Well, I’ve had the vaccine, anyone else?

[Myshinybestlife]

I got mine today!

 

[whitewave]

She looks like she is really going to jab him with gusto lol. DH got his about 30 mins ago!



(DH doesn’t wear a wedding band. He will wear it for special occasions).

 

[whitewave]

I got mine today!

Awesome! Did you get a pic of it?

 

[m-cubed]

FDA analysis of Moderna vaccine is out. Efficacy is great. In a study of over 30,000 people, half in vaccine group and half in placebo, there were 11 cases of COVID in the vaccine group and 185 in the placebo group. In the vaccine group, there was 1 case of severe COVID (didn’t meet the study definition because of timing of test results, but pretty clearly was a severe case of COVID) and 30 cases of severe COVID In the placebo group, 1 of whom died. So the vaccine works to prevent COVID, and it does so across genders, ages, race/ethnic backgrounds and in those with co-morbidities.

Safety profile: This vaccine will probably make you feel pretty crappy, potentially for a few days. Headache, joint pain, fever, chills, etc. The only “severe” adverse events that were really identified as likely caused by the vaccine were a low frequency of swollen, tender lymph nodes in vaccination arm. One case of intractable vomiting and nausea. Be warned, if you use dermal fillers, you could experience facial swelling! You may want to lay off the Juvederm prior to your shot.

One interesting thing that I am seeing now that I’ve seen both the Pfizer and Moderna data is that there may be a very low incidence of Bell’s Palsy (facial paralysis) which might be related to the vaccines (to be super clear, this is NOT proven). Pfizer had 4 cases in vaccine group and 0 in placebo. Moderna had 3 cases in vaccine group and 1 in placebo. That is basically the background rate in population, but it does strike me now that there’s two similar vaccine methodologies, both with an inbalance of this event in vaccine groups. Keep in mind, incidence is very low (a few out of ~15000) and at least in the Moderna group, 2/3 cases in the vaccine group had resolved by the time of analysis. FDA says they can’t rule in or out a causal relationship for Moderna vaccine and the Bell’s Palsy. This is what makes safety evaluation tricky - group sizes are large to try to pick out safety signals above background levels of events, but in a study pop of 15000/group, it may just not be clear. Please do not take this as “m-cubed says vaccines cause facial paralysis” - we just don’t have enough data yet to say and FDA is super clear that this is consistent with background levels of this event.

No severe anaphylaxis events were identified. Very low rate of study drop-out due to adverse events and most people who got 1 dose went on to get the second.

My conclusion? Safe and effective in groups studied. If you have previous history of Bell’s Palsy, you may want to speak with your doctor regarding whether this could be a contraindication for you, at least until there is more data from larger groups available.

 

[whitewave]

FDA analysis of Moderna vaccine is out. Efficacy is great. In a study of over 30,000 people, half in vaccine group and half in placebo, there were 11 cases of COVID in the vaccine group and 185 in the placebo group. In the vaccine group, there was 1 case of severe COVID (didn’t meet the study definition because of timing of test results, but pretty clearly was a severe case of COVID) and 30 cases of severe COVID In the placebo group, 1 of whom died. So the vaccine works to prevent COVID, and it does so across genders, ages, race/ethnic backgrounds and in those with co-morbidities.

Safety profile: This vaccine will probably make you feel pretty crappy, potentially for a few days. Headache, joint pain, fever, chills, etc. The only “severe” adverse events that were really identified as likely caused by the vaccine were a low frequency of swollen, tender lymph nodes in vaccination arm. One case of intractable vomiting and nausea. Be warned, if you use dermal fillers, you could experience facial swelling! You may want to lay off the Juvederm prior to your shot.

One interesting thing that I am seeing now that I’ve seen both the Pfizer and Moderna data is that there may be a very low incidence of Bell’s Palsy (facial paralysis) which might be related to the vaccines (to be super clear, this is NOT proven). Pfizer had 4 cases in vaccine group and 0 in placebo. Moderna had 3 cases in vaccine group and 1 in placebo. That is basically the background rate in population, but it does strike me now that there’s two similar vaccine methodologies, both with an inbalance of this event in vaccine groups. Keep in mind, incidence is very low (a few out of ~15000) and at least in the Moderna group, 2/3 cases in the vaccine group had resolved by the time of analysis. FDA says they can’t rule in or out a causal relationship for Moderna vaccine and the Bell’s Palsy. This is what makes safety evaluation tricky - group sizes are large to try to pick out safety signals above background levels of events, but in a study pop of 15000/group, it may just not be clear. Please do not take this as “m-cubed says vaccines cause facial paralysis” - we just don’t have enough data yet to say and FDA is super clear that this is consistent with background levels of this event.

