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Mon Jan 23, 2023, 02:19 PM

US proposes once-a-year COVID shots for most Americans

Last edited Mon Jan 23, 2023, 03:49 PM - Edit history (1)

Source: AP

WASHINGTON (AP) — U.S. health officials want to make COVID-19 vaccinations more like the annual flu shot.The Food and Drug Administration on Monday proposed a simplified approach for future vaccination efforts, allowing most adults and children to get a once-a-year shot to protect against the mutating virus.

This means Americans would no longer have to keep track of how many shots they’ve received or how many months it’s been since their last booster. The proposal comes as boosters have become a hard sell. While more than 80% of the U.S. population has had at least one vaccine dose, only 16% of those eligible have received the latest boosters authorized in August.

The FDA will ask its panel of outside vaccine experts to weigh in at a meeting Thursday. The agency is expected to take their advice into consideration while deciding future vaccine requirements for manufacturers.

In documents posted online, FDA scientists say many Americans now have “sufficient preexisting immunity” against the coronavirus because of vaccination, infection or a combination of the two. That baseline of protection should be enough to move to an annual booster against the latest strains in circulation and make COVID-19 vaccinations more like the yearly flu shot, according to the agency.

Read more: https://apnews.com/article/health-immunizations-covid-cdd627b7daee5c2f7ebc984a3d9357db



Briefing documents for the upcoming VRBPAC meeting with the recommendations (PDF) - https://www.fda.gov/media/164699/download

Proposal (taken from the above) -

(snip)

Given the evolution of SARS-CoV-2 variants and associated changes in the epidemiology,
susceptibility to reinfection, and waning of vaccine-induced immunity, barring development of a
significantly improved vaccine, periodic future updates to the S protein sequence(s) contained
or encoded in COVID-19 vaccines and revaccination will likely be needed to induce and
maintain vaccine effectiveness (VE), respectively. Therefore, an approach to both simplifying
the immunization schedule, and periodically updating the composition of COVID-19 vaccines as
needed, requires consideration.

Review of the totality of the available evidence on prior exposure to and vaccination against
SARS-CoV-2 suggests that, moving forward, most individuals may only need to receive one
dose of an approved or authorized COVID-19 vaccine to restore protective immunity for a period
of time. Two doses of an approved or authorized COVID-19 vaccine may be needed to induce
the expected protective immunity for those who have a low likelihood of prior exposure (the very
young) or those who may not generate a protective immune response (older and
immunocompromised individuals).

Similar to the approach with influenza, the global nature of SARS-CoV-2 strain evolution
warrants a global response when evaluating and recommending vaccine strain composition
changes. Ideally, any change in vaccine composition, when appropriate, would be implemented
broadly and would be coordinated by the World Health Organization (WHO) with national
regulatory authorities. However, unlike influenza, a well-established, highly coordinated
infrastructure and governance of global semi-annual vaccine composition evaluation and
recommendations do not currently exist for SARS-CoV-2. Furthermore, at this time the current
diversity of vaccine manufacturers and complexities in global supply of COVID-19 vaccines
would make a globally coordinated, simultaneous vaccine composition evaluation and
recommendation quite challenging.

FDA anticipates conducting an assessment of SARS-CoV-2 strains at least annually and to
engage VRBPAC in about early June of each year regarding strain selection for the fall season.
Subsequently, a decision on the recommended vaccine composition would be made in time for
any updated vaccine to be in production in time to be deployed for use no later than September
of each calendar year. Of note, circulation of a more pathogenic vaccine-escape variant of
SARS-CoV-2 would likely prompt, on an as needed and emergent basis, an ad-hoc strain
selection meeting of VRBPAC.

(snip)


I think most of us figured this is what was going to happen eventually and I know there have been clinical trials underway to do this as a combined flu/COVID shot. Because the primary vaccine platform used here in the U.S. is the mRNA one, the most current circulating strain can actually be identified and the vaccine manufactured closer to the high infection season in the fall (i.e., the above mentions by "June" ), whereas the flu strains need to be identified some time in February/maybe March to give enough time to manufacture enough vaccine for that fall season.

Article updated.

Original article -

WASHINGTON (AP) — U.S. health officials want to make COVID-19 vaccinations more like the annual flu shot. The Food and Drug Administration on Monday proposed a simplified approach for future vaccination efforts, allowing most adults and children to get a once-a-year shot to protect against the mutating virus.

