted his paper over. In fact, this letter in the BMJ discusses that only 4 of the 15 studies in the Bryant meta-analysis meet the necessary acceptance criteria for inclusion (along with other issues).

The Bryant meta-analysis also does not appear to include the more recent IVERCOR and TOGETHER studies. These are two of the largest and most rigorously designed studies into Ivermectin, both of which fail to show ANY impact. In fact, IVERCOR shows that patients on Ivermectin required mechanical ventilation 5 days SOONER than those on placebo (this result is statistically significant) though the overall rates of ventilation are not statistically different between the two cohorts. On a side note, the TOGETHER does show some positive potential benefit for Fluvoxamine treatment of COVID when it comes to preventing hospitalization but showed no impact on preventing death.

This article goes into detail on the multitude of issues found in the Elgazzar study and it is pretty damning:


The same author in a different post on Medium discusses how around 1/3 Ivermectin research has significant issues/flaws.

---

IMO, the way Pedro handled this subject is preferable to the way it is too often handled by Big Tech, Fauci, the MSM and even many of the medical journals.

All too often information is deleted, banned or ridiculed instead of using sound scientific analysis as a rebuttal. The branding of misinformation that later turned out to be not only true, but known to be true by those doing the labeling has led to a great amount of skepticism in everything Big Tech now deletes or tags as misinformation or disinformation.

Too often the mania to discredit interferes with the scientific process. One example is the Lancet study on hydroxychloroquine that was published finding that HCQ is dangerous. The publication stopped numerous legitimate studies in their tracks and they were abandoned. The FDA revoked authorization for use of the medicine, as did numerous state pharmacy boards. We then learn that the data for that study was faked and the study was withdrawn. It seems to me that there is a lot of benefit to scientific research, and not benefit at all to quashing research.

I’m making no determination on if something works or doesn’t, my complaint is that real research should be allowed to be conducted.

I’d like to some legitimate studies done with Ivermectin as a potential prophylactic. On the surface the potential use of Ivermectin is fascinating. It has been touted as a wonder drug, and certainly has been found to be effective for both humans and animals.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3043740/

Quote:

---

Originally Posted by PedroDaGr8

I don't mind, this one is easy (since I already did the research on it). This meta-analysis includes the flawed Elgazzar et al and Niaee et al studies in their dataset which automatically makes the results very suspect. These are the same studies which Dr. Hill retracted his paper over. In fact, this letter in the BMJ discusses that only 4 of the 15 studies in the Bryant meta-analysis meet the necessary acceptance criteria for inclusion (along with other issues).

The Bryant meta-analysis also does not appear to include the more recent IVERCOR and TOGETHER studies. These are two of the largest and most rigorously designed studies into Ivermectin, both of which fail to show ANY impact. In fact, IVERCOR shows that patients on Ivermectin required mechanical ventilation 5 days SOONER than those on placebo (this result is statistically significant) though the overall rates of ventilation are not statistically different between the two cohorts. On a side note, the TOGETHER does show some positive potential benefit for Fluvoxamine treatment of COVID when it comes to preventing hospitalization but showed no impact on preventing death.

This article goes into detail on the multitude of issues found in the Elgazzar study and it is pretty damning:


The same author in a different post on Medium discusses how around 1/3 Ivermectin research has significant issues/flaws.

---

Keep up the good fight Pedro! It is appreciated.

Thanks again Pedro. Your information is much appreciated.

Quote:

---

Originally Posted by Catfan73

Keep up the good fight Pedro! It is appreciated.

---

Pedro has been an invaluable resource for our community. Truly.

Quote:

---

Originally Posted by CitizenBBN

Pedro has been an invaluable resource for our community. Truly.

---

Yes he has. Thank you Pedro!

I truly am glad to help out where I can. Especially when it comes to fighting disinformation which is hurting my fellow Americans.


As an aside, this twitter thread does an extremely good job at eviscerating the site ivnmeta.com:

https://twitter.com/GidMK/status/1422044335076306947

Quote:

---

Originally Posted by KeithKSR

I’d like to some legitimate studies done with Ivermectin as a potential prophylactic. On the surface the potential use of Ivermectin is fascinating. It has been touted as a wonder drug, and certainly has been found to be effective for both humans and animals.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3043740/

---

Ivermectin IS a wonder drug in treating parasitic infections that used to devastate lives. For the most part, these are parasites which are not found in developed countries. That being said, it is also a drug which can easily become HIGHLY toxic causing lasting damage and should not be taken lightly. Couple that with the fact that it has shown no benefit and there are more valuable areas for research to occur.

