Fauci expects J&J vaccine to be back later this week

[Johnny2X2X]

https://apnews.com/article/politics-anthony-fauci-coronavirus-pandemic-infectious-diseases-coronavirus-vaccine-6e3b18b44a05d1e49ed35337ec7ce969

Great news. Glad they didn’t break their safety protocols, they exist for good reason. Glad this will be back in use soon.

[Ms. Toad]

1. Yay!

Similarly glad they followed safet protocols. Although I wouldn't have predicted how long the pause would be, I did predict it would be brief, to permit time for exactly what they have done here.

[LisaL]

2. Who is going to use it?

There were major plans to use it on students, but it appears not to be a good idea if younger people are the ones getting clots (however rare those clots are).

[Ms. Toad]

4. They haven't announced yet -

but they did suggest there might be age and gender restrictions.

In some countries that have paused it, they have restarted with >50 restrictions.

My yay is more for following protocols than for Johnson & Johnson, specifically. I've never been a fan of J&J.

[LisaL]

5. We vaccinated most of the seniors by now.

[Ms. Toad]

6. There are still some left -

There's at least one DU member with an elderly stay-at-home mom who hasn't gotten vaccinated yet. To the extent they delayed home vaccination visits for those who can't get out, this provides a simpler option than the two-dose vaccines.

I think about 20% of seniors remain unvaccinated (I couldn't quickly find a number), and generally when they talk about seniors they are referring to the 65+ range - there are more between 50 and 65 who are not yet vaccinated.

There are enough Moderna or Pfizer purchased to go around, so I'm not worried about people being left out. But I do think that even though I would not personally choose J&J, others should have that option. As long as the information is available to make an informed choice.

[LisaL]

8. Maybe they will limit it to men, since most clots apparently appear in women.

So it will be a Dude vaccine.

[Ms. Toad]

9. Since, stereotypically, dudes are less likely to follow up with medical care -

that might not be a bad thing.

Although there are reports with AstraZeneca that up to 1/3 of those with clots are men.

[LisaL]

11. Yea, but we are talking about J&J here.

Apparently there was one man who got these clots during their clinical trial (because he was the only one, it was ultimately decided to be unrelated to the vaccine), but outside the trial everyone who got these clots was a female 18-48.

[Ms. Toad]

12. It's almost certainly the same disorder -

tied to the adenovirus vector for delivery of DNA (used by J&J, AstraZeneca, and Sputnik).

All but 1 of the J&J 6 tested positive for the PF4 antibodies - and the one who was not positive was not tested at all. All 28 patients in one AstraZeneca study tested positive for the PF4 antibodies. This is the same antibody involved in the heparin-induced variety - but none of the 28 had previously had heparin.

It is relativley safe to draw on the data associated with AstraZeneca (and Sputnik, to the extent there is any).

[womanofthehills]

36. EU will end J &J contract at end of year

From Yahoo News ... “ The EU Commission has reportedly decided not to renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson.

That's according Italian daily La Stampa on Wednesday, citing a source from the Italian health ministry.

The paper reported, quote: "The European Commission, in agreement with the leaders of many EU countries, has decided that the contracts with the companies that produce viral vector vaccines that are valid for the current year will not be renewed at their expiry."

[Johnny2X2X]

3. Yeah.

Those saying they should ignore their protocols were puzzling to me. Who do they want making that decision? Do they want politicians to have the power to over rule FDA safety rules? Talk show hosts? The public?

These protocols were developed by experts over years and there is a reason they exist. Glad we followed them.

[janterry]

7. I am waiting and might opt for J&J

not sure.

I posted a video from Dr. Campbell in which his read of the recent vaccine adverse event studies is as follows:

For CVT - both MRNA and AstraZeneca are comparable
AstraZeneca vaccine Cardio Vascular Thromboses CVT= 5.0 per million
For the two MRNA = 4.1 million

so only slightly higher with with Astrazeneca

But abdominal
splanchnic thrombosis (these are basically the veins going into the portal vein)

(by vaccine):
AstraZeneca 53 out of 34 million OR 1.6 per million
With MRNA vaccines: 44 per million

I'd like to hear a bit more about this (and of course more about J&J specifically) before I reschedule (had been scheduled for J&J the day it was paused)

[Ms. Toad]

10. There aren't any reports of the rare disorder that are associated with the mRNA vaccines.

182 million mRNA COVID-19 doses administered with no reported cases to date

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-04/03-COVID-Shimabukuro-508.pdf

Cardio Vascular Thrombosis (or general clots) are not the issue - it is cerebral venous sinus thrombosis with thrombocytopenia

Two different things.

