FDA Approves Booster Shot for People with Weakened Immune Systems

[whatnot]

Scheduled my Booster for Oct 5th!

 

[rodi]

Novavax is said to be scaling up production, after struggling to establish supply chains.

They showed good efficacy data a few months ago.

They will seek approval and their strategy as a latecomer may be to get approval as booster.

That or maybe they will sell most of their production to the developing world.

A friend got the Noravax shots as part of a trial (he was trying to get vaxxed earlier than his age/lack of health problems would qualify hi for last spring.). He's learned that being an early adopter means he a) doesn't qualify for boosters, b) doesn't have a qualified vax for travel to much of Europe.

 

[rodi]

went to an outdoor dinner with friends and my sister last night. One couple had gotten their boosters this week. One had had zero side effects, the other had spiked a 100.3 fever the day after the shot. They both had gotten double jabs with flu shots at the same time.

Sis had moderna - so she's still waiting. Hubby is going to get his second shot in two weeks. I don't qualify yet.

Both sons had gotten shots early in the process under the frontline worker designation (grocery store worker and food worker.) The older one still qualifies - but had moderna - so he's waiting, despite working daily with the public. The other is in college and not currently a food worker, so he has to wait a while too.

tl:dr - no boosters in my family yet - but DH will be the guinea pig.

 

[anethum]

I had a minor headache for 24 hours after each of my first two Pfizer doses. I got a booster this week. Beginning the evening after my booster, I had a moderate headache, and woke up during the night and had a throbbing headache. But when I woke up in the morning, the headache was gone for good.

A friend of mine went to a pharmacy this week to get a flu shot. She was vaccinated with Moderna so isn't eligible for a booster yet. She had a very strong reaction to the shot this week, something which had never happened before with 35 years of flu shots. (She told me last winter that she had a strong reaction to her 2nd Moderna shot.) She's a retired physician and realized afterwards by the size & shape of the different syringes she saw that she was inadvertently given a Pfizer shot. She said the pharmacy was extremely busy with people waiting for flu shots as well as boosters. She is not too upset, but says it was a serious error. She has contacted the pharmacist with procedural suggestions.

 

[ivinsfan]

I had a minor headache for 24 hours after each of my first two Pfizer doses. I got a booster this week. Beginning the evening after my booster, I had a moderate headache, and woke up during the night and had a throbbing headache. But when I woke up in the morning, the headache was gone for good.

A friend of mine went to a pharmacy this week to get a flu shot. She was vaccinated with Moderna so isn't eligible for a booster yet. She had a very strong reaction to the shot this week, something which had never happened before with 35 years of flu shots. (She told me last winter that she had a strong reaction to her 2nd Moderna shot.) She's a retired physician and realized afterwards by the size & shape of the different syringes she saw that she was inadvertently given a Pfizer shot. She said the pharmacy was extremely busy with people waiting for flu shots as well as boosters. She is not too upset, but says it was a serious error. She has contacted the pharmacist with procedural suggestions.

Not too upset, I'd be madder then HE double hockey sticks. Honestly I've never had a vaccine... all at pharmacies where after coming into the room, the person hasn't said Hi you here for a fill in the blank shot, correct.

 

[Time2]

I received the Moderna Vaccine, my wife and son both got the J&J vaccine,

I'm not seeing much info about the J&J vaccine other than the initial efficacy was lower than Pfizer and Moderna, but nothing about what is is at the 120 day mark.
Anything about a booster for the J&J vaccine?

 

[explanade]

I received the Moderna Vaccine, my wife and son both got the J&J vaccine,

I'm not seeing much info about the J&J vaccine other than the initial efficacy was lower than Pfizer and Moderna, but nothing about what is is at the 120 day mark.
Anything about a booster for the J&J vaccine?

They released this data this week.

https://www.cnbc.com/2021/09/21/jj-...rcent-effective-when-given-at-two-months.html

But there could be need for boosters several months down the line.

When they got the initial EUA, they were suppose to be testing 2-shot dose but apparently they never followed up with it.

Then with all the talk about boosters, they apparently went back and tested 2-shots.

 

[Calico]

I got my Pfizer booster yesterday afternoon.

I am now at the 32-hour mark, so I think I am out of the woods. I had zero side effects this time - not even a sore arm! I am feeling very grateful for that, given how the second Pfizer shot kicked my butt for two days.

