The mRNA Vaccines Are Looking Better and Better

[Celerity]

Concerns about blood clots with Johnson & Johnson underscore just how lucky Americans are to have the Pfizer and Moderna shots.

https://www.theatlantic.com/health/archive/2021/04/mrna-vaccines-johnson-blood-clots/618594/



A year ago, when the United States decided to go big on vaccines, it bet on nearly every horse, investing in a spectrum of technologies. The safest bets, in a way, repurposed the technology behind existing vaccines, such as protein-based ones for tetanus or hepatitis B. The medium bets were on vaccines made by Johnson & Johnson and AstraZeneca, which use adenovirus vectors, a technology that had been tested before but not deployed on a large scale. The long shots were based on the use of mRNA, the newest and most unproven technology.

The protein-based vaccines have moved too slowly to matter so far. J&’s and AstraZeneca’s vaccines are effective at preventing COVID-19—but a small number of recipients have developed a rare type of blood clot that appears to be linked to the adenovirus technology and may ultimately limit those shots’ use. Meanwhile, with more than 180 million doses administered in the U.S, the mRNA vaccines have proved astonishingly effective and extremely safe. The unusual blood clots have not appeared with Pfizer’s or Moderna’s mRNA technology. A year later, the risky bet definitely looks like a good one.

The U.S. has ordered enough mRNA vaccines to inoculate its entire population. In that context, the CDC and FDA’s call to pause the J&J rollout this week is a blow to the American inoculation campaign, but hardly a devastating one. (J&J’s vaccine accounts for less than 5 percent of doses administered so far, and AstraZeneca’s has not yet been authorized in the U.S.) But the rest of the world has been banking on the J&J and AstraZeneca vaccines, which are both cheaper and easier to distribute because they don’t require the same cold storage as mRNA vaccines. If the blood-clot risk is real, the divide between the mRNA-vaccine haves and have-nots will only grow. The U.S. will be fine; the rest of the world will face difficult questions about balancing the risks and benefits of an affordable, good-but-not-best vaccine against a disease that has killed nearly 3 million people.

The blood-clot events with the AstraZeneca and J&J vaccines are so rare—appearing in one in 100,000 to one in 1 million vaccine recipients—that they would not have shown up in clinical trials, even ones conducted within more leisurely, non-pandemic timelines. (The COVID-19 vaccine trials, which generally included tens of thousands of participants each, were actually unusually large because researchers wanted data as quickly as possible.) “It’s true with all new medications of any sort. You only find rare events when things are rolled out to very vast numbers of people,” says John Grabenstein, the associate director of scientific communication for the Immunization Action Coalition, who used to work on vaccines for the pharmaceutical giant Merck. “One-in-a-million events are just barely measurable.” That faint signal is especially difficult to see against a noisy background: Some people get blood clots for reasons unrelated to the vaccine, too.

snip

[qazplm135]

1. I'm skeptical that these clots

are anything more than correlation.

[Celerity]

2. see this for a more robust discussion

https://www.democraticunderground.com/100215344414

[Ms. Toad]

4. They are all but certain that the same clotting disorder is caused

by Astra Zeneca (which uses the same adenovirus vector). (Caused, not correlation)

The clotting disorder is strikingly similar to one known to be caused by heparin, and a mechanism has been proposed that explains the similarity between the two.

“Causality is more of a journey to certainty than a binary decision,” says Anthony Cox, an expert on pharmacovigilance at the University of Birmingham. But faced with accumulating cases, the European Medicines Agency (EMA), which had been careful not to point fingers, acknowledged on 7 April “a probable causal association” between the syndrome and the vaccine, recently named Vaxzevria.
. . .

On Friday, some of the first researchers to describe the condition published their observations in The New England Journal of Medicine. One team describes 11 patients in Germany and Austria; the other has observations on five patients in Norway. Both teams found the patients had unusual antibodies that trigger clotting reactions, which use up the body’s platelets and can block blood vessels, leading to potentially deadly strokes or embolisms.

The symptoms resemble a rare reaction to the drug heparin, called heparin-induced thrombocytopenia (HIT), in which the immune system makes antibodies to a complex of heparin and a protein called platelet factor 4 (PF4), triggering platelets to form dangerous clots throughout the body. Sickened vaccine recipients also had antibodies to PF4, the researchers found.

https://www.sciencemag.org/news/2021/04/hard-choices-emerge-link-between-astrazeneca-vaccine-and-rare-clotting-disorder-becomes

[womanofthehills]

12. VAERS data released today by CDC show 795 reports of blood clotting disorders

400 for Pfizer, 337 Moderna and 56 for J & J. More J & J are being reported by drs who did not know it was a side effect. Every Friday, VAERS (Vaccine Adverse Event Reporting System) makes public all vaccine injury reports.

