Randomized Study to evaluate vaccine safety

Study published in Nature on December 14.

A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults

In summary, the safety, tolerability, and immunogenicity results reported here support the use of BNT162b2 to prevent COVID-19 in healthy Japanese adults.

Link

Comments regarding adverse events

Adverse events Adverse events (AEs) from dose 1 through 1 month after dose 2 were reported by 10.1% of BNT162b2 and 7.3% of placebo recipients (Table 2). AEs reported by more than 1 participant in either group were nasopharyngitis (BNT162b2, n = 3 [2.5 %]; placebo, n = 1 [2.4 %]) and headache (BNT162b2, n = 2 [1.7 %]; placebo, n = 1 [2.4 %]). There were no immediate AEs within 30 min of vaccination. There were no serious AEs, no life-threatening AEs, and no deaths through 1 month after dose 2. There was no reported lymphadenopathy, and there were no diagnoses of COVID-19.

Some positive information about the safety of the vaccines. Please see the limitation section in the study. We also need to factor in the size and regionality.

Deny ignorance.

They will say the side effects are well tolerated and identical to Omi symptoms.

a reply to: Jeremyhuex

This thread is more about the safety of the vaccines, nothing about the virus itself.

The vaccine appears to have been well tolerated in the test group.

A bit of a small sample size, and the study is somewhat narrow in scope:

Between October 21, 2020, and November 10, 2020, 160 individuals were randomized at 2 sites (1 hospital and 1 clinic) in Japan; 119 received BNT162b2 and 41 received placebo (Fig. 1). More than 97% of BNT162b2 recipients received 2 doses. All participants were Japanese, 51% were male, and the mean age was 46 years (range 20–76 years); 130 participants were in the younger age group (20–64 years of age), and 30 participants were in the older age group (65–85 years of age) (Table 1). The most commonly reported comorbidities across all participants were dyslipidemia (4/119 [3.4%] BNT162b2 recipients; 2/41 [4.9%] placebo recipients) and hypertension (2/119 [1.7%] BNT162b2 recipients; 2/41 [4.9%] placebo recipients).

That said, these types of studies are useful, and a lot, A LOT more of them should be done, and really no mandates should be put in place without conclusive data from studies over the long haul.

a reply to: SleeperHasAwakened

Agree with you on all points.

Yes, lots more studies are needed to help build the larger picture.

Thank you for the comment.

a reply to: MDDoxs

There was no reported lymphadenopathy, and there were no diagnoses of COVID-19.

It took me 10 seconds to find a study that says the opposite.
Your study size: 160 people... Come on...



The study I quote:

Conclusions
In this era of COVID-19 pandemic and worldwide vaccination, medical staff should be aware that ipsilateral lymphadenopathy to the vaccine injection site may be a common side effect. COVID-19 vaccine related lymphadenopathy is associated with various clinical and sonographic features, but fortunately it shows spontaneous gradual recovery.

Emphasized by me. This study is based on clinical experience, not picking 160 people random.

www.ncbi.nlm.nih.gov...

From your link:
"Pfizer was responsible for study design and conduct, data collection, analysis, and interpretation, and writing of this manuscript. Both Pfizer and BioNTech manufactured the study vaccine. BioNTech was the sponsor of the study and contributed to data interpretation and writing of the manuscript. All study data were available to all authors, who vouch for accuracy of the data and adherence of the study to the protocol."

Best we can surmise is it works better for those of Asian decent than any other ethnicity?

The fox seems to be watching the hen house.

The Blood Clots grow and begin affecting the unfortunate vaccine recipients over months and years. Blood Clots are just one of the dangerous long-term side-effects.

a reply to: ThatDamnDuckAgain

Thanks for the comment and the link.

Your clinical study covers 3 individuals. Interesting, but still limited in scale.

The very conclusions draw are not based in statistics, thus the use of the word MAY, and they have acknowledged the any issues are easily corrected.

Just another piece of the puzzle. Thanks.

originally posted by: carewemust
The Blood Clots grow and begin affecting the unfortunate vaccine recipients over months and years. Blood Clots are just one of the dangerous long-term side-effects.

False. This is not a rolling snow ball that picks up material over a protected amount of time. If I am wrong on this please point me to some information to read.

a reply to: MDDoxs

Yes, because they got lymphadenopathy shortly after receiving the vaccine. The study you quoted surveiled random patients and found none in a sample size of 160, yet there are people running into issues with that.

Check out the pages of results in studys you get where they had people with these issues. You just found or selected the one that supports your argument.

www.qwant.com...

a reply to: ThatDamnDuckAgain

I am not arguing any point other that sharing the conclusion of the Japanese study.

You are incorrect, I picked this study because it is one of the latest in Nature Journal. If it had differing conclusions, I would have shared it all the same.

a reply to: MDDoxs

Here are ten (10) studies contradicting yours with links and quotes, only from the first page, it goes on for pages.....(!)


Lymphadenopathy Associated With the COVID-19 Vaccine
www.ncbi.nlm.nih.gov...

It is worth mentioning that we have described herein only three of many more cases of post-vaccination lymphadenopathy presenting to us within the first month of starting vaccination in our country. The number of cases was remarkable enough for us to report it.

Quoted because you criticized that it's only 3 individuals.



Lymphadenopathy Following COVID-19 Vaccination: Imaging ...
www.ncbi.nlm.nih.gov...

A total of 19 studies (68 cases), including 60 (88.2%) females and eight (11.8%) males with a presentation of LAP after COVID-19 vaccination, were reviewed. LAP was identified after first or second dosages of three types of COVID-19 vaccines, including Pfizer-BioNTech (n = 30, 44.1%), Moderna (n = 17, 25%), and Oxford-AstraZeneca (n = 1, 1.5%). In 20 (29.4%) cases, vaccine type was not reported or only reported as mRNA COVID-19 vaccine.

