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Why is it so difficult to review the Johnson & Johnson vaccine? Data.

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“We will never have perfect data, and there will always be uncertainty,” said Grace Lee, a professor at Stanford University and chair of the Covid-19 Vaccine Safety subgroup’s technical advisory panel, when the team met Wednesday. “It’s really about me getting better risk estimates.”

Committee members agreed to reassemble, after more time, to collect and evaluate data on those most at risk for complications, and how that compares to the risk of catching and spreading the shield.

The six cases reported after the vaccine became very available occurred in women; an additional case — man — was reported in clinical trials. All patients ranged in age from 18 to 48 years and were treated with various thinning blood for heparin, which is usually used to make clots but worsened the condition of these patients. The symptoms are very similar to those associated with the AstraZeneca covido vaccine, as many European countries have stopped limiting or even stopped using it. The active components of both are transmitted to the cells by altered adenoviruses so that they do not recur.

But since there are other treatments that use completely different methods, experts say it makes sense to see if more information is available. The Johnson & Johnson vaccine is only valid 7.5 million of America’s 195 million shots have been fired; Pfizer-BioNTech and Moderna vaccines, which use mrene more than adenoviruses, are responsible for the rest.

“We will never have perfect data, and there will always be uncertainty. It’s really about getting better risk estimates for me. ”

“The risks and benefits of continuing to administer the J&J vaccine cannot be seen in isolation,” says Seema Shah, bioethicist at Lurie Children’s Hospital in Chicago. “If people have alternatives, at least while the FDA is inventing things, it makes sense to drive people in the direction of those alternatives.”

Redoing Johnson & Johnson plans does not mean it is available to everyone. Ensuring the safety of vaccines is especially important because they are given to healthy people, rather than caring for people who are already ill, and successfully guessing which group can lead to gradual recommendations that can see the greatest benefit or the greatest harm. Several EU countries, for example, have said that the AstraZeneca vaccine should be given to older people at higher risk of complications from covetous than to young people who may be at higher risk for complications from the vaccine.

“In the end, it’s a serious problem that I’m a 30-year-old woman and if I get this vaccine, how much will that increase my risk of having that bad thing?” says Arthur Reingold, president of the Covid-19 Scientific Safety Review Workgroup in California and a former member of the CDC’s vaccine advisory team.

The more complicated question is what data the committee will look at to make a final decision.

There is no specific data

Information may be limited because the problem has quickly caught on, and so far the Johnson & Johnson vaccine is only being spread in the US (the company has said it has delayed sending it to European Union countries). But making the decision can also be difficult because America’s medical data is so fragmented.

Without a national health system, there is no comprehensive way to assess the risks and benefits of the different groups that have been vaccinated. There is no conventional federal capability to connect patient data to vaccine records. On the other hand, regulators expect clinicians to be aware of the discontinuation and report cases that have not been linked to vaccines in a bad way before.

“It might stimulate some clinicians to say, ‘God, Mrs. Jones said that three weeks ago,'” Reingold says. .

The voluntary system may seem archaic, but the six cases examined in this way were the attention of the authorities. It was reported to the CDC through an online database Vaccine incident reporting system, or VAERS. It is an open website that can be used by medical staff, patients and caregivers to inform the government of the side effects of vaccines.

Because the system is so open and requires participation, it is impossible to calculate specific risks using VAERS data. Epidemiologists generally see vaccines as a place to look for hypotheses that link them to side effects, rather than as a source that can be used to confirm their suspicions.

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