Coronavirus Vaccine(s)

[Gingergrrl]

I also wanted to add that I have been researching and reading opinions re: the COVID vaccines in some other online groups and in the official national organizations (re: MCAS, Myasthenia Gravis, Lambert Eaton Syndrome/LEMS, Calcium Channel Autoantibodies, Dysautonomia, other autoimmune diseases, and even the Guillain-Barre society).

The official statements from these groups and organizations (so far) are all very moderate and careful not to take a position. They all state that the pros & cons must be weighed and that individual patients should discuss the pros & cons of the COVID vaccines with their individual doctors. I think they must take this stance because the vaccine was just released in the US today and there just is not enough info yet to say anything different (which I totally understand).

 

[Neunistiva]

I've read many cases of people in which a vaccine was the actual trigger of their ME/CFS

I would just like to point out that we don't know for sure what their trigger was. All we know is the sequence of events, and just because something preceeded coming down with ME/CFS does not mean it caused it.

Look at any superstition and you will see how human brain loves to make any connection when left without proper data.

And if anything is missing real data it's ME/CFS, with its paltry funding. I am of course not saying that a vaccine didn't trigger their ME/CFS. Just to frame things with less certainty. We don't know.

I agree and I don't think we will have research on any chronic illness populations

I read that countries where number of cases are low are setting up very careful and detailed vaccine side-effect reporting systems, since they're not in a hurry like Europe and US. Once enough people have been vaccinated we will know about other chronic illness populations. Just not about ME/CFS since majority are undiagnosed and many countries don't consider it a real disease

 

[Wayne]

I read your link but wasn't sure if it was connected to the vaccine or more about COVID symptoms in general?

@Gingergrrl -- More about COVID symptoms in general. I debated whether to even post it, but thought it was interesting enough to post it on this thread, where readers probably have a high interest in all things COVID.

 

[ljimbo423]

The Moderna vaccine is suppose to be approved very soon. It's showing a significant reduction in asymptomatic infections after the first dose.

It makes sense that this reduction will be even higher after the second dose. Maybe much higher. I think this means that not only do people not get sick from covid with this vaccine but most people can't even get the virus, so they can't transmit it to anyone else.

At least in two thirds of people after the first dose and as I said, maybe much higher after the second dose.

Moderna’s analysis, posted by the FDA, also included new data suggesting that the first dose of its vaccine can reduce infections that don’t cause symptoms. If this finding holds up in further analysis—including after the second of the two-dose regimen—it could mean that the vaccine not only protects individuals from disease, but also curbs transmission of the virus from person to person.


A vaccine that prevents asymptomatic infections and curbs viral transmission could hasten the end of the coronavirus pandemic, if enough people get vaccinated.



“If we could demonstrate that they reduce transmission, that would accelerate the time when we can take off our masks and go back to a more normal semblance of life,” said William Schaffner, professor of health policy and preventive medicine at Vanderbilt University. He said more data are necessary to conclude whether the Covid-19 vaccines can do that.


A Pfizer researcher said last week the company was studying whether its vaccine protects against asymptomatic Covid-19 and hopes to complete that analysis early next year.


The Moderna vaccine, if authorized, would be the first of several expected to augment U.S. vaccine supplies following the rollout to Americans this week of the first shot, from Pfizer. Vaccines are considered critical to ending the pandemic, which has killed about 300,000 people in the U.S. and more than 1.6 million world-wide.


FDA analysts found that the Moderna vaccine was effective “across age groups, genders, racial and ethnic groups, and participants with medical comorbidities [underlying conditions] associated with high risk of severe Covid-19.”


Similarly encouraging, FDA scientists also found that the research “suggested benefit of the vaccine in preventing severe Covid-19.” The issue of effectiveness against severe disease has been raised about the studies of Covid-19 vaccines. The study found 30 cases of severe disease in the placebo group, versus zero in the vaccine group.


Moderna found that some people who started the study with no evidence of infection developed asymptomatic infections after the first dose and before the second dose. Of these, Moderna found there were about two-thirds fewer asymptomatic coronavirus infections among vaccine recipients than among those who had gotten a placebo, according to a Moderna document posted by FDA. The document didn’t include results following the second dose.

Moderna’s new data showing a reduction in asymptomatic infections after the first dose means it is possible to “slow down the spread of the virus in the community by being vaccinated, in addition to protecting yourself from severe disease,” said Moderna Chief Executive Stephane Bancel.

Reference

 

[lenora]

Hello All....Please bear with me as I try to explain this in a somewhat convoluted way. Along with a few others, I developed Autoimmune Encephalitis in January of this year (diagnosed then, but had it before). I was on a site yesterday checking info for someone else, when an approximation of this caught my eye, " People with AE should not be getting vaccinated against the virus. The immune system cannot withstand the assault, no matter how slight. In most cases it may bring on another direct attack (of AE, I'm sure). Not only that, but if we do get the vaccination, we still have to always wear masks in public and any other safety measures that may be deemed necessary."

