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Posted on 04/16/2021 12:03:26 PM PDT by Red Badger
The clock is ticking for regulators looking into covid vaccine side effects. But their task is made harder by America’s fragmented data systems.
The future of the single-shot Johnson & Johnson covid vaccine remains in limbo after an advisory panel recommended taking a deeper look into reports of rare—and sometimes fatal—side effects.
The US Centers for Disease Control and the Food and Drug Administration advised suspension of the Johnson & Johnson vaccine on Tuesday, after reports that six people who had received a dose developed rare blood clots in the brain, combined with another disorder that actually inhibits clotting. One patient died.
After discussing the situation, the CDC’s advisors said that the pause would continue for at least a week while information was gathered and reviewed.
“We’ll never have perfect data, and there will always be uncertainty,” said Grace Lee, a professor at Stanford University and chair of the advisory panel’s Covid-19 Vaccine Safety Technical Subgroup, when the group met on Wednesday. “It’s really, for me, about getting better risk estimates.”
Committee members agreed to reconvene once they’ve had more time to gather and assess data about who might be most at risk of complications, and how that compares with the risk of catching and spreading covid.
All six of the cases reported after the vaccine became widely available occurred in women; one additional case—a man—was reported during clinical trials. All patients were between 18 and 48, and several were treated with the blood thinner heparin, which is typically used for clots but worsened the condition of these patients. The symptoms appear very similar to ones associated with AstraZeneca’s covid vaccine, which many European countries have limited or even stopped using. The active components of both are delivered to cells by adenoviruses that have been modified so they can’t replicate.
But because there are other treatments available that use totally different methods, experts say it is sensible to hold off to see if more information becomes available. The Johnson & Johnson vaccine counts for only 7.5 million of America’s 195 million shots delivered; the Pfizer-BioNTech and Moderna vaccines, which use mRNA rather than adenoviruses, are responsible for the rest.
“The risks and benefits of continuing to administer the J&J vaccine can't be looked at in isolation,” says Seema Shah, a bioethicist at Lurie Children’s Hospital in Chicago. “If people have alternatives, at least while the FDA is figuring things out, it makes sense to steer people in the direction of those alternatives.”
Resumption of Johnson & Johnson shots may not mean that it becomes available to everybody, however. Ensuring the safety of vaccines is especially important because they’re given to healthy people, rather than treating people who are already sick, and successfully figuring out which groups might see the most benefit—or most harm—could lead to tiered recommendations. Several EU countries, for instance, have said the AstraZeneca vaccine should be given to older people at higher risk of complications from covid, rather than younger people who might be at higher risk of vaccine complications.
“At the end of the day, the critical issue is if I’m a 30-year-old woman and I get this vaccine, how much will that increase my risk of this bad thing?” says Arthur Reingold, chair of California’s Covid-19 Scientific Safety Review Workgroup and a former member of the CDC’s vaccine advisory panel.
A more complicated question is what data the committee will review to make a final decision.
No comprehensive data Information may be limited because the issue was caught quickly, and because the Johnson & Johnson vaccine is so far being deployed only in the US (the company said it was delaying delivery to European Union countries). But making a determination may also prove difficult because America’s medical data is highly fragmented.
Without a national health-care system, there’s no comprehensive way to assess risks and benefits for different groups that have received the vaccine. There is no routine federal capability to connect patient data with vaccine records. Instead, regulators hope clinicians will hear about the pause and proactively report cases they hadn’t previously connected to vaccinations.
“It might stimulate some clinician to say, ‘Oh my God, Mrs. Jones had that three weeks ago,’” says Reingold. In addition, he says, “there’s still quite a few people who have gotten a dose within the last two weeks, and some of them could develop this rare side effect.”
The voluntary system may seem archaic, but that is how the six cases under review came to the attention of the authorities. They were reported to the CDC through an online database called the Vaccine Adverse Events Reporting System, or VAERS. It is an open website that medical staff, patients, and caregivers can use to notify the government about potential vaccine side effects.
Because the system is so open, and requires opt-in participation, it’s impossible to calculate exact risks using VAERS data. Epidemiologists generally think of it as a place to look for hypotheses that tie vaccines to side effects, rather than a source that can be used to confirm their suspicions.
