Coronavirus Vaccine(s)

[ljimbo423]

The FDA has granted emergency use authorization for Moderna’s coronavirus vaccine, giving the world a second shot at beating back the pandemic and clearing the way for doses to be shipped to states immediately.


“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Dr. Stephen Hahn in a statement.

Reference

 

[nyanko_the_sane]

From the Moderna presentation to the FDA panel

 

[Judee]

I skimmed through the thread and read a lot of the posts on the first pages but don't have mental energy to read them all right now. However, I did noticed this last post and tried to look some things up on the internet.

I found this video by Robert Kennedy Jr titled "The Problem with the COVID vaccine." I'm not sure who the moderator is since I don't watch a lot of tv. (At least, I'm guessing he's from tv with the cartoon characters in the background.

Anyway forgive my ignorance. Mr Kennedy seems to give some basic info on how the studies were conducted.

Just thought I'd post it HERE in case someone would be interested.

 

[nyanko_the_sane]

This video is a CG animated visualization of the mRNA vaccine at work.​

 

[nyanko_the_sane]

The video @Judee posted "The Problem with the COVID vaccine" does present some valid concerns. The following article discusses the reality that even though we have a vaccine we are still not out of the woods.

https://consumer.healthday.com/12-1...nce-you-get-the-covid-vaccine-2649439780.html

While there is still a lot we don't know about how effectively vaccines are going to help us win the covid-19 battle, one things for sure, we will still have to be careful for at least another year.

 

[Fat Viking]

I am hoping that Dr. Nancy Klimas will comment on the safety of these various vaccines for those of us who have immune irregularities. Do you, by chance, know any of her patients? Or perhaps your doctor could contact her? She is uniquely qualified to give input here.

I will Email her and Report back her response.

@Rufous McKinney I watched the video and took seven pages of notes! It brought up lots of questions for me and I intend to research the various COVID vaccine options in great detail and discuss them w/my doctor in the future. As of now, I do not think a COVID vaccine would be safe for my individual medical situation (but I am NOT an anti-vaxxer and my decision is purely medical and not political).

I will summarize the video here (from my understanding as a non-scientist )...

The video was moderated by "Marc Krause" and he interviewed two professors, John Kappler & Philippa Marrack (who are both PhD's in immunology at National Jewish Health in Denver, CO, and are married to each other). The video explained some basics re: immunology, re: autoimmunity (with a focus on Type 1 Diabetes), re: COVID-19, re: various COVID treatments, and re: the upcoming COVID vaccines.

It explained about B-cells and T-cells and how (in a functioning immune system) they fight antigens/foreign invaders like viruses, bacteria, toxins, etc. Then they explained about cases where the immune system is not working properly and after the virus is gone, it goes on causing damage to the host including excess inflammation, allergies, and autoimmunity (which all occurred in my personal situation ).

Next they did an entire segment on Type 1 Diabetes (and I skipped this part b/c it didn't pertain to me) but wanted to mention it in case it is relevant to anyone else reading this.

Then they talked about a special kind of B-cell that they discovered in both mice and humans (usually females) who have autoimmunity including RA, Lupus, Scleroderma, Sarcoidosis, Sjogrens, Crohns, MS, Hashimotos, Myasthenia Gravis, Type 1 Diabetes, and many other autoimmune diseases. They called it "ABC cells" or "Autoimmune B-cells". They said at present, there are no drugs that target ABC cells (but they mentioned later in the video that Rituximab has been successful in many cases). They were not sure, however, if this was because Rituximab specifically targets and destroys ABC cells or because Rituximab destroys ALL B-cells. This part was very interesting to me (separate from my research on the COVID vaccines) b/c Rituximab is what brought about my personal remission.

They pondered in the video if ABC cells (Autoimmune B-cells) might also be doing something useful and protective against viruses and they felt that the answer was yes. They said that women with these ABC cells tended to create a bigger immune response to a virus (like in COVID) and why men are more often likely to have severe cases of COVID (but this is of course a generalization).