Now today I was going through a magazine that probably many of you receive, it's free and is accessed through your neurologist's office. It's called BRAIN & LIFE and covers many neurological illnesses. Today's was of interest b/c of survivors of COVID who seem to have a lot of the same symptoms we have. It's an article worth reading and appears on P. 30 of the magazine. Now just before it, on P. 27 is another article concerning the race for a vaccine. This is a direct quote from p. 29 in the gray block: "People whose immune systems are suppressed should discuss vaccines with their physicians (good luck! If you have 8 physicians, you'll get 8 different opinions, or that's what I found when getting the Shingles vaccine). Now I want to specify this is for those of us with Encephalitis, but close enough that I wouldn't do this without a lot of investigation. Continuing: " Those with epilepsy (which I have) may experience a lowerered seizure threshold after taking a vaccine, says Jonathan Santoro, MC, directotor of neuroimmunology and demyelinating disorders at Children's Hospital Los Angeles.

Anyone with a neorological disorder is particularly vulnerable to diseases like influenza and COVID-19, and the protection afforded by vaccines often outweighs the risks, Dr. Santoro says. People will most likely still need to wear masks after being inoculated for COVID-19 and they may need yearly shots, says Gary Gronseth, MD, FAAN, vice chair or neurology at the Unviersity of Kansas."

So there you have it....another opinion that is basically a non-opinion. Personally, I'm a believer in vaccines, but after reading just these two article, am quite undecided about what to do. We have yearly flu shots, I've never had I a reaction, nor have I had the flu. I did go ahead and have the Shingles vaccine b/c quite frankly, I couldn't live through that ordeal again, and really don't know what I'll do about this one. At present, I'll wait until more info comes in and, hopefully, an Immunologist like Nancy Klimas will have some input to help us. We can't live in a glass bubble, but at present, we've all been living this way for a fair time and a few more
mos. won't matter. I expect there will be more and more of this info available as the mos. go on. Thank you. I wish you a good decision and most of all, good health. Yours, Lenora.

 

[Sushi]

For anyone interested, there is a new Facebook group for ME/CFS patients to discuss information from their doctors on the vaccines and/or their reactions to Covid vaccinations. It is a private group so posts can only be seen by members:
https://www.facebook.com/groups/226441995768222/?ref=share

 

[Jade7]

The “anti-freeze type products” that people are referring to is the PEG (polyethylene glycol) that is used to encapsulate the mRNA. Although it’s not an adjuvant, it is still potentially problematic. This is the ingredient that experts now believe is most likely causing the severe allergic reactions, including in people who hadn’t previously experienced anaphylaxis (like the Alaskan woman who received the Pfizer shot yesterday).

 

[Neunistiva]

PEG (polyethylene glycol) is a common ingredient in skin creams, toothpastes and is even used as a laxative. Due to frequent exposure to it people will develop antibodies to it. Because of this very small percentage will then have an allergic reaction to it, and even smaller percentage of those will go into an anaphylactic shock. The exact same thing happens to some people with peanuts or strawberries.

UK alone administered more than 140,000 doses of this vaccine already, and who knows how many more in Canada and the US. There have been 4 cases of anaphylaxis.

This was a known risk which is why everyone who receives the vaccine is required to wait for 15 minutes (US CDC requires 30 mins). And that is why all of those 4 people have been treated promptly and are alive and well now.

Here is wikipedia page on PEG so you can get informed.

 

[Gingergrrl]

I'm going to split up my reply into 2-3 parts so it is not too long!

I would just like to point out that we don't know for sure what their trigger was. All we know is the sequence of events, and just because something preceeded coming down with ME/CFS does not mean it caused it. Look at any superstition and you will see how human brain loves to make any connection when left without proper data.

My own illness was not triggered by a vaccine but I have talked to many people (from Phoenix Rising and in general) in which their ME/CFS was triggered by a vaccine, including the Gardisil vaccine. I don't think this is superstition and many vaccines throughout history were later were proven to have adverse events that were so dangerous that they were later pulled off the market.

I read that countries where number of cases are low are setting up very careful and detailed vaccine side-effect reporting systems, since they're not in a hurry like Europe and US.

This is great news and I am so glad that there will be a system to carefully track adverse reactions from the COVID vaccines. The FDA tracking system in the US for adverse events to meds, vaccines, etc, does not have a great history. Although maybe this will improve with COVID?

@Gingergrrl -- More about COVID symptoms in general. I debated whether to even post it, but thought it was interesting enough to post it on this thread, where readers probably have a high interest in all things COVID.

No worries and it was interesting! I re-read it to make sure that there was not something in the post re: the vaccine that I had missed.