“It’s a messy system. Anyone can report anything, whether it’s biologically plausible that it’s related to the vaccine or not,” says Mark Sawyer, a member of the FDA’s Vaccines and Related Biological Products Advisory Committee, which reviewed the covid-19 vaccines for public use. “Then the job is to sort through and figure out, is there really a signal here?”
The next best thing to a national health-care system is the CDC’s Vaccine Safety Datalink, a consortium of American health insurers that provide medical care to patients in-house. The system includes records of about 10 million patients. Unfortunately, only 113,000 Johnson & Johnson vaccines have been captured by that system so far.
“There just haven’t been enough Johnson & Johnson vaccine doses given in the context of these other monitoring systems to detect a problem. This is just too rare an event,” says Reingold. “If all you’ve got left is VAERS or another passive reporting system, then you do the best you can.”
There are many ethical and practical concerns around this pause, as discussed at Wednesday’s committee meeting. Because the Johnson & Johnson vaccine requires just one shot and doesn’t need to be frozen, it may be easier to distribute to people who have less access to health clinics. Other members of the panel, meanwhile, expressed concern that a continued pause would stoke vaccine hesitancy.
Many speakers wrestled with the limitations of available data, particularly regarding the breakdown of risks for different groups of people.
“It’s possible we may not have any more information, at which point we’re still going to have to make a decision,” said Stanford’s Lee during the discussion. “But my hope is that in the next week or two, we’ll be able to capture [risk] in a more robust way.”
Additional reporting by Mia Sato
This story is part of the Pandemic Technology Project, supported by the Rockefeller Foundation.
For your interest.
Why anyone believes any of the “Pandemic/Vaccine” data presented by any government agency or resource is beyond me.
None of them can be trusted. Not a one.
You either are an idiot or have an agenda if you are presenting data from a Government Agency on anything COVID related as the basis of your argument.
the same reason it is hard to evaluate any new drug, the manufactures want to make money.
In this case lots of money is at stake, and collateral damage is acceptable.
They have all been linked to clotting disorder ( one of the earliest widely reported was the death of a Dr in FL who took the Pfizer)...and developed symptoms in 3 days
But only JnJ is being targeted
wow thanks!
None of these concerns would matter if COVID were a truly dangerous disease like smallpox or Spanish Flu. When these diseases were rampant, people gladly assumed vaccine risks.
Data? You want data? The WSJ reports that blood clots are ten times more likely in those who’ve had COVID than those who’ve been vaccinated.
“Review by Oxford shows risk of rare, serious blood clotting is eight to 10 times greater in people who caught the coronavirus than among people who received any of the first three Western-developed vaccines”
2 reasons. The facts say ONE thing BUT the money says another.
So, does that mean IF you’ve already HAD THE VIRUS, but were asymptomatic and didn’t know you had it, then get a vaccine, in this case J&J, that your blood clotting is a reaction to the vaccine?..................
Makes some intuitive sense. If you get full-blown China Coof, it is serious. If you get a vaccine, it has it's own issues.
"They cautioned, however, against putting too much stock in the specific findings of the relative risks of Covid-infected and general populations or varying risks among vaccines. They said the data used was too limited for statistically valid comparisons of CVT occurrence among recipients of different vaccines or with the general population. The Oxford scientists said other limits of the data include the rarity of the clotting in all groups and the inclusion of children in the U.S. data set. The data review also didn’t shed light on the cause of clots or mechanisms in the virus or vaccines that might overlap or contribute to clots.
Red Badger wrote: “So, does that mean IF you’ve already HAD THE VIRUS, but were asymptomatic and didn’t know you had it, then get a vaccine, in this case J&J, that your blood clotting is a reaction to the vaccine?..................”
It means that blood clots are ten times more likely in those who’ve had COVID than those who’ve been vaccinated.
Yes, and if you get the vax, it’s probably 10X THAT!...............
What would it take to get Emergency Use Authorization (EUA) from the FDA for HCQ and Ivermectin?
rhetorical
Big Brother wants mRNA delivery.
Because they don’t want us to know the truth.
A Red Sea sized miracle.
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Why is it so hard to find what is in the $1.9 T bill?
Why is it so hard to find what is in the $1.9 T bill?
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