They talked about what is known about COVID by scientists at this point which includes: the sequence, the process of how it infects cells, who is most likely to get a serious infection, various immune responses including Cytokine Storm, methods of transmission, several meds that can alleviate symptoms, and several vaccines still in clinical trials.

Then they talked about several different COVID treatment options: Remdesivir, Convalescent Plasma, Monoclonal Antibodies like Regeneron, and Dexamthasone.

Then they finally started to talk about the vaccines ...

They said that there are several types of vaccines in clinical trial. The first type is "RNA based" and includes Pfizer and Moderna. The next three are "Adenovirus vector based" and includes Astra Zeneca, Johnson & Johnson, and Merck. The next three are "protein based or conventional vaccines" and includes Norovax, Glaxo Smith Kline, and Sanofi. Lastly, they mentioned a Russian vaccine by Gamaleya which is also "adenovirus vector based", and a Chinese vaccine by SinoVac which is "inactivated SARS-COV-2" or another traditional vaccine.

If anyone reading this understands the different types of vaccines that the video mentioned, can you please explain it to me ? They did not explain the pros & cons of the different types of vaccines. The only thing they said is that the two RNA vaccines (Pfizer & Moderna) is a brand new type of vaccine that is able to be created and produced much faster (but it didn't seem that they were saying that it was better or worse than traditional vaccines... just faster to develop).

Then the moderator did a Q&A with the audience (which was pre-recorded).

There were many questions but the one that I am researching was if the COVID vaccines are safe for people with known autoimmune disease (like myself).

Sadly, there was no clear answer and the professors said that "No one knows the answer yet re: which type of COVID vaccines are best or even suitable in autoimmunity because no one with autoimmunity was included in the COVID vaccine trials". They said that there may be data on this within the next year. They said that the same was the case for people with immune deficiencies b/c no one who was immuno-compromised was included in the vaccine trials (just healthy people with normal immune systems).

Another question was asked re: if people with autoimmune disease should wait until more data is available on the vaccines re: autoimmunity (even after the vaccines are FDA approved in the US). The professors did not give a clear answer and said that "each individual should discuss with their own doctor re: their individual disease and risk factors, etc".
----------------------------------

So... I have a lot more research to do and at present, I will NOT be getting a COVID vaccine (once it is available in the US) because I absolutely do not feel that it is safe for me. My immune system is not normal and my illness remains in remission from (prior) IVIG & Rituximab. I have not had to use a wheelchair in 2.5 years and I can now go for an hour walk at a decent pace, including uphill, with no ill effects. I am fully independent within my home and do not require any assistance. My muscle strength and breathing are now completely normal and my POTS & MCAS remain in remission. I am not cured, I still take 6-7 meds, and still have endocrine problems. My attempts to taper off different meds were disasters so (at this point) I expect to be on them for life.

My personal fear of the COVID vaccine is that it could re-trigger my autoimmunity, dysautonomia & POTS, and my neuromuscular & breathing weakness (not to mention potential anaphylaxis to adjuvants in the vaccine ). I plan to rigorously research the different types of COVID vaccines and ask detailed questions in other on-line medical groups where I used to participate including groups on MCAS, LEMS, and calcium channel auto-antibodies (which are at the core of my personal illness).

I am also concerned that the mechanism that caused my muscle weakness is similar enough to the mechanism that causes Guillain Barre from the flu shot. I have never had a flu shot, and I do not know how similar it is to a COVID vaccine but (I think?) that both influenza viruses and coronaviruses are "RNA viruses" so I would assume that the vaccines are similar?

I am hoping that someone reading this who understands the science better than I do can explain any of the issues or questions that I asked here. I hope this summary was helpful and thank you again @Rufous McKinney for posting that video and it was a great starting point for my research on the COVID vaccines.

Molecular mimicry is the primarily accepted theory. "Molecular mimicry is defined as the theoretical possibility that sequence similarities between foreign and self-peptides are sufficient to result in the cross-activation of autoreactive T or B cells by pathogen-derived peptides." In my own words, Foreign Cells such as a Vaccine get mixed up with Self-antigens (your own Cells) and your body attacks both types of Cells.