[Sgent]

13. And to add to that

positive PF4 -- indicating that this is a immune system problem and blood clotting is the end result -- not the primary disease. The PF4 also explains the younger and predominantly female (since women generally suffer from more immune disorders).

[janterry]

15. it could explain it

I'm not sure at this point we could say it does explain it.

It's a compelling hypothesis.

Anyway, I'm waiting on further review. I hope to make a decision this week. I would rather not take the MRNA - it has great short term data at this point. But it's still new. I feel safer with methodology that has been studied longitudinally. But that is my druthers.

[janterry]

14. he shows you the preprint in the video

you can download it

[Ms. Toad]

16. Did you follow the link I provided in my post

to the CDC summary that expressly states there are ZERO reports of the disorder that triggered the J&J pause following mRNA vaccination?

What Dr. Campbell is referencing is cerebral venous thrombosis (not cardiovascular thrombosis, as you reported) without thrombocytopenia. The rare disorder (the reason for the J&J pause) is cerebral venous sinus thrombosis with thrombocytopenia.

The major distinction is that the rare disorder (with thromobcytopenia) is more deadly when treated with heparin (the standard treatment for clots).

The same is NOT true for the condition that Campbell is discussing (which respond normally to heparin). The condition that Campbell is discussing has nothing to do with the pause.

[janterry]

25. I understand

Moreover, the preprint does not include J&J.

I find it interesting that data is not widely disseminated.

But I am cautious by nature and I continue to wait and have gone from the will make a decision this week, to will likely make one this week. I remain open to more data.

[Ms. Toad]

28. The Campbell video

seems to focus on the clotting issue, as it was initially described (a generic concern for clotting - which was pretty quickly dismissed as not much different than the background level of clotting).

[janterry]

29. why is the news reporting on both?

Data showed unusual blood clots were occurring mostly in the vein responsible for draining blood from the brain — a medical condition termed cerebral venous sinus thrombosis (CVST) — and veins inside the abdomen, or splanchnic vein thrombosis (SVT).

https://www.dailymail.co.uk/news/article-9490365/EU-drug-regulator-prepares-issue-advice-J-J-COVID-shot.html

[Ms. Toad]

33. Again - it is clots + thromobcytopenia that is the issue.

J&J is irresponsibly attempting to confuse the issue, by implying that Pfizer and Moderna have the same issue by generally referring to reports of clots following their vaccines, which is accurate. It is not accurate (in the US, at least) that there are CVST clots reported in connection with Pfizer, and the three incidents of CVST clots reported in connection with Moderna were NOT associated with thrombocytopenia - and the combination is the reason for the pause.

Not to mention that the Daily Mail is not a reliable source of information. It is the UK equivalent of the National Enquirer.

[janterry]

42. I didn't see any evidence of trying to obfucate the issue

in this article - nor --should I say is this a huge issue for me - at this point. I continue to watch and wait.

But here is BMJ - also attentive to clots in both areas:

All US cases relating to the Janssen vaccine occurred in people aged under 60 within three weeks post-vaccination, and the majority were in women. However, the Pharmacovigilance Risk Assessment Committee said that there was not yet enough evidence to determine specific risk factors for these clots.

The blood clots occurred mostly at unusual sites in the body, such as in veins in the brain (cerebral venous sinus thrombosis) or in the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.

As of 4 April the EMA said that eight cases had been reported after receiving the Janssen vaccine (all in the US), 287 cases were reported after the AstraZeneca vaccine (142 in the European Economic Area), 25 after Pfizer’s vaccine, and five after Moderna’s.

Commenting on the AstraZeneca figure, Sabine Straus, chair of the Pharmacovigilance Risk Assessment Committee, said, “People in Europe are very aware of it, and we will probably receive more reports now. So, the reporting might be more aligned with the occurrence.” Additional studies into these unusual blood clots are being carried out by AstraZeneca, Janssen, and the EMA.

https://www.bmj.com/content/373/bmj.n1046

[womanofthehills]

39. That statement is not true if you go over to VAERS - just the same amount of cases

[Ms. Toad]

43. You are still confusing two different disorders.

The numbers I recited ARE drawn from VAERS.