No severe anaphylaxis events were identified. Very low rate of study drop-out due to adverse events and most people who got 1 dose went on to get the second.

My conclusion? Safe and effective in groups studied. If you have previous history of Bell’s Palsy, you may want to speak with your doctor regarding whether this could be a contraindication for you, at least until there is more data from larger groups available.

Personally, I had Bell’s palsy last year and it wasn’t that bad. More or less a minor inconvenience.

Given my comorbidities, I’d potential trade that for Covid protection, but I’d still talk to my doctor about it, and I won’t be able to get it probably until the summer at the earliest.

 

[m-cubed]

Personally, I had Bell’s palsy last year and it wasn’t that bad. More or less a minor inconvenience.

Given my comorbidities, I’d potential trade that for Covid protection, but I’d still talk to my doctor about it, and I won’t be able to get it probably until the summer at the earliest.

I am glad to hear your case resolved. I believe in most cases it does with some time. But probably not a lot of fun in the meantime.

 

[MakingTheGrade]

@MakingTheGrade Do you know where we can find out which medical conditions make someone eligible to get the vaccine sooner than the general public? The info I’ve read is a bit vague.

Also, does having a scheduled surgery (1 day in hospital) make someone eligible to get the vaccine sooner? (In my case it’s a cholecystectomy).

Finally, do you feel there are more medical errors occurring in U.S. hospitals now because of worker burnout, cross-coverage, understaffing, etc.?

Sorry for so many questions. I need to decide about my surgery in a week but understand if you don’t feel comfortable responding (or don’t have time).

Thanks,
Sally

I don’t know what medical contraindications would be for this vaccine. As far as surgery, sadly I can’t really speak to how things are at your facility. At my hospital there hasn’t been a significant uptick in adverse safety events but every hospital is a little different. If it’s a surgery that directly impacts your health then the pros likely outweigh the hypothetical risks. If it’s elective then it might be worth postponing.

 

[Myshinybestlife]

Awesome! Did you get a pic of it?

We had a media event for the roll out today. Yes I did!

 

[whitewave]

We had a media event for the roll out today. Yes I did!

Awesome!

 

[OoohShiny]

Thanks for your summary, @m-cubed

May I ask if you can add links to each of the reports? I don't think I've seen the full details over here in the UK - I have a feeling they are not published here by the Government (??).

 

[lilmosun]

Like others, I was at first concerned about the speed to market. But my understanding is that there were no shortcuts in the clinical trials for safety and efficacy, What was fast tracked were all of the administrative steps -and- having steps overlap such as mass manufacturing starting even before the vaccines were proven. This made me feel better and I can't wait for my turn... and I am someone who has even avoided the flu shot because I don't like something that changes every year lol. But this was the year that I was going to travel with my 85 year old mother and I want to do that with her before its too late. But like everything with this virus, everyone has their own tolerance for risk.

 

[OoohShiny]

I did not see a story around antibody injections, but I wonder if it is referring to the monoclonal antibody (mAbs) drugs. Realistically I think that’s a pretty terrible option compared to a vaccine. The mAbs require IV infusion of several grams of protein (this is a TON when it comes to protein) at a cost of probably $50K, and mAb drugs are known to have potential immunogenic side effects. Compared to a vaccine which likely produces durable immunity at a much lower cost and with a good safety profile? That is no comparison in my book.

I can understand people who are currently pregnant wanting to wait until delivery to get a vaccine. However that there could be a future effect on future fertility is fear-mongering based on no data or likely biological mechanism in my opinion.

The price of medical care in the USA is a whole other thread... lol

This is the story I saw on the antibody injections:

Covid: Jab for people who cannot be vaccinated trialled

An injection of antibodies might provide up to six months' protection to immuno-compromised patients.

www.bbc.com

A possible alternative to a vaccine, for people without functioning immune systems, is entering its final stage of trials.