I know she did give me the booster, because I felt the jab when it went in, and the site is very mildly warm to the touch.

 

[Teacher Terry]

Great news calico!

 

[Calico]

Great news calico!

Thanks! I hope you have the same good luck.

 

[gcgang]

I’m 67. Just got my 3rd (booster) Moderna shot yesterday, 10/2. Although my 2nd shot was 4/22, I was going to explain that I’m doing some traveling in a couple weeks and my doc, who was volunteering there, recommended it. But I didn’t need to explain. They welcomed me and thanked me for coming in for the booster. No line, no waiting, and 36 hours later no side effects. I feel like I’ve got a suit of anti-COVID armor on.

I still can’t believe that “proof” of vaccination consists of those little paper cards, or worse, a picture of the card on your phone (which I have had to show for restaurants), although I was told all our info is entered into VAERS (sp?).

 

[Koolau]

I’m 67. Just got my 3rd (booster) Moderna shot yesterday, 10/2. Although my 2nd shot was 4/22, I was going to explain that I’m doing some traveling in a couple weeks and my doc, who was volunteering there, recommended it. But I didn’t need to explain. They welcomed me and thanked me for coming in for the booster. No line, no waiting, and 36 hours later no side effects. I feel like I’ve got a suit of anti-COVID armor on.

I still can’t believe that “proof” of vaccination consists of those little paper cards, or worse, a picture of the card on your phone (which I have had to show for restaurants), although I was told all our info is entered into VAERS (sp?).

If you come to Hawaii, you not only have to have the little card, you have to fill out a form and upload a picture of your card - I suppose so they can check to see if it is authentic BEFORE you arrive. NOW that I've done it, I suppose I could complete the process in perhaps less than an hour. BUT starting from scratch, I think it took 4 hours. Let us hope we don't need something similar to attend anything or go to a restaurant in the future. What a pain. I'm a dinosaur, I admit, so perhaps a young person would breeze through it, but it wasn't trivial. Worst thing, you get to the point where you "submit" and the screen says, uploading - do not close your browser. It said that for 5 hours! So, I checked email and apparently it must have worked. Oh, and then just before your actual travel, you have go back INTO the site and fill out a health questionnaire and receive a QR code (a few months ago, I didn't know what a QR code was!) I think it may get ugly before it gets better. YMMV

 

[Freedom56]

My mother who is now 85 got her Pfizer booster shot last week. She got her first and second jabs in February. Other than a sore upper arm, there were no other side effects.

 

[harllee]

My mother who is now 85 got her Pfizer booster shot last week. She got her first and second jabs in February. Other than a sore upper arm, there were no other side effects.

Same for my mother, age 90. Pfizer booster last week, no side effects.

 

[harllee]

I’m 67. Just got my 3rd (booster) Moderna shot yesterday, 10/2. Although my 2nd shot was 4/22, I was going to explain that I’m doing some traveling in a couple weeks and my doc, who was volunteering there, recommended it. But I didn’t need to explain. They welcomed me and thanked me for coming in for the booster. No line, no waiting, and 36 hours later no side effects. I feel like I’ve got a suit of anti-COVID armor on.

I still can’t believe that “proof” of vaccination consists of those little paper cards, or worse, a picture of the card on your phone (which I have had to show for restaurants), although I was told all our info is entered into VAERS (sp?).

Where I live you cannot get a Moderna booster now (unless you have an autoimmune disease, HIV or certain cancers) because the FDA has not approved the Moderna booster yet. I don't understand how your doctor could give you the Moderna booster since it is not approved yet.

 

[ivinsfan]

Where I live you cannot get a Moderna booster now (unless you have an autoimmune disease, HIV or certain cancers) because the FDA has not approved the Moderna booster yet. I don't understand how your doctor could give you the Moderna booster since it is not approved yet.

I don't think they are being very careful about this from what I'm seeing locally. Still waiting for the half dose Moderna booster...then I can get one now and one in another 6 to 8 months if needed with the same amount of vaccine product.

 

[Aerides]

I don't understand how your doctor could give you the Moderna booster since it is not approved yet.

I'm quite sure there are plenty of doctors or pharmacists who will administer the shot and take their chances, when they have an abundance of supply....vs. argue with dozens of people every day who don't understand why they have to wait because they got Moderna.

