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


“We will never have accurate information and there will always be uncertainty,” said Grace Lee, a professor at Stanford University and chairman of the CEVID-19 vaccine safety technical subgroup on the advisory panel when the group met on Wednesday. “It’s really about a better risk estimate for me.”

The committee members agreed to reconcile if they had more time to collect and evaluate data on how to compare the risk of catching and spreading Covid to the highest risk of complications.

All six reported after the vaccine became widely available in women; An additional case during the clinical trial – one person – was in all patients between the ages of 18 and 48 and several were treated with blood thinner heparin that is commonly used for clots but worsened the condition of these patients. These symptoms are very similar to those associated with the Covid vaccine for estrogen, which many European countries have limited or even stopped using. The active ingredients of both adenoviruses are distributed in cells that have been modified so that they cannot replicate.

However, there are other treatments that use completely different methods, so experts say it is wise to hold on to whether more information is available. The Johnson and Johnson vaccines are only counted 7.5 million deliveries of 195 million shots have been delivered to America; Pfizer-Bioentech and Moderna, which use mRNA rather than adenoviruses, are responsible for the rest.

“We will never have accurate data and there will always be uncertainty. This is true of a better risk estimate for me. ”

Seema Shah, a biologist at Lori Children’s Hospital in Chicago, said: “The risks and benefits of continuing the J&J vaccine system are not isolated. “If people have options, at least when the FDA brings things out, it’s wise to drive people to these options.”

The resumption of Johnson and Johnson shots does not mean that it becomes available to everyone. The safety of vaccines is important because they are given to healthy people instead of treating already sick people and successfully determine which groups can benefit the most – or cause the most harm – meaning U.S. regulators may recommend tides. For example, several EU countries have stated that the AstraZeneca vaccine should be given to older people who are at risk of complications from covid than young people who are at risk of vaccine complications.

“At the end of the day, the critical thing is, if I’m a 30-year-old woman and I get this vaccine, how much will the risk of this bad thing increase?” Arthur Reingold, chairman of the Covid-19 Scientific Safety Review Workgroup in California and a former member of the CDC’s Vaccine Advisory Panel, said.

The more complex question is what data the committee will review to make the final decision.

No detailed information

The data may be limited because the problem was caught quickly, and the Johnson & Johnson vaccine has so far only been deployed in the United States (the agency said it is delaying shipments to EU countries). But determination can also be difficult because American medical data is so fragmented.

Without a national healthcare system, there is no comprehensive way to assess the risks and benefits of different groups who have received this vaccine. There is no regular federal authority to link patient data with vaccine records. Instead, regulators expect clinicians to hear about breaks and actively report incidents that are not immediately linked to their vaccines.

“It might encourage a clinician to say, ‘Oh my God, it was three weeks before Mrs. Jones,'” Ringold said. Also, he said, “There are still a few people who have received a dose in the last two weeks and among them Some people may develop these rare side effects. “

The voluntary approach may seem archeological, but six cases under review have come to the attention of authorities. They were informed in the CDC through an online database called Vaccine Adverse Event Reporting System, Or viruses. It is an open website for physicians, patients and caregivers to inform the government about possible side effects of the vaccine.

Since the system is so open, and requires opt-in participation, it is impossible to accurately calculate the risk using VARS data. Epidemiologists generally see this as a place to look for hypotheses that bind vaccines to side effects rather than a source that can be used to confirm their suspicions.



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