The injection was developed using antibodies - made by the immune system to fight infection - produced by a single Covid patient in the US.

It is hoped it could provide at least six months' protection for patients who cannot receive vaccines.

Trials involving 1,000 UK participants begin in Manchester on Saturday.

A further 4,000 people are involved in the trial globally, which is being organised by pharmaceutical giant AstraZeneca.

Participants will be given either an injection containing two different Covid-19 antibodies, which have been specially engineered to last longer in the body - or a placebo.

It's a bit light on actual technical details but I assume they will be out there somewhere!

 

[m-cubed]

Thanks for your summary, @m-cubed

May I ask if you can add links to each of the reports? I don't think I've seen the full details over here in the UK - I have a feeling they are not published here by the Government (??).

I know relatively little about the UK regulatory authority, so I have no idea what is and isn’t published by your regulator.

Pfizer vaccine docs here: https://www.fda.gov/advisory-commit...-10-2020-meeting-announcement#event-materials

Scroll down to event materials. Sponsor materials are what Pfizer submitted. FDA briefing doc is the FDA analysis.

Moderna here: https://www.fda.gov/advisory-commit...mmittee-december-17-2020-meeting-announcement

 

[m-cubed]

The price of medical care in the USA is a whole other thread... lol

This is the story I saw on the antibody injections:

Covid: Jab for people who cannot be vaccinated trialled

An injection of antibodies might provide up to six months' protection to immuno-compromised patients.

www.bbc.com

It's a bit light on actual technical details but I assume they will be out there somewhere!

Yeah, that’s basically what I expected. Much as I thought, the article says “However, the therapy is significantly more expensive than vaccination and difficult to produce at scale, so it is unlikely to be used on the wider population.” Ignore the retail prices. Making grams of antibodies drugs per person is hella expensive. I think it is a possible prophylactic for those without functional immune systems, but not a replacement for those who can take the vaccine. These drugs are in trials primarily as interventions for those who get infected and are at risk for severe COVID. For example, if a case is identified in a nursing home, dose up all the residents prior to the infection blowing through and taking out a big % of them.

 

[LightBright]

I am familiar with the process. I am an "essential worker" for LA County. Even so, I would feel lucky if I am vaccinated before June 2021. It'll be a long process.

Wow, I had no idea it would take that long for essential workers. Thank you for your service! I just can’t wait to travel again. We haven’t seen my family since December 2019.

 

[SallyBrown]

I don’t know what medical contraindications would be for this vaccine. As far as surgery, sadly I can’t really speak to how things are at your facility. At my hospital there hasn’t been a significant uptick in adverse safety events but every hospital is a little different. If it’s a surgery that directly impacts your health then the pros likely outweigh the hypothetical risks. If it’s elective then it might be worth postponing.

Thank you so much @MakingTheGrade!

 

[LightBright]

So the Pfizer and Moderna vaccines are mRNA vaccines. mRNA is packaged in little fatty bubbles to get into your cells, where the cell then translates it into a portion of one of the virus proteins. It only makes that one protein, which serves as an antigen for your immune system to raise a response to. The vaccine does not have the instructions to make all the other proteins in the virus, so you can’t “get COVID” from the vaccine.

Based on a large scale trial, the Pfizer vaccine is quite safe. Vaccine side effects are expected to start and be identified within weeks, not months or years after injection. with a median follow up of 2 months for close to 35,000 people, the Pfizer vaccine induced common side effects such as headache, fatigue, joint pain, etc. the only “ severe adverse event” that was seen and judged to be likely due to the vaccine was a very low incidence of enlarged lymph nodes. The trial did exclude people with known histories of severe allergic reactions to vaccines - those people are generally advised to not get other vaccines anyhow. And there were some allergic events identified after the first general population vaccinations in the UK, so I would talk to your doc if you have a history of severe (anaphylactic type reactions) before getting the vaccine. Other than that safety profile is really excellent.

FDA analysis for Moderna vaccine will be out tomorrow. if I have time, I will report back once I’ve read the materials (50+ pages).

I am not as familiar with the Oxford/AZ vaccine, and that has not yet been submitted for an emergency use authorization in the US. NY Times vaccine tracker has solid info on all though.