For example, one of the robust well-randomized trials (the TOGETHER trial) into ivermectin also evaluated a few other drugs for treatment including fluvoxamine. While still small-scale it was at least appropriately designed. Whereas ivermectin failed to show any impact in this trial, preliminary (read not peer reviewed) data for fluvoxamine showed a potential 31% reduction in risk of hospitalization.

Quote:

---

Originally Posted by PedroDaGr8

I truly am glad to help out where I can. Especially when it comes to fighting disinformation which is hurting my fellow Americans.


As an aside, this twitter thread does an extremely good job at eviscerating the site ivnmeta.com:

https://twitter.com/GidMK/status/1422044335076306947




Ivermectin IS a wonder drug in treating parasitic infections that used to devastate lives. For the most part, these are parasites which are not found in developed countries. That being said, it is also a drug which can easily become HIGHLY toxic causing lasting damage and should not be taken lightly. Couple that with the fact that it has shown no benefit and there are more valuable areas for research to occur.

For example, one of the robust well-randomized trials (the TOGETHER trial) into ivermectin also evaluated a few other drugs for treatment including fluvoxamine. While still small-scale it was at least appropriately designed. Whereas ivermectin failed to show any impact in this trial, preliminary (read not peer reviewed) data for fluvoxamine showed a potential 31% reduction in risk of hospitalization.

---

It’s easy to see how people could get way too much ivermectin easily. When we had horses we treated them a couple of times a year.



I have a question about the boosters being given. Pfizer just requested the EUA in the past week, and the others haven’t submitted a request yet. Are the boosters being given just an additional dose of the vaccine? I had read that boosters were being designed to use against some of the variants that haven’t yet been found in high number in the US yet.

My cousin passed away today from this horrible disease. She was a wonderful person. She was a nurse, and was early 60s and had been fully vaccinated. She didn’t believe she had covid so let it get too far along I believe and was in severe pain before going to the er. They gave her o2 and sent her home but she had a hernia that caused a bowel obstruction that wasn’t caught early enough. They did emergency surgery and she made it through and made it home to only take a turn for the worse last night. Put on a vent this morning and passed away a few hours ago. Very sad indeed.

Quote:

---

Originally Posted by Padukacat

My cousin passed away today from this horrible disease. She was a wonderful person. She was a nurse, and was early 60s and had been fully vaccinated. She didn’t believe she had covid so let it get too far along I believe and was in severe pain before going to the er. They gave her o2 and sent her home but she had a hernia that caused a bowel obstruction that wasn’t caught early enough. They did emergency surgery and she made it through and made it home to only take a turn for the worse last night. Put on a vent this morning and passed away a few hours ago. Very sad indeed.

---

I’m deeply sorry for your family’s loss. Prayers for you all.

Quote:

---

Originally Posted by KeithKSR

I’m deeply sorry for your family’s loss. Prayers for you all.

---

Thanks Keith. The hits keep on coming, my son at WKU called this morning and said he is coming home for 10 days...he had a sore throat so we told him to go get tested and he was covid positive and has strep. We've all had it before and thought we all had delta a month ago honestly, i suppose we didnt. He's young so hopefully no issues. What a mess this Covid stuff is, i'm thinking at this rate they are going to have to shut things down just to keep the hospitals operating.

There are no ICU beds available in Lexington or in Bowling Green per the governor's report last night. He and staff are jumping thru hoops right now just to keep things running.

Paducah, I just saw your news and wanted to share my condolences with you and your family in this time of grief among your friends and relatives. God bless you all and hope he gives you necessary comfort.

Quote:

---

Originally Posted by Padukacat

Thanks Keith. The hits keep on coming, my son at WKU called this morning and said he is coming home for 10 days...he had a sore throat so we told him to go get tested and he was covid positive and has strep. We've all had it before and thought we all had delta a month ago honestly, i suppose we didnt. He's young so hopefully no issues. What a mess this Covid stuff is, i'm thinking at this rate they are going to have to shut things down just to keep the hospitals operating.

---

Likewise I am very sorry. God bless your family.

