FDA Approves Booster Shot for People with Weakened Immune Systems

I think it's highly unlikely that anti-vax and vaccine hesitant folks are paying much attention at all to Pfizer or the FDA. They're getting their misinformation from other sources.

I see your point. For example, I am ignoring the vaccine advice of my cousin in Trinidad and have turned down my other cousin's offer of Ivermectin. ;) I do think that some of the anti-vaxxer influencers may use this as fodder to add fuel to myths they peddle, but they and their listeners probably were going to be singing that tune anyway.

Actually, I think my post was misunderstood.

I'm all for keeping the front line workers on the job.

My post was on one hand the message is the vaccines are great at protecting with only two doses. Then the other message is folks at high risk needed a booster. Just needed a clarification on the reasoning.

I agree. There seems to be a mixed message that people are safe except for some unclearly defined group. I haven't even seen the reasoning from the FDA that keeping workers on the job is the reason for boosters for some people. And they haven't yet defined who is the "high risk" and how that will be determined. Is it high risk for infection or high risk for severe disease? Health care workers are highly likely to qualify. But, what about people who work in bars and restaurants who are at higher risk to contract the disease but are in their 20s? What about teachers? Which teachers? Elementary school kids aren't eligible to get vaccinated yet. But, at least where I live, there seems to be a higher rate of infection among older kids. What about people who are obese and diabetic and appear to have a higher chance of being hospitalized or dying if they have a breakthrough infection?

The FDA will be making decisions about some of these things later this week, and hopefully that will provide some clarity. It also would be helpful if they explained why the age cut-off is different here than in the U.K. and Israel.
 
<mod note> Let’s please not turn this into another vaccine debate.
 
Exactly. The high frequency of exposure (daily, even hourly) and the high viral load that many healthcare workers are exposed to is a recipe for breakthrough infections, some of which will be severe cases. The severity of a COVID case tends to be highly correlated with the initial viral load someone is exposed to.
Furthermore, my understanding is that the Delta variant produces far more viral load in a shorter time than the original version of the virus so it stands to reason, for example, that the breath of a person infected with Delta will greatly increase the possible exposure of another person to the virus under conditions identical to what might have transpired with the original version of the virus.
 
I found this story yesterday about a very recent CDC report that indicates that Pfizer vaccine protection against hospitalization drops quite a bit after 120 days, whereas Moderna does not.
Amid persistent concerns that the protection offered by COVID-19 vaccines may be waning, a report released Friday by the Centers for Disease Control and Prevention finds that America’s workhorse shot is significantly less effective at preventing severe cases of disease over the long term than many experts had realized.

Data collected from 18 states between March and August suggest the Pfizer-BioNTech vaccine reduces the risk of being hospitalized with COVID-19 by 91% in the first four months after receiving the second dose. Beyond 120 days, however, that vaccine efficacy drops to 77%.
https://www.latimes.com/science/sto...vaccines-at-preventing-covid-hospitalizations

77% is still high, but that’s quite a difference.
 
I found this story yesterday about a very recent CDC report that indicates that Pfizer vaccine protection against hospitalization drops quite a bit after 120 days, whereas Moderna does not.

https://www.latimes.com/science/sto...vaccines-at-preventing-covid-hospitalizations

77% is still high, but that’s quite a difference.

Most people don’t currently need a booster of current vaccines (hence FDA advisory panel voting against widespread boosters 16-2). Some people need to be boosted, hence recommendations for 65 and older and immunosuppressed.

Pfizer and Moderna will likely have a different, 2nd gen version of the vaccine to target Delta more directly around the first of the year. Pfizer has already said that. Bet on it. Those that claim this is all settled science are deluding themselves.
 
The FDA did allow a pretty wide range of people that qualify for the booster since they included health care workers and other people routinely exposed for whatever reason - the latter can be quite broadly interpreted.
 
The FDA did allow a pretty wide range of people that qualify for the booster since they included health care workers and other people routinely exposed for whatever reason - the latter can be quite broadly interpreted.

The good news is anyone can get a booster if they wish. Present as either immunocompromised and get a 3rd shot ( if you had Pfizer or Moderna) or present as never having been vaccinated and get the shot of your choice.
I know several people that got the JNJ shot, and went back and got either the Pfizer or Madonna because they have greater efficacy versus Delta variant. They have now had three shots. I wouldn’t feel guilty at all about getting an additional shot, many places are throwing them away because they’re expiring due to lack of uptake.If you’re waiting on definitive data, it will likely not come until the pandemic is over. That’s the way long-term retrospective analysis works.
 