Here is a list of ingredients and the amounts of each in the Pfizer vaccine. As @JES points out, there aren't any adjuvants in it.

Experts say the ingredients in the COVID-19 vaccine developed by Pfizer and German partner BioNTech, which was authorized Friday by the U.S. Food and Drug Administration, looks pretty standard for a vaccine.

In a letter to the FDA, Pfizer listed the ingredients in its vaccine. They can be organized into four basic categories:

Active Ingredient

• 30 mcg of a nucleosidemodified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.

Fats

• lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3- phosphocholine, and 0.2 mg cholesterol)

Salts

• 0.01 mg potassium chloride
• 0.01 mg monobasic potassium phosphate
• 0.36 mg sodium chloride
• 0.07 mg dibasic sodium phosphate dihydrate

Sugar

• 6 mg sucrose

Reference

4. Moderna COVID-19 Vaccine (mRNA-1273)

4.1 Vaccine Composition, Dosing Regimen

The Moderna COVID-19 Vaccine is a white to off-white, sterile, preservative-free frozen suspension for intramuscular injection. The vaccine contains a synthetic messenger ribonucleic acid (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of SARS-CoV-2 virus.

The vaccine also contains the following ingredients: lipids (SM-102, 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.

The Moderna COVID-19 Vaccine is provided as a frozen suspension [stored between -25º to -15ºC (-13º to 5ºF)] multi-dose vial containing 10 doses. The vaccine must be thawed prior to administration. After thawing, a maximum of 10 doses (0.5 mL each) can be withdrawn from each vial.

Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use. Unopened vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours. After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F) and discarded after 6 hours.


The Moderna COVID-19 Vaccine, mRNA-1273 (100 μg) is administered intramuscularly as a series of two doses (0.5 mL each), given 28 days apart.
FDA has reviewed the CMC data submitted to date for this vaccine and has determined that the CMC information is consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19.

FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA.

PDF Reference

Good to know that neither RNA Vaccine(s) contain Alum. Do you know if either of RNA Vaccine(s) contain other Metals?

 

[lenora]

As someone who has experienced anaphylactic shock, I feel I must insert myself here. My worst reaction was a complete unknown, and it took a long time to come out. I awakened in the a.m. and had it, and it just continued to get worse as time passed. My face was by then the size of a large pumpkin and, worst yet, was that we were to leave for Toronto a few hrs. later.

Rod took me to an ER clinic, and after using 4 epi-pens (one my own), told me to go a hospital. I knew I'd never make it that far, and told them to keep giving me injections with the pen. It finally stopped. So what to do about Toronto?

One gets tired of being sick and missing things, and I made what many would consider a stupid decision on my own. I wanted to go and did. I took two epi-pens with me, and used one that evening "just in case." Years later, I've never had any problems BUT each time I get an injection I know something may happen. I'm not going to get the first the first two vaccines, but will go for the 3rd one. Why? Because enough info should be in by then, and I know exactly what I'm letting myself in for. No, I won't called a TV station beforehand, b/c I'm an adult and I may make the wrong decision, but so what? At least I've had a decision, not some virus that will do whatever it wants in my body.

I live on the edge most of the time. I've lived that way for a very long time now, and at some point we have to find out as much info as possible and then throw things to the fates. We're all guinea pigs, like it or not, that's what we are, including the medical personnel who were the first one inoculated this past week. We'll get statistics, but we only started a week ago, please give them a chance. I'm not telling you whether or not to get vaccinated, b/c it can be scary. But look at so many things in life and tell me they're not scary, too. And yet we do them, don't they? Some are totally unnecessary, but we're human beings and want to enjoy our lives. I've been on many medications, used as a knowing guinea pig for many treatments, and always I've gone into willingly. At this point, I'll get the vaccination, but not until the 3rd one is out, and more statistics are avaiable.

Being allergic to something is really quite common and I personally find it irritating that anyone would call a TV station knowing they're giving false information. (Indeed, if they did...perhaps it was on site.) I'll be getting a new prescription for my existing 2pens, though, as that falls on me. I wish you luck in your decision. Lenora.

