Association of Male Hypogonadism With Risk of Hospitalization for COVID-19 (2 Sept 2022)

[tareload]

Association of Male Hypogonadism With Risk of Hospitalization for COVID-19

This cohort study compares COVID-19 hospitalization rates for men with hypogonadism who were not receiving testosterone therapy, men with eugonadism, and men receiving testosterone therapy.

jamanetwork.com

Open article (enjoy). Also note the abscissa range for Fig. 2 and TT range (IQR) in Table 1 for TRT patients.

Figure 2. Probability of Hospitalization Based on Testosterone Concentrations in Men With Hypogonadism and Men With Eugonadism, After Multivariable Adjustment for Age, Body Mass Index, Charlson Comorbidity Index, Race and Ethnicity, and Immunosuppression Status

 

[tareload]

Supplement

 

[tareload]

Reasonably powered study...

Statistical Analysis
The primary exposure of the study was the gonadal status (hypogonadism, eugonadism, and TTh), and the primary outcome was hospitalization for COVID-19. Statistical adjustments were made for group differences in age, BMI, race and ethnicity (coded as Black, White, or other [Asian, Pacific Islander, or American Indian]), immunosuppression (yes or no), and comorbid conditions (Charlson Comorbidity Index [CCI]). Racial disparities have been noted in outcomes of COVID-19. Hence, we included race and ethnicity as a covariate in our analysis. The CCI is a validated method to assess significant medical comorbidity.18 Continuous variables are presented as either mean (SD) values or median (IQR) values, depending on the distribution of values. Testosterone concentrations were not normally distributed and were log-transformed to conduct parametric tests. All tests were performed using SPSS software, version 27 (SPSS Inc). Group comparisons were performed by t tests, analysis of variance (with Hochberg post hoc analyses), Mann-Whitney rank sum tests, χ2 tests, and Fisher exact tests as appropriate. Multivariable logistic regression analyses are presented as odds ratios (ORs [ie, exponential of the β coefficient with 95% CIs and P values]). Reported P values are 2-sided and considered statistically significant at P < .05. Our study had 90% power to detect a 15% difference in hospitalization rates between the group with eugonadism and the group with hypogonadism.

 

[BigTex]

Thank you for posting this. Very interesting finding:

Conclusions and Relevance This study suggests that men with hypogonadism were more likely to be hospitalized after COVID-19 infection compared with those with eugonadism, independent of other known risk factors.

Just more evidence on why men suffering with low T is not acceptable.

 

[tareload]

Pfizer-BioNTech submits new COVID vaccine booster targeting BA.5 to the FDA for authorization

Pfizer and BioNTech have submitted their new COVID-19 booster that targets the omicron subvariant BA.5 to the FDA for emergency use authorization.

www.usatoday.com

The company has tested the BA.5-specific vaccine only on mice, so far, and is relying on data from both the BA.1 human trials and the BA.5 mice trials for their submission for authorization.

In the study, eight mice that were given the BA.5 booster dose about 100 days after receiving two doses of Pfizer’s original vaccine generated an immune response.

“To rely only on mouse data (for authorization) would be unprecedented in my knowledge and would certainly raise eyebrows,” said John Moore, a vaccine and virology expert at Weill Cornell Medicine in New York. “It doesn’t mimic the human situation,” where many people were vaccinated more than a year ago and have since been boosted.

 

[BigTex]

So much for clinical trials huh.

 

[Systemlord]

Wow, look at the infections are still high between 400-550 and as you get closer to 600, only then do the infections start dropping off.

 

[BigTex]

Seems like the statements by Dr. John Moore kind of sums it all up pretty well.

 

[HarryCat2]

Pfizer-BioNTech submits new COVID vaccine booster targeting BA.5 to the FDA for authorization

Pfizer and BioNTech have submitted their new COVID-19 booster that targets the omicron subvariant BA.5 to the FDA for emergency use authorization.

www.usatoday.com

The company has tested the BA.5-specific vaccine only on mice, so far, and is relying on data from both the BA.1 human trials and the BA.5 mice trials for their submission for authorization.