[Sgent]

20. Yes

but the absence of a PF4 result in that data makes it hard to rely on -- it just signals for more investigation.

[Ms. Toad]

21. The concern isn't the general random formation of clots.

Very early on (in connection with AstraZeneca) the response to the reported clots was the accurate information that clots following vaccines was consistent with the level not associated with vaccines. This came from VAERS and similar data collection sites.

A lot more is known since thse early reports.

The reason for the pause is a very specific, rare, clotting disorder that is associated with the adenovirus vectors (AstraZeneca, Johnson & Johnson, and Sputnik). No incidents have been reported with the mRNA vaccines (even though clots, more generally, have been reported following all vaccines . . . just like deaths following all vaccines are reported - it doesn't mean the vaccines caused them).

Since AstraZeneca was in use earlier than Johnson and Johnson, they have sorted out a lot of the data noise that you are seeing in VAERS (and other similar reporting systems):

What was a worrisome suspicion 4 weeks ago is now widely accepted: The AstraZeneca COVID-19 vaccine can, in very rare cases, cause a disorder characterized by dangerous blood clots and low platelet counts. In Europe, at least 222 suspected cases have been reported among 34 million people who have received their first dose of the vaccine. More than 30 have died.

“Causality is more of a journey to certainty than a binary decision,” says Anthony Cox, an expert on pharmacovigilance at the University of Birmingham. But faced with accumulating cases, the European Medicines Agency (EMA), which had been careful not to point fingers, acknowledged on 7 April “a probable causal association” between the syndrome and the vaccine, recently named Vaxzevria.

. . .

On Friday, some of the first researchers to describe the condition published their observations in The New England Journal of Medicine. One team describes 11 patients in Germany and Austria; the other has observations on five patients in Norway. Both teams found the patients had unusual antibodies that trigger clotting reactions, which use up the body’s platelets and can block blood vessels, leading to potentially deadly strokes or embolisms.

The symptoms resemble a rare reaction to the drug heparin, called heparin-induced thrombocytopenia (HIT), in which the immune system makes antibodies to a complex of heparin and a protein called platelet factor 4 (PF4), triggering platelets to form dangerous clots throughout the body. Sickened vaccine recipients also had antibodies to PF4, the researchers found.

https://www.sciencemag.org/news/2021/04/hard-choices-emerge-link-between-astrazeneca-vaccine-and-rare-clotting-disorder-becomes

So, while it is a different vaccine, they have the adenovirus delivery vector in common (the mechanism that seems to explain the disorder) - AND - the same rare, idiosyncratic, clotting disorder.

[PoindexterOglethorpe]

3. I got the Johnson & Johnson vaccine three weeks ago,

and I'm quite happy with it.

I'm going to guess at least as many people died in car crashes going to or from the vaccine site as have gotten the blood clots.

[Calculating]

5. Same

6 people out of 7 million is almost statistically insignificant. I can't believe they're pausing a perfectly good vaccine over this, it will lead to way more people dying from covid than the vaccine clotting issue could kill in a thousand years.

[Ms. Toad]

7. The US purchased enough of the two mRNA vaccines to vaccinate the entire population.

You are aware that AstraZeneca (same technology) has been paused in more than a dozen other countries - including countries that don't have access to mRNA vaccines, right? This is not the US going out on a limb.

This disorder is deadly (~30%), and is more fatal when the normal treatment for blood clots is used.

[Ms. Toad]

6. That's not really the point.

If the vaccine causes deadly (~30% mortality) blood clots in healthy patients, which become more fatal when treated with the standard treatment for blood clots, that's a bad thing.

Pausing vaccinations allows scientists to confirm causation, prepare new warnings for the vaccines, develop recommended treatments so the cure isn't worse than the disease, and make sure the medical community knows what the signs, symptoms, and treatments are, and figure out who is most at risk so they can choose to have a different vaccine.

Astra Zeneca has been paused in more than a dozen countries - and when unpaused, some have shifted vaccine distribution to limit the AstraZeneca vaccine to individuals 50 and older.