Quote:

---

Originally Posted by Padukacat

Thanks Keith. The hits keep on coming, my son at WKU called this morning and said he is coming home for 10 days...he had a sore throat so we told him to go get tested and he was covid positive and has strep. We've all had it before and thought we all had delta a month ago honestly, i suppose we didnt. He's young so hopefully no issues. What a mess this Covid stuff is, i'm thinking at this rate they are going to have to shut things down just to keep the hospitals operating.

---

The only way to know with any certainty if you’ve had Covid is the antibodies test. The nursing home my wife works at had a lot of false results. If anyone tested positive they would test them twice more to verify the results. A number of positive results would test negative on the two follow ups.

Quote:

---

Originally Posted by KeithKSR

The only way to know with any certainty if you’ve had Covid is the antibodies test. The nursing home my wife works at had a lot of false results. If anyone tested positive they would test them twice more to verify the results. A number of positive results would test negative on the two follow ups.

---

Interesting there are that many false negatives, I may have him go retest here tomorrow, I sure don’t want him sitting in a room in my house for ten days when he could be at school feeding his brain tons of useless information!

Quote:

---

Originally Posted by Padukacat

Interesting there are that many false negatives, I may have him go retest here tomorrow, I sure don’t want him sitting in a room in my house for ten days when he could be at school feeding his brain tons of useless information!

---

I’ve read several personal accounts locally of people who had Covid positive tests, but had few or no symptoms, and then later were positive again with all the symptoms. Typically people aren’t expected to have a worse case if they have antibodies.

Quote:

---

Originally Posted by KeithKSR

It’s easy to see how people could get way too much ivermectin easily. When we had horses we treated them a couple of times a year.



I have a question about the boosters being given. Pfizer just requested the EUA in the past week, and the others haven’t submitted a request yet. Are the boosters being given just an additional dose of the vaccine? I had read that boosters were being designed to use against some of the variants that haven’t yet been found in high number in the US yet.

---

Honestly, it is VERY debatable on if boosters are even needed. The data seems to show that outside of the extremely elderly and immune compromised, there isn't much evidence of reduced efficacy due to time or delta. That being said, the boosters are the same as before and are to grenade a higher and potentially more sustained antibody response. All companies are working on variant specific boosters but so far they aren't necessary because none of the variants have escaped the vaccines yet.

Quote:

---

Originally Posted by KeithKSR

The only way to know with any certainty if you’ve had Covid is the antibodies test. The nursing home my wife works at had a lot of false results. If anyone tested positive they would test them twice more to verify the results. A number of positive results would test negative on the two follow ups.

---

This is not correct PCR tests have a far higher specificity and sensitivity than serology tests (antibody and/or antigen). I say that as someone who works for a company who makes COVID antibody/antigen tests and supports the manufacture of this product. Low-level infections (in this case meaning an infection the body easily fought off) often do not generate sufficient antibodies (or they are very short-lived) to generate a positive test or provide protection. It is much like chicken pox; if you have a very very light case, you are very susceptible to catching it again.

Sent from my SM-N986U using Tapatalk

Quote:

---

Originally Posted by PedroDaGr8

This is not correct PCR tests have a far higher specificity and sensitivity than serology tests (antibody and/or antigen). I say that as someone who works for a company who makes COVID antibody/antigen tests and supports the manufacture of this product. Low-level infections (in this case meaning an infection the body easily fought off) often do not generate sufficient antibodies (or they are very short-lived) to generate a positive test or provide protection. It is much like chicken pox; if you have a very very light case, you are very susceptible to catching it again.

Sent from my SM-N986U using Tapatalk

---

Isn’t the reason the CDC is withdrawing the EUA for the PCR tests due to inconsistent results?

Quote:

---

Originally Posted by KeithKSR

Isn’t the reason the CDC is withdrawing the EUA for the PCR tests due to inconsistent results?

---

No it isn't. The CDC is withdrawing the EUA for THEIR RT-PCR assay only. The CDC assay has been supplanted by other RT-PCR assays (and other technology assays) which are faster, have higher throughput, and are more easily multiplexed with tests for other pathogens/variants. As such, to encourage health departments to move on to these other assays, they are pulling their assay.

Sent from my SM-N986U using Tapatalk

Very sorry, PaducahCat. Kentucky looks bad on the NewYorkTimes maps.

