Fauci says FDA data shows J&J vaccine should have been two shots

[Yo_Mama_Been_Loggin]

Source: The Hill

President Biden's chief medical adviser Anthony Fauci said on Sunday that the Johnson & Johnson COVID-19 vaccine likely should have been a two-dose shot instead of a single inoculation.

ABC's Martha Raddatz asked Fauci on "This Week" if the millions of the Americans who received the Johnson & Johnson COVID-19 vaccine should have been concerned after a Food and Drug Administration (FDA) advisory committee voted unanimously to recommend adults receive a booster shot of the vaccine.

"No, not at all, Martha. I think that they should feel good about it because what the advisors to the FDA felt is that given the data that they saw, very likely this should have been a two dose vaccine to begin with," Fauci said.

"So the idea of making a recommendation that people who originally received J&J should receive a second dose 18 or older with none of the restrictions about whether or not you're at a high risk or not at a high risk, is that everyone who received that first dose of J&J who are 18 and older should receive it," he added.

Read more: https://www.msn.com/en-us/news/politics/fauci-says-fda-data-shows-jandj-vaccine-should-have-been-two-shots/ar-AAPDqAq

[underpants]

1. Good.

I can just smell the “confusion” “many people have” coming.

[HUAJIAO]

2. So when did THEY (and who is THEY?) realize that the J&J vaccine

should have been a 2 shot regimen? Way back when or just now? or? Did I miss something?

[yaesu]

4. good question. All this addition info does is create more concerns over vaccinations, this info

should not be disseminated on talk shows.

[HUAJIAO]

12. I have a lot of respect for Dr Fauci. BUT I think he is perhaps

a bit naive when it comes to the public and the American electorate in general... vis a vis his messaging....

The FDA as well.....

[Cetacea]

15. Fauci has been great

Perhaps your concern should be directed at the head of CDC who told everyone to stop wearing masks after the vax program started?

[HUAJIAO]

16. And here I thought that was Fauci.

See my problem......

[C Moon]

10. Probably CDC and FDA, no?

[BumRushDaShow]

19. Note that the minimum criteria for vaccine approval is "50% efficacy"

and that's for ANY vaccine. Obviously vaccine makers try to aim higher, but as we have seen with the annual flu vaccines, you are lucky to get 60% effective from season to season, with some combos selected based on annual guesses of expected predominate circulating strains of Influenza A and B, missing the mark, and barely reaching the 40% effective range.

At the time of submission, Janssen wanted to promote theirs as a "1-shot" vaccine that not only met the "50% effective" criteria, but was considered to be close to being commensurate, at 85+% effective, to the 2-dose mRNA ones (that were in the 90+% range after 2 doses), knowing how difficult it can be for adults to remember (often requiring prodding) to come back and get a 2nd injection of anything (let alone to even get one shot). Being able to be "one and done" has many benefits for getting to those who are either home bound, transient, or phobic of needles, while still offering good protection from severe disease or death.

With their small trials of using 2 dose intervals at 2 months, 3 months, and 6 months post-1st dose, they were finding that their vaccine actually hit into the 90+% effectiveness after that 2nd dose at the 2 month point (I expect they probably already knew this when they were setting up their original trials because the similar platformed AstraZeneca vaccines are 2-dose).

At this point, I expect a lot of this is a "perception problem", with extremely high expectations that are not normally par for the course for vaccines in general. And it is decidedly rare that the whole vaccine approval process even gets any public attention at all. As it is, most pharma companies have shied away from making vaccines over the years because they never "made any money" from them (in their business model thinking) and world governments have generally had to beg and cajole them to continue to make them.

IOW, vaccines are generally a "loss leader" during pandemics, and a "loss" when there is no pandemic or epidemic, although the COVID-19 pandemic is more an exception to that rule, and has proven to offer profits not normally seen during outbreaks.

[HUAJIAO]

23. That is really interesting. Thank you for taking the time to explain....

[BumRushDaShow]

26. You are welcome

in fact, I think they have exceptions for vaccines that can be so wildly variable from year to year, like the flu one, that they sometimes go as low as 30% efficacy to at least approve something that offers some protection.

[hamsterjill]

24. Exactly.

So much for the “one and done”.

I realize that being in the middle of a pandemic, that science evolves. But it’s been a year now and I would feel better if they got their messaging straight and that it be definitive. There are still a lot of unanswered questions and no new developments with the three original vaccines. Shouldn’t there be more on the market by now, etc.?

I don’t relish having to do it again. That was my reasoning for getting the J&J in the first place. Unlike some here, I’m not just waiting with great anticipation to get another jab. I will speak with my doctor and take her recommendation and I’m interested to learn whether she advises another J&J or one of the others.

[HUAJIAO]

25. I got the Moderna and am glad I did and will get the booster as soon a possible...

I have no problem with vaccinations, or needles in general...

[BumRushDaShow]

27. The vaccine trials and approval process normally takes 2 or more years

What is unprecedented is how lethal COVID-19 has been that has basically demanded that the "normal' approval process be compressed from several years down to a year or less. The "normal" time frame was to allow for discovering any moderate to severe and/or rare adverse events ("side effects" ), including over the long term, that might crop up with the vaccines.

I.e., the dire circumstances that we have been in demanded "instant" and science isn't always "instant".