[qazplm135]

8. with J and J

we are talking one in a million. Which isn't much different than the normal background rate of occurrence.

I'm with the folks who think pausing it over such a tiny number when the odds of dying from COVID are much greater isn't really the wisest course of action.

[Ms. Toad]

10. This particular clotting disorder is incredibly rare -

So the rate of occurrence of this rare clotting disorder is signifiantly higher than the background rate of occurrence. AND - the normal treatment for clots can actually cause a related disorder (or make this one fatal).

For the related disorder (Heparin induced thrombocytopenia), 20% die; 10% receive an amputation or something similar.

This is not your ordinary clotting disorder (which I have had, more than once). It is a killer, and the ordinary treatment makes it worse.

It is something significant enough that, if discovered during the trial stage would have prompted the same pause. (It is currently pausing the clinical trials for children of the AstraZeneca vaccine.)

There are two other vaccines available, which provide better protection than J&J - and the US has purchased enough doses so that everyone in the US can be vaccinated with either Moderna or Pfizer.

It is simply the responsible thing to do - and I would fully expect that once they know more the J&J vaccine will be restarted with appropriate warnings, and guidance as to who should avoid the J&J vaccine, and to doctors as to how to treat it.

[qazplm135]

11. That's not what I've been reading

that this is significantly higher.

"US health agencies are taking concerns about blood clots and the Johnson & Johnson Covid-19 vaccine "seriously" and are working to assess whether the shot is associated with a very small increased risk of rare blood clots, a federal official told CNN."

"Like their US counterparts, the European authorities say they're still investigating these cases and that "it is currently not clear" whether there's a causal association between the vaccine and the clots."

https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-clots-cdc-fda/index.html

You are presenting it like it's established that JJ causes these clots. It isn't. You are presenting it as if 6 out of almost 7 million is a significant occurrence. It isn't.

If they want to pause it, then pause it for the small group that has this disorder, or is at risk for this disorder, or give warnings for Heparin use.

And I know someone who JUST got COVID and is about to die. Everyone isn't being vaccinated right away. There are still lines, still waiting, still more people wanting it than slots to give in a lot of states.

[womanofthehills]

13. The numbers of blood clotting disorders in J & J keeps growing

56 reported to VAERS - this info released by CDC today. Plus a few more cases in the news today. One a 21 yr old college student.

[womanofthehills]

16. It's not just blood clotting - it's blood clots with a low platelet count

This is not a normal occurrence. Also, if you get a blood clot from birth control pills, it will most likely be in your leg. These rare blood clots are in your brain.

[BComplex]

9. The mRNA vaccines are scientifically remarkable, and have such promise for all kinds

of diseases. I'm loving everything I'm learning about them.

[womanofthehills]

14. They are amazing on one level, but too many people are dying from them - according to VAERS reports

The CDC released the Friday vaccine injury reports today - Between Dec 14, 2000 and April 8 - 2,602 deaths and 67,347 adverse events. You can read the death reports submitted at below link. Also this number is probably low because only between one and ten percent of adverse events are reported to VAERS even though health care workers are required to report to VAERS.

https://www.medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&VAX=COVID19&DIED=Yes

[speak easy]

17. Correlation does not prove causation.

190m people received one jab or more between December 14, 2020 and April 8, 2021. 2.8 million Americans die of all causes every year.

[pnwmom]

22. No, that's wrong. The FDA has investigated ALL those deaths and found NO EVIDENCE they were caused

by the vaccines.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html

Over 189 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through April 12, 2021. During this time, VAERS received 3,005 reports of death (0.00158%) among people who received a COVID-19 vaccine. CDC and FDA physicians review each case report of death as soon as notified and CDC requests medical records to further assess reports. A review of available clinical information including death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths. CDC and FDA will continue to investigate reports of adverse events, including deaths, reported to VAERS.

[LisaL]

23. You have to realize that just because someone died after getting a vaccine, it doesn't mean vaccine

was responsible.
For instance, many people died, lets say, after eating breakfast.
It doesn't mean breakfast killed them.
Especially considering elderly in nursing homes were target for vaccinations early on. Many people in that group, out of hundred of millions, would have died regardless.

[speak easy]

15. Pfizer/BioNTech refused to take Warp Speed money.

[womanofthehills]

18. but Moderna got $1.5 billion from Warp Speed and Astra Zenica got $1.2 billion from Warp Speed

I don't know about J & J.

[speak easy]

19. mRNA vaccines would exist with U.S. investment.