Quote:

---

Originally Posted by Padukacat

My cousin passed away today from this horrible disease. She was a wonderful person. She was a nurse, and was early 60s and had been fully vaccinated. She didn’t believe she had covid so let it get too far along I believe and was in severe pain before going to the er. They gave her o2 and sent her home but she had a hernia that caused a bowel obstruction that wasn’t caught early enough. They did emergency surgery and she made it through and made it home to only take a turn for the worse last night. Put on a vent this morning and passed away a few hours ago. Very sad indeed.

---

Somehow missed this, I am very sorry to hear about your cousin.

Thanks to everyone. She was a very kind person and I don’t pretend to be close to her but my mother and close cousin was. Her some is an md out of state. She is one of those that many would have said due to her medical condition she would have died anyways, but that’s simply not the case she would have survived her surgery. She would have enjoyed her grandkids another 10-15 years. Covid deprived her of some special years and it is going to do this to a lot of people we know. It’s very sad and this is not going to end soon. I’m gonna choose not to live in fear of this thing but I know if I were to get really sick I would be scared to death. I really hate this thing. I pray it doesn’t take anyone close to me.

That same website did an analysis from the Israeli data on the impact of boosters:

https://www.covid-datascience.com/po...severe-disease

Basically, for <60 years of age, the boosters do not appear to show a substantial benefit. For >60, there isa VERY sizeable benefit.

Sent from my SM-N986U using Tapatalk

Quote:

---

Originally Posted by PedroDaGr8

That same website did an analysis from the Israeli data on the impact of boosters:

https://www.covid-datascience.com/po...severe-disease

Basically, for <60 years of age, the boosters do not appear to show a substantial benefit. For >60, there isa VERY sizeable benefit.

Sent from my SM-N986U using Tapatalk

---

Thanks, Pedro, good info.

Quote:

---

Originally Posted by PedroDaGr8

That same website did an analysis from the Israeli data on the impact of boosters:

https://www.covid-datascience.com/po...severe-disease

Basically, for <60 years of age, the boosters do not appear to show a substantial benefit. For >60, there isa VERY sizeable benefit.

Sent from my SM-N986U using Tapatalk

---

That’s good information to know. Is there something that happens to the immune system as we age that we can impact with supplements? I’ve been taking D3 for the last three years, vitamin C for the last 2+ years and recently added zinc to try to maintain my immune system.

I really need to up my Vitamin D. Just did blood work and I know it's low. Probably b/c I never see the sun.

Quote:

---

Originally Posted by CitizenBBN

I really need to up my Vitamin D. Just did blood work and I know it's low. Probably b/c I never see the sun.

---

My brother is an MD, turned me on to Vitamin D3 a few years ago. He had read a study that indicated that most people are D deficient. That makes a lot of sense considering our species lived outdoors for most of its existence and now spend a lot more time indoors.

FDA in an uproar over the booster vaccine.

The Biden administration’s decisions over when to administer coronavirus vaccine boosters are triggering turmoil within the Food and Drug Administration, frustrating regulators and sparking fear that political pressures will once again override the agency’s expertise.

FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters' benefits before the administration’s Sept. 20 deadline for rolling them out to most adults. Many outside experts, and some within the agency, see uncomfortable similarities between the Biden team's top-down booster plan and former President Donald Trump's attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments.

Quote:

---

Originally Posted by dan_bgblue

FDA in an uproar over the booster vaccine.

The Biden administration’s decisions over when to administer coronavirus vaccine boosters are triggering turmoil within the Food and Drug Administration, frustrating regulators and sparking fear that political pressures will once again override the agency’s expertise.

FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters' benefits before the administration’s Sept. 20 deadline for rolling them out to most adults. Many outside experts, and some within the agency, see uncomfortable similarities between the Biden team's top-down booster plan and former President Donald Trump's attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments.

---

Biden really began pushing hard on a booster after the Afghanistan debacle.

Biden's presidency has been awesome and incredible.

https://www.wsj.com/articles/where-t...pos_5#cxrecs_s

So I will make a few comments about this without being too political:

1. The White House should not have said a damn thing about booster shots being available until the FDA/CDC had a chance to do their review. The fact that they jumped the gun (even if they end up being right) is absolutely unacceptable. All they had to do was keep their mouth shut and say they are relying on the experts. This is why several of the FDA committee members are resigning at the end of the year.
2. The data on whether we need boosters is a VERY complicated picture and partly depends on what we set as our end-point for efficacy. This is further complicated by the fact that R0/efficacy/% fully vaccinated are all intertwined variables.
   
