FDA Approves Booster Shot for People with Weakened Immune Systems

[ExFlyBoy5]

This is pretty big news IMHO.

https://www.cnbc.com/2021/08/13/cov...mits-third-dose-for-the-immune-deficient.html

The Food and Drug Administration authorized Covid-19 vaccine booster shots for people with weakened immune systems, a highly anticipated move intended to shield some of the most vulnerable Americans from the highly contagious delta variant.

BUT...

The FDA OK is not the final go-ahead. The Centers for Disease Control and Prevention’s vaccine advisory committee has scheduled a meeting Friday to consider shots for immunocompromised Americans. If they issue a recommendation and it is approved by the CDC, third shots could begin immediately.

 

[Alan]

Good news indeed.

The FDA OK is not the final go-ahead. The Centers for Disease Control and Prevention’s vaccine advisory committee has scheduled a meeting Friday to consider shots for immunocompromised Americans. If they issue a recommendation and it is approved by the CDC, third shots could begin immediately.

 

[ivinsfan]

They expected shots to commence by the weekend..The CDC is going to rubber stamp this ASAP.

 

[ExFlyBoy5]

They expected shots to commence by the weekend..The CDC is going to rubber stamp this ASAP.

That is an important point and I have updated my post to reflect this.

 

[ShokWaveRider]

I wonder when boosters will be approved for us over 65's?

 

[Alan]

I wonder when boosters will be approved for us over 65's?

Maybe when there is data showing that immunity is fading in over 65s?

Yesterday we were at the hospital giving blood samples as part of the mixed vaccine trial we are on and we asked this same question as currently the UK is planning boosters initially for vulnerable groups only. Our next and last blood sample will be given in February and unless we are showing reduced immunity then a booster may not be considered necessary.

Booster trials are ongoing in the UK. (Started in May this year)

https://www.gov.uk/government/news/world-first-covid-19-vaccine-booster-study-launches-in-uk

The study will take place at 16 NIHR-supported sites across England, and also within Health and Care Research Wales and NHS Research Scotland sites. It will include a total of 2,886 patients and participants are to begin being vaccinated from early June.

All participants will be monitored throughout the study for any side effects and will have bloods taken to measure their immune responses at days 28, 84, 308 and 365, with a small number having additional blood tests at other times. All sites will have an electronic diary for all participants that will send alerts to the team in real time if needed and a 24-hour emergency phone to a doctor on the study, who can provide further clinical advice.

The initial findings, expected in September, will help inform decisions by the Joint Committee on Vaccination and Immunisation (JCVI) on plans for a booster programme from autumn this year, ensuring the country’s most vulnerable are given the strongest possible protection over the winter period

 

[Sojourner]

I wonder when boosters will be approved for us over 65's?

Maybe when there is data showing that immunity is fading in over 65s?

I believe there is already some data pointing towards that. Apparently, Israel is already giving 3rd shots to anyone 60 or older and is planning to drop the age requirement to 50 soon. Germany and France are also offering booster shots to the elderly (not sure about the age thresholds).

A quote from the Israeli prime minister:

"Whoever is over the age of 60, and has yet to receive the third dose of the vaccine, is six times more susceptible to severe illness and - heaven forbid - death," Bennett said.

 

[Alan]

The last I heard about France and Germany was that they were also going to give boosters to the most vulnerable rather than just above a particular age. However, things change week by week.

https://www.france24.com/en/europe/...despite-who-call-to-prioritise-poorer-nations

French President Emmanuel Macron said France was working on rolling out third COVID-19 vaccine doses to the elderly and vulnerable from September.

“A third dose will likely be necessary, not for everyone straightaway, but in any case for the most vulnerable and the most elderly,” Macron said on his Instagram account.

Germany intends to give boosters to immunocompromised patients, the very elderly and nursing home residents from September, the health ministry said.

 

[tmm99]

I believe there is already some data pointing towards that. Apparently, Israel is already giving 3rd shots to anyone 60 or older and is planning to drop the age requirement to 50 soon. Germany and France are also offering booster shots to the elderly (not sure about the age thresholds).