The Moderna vaccine is suppose to be approved very soon. It's showing a significant reduction in asymptomatic infections after the first dose.

I have been reading across news platforms about the differences between the Pfizer and Moderna vaccines but haven't yet seen the full ingredient list for the Moderna vaccine like I have with Pfizer. If anyone has the full ingredient list for the Moderna vaccine, can you post it in this thread? And I apologize if someone posted it and I missed it!

 

[ljimbo423]

If anyone has the full ingredient list for the Moderna vaccine, can you post it in this thread?

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

 

[Neunistiva]

but I have talked to many people (from Phoenix Rising and in general) in which their ME/CFS was triggered by a vaccine, including the Gardisil vaccine. I don't think this is superstition and many vaccines throughout history were later were proven to have adverse events that were so dangerous that they were later pulled off the market.

You talked to people who developed ME/CFS after getting a vaccine. Without research we can't know if the two are connected.

I didn't say it was superstition, I was explaining how human brain works, and why we can't trust it to find the cause. That's why we developed the scientific method, and take antibiotics instead of killing black cats

I also didn't say the vaccine wasn't a trigger for some ME/CFS. I said we don't know, and that remains the truth.

The FDA tracking system in the US for adverse events to meds, vaccines, etc, does not have a great history. Although maybe this will improve with COVID?

I'm not from the US, so I'm not familiar with that, sorry.

 

[Gingergrrl]

I was on a site yesterday checking info for someone else, when an approximation of this caught my eye, " People with AE should not be getting vaccinated against the virus. The immune system cannot withstand the assault, no matter how slight. In most cases it may bring on another direct attack (of AE, I'm sure)

@lenora Do you have a link re: what you mentioned above about the COVID vaccine for people with AE? I would love to read more about this. I do not have AE but I have other obscure autoantibodies that caused me significant muscle weakness, breathing weakness, and POTS. I did three years of infusions that led to my remission. Like you said in your quote above, I do not think my immune system could withstand the assault of the COVID vaccine and it could re-trigger the auto-antibodies to cause another attack.

Those with epilepsy (which I have) may experience a lowerered seizure threshold after taking a vaccine, says Jonathan Santoro, MC, directotor of neuroimmunology and demyelinating disorders at Children's Hospital Los Angeles.

Thank you for this info and my best friend has epilepsy. She is in remission but avoids anything that could lower her seizure threshold.

Personally, I'm a believer in vaccines, but after reading just these two article, am quite undecided about what to do.

I am also a believer in vaccines but, like you, I am very concerned and undecided what to do. My concerns are purely medical and have nothing to do with politics whatsoever.

At present, I'll wait until more info comes in and, hopefully, an Immunologist like Nancy Klimas will have some input to help us.

I am hoping that Nancy Klimas will make a public statement on the COVID vaccine at some point (although to be safe, she will probably need to say that every patient should discuss the issue with their individual doctors). I agree with this and will be discussing it with my own doctor and I trust his opinion. It is just that these vaccines are so new that we do not yet know what adverse effects they might cause (besides anaphylaxis and Bell's Palsy which have both been reported so far).

The “anti-freeze type products” that people are referring to is the PEG (polyethylene glycol) that is used to encapsulate the mRNA. Although it’s not an adjuvant, it is still potentially problematic.

Thank you for explaining that @Jade7. I had a colonoscopy about a year ago and the main ingredient in the prep drink was a form of PEG and I was not allergic to it whatsoever. Does anyone know if this means that someone who is not allergic to the oral form of PEG would probably also not be allergic to the injectable form of PEG? Or are they very different?

This is the ingredient that experts now believe is most likely causing the severe allergic reactions, including in people who hadn’t previously experienced anaphylaxis (like the Alaskan woman who received the Pfizer shot yesterday).

The official CDC and FDA info state that there should be one case of anaphylaxis per MILLION with a vaccine so it seems very high to me that two people in the UK and two people in the US had anaphylaxis on the very first day of the vaccine being available. It seems that the COVID vaccine will have a much higher rate of anaphylaxis (if this trend continues).

UK alone administered more than 140,000 doses of this vaccine already, and who knows how many more in Canada and the US. There have been 4 cases of anaphylaxis.

I didn't know the numbers but if it was 140,000 doses than that means four cases of anaphylaxis out of 140,000 (versus one per million with other vaccines). Is this correct or did I misunderstand it. I just want to confirm.

 

[Neunistiva]

I didn't know the numbers but if it was 140,000 doses than that means four cases of anaphylaxis out of 140,000

No, 2 cases in UK and both of those people had previous history of anaphylaxis and carried epinephrine with them.

 

[Gingergrrl]

No, 2 cases in UK and both of those people had previous history of anaphylaxis and carried epinephrine with them.