In the study, eight mice that were given the BA.5 booster dose about 100 days after receiving two doses of Pfizer’s original vaccine generated an immune response.

“To rely only on mouse data (for authorization) would be unprecedented in my knowledge and would certainly raise eyebrows,” said John Moore, a vaccine and virology expert at Weill Cornell Medicine in New York. “It doesn’t mimic the human situation,” where many people were vaccinated more than a year ago and have since been boosted.

Not a good idea to get your info from a place like USAToday. Try this.

 

[BigTex]

I don't really care for USA Today but the comments on USAToday were made by Dr. John More of Cornell Medical College

Professor of Microbiology and Immunology, Microbiology and Immunology , Weill Cornell Medical College. He seems to be well published in the field.

 

[HarryCat2]

I don't really care for USA Today but the comments on USAToday were made by Dr. John More of Cornell Medical College

Professor of Microbiology and Immunology, Microbiology and Immunology , Weill Cornell Medical College. He seems to be well published in the field.

Well, he's clearly misinformed on the booster vaccine approval process.

 

[tareload]

Not a good idea to get your info from a place like USAToday. Try this.

Developed brains read from all kinds of sources and use critical thinking, analysis and reasoning to make their own conclusions.

Thanks for the video link.

 

[BigTex]

Well, he's clearly misinformed on the booster vaccine approval process.

Because he disagrees with you?

IMHO, the FDA is not unsderstanding the clinical process which NONE of these vaccine have completed

https://www.mosio.com/clinical-protocol/

 

[tareload]

Not a good idea to get your info from a place like USAToday. Try this.

I guess Science.org is also fake news. Your video is misleading by omission and the guy talking knows it too. The layperson watches his video and doesn't have the scientific training and reading comprehension to tell he is purposely misleading.

Be careful where you get your info.

Science | AAAS

www.science.org

Regarding BA.5 EUA...


For the BA.4/BA.5 boosters, the companies have submitted animal data. They have not released those data publicly, although at the June FDA meeting, Pfizer presented preliminary findings in eight mice given BA.4/BA.5 vaccines as their third dose. Compared with the mice that received the original vaccine as a booster, the animals showed an increased response to all Omicron variants tested: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5.

How can authorities consider authorizing vaccines without data from human trials?​

Influenza vaccines are updated each spring to try to match the strain most likely to circulate in the fall and winter. The reformulated shots don’t have to undergo new clinical trials unless the manufacturers significantly change the way they make the vaccine. A similar approach for new COVID-19 variants makes sense, says Leif Erik Sander, an infectious disease expert at the Charité University Hospital in Berlin. The changes to the mRNA are minor and providing updated vaccines as quickly as possible is “an ethical issue,” Sander says. “We need to allow people to protect themselves from a virus that we can’t fully control.”

But there is a potential downside: Authorizing updated vaccines without clinical data could lower public acceptance. “If a variant booster is going to reduce overall uptake, that’s a potential problem” that could offset the gains in protection from the new vaccine, says Deborah Cromer, a mathematical modeler at the Kirby Institute of the University of New South Wales.


Next i suppose you want the emails from Pfizer to the FDA?

 

[BigTex]

I guess Science.com is also fake news. Your video is misleading and the guy talking knows it too.

Science | AAAS

www.science.org

Regarding BA.5 EUA...


For the BA.4/BA.5 boosters, the companies have submitted animal data. They have not released those data publicly, although at the June FDA meeting, Pfizer presented preliminary findings in eight mice given BA.4/BA.5 vaccines as their third dose. Compared with the mice that received the original vaccine as a booster, the animals showed an increased response to all Omicron variants tested: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5.

Science is only fake news if it does agre with your ideas, right. Not suprised with the results.

"Pfizer reportedly made $36 billion from COVID-19 vaccines this year(2021) Heading into next year, the U.S. drugmaker expects to make $29 billion from COVID-19 vaccines. Those projections could rise as Pfizer seeks to sign more deals with countries to produce vaccines. Overall, Pfizer hopes to produce four billion vaccines in 2022. Of those four billion doses, the drugmaker plans to allocate at least one billion vaccines for low and middle income countries."