 

[gbells]

It looks safe. Allegic rxn in 0.5% is the only reported side effect and it prevents infection. Get it if you are high risk.

 

[Okian]

https://www.fox32chicago.com/news/s...-after-4-workers-experience-adverse-reactions -
Suburban hospital pauses COVID vaccinations after 4 workers experience adverse reactions

https://www.cbsnews.com/news/alaska-covid-vaccine-allergic-reaction-health-care-worker/ -
2 Alaska health care workers have allergic reactions after taking Pfizer's COVID-19 vaccine

 

[Okian]

https://www.fda.gov/media/143557/download

 

[lenora]

Okian...Good Morning to you. Get all of the information, and it will scare the bejingles out of you, and then wait a short time and make your decision. That's freedom of choice and sadly, we'll never be given a guarantee about anything, except perhaps mechanical things. Our health....never, not ever.

I sincerely encourage to make your own decision for the right reason. If you choose to not have the immunization you are still making a decision. Always, they have to be made. Wishing you well. Yours, Lenora.

 

[Fat Viking]

It's not just Coronavirus Vaccine(s) that include Alum. There's a long history of Vaccine(s) containing Alum and how that particular Vaccine caused adverse reactions. Even the Package Insert contains this Information: https://www.gsksource.com/pharma/co...ibing_Information/Engerix-B/pdf/ENGERIX-B.PDF

See any Vaccine(s) and then Click on Package Insert Information, then the First few Pages will tell you all you need to know about adverse reactions. This is straight from the Manufacturers:
https://www.cdc.gov/vaccinesafety/vaccines/index.html

https://www.fda.gov/media/143557/download

Thank you for that. Even though there's no Alum (or Mercury?) in that specific Coronavirus Vaccine, it still has neurologic or autoimmune diseases that arise from Alum Vaccine(s) as adverse reactions.

 

[YippeeKi YOW !!]

I found this video by Robert Kennedy Jr

Robert Kennedy Jr is a pretty well-known anti-vaxer, whose own family has called him out for his tragic spreading of mis- and disinformation in this area, " ... We love Robert F. Kennedy Jr., but he is part of a misinformation campaign that's having heartbreaking—and deadly—consequences."

Unless he's changed his views in the wake of COVID-19, it might be good to take his input with a very large grain of salt ....

 

[Wayne]

Robert Kennedy Jr is a pretty well-known anti-vaxer, whose own family has called him out for his tragic spreading of mis- and disinformation in this area

Hi @YippeeKi YOW !! -- Just because one's family calls them out on something doesn't necessarily mean the family is right and the one being called out is wrong. I don't know whether Robert Kennedy Jr. is correct on everything he says about vaccines, but he's done a LOT of research in this area, and I believe he's more accurate in his assessments than those who say all vaccines are "safe and effective".

Those words are such a rote refrain that is expressed so redundantly, it almost makes me gag, because it smacks so much as manipulation. -- Whether or not Kennedy is accurate in all his public comments, I do believe he's sincere, and also quite intelligent. I trust him more than I trust mainstream medicine at this time. Perhaps time will show me otherwise.

I've read quite a few testimonials over the years from parents who believed everything they'd been told for years about how safe and effective vaccines were, only to discover otherwise after their children experienced life-changing "side-effects" from those very "safe and effective" vaccines. Their common refrain: I wish I'd have done my homework before having my kids vaccinated.

Unless he's changed his views in the wake of COVID-19, it might be good to take his input with a very large grain of salt ....

I think that's good advice. I think it's also good advice to take any input on vaccines with a grain of salt, including mine. I feel I'm pretty accurate in the things I feel I've discerned over many years of following the vaccine controversies quite closely, but I'm always open to new input. On the surface, it seems there's good potential to make safer vaccines using the new mRNA technology that went into the COVID-19 vaccine.

 

[YippeeKi YOW !!]