This means Americans would no longer have to keep track of how many shots they’ve received or how many months it’s been since their last booster. The proposal comes as boosters have become a hard sell. While more than 80% of the U.S. population has had at least one vaccine dose, only 16% of those eligible have received the latest boosters authorized in August.

The FDA will ask its panel of outside vaccine experts to weigh in at a meeting Thursday. The agency is expected to take their advice into consideration while deciding future vaccine requirements for vaccine makers.

In documents posted online, FDA scientists say many Americans now have “sufficient preexisting immunity” against the coronavirus because of vaccination, infection or a combination of the two. That baseline of protection should be enough to move to an annual booster against the latest strains in circulation and make COVID-19 vaccinations more like the yearly flu shot, according to the agency.

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Arrow 32 replies Author Time Post
Reply US proposes once-a-year COVID shots for most Americans (Original post)
BumRushDaShow Monday OP
Lovie777 Monday #1
Initech Monday #2
hamsterjill Monday #4
Initech Monday #7
electric_blue68 Tuesday #30
Orrex Monday #16
SouthernDem4ever Tuesday #29
deurbano Monday #3
hamsterjill Monday #6
ThoughtCriminal Monday #17
hamsterjill Monday #24
BumRushDaShow Monday #8
hamsterjill Monday #25
BumRushDaShow Tuesday #28
hamsterjill Tuesday #32
ananda Monday #5
TomCADem Monday #9
ananda Monday #10
friend of a friend Monday #14
Eric J in MN Monday #11
Post removed Monday #18
sybylla Monday #12
Karma13612 Monday #13
cstanleytech Monday #15
BumRushDaShow Monday #21
Martin68 Monday #19
Hortensis Monday #26
republianmushroom Monday #20
area51 Monday #22
madville Monday #23
dalton99a Monday #27
LineNew Reply +
llashram Tuesday #31

Response to BumRushDaShow (Original post)

Mon Jan 23, 2023, 02:53 PM

1. About a year ago there was some whispers that COVID shots would be like.......

flu shots.

Pretty much on target.

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Response to BumRushDaShow (Original post)

Mon Jan 23, 2023, 02:56 PM

2. Oh yeah good luck getting the MAGA shitheads to go along with this.

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Response to Initech (Reply #2)

Mon Jan 23, 2023, 03:11 PM

4. I agree.

But it’s not just the MAGA’s. Less than half of the population gets flu shots.

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Response to hamsterjill (Reply #4)

Mon Jan 23, 2023, 03:22 PM

7. I got my first flu shot this year.

I've never had the need to get one but I heard with the COVID and flu going around I decided to go for it.

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Response to Initech (Reply #7)

Tue Jan 24, 2023, 09:04 AM

30. Me, too. I haven't had the flu since I was 16 (69 now). I never got one but like you...

with covid and flu around I figured it was time. Actually I waited till too late to get it in '21.

Idk why I never got it again; extra good genes, luck, extra vits & minerals at times? What ever it was I'm grateful since I live in a big city, and not a sparse rural area, so more chances of getting it. So now some more protection is good.

(Totally vaxxed & maxxed from the get go re Covid)

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Response to Initech (Reply #2)

Mon Jan 23, 2023, 05:48 PM

16. Honestly I'm not sure that the Left will be much better about it

Mention mandatory mask use or restricted public gatherings for the sake of health and safety, and the Left loses its shit as quickly as the Right, with all kinds of dubious "evidence" about the futility of such measures.

For some on the Left, any measure at all that imposes any inconvenience or discomfort, no matter how trivial, is monstrous and must be opposed.

I'm not making this up: I've had this heated exchange more than once here on DU, with their final rebuttal often taking the form of "look, if you want to wear a mask, no one's stopping you."


The Right has no monopoly on selfish thinking or short-sightedness.

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Response to Initech (Reply #2)

Tue Jan 24, 2023, 08:26 AM

29. Just let the virus do it's job

on stupid people.

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Response to BumRushDaShow (Original post)

Mon Jan 23, 2023, 02:57 PM

3. I wish they'd make some faster progress with the nasal sprays. I heard of one possibility

where we could spray daily, even more than once daily, to prevent any exposure from gaining hold, and that this approach could work for any potential variants, and even the flu. That would really help even the more vulnerable amongst us get back to "normal" life.