A quote from the Israeli prime minister:

"Whoever is over the age of 60, and has yet to receive the third dose of the vaccine, is six times more susceptible to severe illness and - heaven forbid - death," Bennett said.

Just to add to this, about 10 days ago, Face the Nation featured Dr. Sharon Alroy-Preis (Isreal's Director of Public Health Services) and the doctor confirmed that "Last week, Israelis started giving those over the age of 60 booster shots, becoming the first country in the world to do so after data showed diminished protection against covid among those who had been vaccinated eight months ago."

So from that, I surmise that they're targeting people over 60 years old who were fully vaccinated months ago for the booster shot, and not people over 60 who were vaccinated, say, just four months ago. According to Dr. Alroy-Preis, younger folks (<60) who were vaccinated eight months ago are not getting severe COVID, but people over 60 are. I imagine people in the 50s are not far behind the people who are in their 60s as to the diminishing immunity.

Here's the transcript:
https://www.cbsnews.com/news/transcript-dr-sharon-alroy-preis-on-face-the-nation-august-1-2021/
Here's the full video:
https://www.cbsnews.com/video/81-fauci-manchin-kashkari-alroy-preis-gottlieb/

I believe the key is how much of an immune/antibody response your particular body is capable of producing regardless of age, but age is one good indicator...

 

[goingtotravel]

Back to the original post since there are a few folks here who have spouses that are immune compromised and have been anxiously awaiting approval. DH already has a message in to his medical team about getting his 3rd dose. Hopefully by Monday he will have an appointment for another shot. Just wish they would measure his antibodies. He has asked about getting an antibody test and was told that it wasn't recommended so not sure how they will know if he actually is getting some protection, given the particular combo of meds he's on, from this additional dose. (None of the studies we've read have tested patients with the exact combo of immunosuppressive meds that he takes).

 

[ivinsfan]

How about that, all the grumbling we did back in January about my being able to find vaccine is paying off. Apparently with Delta a later vaccination was a good thing.


Also saw a Mayo early study saying Moderna seemed to be more effective against Delta then the other two vaccines but Moderna came online later due to FDA approvals rules so maybe it's the time not actually the type of vaccine.

 

[Sojourner]

Also saw a Mayo early study saying Moderna seemed to be more effective against Delta then the other two vaccines but Moderna came online later due to FDA approvals rules so maybe it's the time not actually the type of vaccine.

I heard about that, as well, and my immediate thought was that it might be due to the larger mRNA payload in the Moderna shot compared with Pfizer. Each dose of Moderna contains 100µg of mRNA molecules, vs. only 30µg in a dose of the Pfizer shot. Maybe that leads to the production of more antibodies, so that more of them remain after, say, six months?

 

[harllee]

My DH who is immuncompromised has been on the phone all day trying to get his third booster shot, so far no luck. He has called his GP and his rheumatologist and they seem to know nothing about it. He has called several pharmacies, no luck. He thinks he will drive over to the adjacent state to get the booster shot at Walmart there since they do not check our state's records.

 

[REWahoo]

My DH who is immuncompromised has been on the phone all day trying to get his third booster shot, so far no luck. He has called his GP and his rheumatologist and they seem to know nothing about it. He has called several pharmacies, no luck.

Patience. They don't know about it yet because the FDA didn't approve it until yesterday and it wasn't "official" until the Advisory Committee voted on it today. It will take a few days to spread the word. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised

 

[Midpack]

I am not immunocompromised, but I will take a booster when it's recommended and available in the US. In the meantime, I am minimizing being in crowds indoors and masking up/social distancing whenever in any doubt.

 

[anethum]

Israel lowered the age today for booster shots to 50.

https://www.reuters.com/world/middl...-campaign-over-50s-health-workers-2021-08-13/

 

[Sojourner]

My DH who is immuncompromised has been on the phone all day trying to get his third booster shot, so far no luck. He has called his GP and his rheumatologist and they seem to know nothing about it. He has called several pharmacies, no luck. He thinks he will drive over to the adjacent state to get the booster shot at Walmart there since they do not check our state's records.

