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Fri Sep 17, 2021, 04:28 PM

FDA vaccine advisers vote to recommend booster doses of Covid-19 vaccine in people 65 and older

Source: CNN

(CNN)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. Members of the FDA's Vaccines and Related Biological Products Advisory Committee also informally advised the FDA to include health care workers or others at high risk of Covid-19 exposure in the EUA.Earlier, the advisers had rejected a broader application to approve the use of booster doses of Pfizer's vaccines in everyone 16 and older six months after they are fully vaccinated.

Members of the committee expressed doubts about the safety of a booster dose in younger adults and teens, and complained about the lack of data about the safety and long term efficacy of a booster dose. Biden administration officials have previously announced a plan to begin administering booster doses to the general population during the week of September 20, pending signoff from the FDA and US Centers for Disease Control. Some of the advisers -- a group of vaccine experts, immunologists, pediatricians, infectious disease specialists and public health experts -- have said the process was rushed because of that target date. On Friday, several said they wanted to see more data, or they believed boosters were likely necessary, but for a more limited segment of the population.

"I don't think a booster dose is going to significantly contribute to controlling the pandemic," said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine, said during the meeting. It is very important that the main message that we still transmit is that we have got to get everyone two doses. Everyone has got the get the primary series. This booster dose is not likely to make a big difference in the behavior of this pandemic." During the meeting, Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said several studies indicate that people's immunity can and does wane and that giving booster doses restores that immunity -- sometimes to levels higher than seen at initial vaccination.

He said people who got the boosters did not have any more side effects than seen after the first two doses. And Gruber said while the two-dose Pfizer vaccine continues to protect well against severe infection, hospitalizations and deaths, there are hints that could change. The company relied heavily on data from Israel, where vaccinated people started to get breakthrough infections. Israeli researchers earlier told the meeting that adding booster shots in Israel helped keep many people out of the hospital. The Israeli experience could portend the US Covid-19 future," Gruber said. "The Israeli experience could portend the US Covid-19 future," Gruber said. "Israel and the United States real world evidence suggests that vaccine efficacy against Covid-19 infection wanes approximately six to eight months following the second dose," he added.

Read more: https://www.cnn.com/2021/09/17/health/fda-vrbpac-booster-meeting/index.html



Full new headline: FDA vaccine advisers vote to recommend booster doses of Covid-19 vaccine in people 65 and older and those at high risk



Original article and link -

FDA panel endorses coronavirus boosters for older adults and those at risk of serious disease

BREAKING: In an all-day FDA advisory meeting, experts unanimously recommended a coronavirus vaccine booster be authorized for people 65 and older and those at high risk of severe disease. The panel earlier resoundingly voted against approving Pfizer's application for a broader approval of boosters for everyone 16 and older.

Expert advisers to the Food and Drug Administration are meeting Friday on the increasingly contentious issue of coronavirus vaccine boosters, the first phase of what could be a multiday effort to come up with government policy on who should get the extra shots and when.

https://www.washingtonpost.com/health/2021/09/17/covid-booster-shots-fda-recommendation/

39 replies, 3324 views

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Arrow 39 replies Author Time Post
Reply FDA vaccine advisers vote to recommend booster doses of Covid-19 vaccine in people 65 and older (Original post)
BumRushDaShow Sep 17 OP
RussBLib Sep 17 #1
getagrip_already Sep 17 #2
LisaL Sep 17 #4
I_UndergroundPanther Sep 17 #21
emmaverybo Sep 19 #39
Laura PourMeADrink Sep 18 #32
wnylib Sep 18 #37
Laura PourMeADrink Sep 18 #38
sinkingfeeling Sep 17 #5
BumRushDaShow Sep 17 #8
Pachamama Sep 17 #3
JohnSJ Sep 17 #6
BumRushDaShow Sep 17 #10
JohnSJ Sep 17 #11
BumRushDaShow Sep 17 #13
BumRushDaShow Sep 17 #7
Sgent Sep 18 #29
BumRushDaShow Sep 18 #31
Farmer-Rick Sep 18 #33
twodogsbarking Sep 18 #34
BumRushDaShow Sep 18 #36
Raven123 Sep 17 #27
ananda Sep 17 #9
Tomconroy Sep 17 #12
left-of-center2012 Sep 17 #14
BumRushDaShow Sep 17 #16
BumRushDaShow Sep 17 #20
left-of-center2012 Sep 17 #15
Tomconroy Sep 17 #18
BumRushDaShow Sep 17 #19
Lasher Sep 17 #23
BumRushDaShow Sep 17 #25
TomCADem Sep 17 #17
BumRushDaShow Sep 17 #22
Igel Sep 17 #24
BumRushDaShow Sep 17 #26
cstanleytech Sep 18 #28
BumRushDaShow Sep 18 #30
Farmer-Rick Sep 18 #35