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Response to deurbano (Reply #3)

Mon Jan 23, 2023, 03:13 PM

6. Me, too.

The needle phobe that I am!!!

I feel like this technology is being put on the back burner. Every time I I hear that there is progress, in a month or two, the research has been stopped. They might LEARN something via this method.

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Response to hamsterjill (Reply #6)

Mon Jan 23, 2023, 05:52 PM

17. I would consider myself a needle-phobe

But I've had 4 doses of Moderna and it is by far the least noticeable shot I have ever received. I did not feel any pain at all.

The downside it still the after-effects - a day or two of fever and aches and I doubt that a nasal dose will solve that.

Having to deal with that twice a year is a problem, and one I'm willing to deal with, but it would be easier if it was annual.

I also wish that more progress was made on needle alternatives for other vaccines as well. I sometimes think that it is not a priority in the medical profession since needle-phobia is just seen by many as a personal weakness.

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Response to ThoughtCriminal (Reply #17)

Mon Jan 23, 2023, 10:29 PM

24. Totally agree.

We are few in number in the world’s eye and are expected to just suck it up. Easier said than done.

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Response to deurbano (Reply #3)

Mon Jan 23, 2023, 03:25 PM

8. Being worked on

India has one that they plan to release next week - https://timesofindia.indiatimes.com/life-style/health-fitness/health-news/indias-intranasal-covid-vaccine-incovacc-to-be-launched-on-republic-day-key-points-to-know/photostory/97225602.cms?from=mdr

Health
COVID-19 vaccines: From nasal drops to a redesign, what 2023 could have in store

By Alexander Tin

January 9, 2023 / 3:08 PM / CBS News

Several vaccine companies say they are expecting breakthroughs as early as this year as they pursue new ways to protect people against SARS-CoV-2, the virus that causes COVID-19.The Food and Drug Administration is set to convene a panel of its outside vaccine advisers later this month to weigh key issues over the future of COVID-19 vaccines, including when and how to greenlight new boosters and changes to which strain the vaccines target.

Here's a peek at some of what's expected this year for the next generation of COVID-19 vaccines.

New vaccines by nose or mouth

Several companies have been pursuing approaches that could offer better protection against infections themselves, instead of merely blunting the severity of the disease. Potential vaccines to build this kind of "mucosal immunity" aim to bring antibodies to fend off the virus at the sites where it first enters the body, through vaccines that could be taken through drops, sprays or pills.

A few of these vaccines have been licensed in other countries, but none in the U.S. — and the data behind them isn't robust, said Dr. John Beigel, associate director for clinical research at the National Institute of Allergy and Infectious Diseases. Even if Congress had granted the Biden administration's request to pour resources into developing potential next-generation mucosal vaccines to broad clinical trials, Beigel said it would be challenging to "pick the winners" for government backing. 

(snip)

Changes to existing vaccines

(snip)

"A combination influenza and COVID vaccine — that still looks very optimistic that that might be available for next season, and I think it might do something good to combat the vaccine fatigue that's out there at the moment," says Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center.

(snip)

More: https://www.cbsnews.com/news/covid-19-vaccines-nasal-sprays-pills-breakthroughs-2023/

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Response to BumRushDaShow (Reply #8)

Mon Jan 23, 2023, 10:30 PM

25. These articles have been promising this for over two years.

I will be glad when something finally materializes.

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Response to hamsterjill (Reply #25)

Tue Jan 24, 2023, 04:28 AM

28. I think the issue is getting enough data

and solid/verifiable results from the clinical trials. There are trials going on but I expect either they are too small or have not been conclusive enough.

Basically what is being asked is to fulfill the long running pipe dream of "curing the 'common cold'" ( 'colds' are viruses, in some cases including a mix of rhinoviruses and benign coronaviruses). If the mechanism to neutralize something like these respiratory viruses is found, it will be a game-changer!

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Response to BumRushDaShow (Reply #28)

Tue Jan 24, 2023, 04:26 PM

32. All most of us are asking for is a different vehicle for administering the vaccine.

Some of us do not relish standing there and letting someone stick a needle in our arm.

But I believe your arguments are sound.