You are including numbers that have ONE of the two components: CVST combined with thrombocytopenia

There are 0 reports for Phizer of CVST and 3 for Moderna. The 3 for Moderna are without thrombocytopenia,

[womanofthehills]

17. VAERS data (released Fri)submitted to CDC Shows differently

However, the CDC’s VAERS (Vaccine Adverse Events Reporting System) data released Friday showed 795 reports related to blood clotting disorders with 400 attributed to Pfizer, 337 to Moderna and 56 to Johnson & Johnson between Dec. 14, 2020 and April 8, 2021. healthcare workers are required to report all adverse events to VAERS.

[Ms. Toad]

18. The CDC reads VAERS data very differently from you

Last edited Sun Apr 18, 2021, 07:41 PM - Edit history (1)

NONE of those you are noting are the rare clotting disorder associated with J&J and AstraZeneca.The reason for the pause was the very rare, very deadly condition: cerebral venous sinus thrombosis with thrombocytopenia.

As of April 12, there have been precisely 6 cases reported in the US, NONE of which are associated with the mRNA vaccines:

Reports of CVST to VAERS after COVID-19 vaccines as of April 12, 2021

 Janssen COVID-19 vaccine
6 reports of CVST with thrombocytopenia (platelet counts {under} 150K/mm3)
following 6.86 million doses administered
• Reporting rate of 0.87 cases per million doses administered

 Pfizer-BioNTech COVID-19 vaccine
0 reports following 97.9 million doses administered

 Moderna COVID-19 vaccine
3 reports following 84.7 million doses administered
All 3 with normal platelet counts; onset 2, 6, and 12 days after vaccination

(Note: thrombocytopenia = low platelet counts, so while the Moderna reports are CVST, because the platelet counts are normal they are not the rare condition that triggered the pauses in J&J or AstraZeneca)

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-04/03-COVID-Shimabukuro-508.pdf

Here is the CDC alert, differentiating the rare condition, which triggered the pause, from generic clotting conditions:

https://emergency.cdc.gov/han/2021/pdf/CDC-HAN-00442.pdf

[LisaL]

19. Yep, clots associated with J&J are rather unusual.

They are similar to what sometimes occurs with heparin, and accompanied by drop in platelet count.

[Ms. Toad]

20. Precisely - and all who have been tested have the same antibody as the heparin-induced variety.

And - if you have low platelet (but are clotting anyway) - and they "thin the blood" by adding heparin (the standard treatment for clots) - you risk bleeding-out - even though there are clots in other parts of your body.

Which is why it was dangerous enough to pause until they could sort it out and issue appropriate warnings.

[womanofthehills]

22. The problem being reported by the NYT is that the CDC

Has no one compiling and reporting on the VAERS data. Anyone can read it - Here are a few reports from NYT’s in February. ........ “A Few Covid Vaccine Recipients Developed a Rare Blood Disorder
A link to the vaccines is not certain, and investigations are underway in some reported cases.

By Denise Grady
Published Feb. 8, 2021
Updated Feb. 10, 2021

One day after receiving her first dose of Moderna’s Covid vaccine, Luz Legaspi, 72, woke up with bruises on her arms and legs, and blisters that bled inside her mouth.

She was hospitalized in New York City that day, Jan. 19, with a severe case of immune thrombocytopenia — a lack of platelets, a blood component essential for clotting.

The same condition led to the death in January of Dr. Gregory Michael, 56, an obstetrician in Miami Beach whose symptoms appeared three days after he received the Pfizer-BioNTech vaccine. Treatments failed to restore his platelets, and after two weeks in the hospital he died from a brain hemorrhage.”

[Ms. Toad]

23. Remember that VAERS takes reports from anyone -

Not just medical professionals. Those reports must be vetted by people trained to sort, interpret, and draw trends from such reports..

So - I'm going to stick with reports from medical professionals and scientists in numerous cou tries who are reviewing the reported cases and reporting formally AFTER sorting out things that may look similar on first glance.

As to the NY Times articles, it was addressing (again) half of the disorder - albeit the other half than this thread has been discussing so far (the lack of platelets). Neither of these two individuals were reported to have cerebral venous sinus thrombosis.

J&J (and Astrazeneca) have both been paused because of a rare clotting disorder (absent in the cases you noted) which also includes thrombocytopenia.

(I'm not ruling out a different disorder associated with the mRNA vaccines - but none so far has been isolated and reported by medical professionals and scientists, and the disorder that paused J&J has not been reported - at all - in connection with the mRNA vaccines.)

[womanofthehills]

40. you can actually read the individual reports supplied by medical professionals

if you do, you will change your mind

[Ms. Toad]

41. I doubt it.

Since you keep posting numbers drawn from those reports which are not narrowly drawn to include the specific disorder that created theJohnson & Johnson pause with the goal of proving the other vaccines have the same issue as the J&J vaccine, when they don't.

