CDC vaccine advisers seek more data on rare blood clots before deciding whether to resume J&J shots

[BumRushDaShow]

Source: Washington Post




A federal vaccine advisory committee said Wednesday it wanted more data before deciding whether to resume use of Johnson & Johnson’s coronavirus vaccine, leaving in place a temporary pause that federal officials had recommended because of a rare and severe type of blood clot identified so far among six of the 7.5 million people who received the shot. The move means the single-shot Johnson & Johnson product will remain on the shelf for at least a week. At a hastily arranged emergency meeting a day after federal officials recommended a temporary pause in use of the vaccine, advisers to the Centers for Disease Control and Prevention agreed to reconvene within 10 days, acknowledging the urgency of making a decision about a vaccine that is a key part of the strategy to end the pandemic in the United States and globally.

The expert committee reviewed details about six cases of blood clots in women who were between the ages of 18 and 48. The women developed symptoms, most often headaches, six to 13 days after vaccination. One vaccine recipient, a Virginia woman, died in March, and another is in critical condition, health officials have said. Two have been discharged and three remain in the hospital. Instead of voting on a recommendation about whether and how the vaccination campaign could be restarted, panel members said they wanted more information on the risks, cause and frequency of the rare brain blood clots. When the panel reconvenes, they could vote at that time to recommend the vaccine for people 18 and older, continue an overall pause, or pause use for certain age groups or people.

“We are very fortunate, because we have multiple other alternatives in the U.S. to help stop this pandemic. We have very good, well-proven alternatives where we are not seeing safety signals,” said Helen Keipp Talbot, an associate professor of medicine at Vanderbilt University and committee member. “I think that puts us in a little bit of a different position, and we can be much more cautious and thoughtful and use the old model of, ‘First, do no harm.’” Beth Bell, a global health expert at the University of Washington who leads the panel’s coronavirus vaccine work group, said she did not want to take a vote Wednesday for fear of undermining support for the easier-to-use vaccine.

A national Economist-YouGov poll found that public confidence in the Johnson & Johnson vaccine might already be declining. The share of people who thought the vaccine was “very or somewhat unsafe” increased in a matter of days, from 26 percent of people during the past weekend and Monday, to 39 percent on Tuesday after federal officials recommended a pause. The vaccine has been viewed as a powerful tool for building immunity among vulnerable communities, such as homebound people or homeless populations who may not be able to return for a second shot. The decision will also almost certainly reverberate around the globe.

Read more: https://www.washingtonpost.com/health/2021/04/14/johnson-and-johnson-vaccine-blood-clots/

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Full headline: CDC vaccine advisers seek more data on rare blood clots before deciding whether to resume Johnson & Johnson shots

[dawg day]

1. hmm, only women of reproductive age...

Birth control pills, hormones?

[BumRushDaShow]

2. One of the commentaries I heard today

was that they are going to need to actually determine if those are the only ones because apparently many physicians might not know how to spot this phenomena and there could be other cases out there unreported and attributed to something else. I expect that where much of that type of data might lie is with the AstraZeneca vaccine, since that has been given to many many more people and over a longer period of time than Janssen's... and both use the same sort of viral platform to create the vaccine (a neutralized adenovirus).

[Deminpenn]

13. During the trials this did appear once, in a male who got

the vaccine, but there was also a person in the control group who also developed the same kind of blood clot.

Genetic predisposition is mho.

Also, heard that another reason for the pause is that the CDC wants clinicians to know how to treat this particular kind of cerebral clot as those affected also have low platelet counts. Normally clots are treated with blood thinners, but because of the low platelets, using blood thinners is exactly wrong.

[regnaD kciN]

15. For that matter, there was a male doctor who died of a blood clot after taking the PFIZER vaccine...

...but it was written-off as being unrelated, since no one had seen any other reports of the mRNA vaccine type causing blood clots. I'm wondering if they're going to take another look at that one as well.

But, yes, it would seem the most logical step at the moment would be to authorize it for males only. The gender imbalance in these cases seems quite striking so far.

[cate94]

4. That is exactly what I thought.

I also wondered if the commonality might be hormonal driven migraines.

[TexasBushwhacker]

6. I thought that too

Hormonal birth control is already a risk factor for blood clots. Other risk factors for CVTS include low iron levels, anemia, pregnancy and post delivery. It isn't at all unusual for women still having periods to be borderline anemic all the time. I wasn't able to donate blood until after menopause.

The thing about this particular blood clot is that because it's in the brain, it can cause a stroke. Normally, someone having trouble with blood clots would be put on a blood thinner like heparin, but for this type of blood clot, that is the worst thing you can do.

Maybe it will just be better for people with other risk factors for CVTS to get the Moderna or Pfizer vaccine. The thing is, we desperately need the J&J and Astrazeneca vaccines for places like Africa and South America where the super refrigerators aren't as available.

[ananda]

7. I was wondering about that too.

???

[luvtheGWN]

11. Why not continue with the J&J

but only give it to men and to women post-menopausal (55+)?

[LisaL]

14. Because they aren't exactly sure that this adverse effect is limited to

women under 50.

