FDA Approves Booster Shot for People with Weakened Immune Systems

[Koolau]

The UK approved Pfizer shots for 12-15 year olds today and tomorrow are expected to announce booster shots for all over 50s. ( they currently are only giving boosters to the clinical vulnerable)

Are there current guidelines for "clinical vulnerability" and are there requirements for documentation? Do clinic employees require such documentation or just take someone's word for it? It could get sticky at some point. YMMV

 

[ExFlyBoy5]

+1

Also, it's puzzling how this study in The Lancet could dismiss the data coming out of Israel showing a 4-5x reduction in severe disease and death among older folks who've received a Pfizer booster shot. The chart showing these results was posted here.

I would assume how other reports contradict other reports that contradict other reports. Especially in science. I think the search (or need?) for concrete facts (and some stories/reports that have done exactly that) is what has gotten us in trouble. Folks seem to have forgotten that science is all about figuring things out and very often, it is fluid...VERY fluid...especially when it's NOVEL. So, when the science evolves, people yell (sometimes VERY LOUDLY) that they have been sold a bunch of lies.

 

[Alan]

Are there current guidelines for "clinical vulnerability" and are there requirements for documentation? Do clinic employees require such documentation or just take someone's word for it? It could get sticky at some point. YMMV

All vaccinations are done through the NHS who also maintain the lists of the clinical vulnerable. You either get a call from your local GP office to make an appointment or, as we and our son did, go online to make an appointment once your cohort is eligible. On entering your NHS number the system checks your age and health record before you can proceed and book an appointment. The actual vaccine shots may be administered in many places (including football stadiums), not just NHS premises.

 

[audreyh1]

Well, I'm just going to see what they announce in US next week. I'm in no hurry.

 

[Koolau]

All vaccinations are done through the NHS who also maintain the lists of the clinical vulnerable. You either get a call from your local GP office to make an appointment or, as we and our son did, go online to make an appointment once your cohort is eligible. On entering your NHS number the system checks your age and health record before you can proceed and book an appointment. The actual vaccine shots may be administered in many places (including football stadiums), not just NHS premises.

Thanks. It all makes sense for the UK.

That is interesting. I'm guessing the USA has nothing similar to NHS. IOW there wouldn't be a repository of national data on those eligible. Medicare probably has access to such info on 65+ (on the system), but would (my guess) be legally prohibited from sharing the data. I'm okay if it requires a "note from my doctor" or, better yet, if my doc decides and (his nurse - heh, heh, not the doc, perish the thought) administers the booster. YMMV

 

[Alan]

A friend just sent me this chart showing how the booster shots given in Israel to people age 60+ are doing:

I wonder what their criteria for severe illness is as I heard an item on the news today about how Israel counts Covid hospitalizations. In the UK when you see “x” people admitted to hospital each day for Covid it means they were sick enough from Covid to need hospital treatment. In Israel anyone admitted for any reason to hospital who then tests positive for Covid is counted as a Covid hospitalization. (Like the UK everyone admitted to hospital for any reason is tested for Covid)

 

[ivinsfan]

I wonder what their criteria for severe illness is as I heard an item on the news today about how Israel counts Covid hospitalizations. In the UK when you see “x” people admitted to hospital each day for Covid it means they were sick enough from Covid to need hospital treatment. In Israel anyone admitted for any reason to hospital who then tests positive for Covid is counted as a Covid hospitalization. (Like the UK everyone admitted to hospital for any reason is tested for Covid)

I noticed yesterday our state reported break through hospitalization the same way Israel does which can be. misleading.

 

[Sojourner]

The New England Journal of Medicine has published the results of a study looking at the effect of booster shots among Israeli citizens 60+ years old. Here is a link to a short summary of the NEJM study from the Bloomberg website.

https://archive.is/igehl

(Actually, the above URL is from an "archive" site that shows the full text of article, since the original Bloomberg article is behind a paywall.)

The data seem extremely compelling to me. Dramatically lower incidence of infection, severe illness, and death among those Israelis who received a 3rd dose of Pfizer.

Here is a link to the full NEJM study. https://www.nejm.org/doi/full/10.1056/NEJMoa2114255

 

[Alan]

The UK has said that their booster program will be 100% Pfizer regardless of what a person’s first 2 doses were. Obviously they have concluded from the various mixed vaccine trials that Pfizer mixes well with both AZ and Moderna, the other 2 vaccines that have been used so far.

 

[Koolau]

The New England Journal of Medicine has published the results of a study looking at the effect of booster shots among Israeli citizens 60+ years old. Here is a link to a short summary of the NEJM study from the Bloomberg website.

https://archive.is/igehl

(Actually, the above URL is from an "archive" site that shows the full text of article, since the original Bloomberg article is behind a paywall.)

The data seem extremely compelling to me. Dramatically lower incidence of infection, severe illness, and death among those Israelis who received a 3rd dose of Pfizer.

Here is a link to the full NEJM study. https://www.nejm.org/doi/full/10.1056/NEJMoa2114255

Those results appear impressive. I wonder if the study would translate to Moderna without the rigorous testing. I think I'd sign up if available.