Response to BumRushDaShow (Original post)

Fri Sep 17, 2021, 04:29 PM

1. I just barely made the cut

turned 65 2 months ago

I'll be looking for a booster ASAP

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Response to BumRushDaShow (Original post)

Fri Sep 17, 2021, 04:32 PM

2. paywall up - what are the qualifiers besides age? n/t

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Response to getagrip_already (Reply #2)

Fri Sep 17, 2021, 04:39 PM

4. It just says high risk for severe covid.

I am assuming FDA and CDC will have to clarify who qualifies for that.

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Response to LisaL (Reply #4)

Fri Sep 17, 2021, 05:18 PM

21. I hope they include metabolic disorders

And obesity because those are serious risk factors

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Response to I_UndergroundPanther (Reply #21)

Sun Sep 19, 2021, 01:16 PM

39. Obesity IS a metabolic disorder according to some experts. NT

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Response to LisaL (Reply #4)

Sat Sep 18, 2021, 09:44 AM

32. Well evidently this information is not enforced by CVS

My 55-year-old friend got a booster the other day. He said he was qualified, and it had been 6 mod, and boom he got the shot

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Response to Laura PourMeADrink (Reply #32)

Sat Sep 18, 2021, 10:43 PM

37. I overheard two pharmacy employees at my

local CVS say that they will not challenge anyone who comes in for a booster and says they are eligible due to a health condition. They are not requiring proof.

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Response to wnylib (Reply #37)

Sat Sep 18, 2021, 11:35 PM

38. Exactly. I agree not kosher... But he said the fine

print for eligibility was so long he felt he would have had to fit something.

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Response to getagrip_already (Reply #2)

Fri Sep 17, 2021, 04:40 PM

5. Nothing more at site. It's listed as 'Breaking' ahead of an older story about the meeting .

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Response to getagrip_already (Reply #2)

Fri Sep 17, 2021, 04:45 PM

8. I just posted a screenshot image of the question (with the qualifiers) and the vote



(have been streaming it since 8:30 am EDT this morning and took the screen cap)

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Response to BumRushDaShow (Original post)

Fri Sep 17, 2021, 04:36 PM

3. They are hedging bets

trying to give approval for 65+ But not all others…

I predict that this is a mistake and in next six months they will realize that.

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Response to Pachamama (Reply #3)

Fri Sep 17, 2021, 04:42 PM

6. I think it is a mistake also. There is a chance that the FDA will over-rule the advisory committee

but that is rare

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Response to JohnSJ (Reply #6)

Fri Sep 17, 2021, 04:48 PM

10. They may leave it at the 65+ approval

and perhaps in another couple months, start dropping it down.

The thing is - the youngest demographics were generally put at the END of the priority and were much later to get vaccinated so they haven't reached 6 months yet.

I am under 65 and managed to finally get my first shot March 17th and the 2nd the April 21st, so I wouldn't hit 6 months until the end of next month as it is.

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Response to BumRushDaShow (Reply #10)

Fri Sep 17, 2021, 04:50 PM

11. All valid points

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Response to JohnSJ (Reply #11)

Fri Sep 17, 2021, 04:52 PM

13. It got a little hot and heavy in there after the 1st vote

and they took a 10 minute break. Then they went on with the 2nd vote, which was unanimous to approve for the older demographic.

So it was like "a draw" in terms of "booster" ("3rd dose" ) approvals.

(battle of the GS-1000s )

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Response to Pachamama (Reply #3)

Fri Sep 17, 2021, 04:44 PM

7. In reality you have this issue

(which I agree with)

#1 - your oldest demographic actually got prioritized to be FIRST so many are already well past the 6 m onths
#2 - the youngest end of the demographic (the teens down to the age 16, have very little data because not that many have been vaccinated when they were gathering the data and I expect the same is true - even with the EUA for 12 - 15
#3 - the older demographic tends to have more health issues that make it harder for them to stave off the infections

Pfizer had requested approval for 16+ and they will basically get 65+.