[womanofthehills]

16. I read something similar

An article saying they might decide to recommend it only for men over 50. It's similar to Astra Zenica and I believe many countries are recommending not to give it to the young -similar rare blood clot side effects. Some post menopausal women are bleeding after the vaccines & younger women are reporting heavy & prolonged bleeding (individual women reporting this on Twitter, Facebook, etc. and they want the vaccine companies to address this)

[JohnSJ]

3. They are doing the right thing. People need to make an informed decision

[ecstatic]

5. The only way to fix this debacle is to tweak the guidance in some way, even if

it's BS. Say women under 65 should not take it and move forward. They have no choice but to make some kind of change now or nobody will feel comfortable taking J&J.

[BumRushDaShow]

8. That is basically what the EU did for AstraZeneca's vaccine

except the cutoff was for "under-30s" -

Covid: Under-30s offered alternative to Oxford-AstraZeneca jab

By Nick Triggle
Health correspondent

Published 7 April


Under-30s in the UK are to be offered an alternative Covid vaccine to the AstraZeneca jab due to the evidence linking it to rare blood clots. The recommendation comes after a review by the UK drugs regulator found that by the end of March 79 people had suffered rare blood clots after vaccination - 19 of whom had died. The regulator said this was not proof the jab had caused the clots. But it said the link was getting firmer.

How do you weigh up the risks of the AstraZeneca vaccine?

The review by the Medicines and Healthcare products Regulatory Agency (MHRA) found:

The 79 cases and 19 deaths occurred after 20 million doses were administered - giving a risk of about four in one million of developing a blood clot, and one in a million of dying

Nearly two-thirds of the cases of rare clots were seen in women

The people who died were aged between 18 and 79, with three of them aged under 30

All the recorded cases occurred after the first dose, although the lower number of second doses meant it was not possible to draw any conclusions from this

Meanwhile, the EU's medicines regulator says unusual blood clots should be listed as a possible very rare side effect of the AstraZeneca jab, but that the benefits outweighed the risks. Some European countries have restricted the vaccine's use.

The World Health Organization said the link between the vaccine and blood clots was "plausible" but not confirmed, adding that the clotting incidents were "very rare" among nearly 200 million people who have received the jab worldwide.

https://www.bbc.com/news/health-56665517

I expect they could do "under 50" here...

[rockfordfile]

17. I don't blame them if "people feel uncomfortable". Until they find out what's causing it

They shouldn't be giving people that vaccine.

[progree]

9. Hopefully they are looking at the risk of people not being vaccinated for weeks longer

than they otherwise would be. I'm 69 and still haven't gotten an appointment in Minnesota, and the MN Dept of Health says it will reduce their supply (and demand exceeds supply virtually everywhere in the state, and says it will reduce their pace of vaccinations) but fuck it I guess, I'm retired and I'm just a Social Security and Medicare benefits eater, so life sucks and then one dies, and the federal deficit and all that, I understand. (Yes, I can play fucking Hunger Games every night and probably would have wrangled an appointment by now, but then someone else wouldn't get one, so it would solve my problem but not the larger problem of not enough supply)

6 cases of blood clots with J&J while 987 are dying of Covid in the U.S. per day (7 day average). And U.S. cases are rising -- a 31.8% increase since March 22 in the 7 day moving average, to 71,215/day. But out of an abundance of caution or something, I understand I guess. Do no harm and just watch 'em die.

https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html

Worldwide, daily new cases are up 99.6% since Feb 15, to 716,614 per day (7 day moving average) -- providing Covid with lots of opportunity to evolve new variants. And a hair's breath away from reaching the all time high set around January 11. Deaths are up by nearly 1/2 since mid March.

https://www.nytimes.com/interactive/2020/world/coronavirus-maps.html

[BumRushDaShow]

10. Here in Philly

they were poised to open 2 mass-vaccination clinics with the expansion of the eligibility phase (one that was already established and FEMA-run and the other located in a predominately Hispanic neighborhood). Both were planning on using the city's allotment of J&J starting yesterday but immediately halted deployment yesterday right after the pause was announced, literally as they were about to open.

Today, the FEMA site reopened and has gone back to using the Pfizer vaccine that they were originally using and the other site has to recalibrate in order to handle the Pfizer or Moderna vaccines, so that site remains closed until that happens. Their worry is getting people to commit to come back for the 2nd dose.

I think part of the other hesitancy here to go back to Pfizer was apparently the number of doses per tray that are shipped. I.e., according to CDC, each Pfizer tray has 195 vials for a total of 1,170 doses, and apparently they thaw and prep the entire tray's worth once they pull it out of deep freeze. So there is a higher potential, when used at a mass-vaccination site, for wasted doses if they can't get "standbys" able to wait around for the leftovers.

[NH Ethylene]

12. My sympathies are with you.

I am 66 and at high risk, and I'm teaching high school where new cases among students are popping up every day. I spent weeks trying to get an appointment, competing with many other less vulnerable groups. I finally got them and am all set, but I remember well the frustration and discouragement.

And you're right. People are far more likely to die of Covid if they don't get the vaccine than of a blood clot if they do.

Stay home and stay safe. Sooner or later we'll see the vaccine 'glut' we've been promised.