There have been developments by all of the vaccine makers but they need time to let the testing and clinical observations play out. Some of the research that they have been engaging in involve more targeted biologic entities for their vaccines to deal with variants, as well as adjusting the dosage and the timing between doses - plus even eventually combining with the flu vaccine, either as a heterologous shot (e.g., mRNA COVID-19 + viral component Influenza A/B) or homologous (both COVID-19 and Influenza A/B vaccines as a mRNA combo shot).

For example, 3 current vaccine makers announced trials for a mrNA Influenza A/B vaccine that could later be combined with a COVID-10 one at some point (one of the 3, GSK/Sanofi had dropped their mRNA COVID-19 vaccine early on and focused on the mRNA Influenza A/B one).

You saw what occurred earlier with both the Janssen and AstraZeneca vaccines with respect to a rare condition that popped up for a certain demographic and that needed to be narrowed and elucidated so that medical providers could offer better advice regarding risks/benefits for any who might be impacted.

In any case, like the flu shot, this is not going to be like a MMR or Polio or DTaP vaccine as a "one or a series and done for a decade" or more (perhaps with a later booster). This may have to be an annual thing.

[hamsterjill]

28. Yes, I understand all of that.

Less than half the population gets the flu shot. Why would the powers that be believe that the majority will get an annual COVID vaccine when they have already not been successful at getting more people (yes, the dumbasses) to get even ONE shot?

I’m just saying we need some new approaches…and this IS still America and so I expect great things.

[BumRushDaShow]

29. Oh I agree

It's a problem but I think it's also a "human nature" issue too and you are just not going to get "100%". I doubt they believe that "the majority" would get something like this annually, but I think right now they are focusing on trying to get the virus under control to reduce the mutations and variants, and then move on from there for the future. They still have the 1918 flu pandemic as a guide to how eventually viruses like this become "endemic". But in that case and probably this case, it will probably take years. From what I gather, the original 1918 virus (and/or variant) is still actually circulating.

"Messaging" without complete government control of every form of communications, is not going to work.

The only other immediate "approach" at this moment in time is literally rounding people up and strapping them down to be force-vaccinated. You can try to "sell" something all you want but if there are people out there among the 7 billion on this planet who are "not buying", then there's not much more you can do but try to get the transmission rates down enough to keep it contained.

I know there are some various technologies being researched/investigated and even tested and/or trialed like laser epicutaneous vaccination and/or vaccine delivery via a transdermal patch as an alternative to an intra-muscular shot, and this is actually being done with some COVID-19 vaccines.

The good news is as we have seen with the amazing first time use of mRNA technology for a vaccine, this pandemic has spawned all kinds of new ideas and illustrates the old adage of "necessity being the mother of invention".

If the mRNA vaccines are able to be shown to be effective without any long term consequences over time (years), it will be a game-changer that could once and for all, eliminate the need for creating vaccines in animal cells (like the eggs often used for the flu vaccines, which is a major issue for those who have egg allergies). The one caveat would be the ultra-cold storage temps, which is a hurdle that needs to be dealt with.

[GPV]

3. Id still rather boost w Moderna.

[Phoenix61]

5. Me too based on the data from INH.

and having a really strong reaction to the J&J. Felt like crap for 2-3 days.

[LisaL]

6. I hope people are allowed to do that sooner rather than later.

NT

[bamagal62]

7. Me too.

I got the J&J because we were told to take which ever one was available. If I had waited 2-3 weeks, turns out I could have had my choice. I’m
Tempted to just wait and see if I can mix and match instead of running out and getting the second J&J.

[GPV]

14. I'm waiting

[ananda]

8. I feel so lucky to have gotten the three Moderna shots.

I feel much safer now.

[LisaL]

9. Same here.

J&J should be allowed to boost with Moderna or Pfizer-that seems to get the best results.

[ananda]

20. Yeah, I don't see anything wrong with mixing vaccines.

...

[C Moon]

11. When it was my turn, I searched everywhere nearby to find a J&J shot...

because I didn't want to go for two shots.
I gave in and got the two Moderna shots.
I am so glad I didn't find the J&J.

[LisaL]

18. I wanted Pfizer, but couldn't find that nearby.

I wanted Pfizer because there were more information available on it at the time. So I got Moderna, but now I am happy with that since Moderna seems to be more durable and more protective.

[OldBaldy1701E]

13. When I got my vaccine it was random.

I got it through the hospital that my doctor is part of, and once I got there, it was a random choice (supposedly). So, I got the Janssen one. I suppose I will need to get a booster. But, it will have to be free.

[LisaL]

17. Boosters are free.

NT

[ChazII]

21. I will admit that now I am confused.

I was able to get the Pfzier back in March and April. My 3rd shot will be in the beginning of December but I have not signed up for it yet because I am under 65. Wish I could get Moderna (sp) for my 3rd. I will need to consult with my pcp.

[cadoman]

22. I'm a bit shocked that they don't have to go back through the approval process for boosters

Wouldn't you want to run the same set of tests before recommending them? Perhaps the safety profile of these vaccines been proven to be so excellent that boosters can be recommended without testing? Perhaps they are a product that has no accumulative effects? 17 people followed for six months seems a bit on the small side.

Thankfully the FDA/CDC/WHO/NIH are there to do the analysis for us and their work has been proven wonderful so far. Thanks to all the medical workers that are doing their part to bring us more vaccines!