I found this story yesterday about a very recent CDC report that indicates that Pfizer vaccine protection against hospitalization drops quite a bit after 120 days, whereas Moderna does not.

https://www.latimes.com/science/sto...vaccines-at-preventing-covid-hospitalizations

77% is still high, but that’s quite a difference.

Your link was behind paywall, so I couldn't get to it, but I found another article talking about the same thing. Evidently this data was published Friday, and I don't think it was included in the FDA discussion.

https://www.bloomberg.com/news/arti...ection-against-hospitalization-wanes-in-study

Pfizer Inc.’s Covid-19 vaccine declined in protection against hospitalization after four months, while Moderna Inc.’s remained stable, U.S. researchers found in an analysis of data from 21 US hospitals across 18 states.

Two doses of either vaccine provided more protection against hospitalization than the one-dose Johnson & Johnson vaccine, the study found, though Pfizer’s advantage over J&J narrowed over time, according to the study published Friday by the Centers for Disease Control and Prevention with collaborators across the country. All three vaccines provided substantial protection after four months -- Moderna’s was 92% effective against hospitalization by then, with Pfizer’s at 77% and J&J at 68%.

The researchers noted that the vaccine effectiveness differences between Moderna and Pfizer’s shots, which both use a mechanism called messenger RNA, could be due to differences in timings between doses.
 
Your link was behind paywall, so I couldn't get to it, but I found another article talking about the same thing. Evidently this data was published Friday, and I don't think it was included in the FDA discussion.

https://www.bloomberg.com/news/arti...ection-against-hospitalization-wanes-in-study

The timing between doses isn’t because Moderna was approved later, it’s because interval between shot 1 & 2 is 3 weeks for Pfizer and 4 weeks for Moderna. I was in the Moderna trial. Had Covid not been a pandemic (emergency) they would have designed trials to have shots spaced 6 months apart, more like flu shots. Both Pfizer and Moderna first shots had greater than 80% efficacy initially
 
The timing between doses isn’t because Moderna was approved later, it’s because interval between shot 1 & 2 is 3 weeks for Pfizer and 4 weeks for Moderna. I was in the Moderna trial. Had Covid not been a pandemic (emergency) they would have designed trials to have shots spaced 6 months apart, more like flu shots. Both Pfizer and Moderna first shots had greater than 80% efficacy initially

When which vaccine was approved has nothing to do with what interval was picked. The shorter interval was picked so they could roll out the vaccines sooner rather than later.

A lot of people in the UK got their shots 12 weeks apart regardless of which vaccine. I live in Canada and due to the same reason as the UK (shortage of supplies), I received mine (Pfizer) about 12 weeks apart as well (The 2nd shot was actually scheduled 16 weeks from my first shot, but Canada overcame its supply shortage sooner than expected.) If the researcher sited is correct, then, I probably have better protection from the longer interval between the shots.
 
Another difference is that the Moderna vaccine is a much larger dose.

I don’t think they know yet why the difference in waning.

Right, Moderna, I think, has three times the dose of Pfizer.
 
While the initial approval of the vaccine booster will be for 65 and up I expect that it will be offered to younger folks once the booster demand has abated. Data aside choose the most vulnerable first, then others. Keep in mind the fact that antibodies in older folks wane much quicker than in younger ones.
 
If you are curious as to your antibody status, you can go to a lab (Labcorp in my case) and get a Sars-CoV-2 Semi-Quant Total Ab test.
Cost $10 out of pocket for me. Results in 48hrs.

This will give you information as to your antibody status. You can compare the value given to the value ranges in the study published in JAMA August 30,2021
comparing antibody response following vaccination with Pfizer vaccine vs Moderna.

It may help guide a decision regarding boosters, along with guidelines and consultation with your doctor.
 
If you are curious as to your antibody status, you can go to a lab (Labcorp in my case) and get a Sars-CoV-2 Semi-Quant Total Ab test.

Cost $10 out of pocket for me. Results in 48hrs.



This will give you information as to your antibody status. You can compare the value given to the value ranges in the study published in JAMA August 30,2021

comparing antibody response following vaccination with Pfizer vaccine vs Moderna.



It may help guide a decision regarding boosters, along with guidelines and consultation with your doctor.


We did our antibody tests recently. Got the score. But had no idea what it meant. I just looked at some JAMA results based on your reference. Not sure if I’m looking at the right article. But still have no idea how to relate the score we received versus what is in that article.
 
We did our antibody tests recently. Got the score. But had no idea what it meant. I just looked at some JAMA results based on your reference. Not sure if I’m looking at the right article. But still have no idea how to relate the score we received versus what is in that article.