At this point, the CDC's Committee (ACIP) will also be looking at this and probably doing their own vote. I haven't had chance to check when they were going to do it...

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Response to BumRushDaShow (Reply #7)

Sat Sep 18, 2021, 03:35 AM

29. Some other issues

younger demographic has had more severe side effects to the vaccine (including about 20x hospitalization for 19-29 males).
younger people are much less likely to have a severe infection even if they get covid.

Its entirely possible if a 3rd vaccine causes more side effects than a 2nd, that a third immunization in certain demographics could cause more harm than if they hadn't got it and had gotten covid. The committee believes 16-2 as of now they don't have enough data.

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Response to Sgent (Reply #29)

Sat Sep 18, 2021, 06:00 AM

31. What the lay public is seeing

is stuff that is actually what happens when it comes to evaluating, testing, and eventually approving (with ongoing tweaks) the use of new vaccines, which is a procedure that normally takes 2 - 3 years to accomplish. However because of the crisis of COVID-19, the normal process has been compressed into a year, and has been politicized, causing hair-on-fire responses, with the expected push back from the scientific community who are normally involved in vaccine approvals. I.e., these Committees are not just solely "COVID-19 vaccine reviewers" as part of their jobs - they evaluate any vaccines that come through for a new approval or will review any supplemental data from existing vaccine manufacturers who are are requesting addendums to their current approvals. I dismiss the noise from the anti-vaxxer organizations.

One can see where certain vaccines are generally approved for certain age demographics with all sorts of caveats. For example, you don't see children getting the Shingles vaccine (recommended for 50+ and approved in 2006) because they normally get a Chicken Pox one that appears to cover them for an extended period of time.

Shingles Vaccination

What Everyone Should Know about the Shingles Vaccine (Shingrix)

Shingles vaccination is the only way to protect against shingles and postherpetic neuralgia (PHN), the most common complication from shingles. CDC recommends that healthy adults 50 years and older get two doses of the shingles vaccine called Shingrix (recombinant zoster vaccine), separated by 2 to 6 months, to prevent shingles and the complications from the disease. Your doctor or pharmacist can give you Shingrix as a shot in your upper arm.

Shingrix provides strong protection against shingles and PHN. Two doses of Shingrix is more than 90% effective at preventing shingles and PHN. Protection stays above 85% for at least the first four years after you get vaccinated.

Who Should Get Shingrix?

Healthy adults 50 years and older should get two doses of Shingrix, separated by 2 to 6 months. You should get Shingrix even if in the past you

  • had shingles
  • received Zostavax*
  • are not sure if you had chickenpox


  • There is no maximum age for getting Shingrix.

    (snip)

    https://www.cdc.gov/vaccines/vpd/shingles/public/shingrix/index.html


    Similarly when it comes to the Pneumonia vaccines, with various recommendations that cover different age demographics -

    Pneumococcal Vaccination

    Pronounced (noo-muh-KOK-uhl)

    Vaccines help prevent pneumococcal disease, which is any type of illness caused by Streptococcus pneumoniae bacteria. There are two kinds of pneumococcal vaccines available in the United States:

  • Pneumococcal conjugate vaccine or PCV13
  • Pneumococcal polysaccharide vaccine or PPSV23


  • CDC recommends PCV13 for all children younger than 2 years old and people 2 years or older with certain medical conditions. Adults 65 years or older also can discuss and decide, with their clinician, to get PCV13.

    CDC recommends PPSV23 for all adults 65 years or older, people 2 through 64 years old with certain medical conditions, and adults 19 through 64 years old who smoke cigarettes.

    Talk with your or your child’s clinician if you have questions about pneumococcal vaccines.

    (snip)

    https://www.cdc.gov/vaccines/vpd/pneumo/index.html


    In all of these vaccines, there are huge inserts (considered "labeling" by the FDA) for the medical provider that spell out all sorts of things including indications for use, dosage, dose frequency, contraindications, possible adverse events for certain individuals, etc.

    Unfortunately the current vaccine Committees are being forced to do this deliberative process "in the media".