   1. If the end point is preventing hospitalization/severe cases/death then there is very very little evidence that boosters are needed for those who aren't immunocompromised or 60+ years old. For those in those two categories then booster shots are DEFINITELY warranted.
   2. If the end point is preventing infection. There is a notable case that a booster dose could be beneficial based on decreasing efficacy numbers against outright infection. These numbers are not nearly as bad as some are indicating but have declined.
3. It will be very telling how the debate at the FDA and CDC go. It would not surprise me if they decide that it is not necessary for those under 60.

FDA punted today. CDC and White House way out ahead of science here.

Quote:

---

Originally Posted by bigsky

FDA punted today. CDC and White House way out ahead of science here.

---

I think you can call that "ignoring the science" as well.

CDC is obviously political, and have just about ruined their standing with a lot of Americans. They had a ton of credibility with most people, but I think most of it is now gone.

Quote:

---

Originally Posted by bigsky

FDA punted today. CDC and White House way out ahead of science here.

---

Quote:

---

Originally Posted by CitizenBBN

I think you can call that "ignoring the science" as well.

CDC is obviously political, and have just about ruined their standing with a lot of Americans. They had a ton of credibility with most people, but I think most of it is now gone.

---

Honestly, they didn't really punt as much as state the current state of the science: things are murky and NOT fully definitive. Science isn't always clean with a pretty picture when you are in the midst of the "fog of war".

As I mentioned before, if our target end point is preventing severe infection/hospitalization/death then the need for boosters is very debatable at this time.

There is some strong evidence that efficacy against severe cases/hospitalization is dropping over time but this is heavily aliased with age/risk profile/variant/etc. Furthermore, there is conflicting data across many of the studies with some showing steeper drops than others. Previous studies including the one to which I linked had some notable difficulties teasing out what deviation is due to age versus how long ago one was vaccinated. As older patients are more likely to have been vaccinated early versus younger patients, there is the possibility that the reduced efficacy seen in older patients is due to time since vaccination and not due to age itself.

Now on the other hand, if the end goal is to prevent infection/spread, then there is a notable case that boosters are needed.

In particular, there is evidence that across all age strata the risk of a breakthrough infection increased approximately 50% for people vaccinated around 6-8mo ago versus those vaccinated <6mo ago. Per the data, this results in efficacy against infection dropping from around 80% to around 50%. On a slightly good note, there is no statistical difference in the efficacy rates between Delta and the other variants. On the bad side, this means the efficacy against infection/severe COVID/hospitalization/etc. is waning due to length of time. Depending on your view point on the unvaccinated, this could indicate that a booster is the best way to get out of this mess or you could feel that those doses are better served going to other countries.


As for the booster doses, some of the recent data is showing that a booster shot at 6-8 months is producing over 3x the antibodies we saw after Dose 2. Based on what we know about post-Dose2 efficacy against infection this is FAR more than enough to generate complete immunity against infection in over 90% of the population.

Based on the above data, we can summarize: there is some degree of waning in efficacy over time and the booster increases efficacy against infection to higher than it was at the end of dose 2. The questions which remain are 1) is this waning efficacy enough of a risk to warrant another booster or could it reach that level in the near future (could it be bad enough 6 mo from now), 2) is this waning efficacy occurring across all ages, 3) does this waning efficacy warrant the risk of a booster dose, 4) does it warrant redirecting doses which could be used to provide first doses to other countries.

The FDA has a lot of options here, they could not authorize any booster doses, they could authorize a booster dose for those above a certain age and/or with specific comorbidities (as they did for the immunocompromised), or they could authorize a booster dose for anyone (plus pretty much every variant between those points). To be clear, the FDA also has the bias that their job is to protect the American public, meaning that concerns about other countries will weigh less than concerns about Americans directly.

None of this excuses Biden et al from opening their damn mouth before the data was readily available. The fact it appears they might be right does not excuse them from speaking before they could speak truthfully. I view it the same way I view Russia skipping Phase III trials for the Sputnik vaccine. Yes, they made at best an educated guess and they are lucky it worked out in their favor but it is still a **** move and is totally unacceptable.

Quote:

---

Originally Posted by CitizenBBN

I think you can call that "ignoring the science" as well.

CDC is obviously political, and have just about ruined their standing with a lot of Americans. They had a ton of credibility with most people, but I think most of it is now gone.

---

The CDC has jumped the shark. Once you jump the shark your audience never views you the same way.