[LisaL]

24. They didn't have clots, just low platelet count.

If it's connected to mRNA vaccines, it appears to be extremely rare.

[womanofthehills]

31. Two young woman posting today on TicToc from hosp/rehab

21 and 33 yrs old - both paralyzed after Pfizer shot. One is at Cleveland Clinic & one in rehab in Arizona. One went to bed after shot & woke up paralyzed-she was able to call to her young daughter to help her. Both women have gotten feeling back in arms but not legs. This is the 3rd young women posting this on TicToc. Sounds like Guillian-Barre. Both posted they were super healthy- no under lying conditions.

[Ms. Toad]

32. Again, not the same rare condition.

Guillian-Barre is a known side effect of some vaccines, and treating it in the same way you treat Guilian-Barre in the same way as you treat it when it is caused by anything else does not make it more deadly. (Guillain-Barre was discussed in connection wtih the vaccines before they were approved for emergency use - noting that although it did not occur during the trials, it would not have been expected to since it is an exceedingly rare condition, and there is also arisk of result of contracting it following COVID-19.)

I have not ever claimed that there are no side effects with Pfizer or Moderna - just that the specific rare condition that was the reason for pausing the J&J vaccine is not associated with the mRNA vaccines.

That's not to say it isn't tragic - I have a friend with Guillain-Barree. Just that it doesn't fall in the category of completely unexpected following a vaccinate nor is it made more deadly by the standard treatment for that condition.

[womanofthehills]

34. This is the third young woman I saw reporting this on Toc Toc

Just saying- if 3 are on Tic Toc, there must be more. Might be higher levels of Guillian-Barre with these vaccines. Young women also posting pics themselves with Bells Palsy after Vax. Millions of kids are seeing these on TicToc and declaring they will not get the vaccines - so it’s not just Republicans.

[Ms. Toad]

38. People report all sorts of things on social media -

it doesn't make their reports medically accurate, or otherwise true. There were also coronavirus hoaxes on Tik Tok.

Here's what has been confirmed, that I can find:

MINNEAPOLIS - Two people participating in a COVID-19 vaccine trial, one who received the vaccine and one who received a placebo of saline solution, developed Guillain-Barré syndrome according to a new case report published in the April 6, 2021, online issue of Neurology®, the medical journal of the American Academy of Neurology. Researchers emphasized that just because a vaccinated person later developed Guillain-Barré syndrome does not prove the vaccine was the cause, as supported by how the person who received the placebo in the trial also developed the syndrome. Both people were enrolled in the Johnson & Johnson vaccine trial.


https://www.aan.com/PressRoom/Home/PressRelease/4878

Also reported here: https://www.physiciansweekly.com/guillain-barre-case-reported-after-covid-19-vaccination/

One following Pfizer reported here:

https://www.cureus.com/articles/52295-neurological-complications-of-covid-19-guillain-barre-syndrome-following-pfizer-covid-19-vaccine

Vaccine not specified here (but has to be Moderna or Pfizer, since it says 1st dose):

https://www.click2houston.com/news/local/2021/04/05/local-teen-diagnosed-with-guillain-barre-syndrome-questions-covid-19-vaccine-after-receiving-first-dose/

I'm sure they are watching the reports and will evaluate numbers and determine if it is coincidence - or causation. Since this was included in the discussions prior to emergency approval (and I've seen it in warnings related to all vaccines), unless there is evidence that it is worse than with other vaccines, I wouldn't expect a pause.

[Johonny]

27. There's a lot to like about 1 and done

Particularly if you have to travel to the vaccination site, etc...

The 5-6 week routine works better for mobile people.

The risk is relatively low compared to the actual virus.

[sarcasmo]

21. Great news indeed, I can reschedule soon.

[OhioChick]

26. This is great news! n/t

[malaise]

30. A doctor friend of mine told me that

that J & J has the same miniscule issues as do the others, but that it's the big pharma boys who set out to destroy the competition because the one shot is popular.

[JuJuChen]

35. I know I got the J&J a month ago, 35yo female, no clots and feeling fine.

[clutterbox1830]

37. The problem will many people willing to take it given the options.

I talked to a number of people who are vaccine hesitant. I convinced a few to take the vaccine, but all were vehemently oppose of them taking the J&J shot despite the extremely low side effects. That is the problem taking the drug off the market entirely unless the company is not going to change anything with the vaccine.

[Hortensis]

44. Good. Over 7 billion people, 1/4 fully vaccinated here, and...one shot! nt