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    Response to BumRushDaShow (Reply #31)

    Sat Sep 18, 2021, 09:53 AM

    33. Back in 2016 or so, the shingles vaccine was only available to 65+

    They changed it to 50 around 2018, I think.

    I know this because my uncle was about 63. He wanted the shingles vaccine but they wouldn't give it to him. About a year later, he had a really bad case of Shingles. It is the worst pain you can imagine. More people commit suicide from the pain of shingles then from any other pain.

    So, I really suspect that in a few years that 65+ will be changed. But what if you are like my uncle and are not 65 but so close that you have the same risks as the 65+?

    I think it is a mistake, like the age limit of 65 on the Shingles vaccine.

    By the way, if you are over 50 get your Shingles vaccine now. It is a horribly painful disease that makes me wonder how so many people survived it.


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    Response to Farmer-Rick (Reply #33)

    Sat Sep 18, 2021, 10:04 AM

    34. I had shingles. Y'all don't want shingles.

    Trust me. I was on the waiting list for vaccine. Now there usually is no wait.
    Shingles creates new pain like you have likely never experienced. The scabs
    clear up but under the skin there is still pain. Takes months to go away.
    I got the shingles vaccine as soon as I could. Stay well.

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    Response to Farmer-Rick (Reply #33)

    Sat Sep 18, 2021, 10:39 AM

    36. Yes - that's how it works

    They are continually updating their guidance as they get more study and observational data in.

    I have a younger cousin (she's the "baby" of the 7 of us from my maternal side, who just turned 50 last year) who got shingles late last year - and it manifested around one of her eyes. She texted the selfies. My other cousin who is an optometrist was advising her on what to have the ophthalmologists look for and test for with respect to it and she recovered quite well.

    We are in unprecedented times, "unprecedented" in that the last time this came up was the 1918 pandemic, where they had no idea what the structure of the virus was and there were no vaccines for it, yet we seem to be having the same types of outcomes. I.e., despite all the tech including the resources for genetic mapping, sequencing, and splicing (the "double helix" structure wasn't even discovered and published until the early '50s). The arguments about masking were the same then as now and we are seeing how those types of simple mitigation strategies could have helped us significantly, bolstering our knowledge of the intricate details about the virus.

    In fact I just saw this was published yesterday -

    The coronavirus death toll is approaching the 1918 flu pandemic — with some key caveats

    By Aaron Blake
    Senior reporter
    September 16, 2021 at 5:00 p.m. EDT

    The United States just hit a grim milestone when it comes to the toll of the coronavirus, with now 1 in 500 Americans having died. But for some, an even-grimmer milestone is fast-approaching: When the death toll exceeds the 1918 influenza pandemic. We’re currently on-pace to surpass the 675,000 deaths that have been attributed to the last comparable pandemic in the coming days. The Washington Post’s tracker shows more than 668,000 deaths so far, with a still-increasing seven-day average of nearly 1,800 deaths per day. That means we’re likely to hit that number by early next week. “The number of reported deaths from Covid in the US will surpass the toll of the 1918 flu pandemic this month,” Tom Frieden, the former director of the Centers for Disease Control and Prevention, wrote on Twitter. “We cannot become hardened to the continuing, and largely preventable, tragedy.”




    This is certainly a milestone — particularly given early comparisons by covid-doubters, including former president Donald Trump, who frequently compared the virus to the regular flu: “Many people every year ... die from the Flu,” Trump said in October 2020, adding that “we have learned to live with it, just like we are learning to live with Covid, in most populations far less lethal!!!” But this moment also requires context. The first obvious point is that our nation’s population is much larger now — by more than three times: The U.S. population in 1918 was just over 100 million, compared to nearly 330 million today. So while the 1918 death toll accounted for about 1 in 150 Americans, we’re currently at 1 in 500. Another is that it’s possible we’ve already surpassed 1918 in terms of raw numbers. The 675,000 estimate from back then involves some extrapolation. Essentially, the official mortality statistics only included a little more than 30 of the then-48 states, plus some cities in the other states.

    (snip)

    Another key difference Ewing cites is in the relatively rapid escalation and decline of the influenza pandemic. That pandemic is generally understood to have lasted around a year in the United States, with the worst month coming in October 1918, right after the start, when as many as 200,000 died of the flu and pneumonia. This was followed by five months of heavy but declining deaths, and then a relatively similar number of deaths to before the pandemic. By contrast, the worst of the first wave of the coronavirus came about three months after the problem was recognized, in April 2020, and the worst wave to date came about a full year later, last winter. Ewing also suggests this is a black mark against the official response to the coronavirus.