I expect Moderna vaccine to likely get authorized for emergency use.

will you have a choice? Maybe. I personally will take whichever one is available to me first, assuming there’s no surprise reason it would be contraindicated for me. So you may have a choice if you are willing to wait. Right now, it is your choice to be vaccinated or not (unless your employer requires it), but we do need to reach threshold levels of vaccination to get life back to normal.

I am a scientist involved in research in this area, and I am happy to answer questions.

Thank you for this explanation, it is very helpful!

 

[LightBright]

We had a media event for the roll out today. Yes I did!

Awesome, thank you for your service, and your bling is terrific!

 

[SallyBrown]

I believe this is one set of guidelines/proposals the U.S./states will be using when determining an individual’s place in line for the vaccine, but don’t quote me on that. It was cited by the New York Times. It’s a long document but you can search it by key word, such as by a medical condition:

Front Matter | Framework for Equitable Allocation of COVID-19 Vaccine |The National Academies Press

Read chapter Front Matter: In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national government...

www.nap.edu

 

[Daisys and Diamonds]

My husband...bless him I love him so much, but unfortunately he believes some alternative news sources that have told their readership that the vaccine will have dyes, tracking devices and all sorts of nefarious things *sigh*. Maybe he doesnt believe exactly, but he is uneasy.

I told him I intend to get the vaccine (over 55, fat, diabetic) ASAP. He was genuinely worried that if I take it, something bad will happen to me. I went through the odds of something happening (0 vaccine deaths) vs getting COVID (maybe 3-5% death rate for my age and comorbidities).

There are so many like him....due to the proliferation of misinformation. If the US makes it mandatory, he will NOT get the vaccine. However, if those around get the vaccine and he sees it is harmless, he may get it.

This year has been complete suckage. I am so tired of fighting misinformation.

Its so frustratingly
I have a freind the same
it doesn't make them bad peoplev

 

[Austina]

As of last week when they started rolling out the vaccine here (UK), there were 2 cases of front line workers who had an allergic reaction. They both carried epi pens, so had suffered anaphylactic shock before. Much has been made of this by people who are anti vaccines, but 2 highly allergic people out of 5000 hasn’t made me change my mind about having the vaccine as soon as it’s my turn.

Our neighbour, a former dentist, has undergone the training to administer the vaccine, and is hopeful we will be vaccinated by February/March time.

If people are not going to take up the vaccine, then I think anyone who is vaccinated should be given a card to prove they have to enable them to travel etc., and anyone not able to produce the card should not be allowed to, for the safety of others.

I’m hoping they’ll carry out the mass vaccinations much as they have the flu jab. They‘ve set up a drive through at our local hobby airport, it’s been quick and very efficient and will enable them to get through 100’s if not 1000’s a day.

 

[Daisys and Diamonds]

As of last week when they started rolling out the vaccine here (UK), there were 2 cases of front line workers who had an allergic reaction. They both carried epi pens, so had suffered anaphylactic shock before. Much has been made of this by people who are anti vaccines, but 2 highly allergic people out of 5000 hasn’t made me change my mind about having the vaccine as soon as it’s my turn.

Our neighbour, a former dentist, has undergone the training to administer the vaccine, and is hopeful we will be vaccinated by February/March time.

If people are not going to take up the vaccine, then I think anyone who is vaccinated should be given a card to prove they have to enable them to travel etc., and anyone not able to produce the card should not be allowed to, for the safety of others.

I’m hoping they’ll carry out the mass vaccinations much as they have the flu jab. They‘ve set up a drive through at our local hobby airport, it’s been quick and very efficient and will enable them to get through 100’s if not 1000’s a day.

I did not know those two peeps had had allergic reactions before, thank you for bringing it to our attention

 

[SallyBrown]

I have a history of anaphylaxis and I STILL plan to get the vaccine. I’ll talk to my doctor about trying to get a non-Pfizer jab and I’ll make sure I’m right near an emergency room just in case. Plus I’ll have my Epi-Pen at the ready.

I think/hope by the time I’m eligible for the shot they’ll have figured out which vaccine component caused the allergic reactions.

 

[Daisys and Diamonds]

I have a history of anaphylaxis and I STILL plan to get the vaccine. I’ll talk to my doctor about trying to get a non-Pfizer jab and I’ll make sure I’m right near an emergency room just in case. Plus I’ll have my Epi-Pen at the ready.