Over a million people got off-label pre-approval boosters in August, this isn't even slightly surprising.

 

[harllee]

I'm quite sure there are plenty of doctors or pharmacists who will administer the shot and take their chances, when they have an abundance of supply....vs. argue with dozens of people every day who don't understand why they have to wait because they got Moderna.

Over a million people got off-label pre-approval boosters in August, this isn't even slightly surprising.

I guess where I live the pharmacies and health department is being stricter. As far as I can tell, no Moderna boosters are being given here unless you meet the autoimmune requirements.

 

[gcgang]

Where I live you cannot get a Moderna booster now (unless you have an autoimmune disease, HIV or certain cancers) because the FDA has not approved the Moderna booster yet. I don't understand how your doctor could give you the Moderna booster since it is not approved yet.

Not approved? I thought even the President got a booster shot!

Other than the hallucinations, severe skin rash and extra nipple I’ve grown, doesn’t seem like much downside to getting it early.

Would you do it, with upcoming travel/higher risk activities scheduled, if you could?

 

[harllee]

Not approved? I thought even the President got a booster shot!

Other than the hallucinations, severe skin rash and extra nipple I’ve grown, doesn’t seem like much downside to getting it early.

Would you do it, with upcoming travel/higher risk activities scheduled, if you could?

The Pfizer booster has been approved by the FDA, not the Moderna. The President got a Pfizer booster. Moderna is considering recommending only a half dose for the booster. I would love to get a Moderna booster now but I am going to wait for the recommended dose by Moderna to be approved by the FDA. I am not doing high risk activities now and will not do them even after I get the booster.

 

[bluelight]

Had my Pfizer booster this afternoon. The pharmacist at CVS had a steady stream of customers for vaccines.

The 2nd shot in March kicked my butt hard. I had chills, fever and brutal body aches for 3 days. The only thing that didn't hurt then was the injection site. I spent the last few days food shopping and generally preparing incase I'm in bed for another 3 days.

Good to read that some have had no issues with the booster. I guess I'll find out tonight.

 

[CardsFan]

I'm quite sure there are plenty of doctors or pharmacists who will administer the shot and take their chances, when they have an abundance of supply....vs. argue with dozens of people every day who don't understand why they have to wait because they got Moderna.

Over a million people got off-label pre-approval boosters in August, this isn't even slightly surprising.

Bold by me. What the heck does that mean? "Take their chances"?

Are we supposed to follow CDC guidelines or not?

Any doctor or pharmacist administering drugs "off label" is risking their license AND the patient.

 

[USGrant1962]

Bold by me. What the heck does that mean? "Take their chances"?

Are we supposed to follow CDC guidelines or not?

Any doctor or pharmacist administering drugs "off label" is risking their license AND the patient.

Well, off label use is a decision between the doctor and patient. At least according to FDA.

From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.

https://www.fda.gov/patients/learn-...rstanding-unapproved-use-approved-drugs-label

 

[Aerides]

Bold by me. What the heck does that mean? "Take their chances"?

Are we supposed to follow CDC guidelines or not?

Any doctor or pharmacist administering drugs "off label" is risking their license AND the patient.

I'm not condoning or scolding - simply stating what we all know is happening, thousands of times every day, for the past few months.

Much like Dr's prescribe antibiotics to patients who insist upon them, I'm sure many are faced with anxious patients who implore them for another jab. Off label stuff happens all over the place for almost every medication.

For example, DH doesn't fit any of the criteria for a booster, yet, but a recent illness he recovered from has me concerned he might (temporarily) be more susceptible to getting sick if he's exposed to covid now. It's a "niche" thing not covered by the current list of criteria. Should his Dr refuse him on guidelines 100% or consider that this might be a reasonable case for an exception? I don't know, that's for DH and his Doc to determine. Those conversations are happening all over the country, always have, always will.

 

[harllee]

Bold by me. What the heck does that mean? "Take their chances"?

Are we supposed to follow CDC guidelines or not?

Any doctor or pharmacist administering drugs "off label" is risking their license AND the patient.

I think any doctor or pharmacist who administers the Covid vaccine off label is risking a medical malpractice suit. I know several people who lied on the forms and certified they were immune compromised to get the Moderna booster even though it is not approved--the doctor or pharmacist is probably protected in that case.