    “The fact that deaths surged at the end of 2020, nine months after the pandemic reached the United States, with the highest daily death tolls in early January 2021, is perhaps the most discouraging comparison to the historical record,” Ewing concludes. “We ignored the lessons of 1918, and then we disregarded warnings issued in the first months of this pandemic. We will never know how many lives could have been saved if we had taken this threat more seriously.”

    https://www.washingtonpost.com/politics/2021/09/16/coronavirus-death-toll-is-approaching-1918-flu-pandemic-with-some-key-caveats/


    TEXT from above tweet

    Dr. Tom Frieden
    @DrTomFrieden
    The number of reported deaths from Covid in the US will surpass the toll of the 1918 flu pandemic this month. We cannot become hardened to the continuing, and largely preventable, tragedy.
    1:27 PM · Sep 13, 2021

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    Response to Pachamama (Reply #3)

    Fri Sep 17, 2021, 06:58 PM

    27. Perhaps, but vaccine eligibility was partly age-based with older folks first

    They just may be waiting a bit longer for the data on those below 65.

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    Response to BumRushDaShow (Original post)

    Fri Sep 17, 2021, 04:47 PM

    9. Good. I can get mine next month.

    Yay

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    Response to BumRushDaShow (Original post)

    Fri Sep 17, 2021, 04:51 PM

    12. I think most data is showing most breakthrough

    Deaths among the elderly.

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    Response to BumRushDaShow (Original post)

    Fri Sep 17, 2021, 04:54 PM

    14. Here's a non-paywall link for info

    FDA advisory panel endorses COVID-19 booster shots only for Americans 65 and over or at high risk for severe disease

    https://www.kmov.com/news/fda-advisory-panel-endorses-covid-19-booster-shots-only-for-americans-65-and-over-or/article_707fa70e-c3db-5c01-ab93-467b39fc58e6.html?block_id=990844

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    Response to left-of-center2012 (Reply #14)

    Fri Sep 17, 2021, 05:03 PM

    16. Since WaPo hasn't updated - I am going to put up a CNN replacement and link in a sec

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    Response to left-of-center2012 (Reply #14)

    Fri Sep 17, 2021, 05:15 PM

    20. Just updated!

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    Response to BumRushDaShow (Original post)

    Fri Sep 17, 2021, 04:57 PM

    15. So ... Can I get a booster with Moderna, which my first two were?

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    Response to left-of-center2012 (Reply #15)

    Fri Sep 17, 2021, 05:03 PM

    18. This may only cover Pfizer. It was their application

    In the Lancet article they suggested the possibility you are better off getting a booster different from the first two jabs. They wanted it studied.

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    Response to left-of-center2012 (Reply #15)

    Fri Sep 17, 2021, 05:06 PM

    19. Moderna hasn't had their request for a booster evaluated yet

    Since they only submitted it September 1st - https://www.cnbc.com/video/2021/09/01/moderna-submits-initial-covid-booster-data-to-fda.html

    This is just for Pfizer (which is the majority of the shots that have been given in the U.S.).

    I got Moderna too by the way.

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    Response to BumRushDaShow (Reply #19)

    Fri Sep 17, 2021, 05:36 PM

    23. That was what I was wondering.

    Maybe this will accelerate the Moderna ruling.

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    Response to Lasher (Reply #23)

    Fri Sep 17, 2021, 05:53 PM

    25. Well there have been reports out

    that Moderna hasn't had the same level of drop off of efficacy after "x" amount of time as Pfizer. Some have speculated that this is due to the amount of the active biologic entity being injected - i.e., Pfizer is injecting 30ug of their selected candidate vs Moderna, that is using 100ug of theirs.

    So a whole bunch of variables in that case on whether the difference is due to the actual entity they are using or the quantity of that entity, or both.

    For example this was posted - https://www.democraticunderground.com/10142801544

    And regarding the timing - Pfizer had submitted their request in May and are just now getting a decision, so even if they speed it up, it will still probably be a few months - and really, it might not be needed at all for Moderna and the extra time can mean extra data to confirm either way.