COVID-19 Vaccination–related Lymphadenopathy: What To Be ...
pubs.rsna.org...

How Common Is Vaccine-induced Axillary Lymphadenopathy?
Although unilateral lymphadenopathy is a known side effect of vaccines, it is rarely reported with vaccines such as the bacillus Calmette–Guérin, influenza, and human papillomavirus vaccines (3–5). In a larger series examining 83 recipients of the influenza vaccine, four patients had unexpected fluorodeoxyglucose axillary node accumulations on imaging (5). In addition, lymph node uptake on nuclear medicine studies after vaccination has been shown by multiple studies.

Lymphadenopathy Associated With the COVID-19 Vaccine
pubmed.ncbi.nlm.nih.gov...

Time elapsed from the injection until the appearance of the enlarged nodes, clinical symptoms, and sonographic features differed between the patients, but in all cases gradual regression was noted in the enlarged nodes until complete resolution. Accordingly, to our knowledge, this is the first report describing post-COVID-19 vaccine lymphadenopathy detailing the clinical aspects, sonographic features, and outcomes.

Lymphadenopathy in COVID-19 Vaccine Recipients: Diagnostic ...
pubmed.ncbi.nlm.nih.gov...

Five cases of axillary lymphadenopathy are presented, which occurred after COVID-19 vaccination and mimicked metastasis in a vulnerable oncologic patient group. Initial radiologic diagnosis raised concerns for metastasis.

Unilateral Lymphadenopathy After COVID-19 Vaccination: A ...
pubmed.ncbi.nlm.nih.gov...

The authors report isolated unilateral axillary lymphadenopathy (i.e., no imaging findings outside of visible lymphadenopathy), which is ipsilateral to recent (prior 6 weeks) vaccination, as benign with no further imaging indicated. Clinical management is recommended, with ultrasound if clinical concern persists 6 weeks after the final vaccination dose.

Supraclavicular lymphadenopathy after COVID-19 vaccination ...
www.ncbi.nlm.nih.gov...

We report a case of ipsilateral supraclavicular lymphadenopathy confirmed as reactive lymphadenopathy following administration of the Pfizer–BioNTech vaccine against COVID-19. The enlarged supraclavicular lymph nodes showed a size decrease with normalization of morphology on 1-week and 2-week serial follow-up ultrasound.

Vaccination-associated adenopathy occurs in the ipsilateral axillary and/or supraclavicular regions related to local immune response activation.3 , 5 In the Pfizer–BioNTech COVID-19 vaccine trial, the self-reported rate of ipsilateral axillary and supraclavicular lymphadenopathy was 0.3% among vaccine recipients

Lymphadenopathy after the third Covid-19 vaccine ...
europepmc.org...

reactive ipsilateral axillary lymphadenopathy (ral) has been clinically and radiologically very well reported after administration of covid-19 vaccines (local reactions 2021; local reactions

COVID-19 vaccine as a cause for unilateral lymphadenopathy ...
pubmed.ncbi.nlm.nih.gov...

COVID-19 vaccine as a cause for unilateral lymphadenopathy detected by 18F-FDG PET/CT in a patient affected by melanoma. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2659-2660.doi: 10.1007/s00259-021-05278-3. Epub 2021 Mar 6. Author

Pfizer-BioNTech COVID-19 Vaccine Reactions & Adverse ...
www.cdc.gov...

Reports of lymphadenopathy were imbalanced with 58 more cases in the vaccine group (64) than the placebo group (6); lymphadenopathy is plausibly related to the vaccine.

a reply to: ThatDamnDuckAgain

Thank you for all the links. I will review them and get back to you.

originally posted by: MDDoxs

originally posted by: carewemust
The Blood Clots grow and begin affecting the unfortunate vaccine recipients over months and years. Blood Clots are just one of the dangerous long-term side-effects.

False. This is not a rolling snow ball that picks up material over a protected amount of time. If I am wrong on this please point me to some information to read.

That jab you advocate targets leukocytes ability to function properly for a virus that was once upon a time 99% recoverable without visiting hospital.

blood clots

wbc

👎

more

a reply to: MDDoxs

You ignore the all-cause mortality rate, showing the vaxed are dying at twice the rate of the unvaxed. You can only trust the all-cause death rate, and I doubt whether you can trust these figures for much longer. They can prove or disprove anything then run with it. It is all lawyers talk to protect their asses.

a reply to: MDDoxs

Well tolerated is a relative term. As long as the participants didn't die, they will say the vaccine is well tolerated.

a reply to: carewemust

is that every recipient?

Didnt you say someone in your family was vaccinated (i think you said your wife), have they had any symptons?

So it looks like they gave them one of the good batches to do the trials with, with an "enormous" 160 person testing pool.

howbad.info...

Even if the vaccine is well tolerated, most people have a well functioning immune system.

By all means, vaccinate those at risk, but I question the wisdom of isolating the healthy part of the population for almost two years and preventing the spread of innocuous bugs that normally would keep our immune systems working.

I once mentioned a swollen gland in my neck to a doctor who was checking a mole out for me and he said that the swelling just means the glands are fighting something and it was a good sign it was working, that he'd be more concerned if they don't do this or persisted longterm.

We may be doing a huge disservice to our natural immunity with isolation, handwashing, distancing. I for one want to keep my immunity doing it's job and won't be boosting it in an unnatural manner. Would be different if my own system was compromised but I don't want it to become compromised by lack of interaction over time either.