More...

"After resigning as FDA commissioner in March, Scott Gottlieb now joins the pharmaceutical industry (Pfizer) he once regulated."

​

 

[tareload]

Science is only fake news if it does agre with your ideas, right. Not suprised with the results.

"Pfizer reportedly made $36 billion from COVID-19 vaccines this year(2021) Heading into next year, the U.S. drugmaker expects to make $29 billion from COVID-19 vaccines. Those projections could rise as Pfizer seeks to sign more deals with countries to produce vaccines. Overall, Pfizer hopes to produce four billion vaccines in 2022. Of those four billion doses, the drugmaker plans to allocate at least one billion vaccines for low and middle income countries."

More...

"After resigning as FDA commissioner in March, Scott Gottlieb now joins the pharmaceutical industry (Pfizer) he once regulated."

​

Unfortunately @HarryCat2 is either one of those laypersons i mention above or purposely trying to mislead people here.

Follow the $$$$$. The article above is full of I don't know. Embarrassed for the leaders of FDA. Sad.

 

[HarryCat2]

The human trial data submitted by Pfizer/Biontech is summarized in this presentation submitted to the FDA. The data in mice is also included. This data has not gone through peer review.

https://www.fda.gov/media/159496/download

 

[BigTex]

Peer review is not a clinical trial. Nor has it goen through the peer review process. Clinical trials are necessary with Pharmaceuticals, Food Supplements, Medical Devices and Over The Counter(OTC) therapies before they are approved by the FDA. The main goal of a clinical trial is to find out whether the suggested treatment being trialed is safe for use in humans. Makes my stomach turn over knowing the FDA Chairman, Scott Gottlieb that approved emergency use of the Covid vaccines without completing Stage III or IV, was the head of the FDA. After he resigned in 2020 he was given a position with Pfizer on the Board of Directors

 

[HarryCat2]

Peer review is not a clinical trial. Nor has it goen through the peer review process. Clinical trials are necessary with Pharmaceuticals, Food Supplements, Medical Devices and Over The Counter(OTC) therapies before they are approved by the FDA. The main goal of a clinical trial is to find out whether the suggested treatment being trialed is safe for use in humans. Makes my stomach turn over knowing the FDA Chairman, Scott Gottlieb that approved emergency use of the Covid vaccines without completing Stage III or IV, was the head of the FDA. After he resigned in 2020 he was given a position with Pfizer on the Board of Directors

My only issue was the suggestion that there was no clinical data collected in humans, and that the FDA was moving ahead only with data collected it mice. The human data, as limited as it is, has been publicly available since June.

If you are interested in a thoughtful interview with a member of the FDA vaccine advisory committee who voted against approval of a BA4 BA5 specific booster watch the first hour of this.

 

[BigTex]

My only issue was the suggestion that there was no clinical data collected in humans, and that the FDA was moving ahead only with data collected it mice. The human data, as limited as it is, has been publicly available since June.

If you are interested in a thoughtful interview with a member of the FDA vaccine advisory committee who voted against approval of a BA4 BA5 specific booster watch the first hour of this.

Thanks for the video. Anyone in science knows data related to mice doesn't always work the same in humans. That is why clinical trials exist, to do further with humans before th edrug is released.. Here is a good study to look over, this IS a peer reviewed meta-analysis. Very good evidence. This evidence certainly coinsides with the data from VAERS. Now I agree that YouTube opinions, even coming from and expert in the field are very weak evidence, but Clinical trials and meta-analysis are right up there at the top.

Joseph Fraiman, Juan Erviti, Mark Jones, Sander Greenland, Patrick Whelan, Robert M. Kaplan, Peter Doshi. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 2022. ISSN 0264-410X, Redirecting.

Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults

In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potentia…

www.sciencedirect.com

Abstract​

Introduction​

In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.

Methods​

Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.

Results​

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).

Discussion​

The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.