    One of the Committee members brought up something early in the meeting and that had to do with FDA's minimal criteria for a vaccine - i.e., that it have "at least 50% efficacy". So he felt that peopole should not get upset about a drop from say 95% to 88% when the "minimum" acceptable is "50%".

    Of course I yelled at the computer screen about how many of the other diseases that we get vaccinated for, haven't had anywhere NEAR the death toll that COVID-19 has. And thankfully the screen didn't respond back.

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    Response to BumRushDaShow (Original post)

    Fri Sep 17, 2021, 05:03 PM

    17. That makes sense. It is a pretty cautious approval that benefits a particularly vulnerable pop

    Also, this avoids creating any supply issues by initially limiting boosters to those whose immunity might be most compromised. Of course, I hope that there will be more updates toward the end of the year and the start of the next.

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    Response to TomCADem (Reply #17)

    Fri Sep 17, 2021, 05:20 PM

    22. One of the things also brought up about that age group

    is that they were generally prioritized "first", so they were getting shots any time from the end of December (right after the EUA approval) through to about February before many states were shifting to the "next phases" for more categories of people and occupations.

    So the December group hit 6 months at the end of June, the January group hit it at the end of July, and the February group hit it at the end of August.

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    Response to BumRushDaShow (Reply #22)

    Fri Sep 17, 2021, 05:47 PM

    24. Another thing about that age group is

    they generally have a less robust immune response and the response fades more quickly.

    It's not just "they were vaccinated first." It's that they were vaccinated first *and* are the second-most likely group to have a reduced immune response after 4 week *and* second-most likely group to see their immunity fade rapidly.

    The upshot is that younger cohorts are less likely to need the booster, not that they're being deprived of something that's justly theirs. Until the data support that claim, let's (not) follow the (political) science.

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    Response to Igel (Reply #24)

    Fri Sep 17, 2021, 06:05 PM

    26. Yes

    Last edited Fri Sep 17, 2021, 09:31 PM - Edit history (1)

    I think I had posted that in a companion thread to this one thread while arguing with a (excuse my language) fucking troll (who is now gone) in yet another thread.

    Had posted something here - https://www.democraticunderground.com/?com=view_post&forum=1017&pid=681902
    And here - https://www.democraticunderground.com/?com=view_post&forum=1017&pid=681911

    ETA2 - realized I posted more here - https://www.democraticunderground.com/?com=view_post&forum=1014&pid=2801616

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    Response to BumRushDaShow (Original post)

    Sat Sep 18, 2021, 02:06 AM

    28. What about getting the Moderna shot after 6 months instead of a booster for the Pfizer?

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    Response to cstanleytech (Reply #28)

    Sat Sep 18, 2021, 05:28 AM

    30. NIH has partnered with a couple Universities to do a study on that

    News Releases

    Tuesday, June 1, 2021
    NIH clinical trial evaluating mixed COVID-19 vaccine schedules begins

    If you are interested in joining this trial, please visit clinicaltrials.gov and search identifier NCT04889209 for more information. Please DO NOT contact the NIAID News & Science Writing Branch.
    20210601-covid.jpg
    Novel Coronavirus SARS-CoV-2

    The National Institutes of Health has started a Phase 1/2 clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens. The National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, is leading and funding the study through the Infectious Diseases Clinical Research Consortium, a clinical trials network that encompasses the Institute’s long-standing Vaccine and Treatment Evaluation Units (VTEUs).

    “Although the vaccines currently authorized by the U.S. Food and Drug Administration offer strong protection against COVID-19, we need to prepare for the possibility of needing booster shots to counter waning immunity and to keep pace with an evolving virus,” said NIAID Director Anthony S. Fauci, M.D. “The results of this trial are intended to inform public health policy decisions on the potential use of mixed vaccine schedules should booster doses be indicated.”

    The trial is led by principal investigators Robert L. Atmar, M.D., at Baylor College of Medicine, Houston, and Kirsten E. Lyke, M.D., at the University of Maryland, College Park. It will include approximately 150 individuals who already have received one of the three COVID-19 vaccine regimens currently available under FDA Emergency Use Authorization in the United States: the Janssen COVID-19 vaccine (also referred to as the Johnson & Johnson vaccine, or Ad26.COV2-S), the Moderna COVID-19 vaccine (also known as mRNA-1273), and the Pfizer-BioNTech COVID-19 vaccine (also known as (BNT162b2). Each vaccine group will enroll about 25 people ages 18 through 55 years and approximately 25 people age 56 years and older. Twelve to 20 weeks following their initial vaccination regimen, participants will receive a single booster dose of the Moderna COVID-19 vaccine as part of the trial.