Just because one's family calls them out on something doesn't necessarily mean the family is right

Also:

• ArsTechnica,
• WAPO,
• NYT,
• Wikipedia,
• The Globe & Mail,
• NBC, ABC, CBS News,
• The Atlantic,
• Scientific American,
• The Guardian,
• Time Mag,
• The Council on Science and Health,
• The Daily Beast,
• Forbes,
• StatNews.com,
• ScienceAlert.com ...
• Commonwealth Magazine
• Texas Monthly

While I agree with some of RFK, Jr's positions re possible negative aspects of some vaccines, his swing towards anti-vaxxing, and anti-vaxxers generally, is disturbing ...

 

[ljimbo423]

Good to know that neither RNA Vaccine(s) contain Alum. Do you know if either of RNA Vaccine(s) contain other Metals?

I really haven't looked in to the mRNA vaccines having other metals in them. So I don't know.

 

[IThinkImTurningJapanese]

She collapsed from the needle stick--not any ingredient in the vaccine. She knew that she had a medical condition that made you prone to fainting if she experienced pain. Maybe vaso-vagal reaction? I've fainted from a needle stick too.

17 minutes later?

Fairbanks clinician is third Alaskan with adverse reaction to Covid-19 vaccine

ANCHORAGE, Alaska (Reuters) - A Fairbanks clinician suffered anaphylactic symptoms after being given the Pfizer Inc coronavirus vaccine, a hospital said on Friday, becoming the third Alaska health care worker to suffer an adverse reaction to the new drug.
The clinician, whose name was not released, started showing symptoms about 10 minutes after being inoculated on Thursday, according to Foundation Health Partners, operator of the Fairbanks Memorial Hospital.
The health care worker was treated in the hospital’s emergency room with epinephrine and released about six hours later, Foundation Health Partners said in a written statement.

 

[Okian]

Do your own research people and don't believe what you hear left and right! Stay safe out there!

 

[gbells]

17 minutes later?

Fairbanks clinician is third Alaskan with adverse reaction to Covid-19 vaccine

Risk of allergic reaction for covid vaccine is 0.5% and it is treatable. The media shouldn't hype this up.

 

[lenora]

We had a neighbor who had severe allergies (everyone in our city seems to, especially after the first 2 yrs.). Each week he went to his doctor for the exact same injection.

One week, he had waited his 15 minutes, left and was in a meeting when he suddenly felt sick and passed out. His secretary knew his schedule and the doctor's office was called. He was rushed back to the office (not to an ER) and was treated and recovered immediately. He remembered nothing except feeling hot. He did NOT call a lawyer, did not blame the doctor and, like me, said "These things may happen." He knew and accepted that not only all injections (which was exactly the same as the ones he had before), but everything we put in our mouths can perhaps cause an allergic reaction. That's why there are such things as Epi-pens. They're easy to use, don't hurt and usually stop an attack immediately. True, they do expire, but then the onus is on us to get a new prescription (usually for two...and no, they aren't cheap) and have them on hand and, if necessary, travel with them.

Do you know that until recently sunstroke could kill you? An injection now takes care of the death problem, but how many people are allergic to it? Does that stop them from being treated? Of course not, but extra precautions are taken and yes, you may almost or even die. It has happened to me (not b/c of sunstroke) just recently I may add, had nothing to do with an injection of any sort, but did happen in the ER with doctors present. Next time I may not be so fortunate. I was unconscious for 2 days, and it happened again a few mos. later....same thing, and once again I was in the ER, and just became unconscious....this was due to epilepsy that I wasn't even aware that I had, although there had been plenty of warnings...a broken wrist after falling 6" (yes, inches), at least 8 falls at that point....one second I was fine, and then I was flat on my back on the floor. So, things happen, be prepared because this is life. By all means do what you can to avoid trouble, know which vaccine may be best suited for you....but the virus, especially it's newest variant, is definitely going to cause severe problems for those in a weakened state to begin with. By the way, as of now it isn't known if the newest vaccines can work against the new virus. Sometimes we have to have hope. Take care...Yours, Lenora.