So in the UK alone on the very first day of Pfizer COVID vaccines (140,000 doses total), two people had anaphylaxis vs. the statistics are that it should be one person per million doses of a vaccine. Is this correct? Maybe the UK is different than the US re: epipens (I truly do not know) but many people have them here due to prior severe allergic reactions or anaphylaxis (myself included) and other members of my family & friends.

 

[Gingergrrl]

@ljimbo423 Thank you for posting the ingredients of the Moderna COVID vaccine (in post #83 in this thread). It lists "tromethamine" and "tromethamine hydrochloride" and I Googled this to see what it is and it seems to be an NSAID (unless Google is giving me incorrect information)? I have been allergic to NSAIDS in the past and avoid them. Does anyone know what tromethamine is and why it is in the Moderna vaccine?

 

[Neunistiva]

So in the UK alone on the very first day of Pfizer COVID vaccines (140,000 doses total), two people had anaphylaxis vs. the statistics are that it should be one person per million doses of a vaccine. Is this correct?

No, it's not correct.

1. Vaccine has been administered in the UK for 10 days, with 2 cases in those 10 days.

2. There are no statistics about what number of allergic reactions there "should" be.

3.You are comparing apples and oranges. COVID-19 vaccine is administered to specific groups of people first, so you can't compare it with data on general population for other vaccines.

Just wait a bit. They said that people who had previous history of anaphylaxis should wait while they research who and why is at risk of allergic reactions.

Administration of this vaccine has just started, it is irresponsible to be drawing any conclusions yet, and there will be other vaccines that may prove more appropriate for certain age groups, disease histories etc.

Trust me, I undertand, I feel impatient too, but this is the time to wait and observe, not be drawing conclusions and making decisions.

 

[ljimbo423]

@ljimbo423 Thank you for posting the ingredients of the Moderna COVID vaccine (in post #83 in this thread). It lists "tromethamine" and "tromethamine hydrochloride" and I Googled this to see what it is and it seems to be an NSAID (unless Google is giving me incorrect information)? I have been allergic to NSAIDS in the past and avoid them. Does anyone know what tromethamine is and why it is in the Moderna vaccine?

Happy to help.

Here's what I found for Tromethamine......

Tris, or tris(hydroxymethyl)aminomethane, or known during medical use as tromethamine or THAM, is an organic compound with the formula (HOCH2)3CNH2. It is extensively used in biochemistry and molecular biology as a component of buffer solutions[1] such as in TAE and TBE buffers, especially for solutions of nucleic acids.

Reference

 

[Gingergrrl]

2. There are no statistics about what number of allergic reactions there "should" be.

There are statistics from the CDC re: allergic reactions and anaphylaxis to vaccines per million people in the population. This is from the CDC website from ACIP (Advisory Committee on Immunization Practices).

https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/adverse-reactions.html

Although allergic reactions are a common concern for vaccine providers, these reactions are uncommon and anaphylaxis following vaccines is rare, occurring at a rate of approximately one per million doses for many vaccines

Edited to Add: I wanted to clarify that the CDC data that I quoted above is re: anaphylaxis rates from vaccines in general and is not about the COVID vaccine.

Just wait a bit. They said that people who had previous history of anaphylaxis should wait while they research who and why is at risk of allergic reactions.

Trust me, I undertand, I feel impatient too, but this is the time to wait and observe, not be drawing conclusions and making decisions.

I am definitely waiting and this is not an issue! The vaccines will not be available to the general population for quite a while (I suspect at least March or April). I will wait and see what they recommend for people with a history of anaphylaxis and autoimmune disease. I am just trying to gather information now from as many different places as possible. I cannot compare myself to healthy controls in the vaccine trials b/c my immune system is not normal.

 

[Neunistiva]

There are statistics from the CDC re: allergic reactions and anaphylaxis to vaccines per million people in the population. This is from the CDC website from ACIP (Advisory Committee on Immunization Practices).

https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/adverse-reactions.html

1. Your link says "anaphylaxis following vaccines is rare, occurring at a rate of approximately one per million doses for many vaccines." Many. Not all.

2. That still doesn't say what should be. It will be what it is, and then they will decide if it's acceptable risk.

3. So far it looks acceptable. It's very rare with no deaths. But we don't know yet. To get rate per million you need to administer many millions. We aren't even close to 1 million. We don't know the rate for this vaccine and trying to guess it will make us look foolish in the future. We just don't know.

 

[ljimbo423]

This was just voted on a short while ago, today.

A second coronavirus vaccine is one step closer to the arms of Americans. An advisory panel voted Thursday to recommend the Food and Drug Administration authorize Moderna's vaccine for emergency use, as they did last week for Pfizer's vaccine.

Members of the Vaccines and Related Biological Products Advisory Committee voted 20-0 with one abstention in favor of the vaccine.

The FDA is expected to quickly authorize emergency use of the vaccine in the fight against COVID-19, which means it could start being administered as early as next week.

Reference