    People who have not yet received an FDA authorized COVID-19 vaccine are also eligible to enroll in the trial in a separate cohort. Initially, these volunteers will receive the two-dose Moderna COVID-19 vaccine regimen and will be assigned to receive a booster dose of a vaccine about 12 to 20 weeks later.

    The trial has an adaptive design and may add arms as vaccines are awarded EUA and/or variant lineage vaccines become available for evaluation.

    All trial participants will be followed for one year after receiving their last vaccination as part of the study. They will be asked to complete telephone check-ins and various in-person follow up visits. Trial investigators will evaluate participants for safety and any side effects post-vaccination. Participants also will be asked to provide blood samples periodically so that trial investigators can evaluate immune responses against current circulating strains of SARS-CoV-2, as well as emerging variants. If trial participants develop laboratory-confirmed symptomatic COVID-19, investigators will perform genetic sequence analyses on the participant samples to see if a variant strain of SARS-CoV-2 caused the infection.

    Initial trial results are expected in late summer 2021. For more information about the trial, including a list of enrollment locations, please visit clinicaltrials.gov and search identifier NCT04889209.

    NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

    About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

    NIH…Turning Discovery Into Health®

    ###

    https://www.nih.gov/news-events/news-releases/nih-clinical-trial-evaluating-mixed-covid-19-vaccine-schedules-begins


    Some more on that - https://www.cnbc.com/2021/07/26/delta-people-are-mixing-and-matching-covid-vaccines-over-concerns-about-variant.html

    Last I heard, some of the Universities involved (in Washington state and Maryland) had still been recruiting trial participants, so despite the above about "results in late summer", they may be running behind on that.

    Hunting around, I found this recent update -

    University of Maryland
    Can You Mix COVID Vaccine Brands for Booster Shots? UMd. Researchers Help Lead Study to Find Out

    By Jodie Fleischer, Katie Leslie and Jeff Piper • Published September 14, 2021 • Updated on September 14, 2021 at 7:00 pm


    With a federal advisory committee expected to consider whether to approve third doses of the Pfizer mRNA vaccine this Friday, Dr. Kirsten Lyke hopes her research will be part of their broader booster conversation. The University of Maryland School of Medicine infectious disease specialist has spent months studying the mixing and matching of COVID-19 vaccines among volunteers across the country — research she said is being submitted to officials at the Food and Drug Administration and the National Institutes of Health.

    "We're trying to decide when we need to do a booster and what's the best booster," Lyke, a professor of medicine in the Center for Vaccine Development and Global Health, told News4. "It's something that's on the minds of everyone and everyone is just worried about whether they need to get a booster.” Lyke is helping lead the NIH-funded clinical trial at more than 10 sites around the country, including in Maryland. She said roughly 700 volunteers have participated so far.

    The volunteers received either Pfizer, Moderna or Johnson & Johnson shots for their original vaccination at least 12 weeks earlier. The researchers then decide which booster to give them and track the effectiveness of each combination by testing for antibodies. “One of the reasons we're doing this trial is to establish whether it's safe and what's the best way to approach things, depending on [which vaccine you] originally got,” she said, adding: “This is all about looking at the immune response and comparing it to what we would have expected with the original vaccinations."

    Her research comes amid a heated international debate among scientists and public leaders over whether vaccine boosters are needed for the general public. In August, President Joe Biden announced a plan to make boosters available to all people who received an mRNA vaccine -- pending approval from the FDA and Centers for Disease Control and Prevention. But so far, the feds have only greenlighted boosters for the immune-compromised.

    https://www.nbcwashington.com/news/local/can-you-mix-covid-vaccine-brands-for-booster-shots-umd-researchers-help-lead-study-to-find-out/2801059/


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    Response to BumRushDaShow (Original post)

    Sat Sep 18, 2021, 10:29 AM

    35. Crap....I'm so close

    The CDC does not consider my medical problem a comorbidity. I am 64 and 5 months old. I am on month 6 of my full vaccination. I was counting on the booster in the hopes of being able to air travel in November.

    This just sucks for me.

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