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Response to BumRushDaShow (Original post)

Mon Jan 23, 2023, 03:13 PM

5. Yes. Covid and flu together. Easy peasy.

...

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Response to ananda (Reply #5)

Mon Jan 23, 2023, 03:51 PM

9. Is it together in just one shot?

I thought the story was that the COVID booster would be offered annually like a flu shot. That would be great if they had a combo flu and COVID shot.

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Response to TomCADem (Reply #9)

Mon Jan 23, 2023, 04:11 PM

10. It's two shots, best in different arms.

That's what I did last September.

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Response to ananda (Reply #10)

Mon Jan 23, 2023, 04:47 PM

14. I November, I got my 5th Moderna shot, and flu shot in the same arm.

They were so close together that I only needed 1 bandaid.

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Response to BumRushDaShow (Original post)

Mon Jan 23, 2023, 04:16 PM

11. The effectiveness of boosters starts to fade after 4 months.

This is wishful thinking: If we say COVID is analogous to the flu then it will be.

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Response to Eric J in MN (Reply #11)


Response to BumRushDaShow (Original post)

Mon Jan 23, 2023, 04:16 PM

12. I am a bit bothered by this.

On the one hand, I get it. Development and implementation of multiple vaccines per year is problematic.

OTOH, try tabulating the number of variants that develop worldwide in one year. We will be forever vulnerable to the worst six months in.

Again, this seems to be far too focused on what "people" want and not the reality of epidemiology, immunology, the long-term impacts of multiple infections of COVID, and the impacts of both long- and short-term sickness on world's and our economy.

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Response to BumRushDaShow (Original post)

Mon Jan 23, 2023, 04:32 PM

13. Yup, that's kinda what I expected.

Hopefully SOMEDAY they might be able to combine them (Flu and COVID) for those of us who are needle-averse. Hahaha!

I’ve had every recommended vax and booster for COVID, and I always get a Flu shot. I just would like to have it be combined.

Thanks for this updated info ❤️

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Response to BumRushDaShow (Original post)

Mon Jan 23, 2023, 05:43 PM

15. I am just surprised it was not done a year ago because imo its needed since

this virus has clearly shown it can mutate alot just like the flu can.

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Response to cstanleytech (Reply #15)

Mon Jan 23, 2023, 06:36 PM

21. A year ago we were at the peak of Omicron and infections were finally dropping

and that is when many "discovered" that "Yes Virginia, there are 'break-through' cases" and it's not "rare".





And "Also Virginia, children were getting it and in some cases, pretty badly and ending up in the hospital thanks to Omicron".



I had watched most if not all of the FDA VRBPAC and CDC ACIP meetings and there were members on both Committees who were strongly against the idea of "boosters". They have fortunately been in the minority when voting but it reflects the often divergent views in the epidemiology and medical communities. You also had a contingent from W.H.O. who were demanding that western countries halt boosters in order to get vaccines to the developing world.

So this pandemic has been a textbook case of fits and starts and guessing and assuming.

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Response to BumRushDaShow (Original post)

Mon Jan 23, 2023, 06:07 PM

19. I'll just keep one getting every shot that is recommended. Covid-free so far,

knock on wood.

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Response to Martin68 (Reply #19)

Mon Jan 23, 2023, 11:19 PM

26. :) Same here. I'm immunocompromised, though, so

won't expect the recommendation to be the same as for the once-a-year "most Americans."

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Response to BumRushDaShow (Original post)

Mon Jan 23, 2023, 06:11 PM

20. figured this was coming

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Response to BumRushDaShow (Original post)

Mon Jan 23, 2023, 08:28 PM

22. "... boosters have become a hard sell."

A hard sell at currently $0 cost. Wait 'til people get charged $110+ for any future Covid boosters.

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Response to area51 (Reply #22)

Mon Jan 23, 2023, 09:41 PM

23. Very few will pay for one, even a small copay

Only way they’ll get maybe 30% compliance is for it to remain zero out of pocket cost. I know several people that have gotten the flu shot this year but are declining any further COVID shots.

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Response to area51 (Reply #22)

Mon Jan 23, 2023, 11:33 PM

27. +1. Good luck with that

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Response to BumRushDaShow (Original post)

Tue Jan 24, 2023, 11:58 AM

31. +

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