I think/hope by the time I’m eligible for the shot they’ll have figured out which vaccine component caused the allergic reactions.

Your wonderful @Sally Brown
i hope by the time they get around to you everything is 100% safe for peeps like you
Please weight up the risks with your doctor carefully
People like you are one of the reasons I'm ready to get vaccinated

 

[Daisys and Diamonds]

So down here in NZ we are still waiting on the freezers and its looking like well into next year before we get done, so long as our present situation doesn't change its boarder workes first

So the govt must be happy to leave us all in limbo until then

out of curiosity does anyone know how many doses can be had for NZ$75M (US$55.3 million) ?
as we have earmarked that to help our Pacific neighbours out

New Zealand to offer free Covid-19 vaccines to everyone from mid-2021

Free Covid-19 vaccines will be offered to everyone in the country from the middle of 2021, the prime minister says.

i.stuff.co.nz

 

[SallyBrown]

Your wonderful @Sally Brown
i hope by the time they get around to you everything is 100% safe for peeps like you
Please weight up the risks with your doctor carefully
People like you are one of the reasons I'm ready to get vaccinated

Thank you so much @Daisys and Diamonds!

 

[TooPatient]

Looks like places administering vaccines are equipped to handle allergic reactions if needed. For anyone prone to them, might be worth confirming the location you go to has the capability.

Just saw this article on a healthcare worker with no history of reactions needing treatment for anaphylaxis. The vaccine location handled it well.

https://www.king5.com/mobile/articl...cine/507-17a3b532-de7a-4dbe-a1f1-4cf611f15b73

 

[Daisys and Diamonds]

Looks like places administering vaccines are equipped to handle allergic reactions if needed. For anyone prone to them, might be worth confirming the location you go to has the capability.

Just saw this article on a healthcare worker with no history of reactions needing treatment for anaphylaxis. The vaccine location handled it well.

https://www.king5.com/mobile/articl...cine/507-17a3b532-de7a-4dbe-a1f1-4cf611f15b73

Even with the flu jab they get you to hang around for 20min to make sure everything is ok, so i would hope 99% of places would have a plan for this

i feel sorry for the people allergic to egg
I guess the covid ones must be ok for the egg allergies because i havn't seen it mentioned ?

 

[m-cubed]

Even with the flu jab they get you to hang around for 20min to make sure everything is ok, so i would hope 99% of places would have a plan for this

i feel sorry for the people allergic to egg
I guess the covid ones must be ok for the egg allergies because i havn't seen it mentioned ?

Many flu vaccines are actually grown in eggs. Whole "live" virus is injected into special chicken eggs. The eggs permit viral replication. The virus is then purified from the eggs and inactivated, further purified and then this is the vaccine. This is a pretty slow process, which is fine for annual flu vaccines, but not for this race against time siutation. The Pfizer and Moderna vaccines are mRNA vaccines which are essentially synthesized rather than grown. No eggs are involved.

I am not aware of any advanced COVID vaccine candidates being grown in eggs, but that doesn't mean there aren't some that use that technology. There are MANY vaccine candidates, and I've not followed them all.

 

[m-cubed]

Looks like places administering vaccines are equipped to handle allergic reactions if needed. For anyone prone to them, might be worth confirming the location you go to has the capability.

Just saw this article on a healthcare worker with no history of reactions needing treatment for anaphylaxis. The vaccine location handled it well.

https://www.king5.com/mobile/articl...cine/507-17a3b532-de7a-4dbe-a1f1-4cf611f15b73

CDC is requiring that allergic reaction treatment be available for Pfizer vaccine administration. Details below:

"Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 vaccine. Vaccine providers should observe patients with a history of anaphylaxis (due to any cause) for 30 minutes after vaccination. All other persons should be observed for 15 minutes after vaccination to monitor for the occurrence of immediate adverse reactions."

Interim Clinical Considerations for Use of Pfizer-BioNTech COVID-19 Vaccine | CDC

Find interim clinical considerations for the use of Pfizer-BioNTech COVID-19 Vaccine.

www.cdc.gov

If you scroll down on this page, it has a nice chart of recommendations for patients with various levels of allergy history.