Not sure what state you live in, but around here (Georgia) the vaccines are widely available to anyone without appointments. It would be no problem to simply walk into just about any pharmacy and get a shot of Moderna or Pfizer on the spot, regardless of whether you've previously received one (or two). Of course, you'd have to be OK with saying you hadn't already been fully vaccinated, but it would be a "little white lie" considering the FDA approval. The risk of being flagged for getting an unauthorized 3rd shot would seem to be extremely minimal.

 

[ivinsfan]

My DH who is immuncompromised has been on the phone all day trying to get his third booster shot, so far no luck. He has called his GP and his rheumatologist and they seem to know nothing about it. He has called several pharmacies, no luck. He thinks he will drive over to the adjacent state to get the booster shot at Walmart there since they do not check our state's records.

This would work but I'm curious if they are going advice a third dose of your original vaccine or say a mix and match is OK.


You've waited this long hopefully the picture will get more clear in a day or two or by Monday for sure.

 

[ivinsfan]

Not sure what state you live in, but around here (Georgia) the vaccines are widely available to anyone without appointments. It would be no problem to simply walk into just about any pharmacy and get a shot of Moderna or Pfizer on the spot, regardless of whether you've previously received one (or two). Of course, you'd have to be OK with saying you hadn't already been fully vaccinated, but it would be a "little white lie" considering the FDA approval. The risk of being flagged for getting an unauthorized 3rd shot would seem to be extremely minimal.

So from your earlier post do you think it's worthwhile to try and get the third shot to be Moderna on the off change it gives you a little more bang for your buck.

 

[Chuckanut]

Also saw a Mayo early study saying Moderna seemed to be more effective against Delta then the other two vaccines but Moderna came online later due to FDA approvals rules so maybe it's the time not actually the type of vaccine.

Emphasis added.

Good point. I have read comments that these studies did not correct for the amount of time since vaccination. Good science says you change one thing at a time (just the vaccine in this case) when testing a hypothesis. So now they must apply some statistical fixes to lessen the effect of the time differences.

 

[ivinsfan]

Emphasis added.

Good point. I have read comments that these studies did not correct for the amount of time since vaccination. Good science says you change one thing at a time (just the vaccine in this case) when testing a hypothesis. So now they must apply some statistical fixes to lessen the effect of the time differences.

When I said I had no idea that Moderna had triple the mRNA payload of the Pfizer...so maybe it's a combination of the two things. I had Moderna

 

[Chuckanut]

When I said I had no idea that Moderna had triple the mRNA payload of the Pfizer...so maybe it's a combination of the two things. I had Moderna

It might be. I am sure we will find out in the fullness of time.

 

[Brat]

SIL had a double lung transplant, did not mount an immune response to Pfizer. My daughter said that she is confident that if his physicians want him to receive a booster they will call him.

 

[harllee]

Not sure what state you live in, but around here (Georgia) the vaccines are widely available to anyone without appointments. It would be no problem to simply walk into just about any pharmacy and get a shot of Moderna or Pfizer on the spot, regardless of whether you've previously received one (or two). Of course, you'd have to be OK with saying you hadn't already been fully vaccinated, but it would be a "little white lie" considering the FDA approval. The risk of being flagged for getting an unauthorized 3rd shot would seem to be extremely minimal.

But here in NC when you show up to get your vaccine you have to show your ID and then they check the NC databank to see if you have already been vaccinated. So DH is thinking of driving an hour or so to another state where they would not check the NC database.

 

[tulak]

But here in NC when you show up to get your vaccine you have to show your ID and then they check the NC databank to see if you have already been vaccinated. So DH is thinking of driving an hour or so to another state where they would not check the NC database.

That could be risky if you ever need an official record. That could make it harder to travel or get into facilities requiring full vaccination, taking into account any future requirements such as booster shots.

I suspect that by next week, you’d be able to find somewhere locally. The CDC approved this just now, so it could take a day or two before the new rule gets processed. Fortunately, there should be plenty of vaccines available. At least that problem has been solved.