This is very complicated, and most of it’s way above my head. My number was greater >2500 U/mL . If you look at the excerpt of the paper that I referenced, you will see number ranges for both the Moderna and Pfizer vaccine. I believe the value given from the lab test is the number that these ranges reference.
Look in the 2nd and 3rd paragraph in the section under results. Page 3 of the paper. They have yet to validate a range, but there is a strong correlation
 
If you are curious as to your antibody status, you can go to a lab (Labcorp in my case) and get a Sars-CoV-2 Semi-Quant Total Ab test.
Cost $10 out of pocket for me. Results in 48hrs.

This will give you information as to your antibody status. You can compare the value given to the value ranges in the study published in JAMA August 30,2021
comparing antibody response following vaccination with Pfizer vaccine vs Moderna.

It may help guide a decision regarding boosters, along with guidelines and consultation with your doctor.

Good to know about this test. Thanks for posting. However, even if I were to get the test and find out that my antibody levels are "low", I still would be ineligible for a booster shot due to my age and health profile. So I'd be stuck in a quandary, feeling relatively less protected than I could be (should be?), but not able to do anything about it unless I lied to get a booster shot.
 
Good to know about this test. Thanks for posting. However, even if I were to get the test and find out that my antibody levels are "low", I still would be ineligible for a booster shot due to my age and health profile. So I'd be stuck in a quandary, feeling relatively less protected than I could be (should be?), but not able to do anything about it unless I lied to get a booster shot.

You may find out that you actually have more antibodies than you think. In my case that was true. I got my second shot in early February and still have pretty high antibody levels. Secondly, I have a relative that got the J&J shot initially and then when we found out that the Delta variant wasn’t well covered by that shot, she went to Stanford and asked for one of the mRNA vaccines to provide further coverage for Delta. She didn’t lie, and they gave her one shot of Pfizer vaccine. As Scott Gottlieb, MD said on TV this week, the CDC can’t provide real time data.
 
If you get the booster shot, say, six months after your last shot, my feelings are that the chances are good that your body produces a much higher amount of antibodies than getting it sooner, but we don't know how much your immunity wanes within that six months, so I'm not sure when the sweet spot is.
 
I guess neutralizing antibodies is one piece of the puzzle, but it seems what's important as well is T-cells and most importantly, "helper" T-cells, which support long-term immune memory... I don't know if that's easy to test.
 
So I believe I found the article regarding antibodies that has been mentioned:
https://jamanetwork.com/journals/jama/fullarticle/2783797

Here's my understanding of the article, FWIW.

They measured antibodies 6-10 weeks after the second vaccine dose.

They found antibody titers were higher for those vaccinated with Moderna vs Pfizer.

The mean titer was 3836 u/ml for Moderna, vs 1444 U/ml for Pfizer.

The study did include those who had already had COVID prior to vaccination. Their titers were higher than those who didn't previously have COVID.

For those previously uninfected, the mean titer was 2881 u/ml for Moderna, vs 1108 u/ml for Pfizer.

For those previously infected, the mean titer was 10,708 u/ml for Moderna, vs 8174 u/ml for Pfizer.

So, we know that Moderna creates more antibodies. What we don't know is how does a certain antibody level correlate with risk for infection...apparently you can't assume a low antibody number means you are at high risk, because other parts of the immune system (T-cells) play a role in fighting off infection.

See this article: https://www.npr.org/sections/health...as-a-reliable-indicator-of-vaccine-protection

In fact, it's pretty clear that antibodies alone don't explain why some people are protected, and other parts of the immune system also play important roles in fighting off the coronavirus, including T-cells.

"Two percent of the individuals who were vaccinated had very, very low levels. Levels of antibodies that were below that lower limit of detection," says Christopher Houchens, a biomedical researcher at the Biomedical Advanced Research and Development Authority, another author of the study. "However, about 50% of those individuals in that 2% of the population were still protected and did not come down with symptomatic COVID-19 disease."


So, if you get yourself tested for antibodies, and they are low, you might actually still be protected by your vaccine, apparently because your T-cells may be very active against the virus still. I think I'm correct in understanding this, but not 100% sure...so someone I'm sure will chime in if I've misunderstood this.
 
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I thought antibodies naturally waned over time, expected. But other parts of the immune system are still primed to fight the virus.

The CDC report for efficacy against hospitalization wasn’t based on measuring antibodies, it has to have been based on actual hospitalizations.
 
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T cells and B cells go to your lymph nodes and then migrate to the bone marrow.

So they are not easily measured.

Some researchers are trying to determine the "correlates of protection" or the levels of antibodies which equate to protection.

Some companies are working on nasal vaccines, to protect vs. infections but they're in the early stages.

https://www.news-medical.net/news/2...g_WE1CDqGzg_YKi-fL9eg4D0yiH7SQ5h1i5bEC6Uh_rA8
 
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