 

[Koolau]

The UK has said that their booster program will be 100% Pfizer regardless of what a person’s first 2 doses were. Obviously they have concluded from the various mixed vaccine trials that Pfizer mixes well with both AZ and Moderna, the other 2 vaccines that have been used so far.

I would definitely be okay with Pfizer booster with my 2-dose Moderna.

 

[explanade]

Here's an article about how Fauci and the NIH has been tracking variants and vaccine efficacy since at least February.

https://khn.org/news/article/how-fauci-and-the-nih-got-ahead-of-the-fda-and-cdc-in-backing-boosters/

Fauci also believes that eventually, protection vs. severe disease and death will wane, as protection vs. symptomatic infections has, leading to the breakthroughs, most of which are considered "mild" for now.

He says there is data "for spades" making the case for boosters.

 

[Alan]

Here's an article about how Fauci and the NIH has been tracking variants and vaccine efficacy since at least February.

https://khn.org/news/article/how-fauci-and-the-nih-got-ahead-of-the-fda-and-cdc-in-backing-boosters/

Fauci also believes that eventually, protection vs. severe disease and death will wane, as protection vs. symptomatic infections has, leading to the breakthroughs, most of which are considered "mild" for now.

He says there is data "for spades" making the case for boosters.

Good article, although he said there is data “in spades” rather than “for spades”. I thought maybe he was reaching out to gardeners.

 

[Sojourner]

Ugh... this is disappointing. Looks like we all may be waiting awhile for booster shots. Meanwhile, the Delta variant rages on.

https://www.cnbc.com/2021/09/17/fda-panel-begins-voting-on-pfizers-covid-booster-doses-rejecting-shots-for-general-public.html

An influential Food and Drug Administration advisory committee on Friday resoundingly rejected a plan to administer booster shots of Pfizer and BioNTech’s Covid-19 vaccine to the general public, saying they needed more data.

The panel, however, could still clear the shots for older populations. Scientists continued debating the need for a third dose of the vaccines for older populations after their initial vote, leaving open the possibility of other votes.

 

[ExFlyBoy5]

Ugh... this is disappointing. Looks like we all may be waiting awhile for booster shots. Meanwhile, the Delta variant rages on.

https://www.cnbc.com/2021/09/17/fda-panel-begins-voting-on-pfizers-covid-booster-doses-rejecting-shots-for-general-public.html

The good news is that the "raging" is almost exclusively in those that are unvaccinated. Of course, that isn't much comfort to those that might have an unrelated medical condition that requires a visit to the ER (heart attack, etc).

I do find it interesting that they summarily dismissed the extensive studies that have come out of Israel.

 

[explanade]

They run a risk. If as some believe that protection against severe disease will wane, just as protection vs. "mild" infections have waned, then they may be blamed if severe breakthrough infections increase, especially in the winter months.

 

[harllee]

So maybe all my friends who have already gotten the booster by lying on the forms and certifying they are immune compromised did the right thing? Should I rethink my decision to not lie on the form?

 

[audreyh1]

They haven’t voted on 60+ yet.

 

[harllee]

They haven’t voted on 60+ yet.

But I got Moderna and they are not even considering the booster for that yet.

 

[REWahoo]

Just in:

Vaccine advisers to the US Food and Drug Administration voted unanimously Friday to recommend emergency use authorization of a booster dose of Pfizer’s vaccine six months after full vaccination in people 65 and older and those at high risk of severe Covid-19.

 

[Sojourner]

The good news is that the "raging" is almost exclusively in those that are unvaccinated.

Yeah, I suppose it's only truly "raging" among the unvaccinated. But still, the Israel data show that the incidence of severe COVID cases is ten times lower among "boostered" people (60 and older) than among fully vaccinated, nonboostered people. And there seems to be very, very little downside to the 3rd shot, with only one confirmed case of myocarditis out of 2.9 million who received a booster shot in Israel. I'm just not getting the FDA's rationale here.

 

[audreyh1]

But I got Moderna and they are not even considering the booster for that yet.

UK says Pfizer booster for everyone 60+ regardless of initial shots.

 

[ivinsfan]

So maybe all my friends who have already gotten the booster by lying on the forms and certifying they are immune compromised did the right thing? Should I rethink my decision to not lie on the form?

I'm not going to, we are playing the long game here, I'm 6 months in with Moderna and content to wait. I'm not interested in running out and getting a shot every 4 to 5 months.



Reading more about long haul some are saying it seems to comes from your body overreacting and going into overdrive to attack Covid.


Who knows what your body will thinks after repeated too close doses of vaccine? For someone compromised like your DH that's an easier call.

 

[audreyh1]

Just in:

Vaccine advisers to the US Food and Drug Administration voted unanimously Friday to recommend emergency use authorization of a booster dose of Pfizer’s vaccine six months after full vaccination in people 65 and older and those at high risk of severe Covid-19.

Ooops! Too young again. But at least it covers DH.

 

[ivinsfan]

UK says Pfizer booster for everyone.

I'm not in a hurry, I've seen at least two studies that say Moderna is showing longer immunity then P. I have Moderna and all things considered would prefer to stay with it.