“We will not have perfect information, and there will always be uncertainty,” said Grace Lee, a professor at Stanford University and chair of the COVID-19 Vaccine Safety Technical Subgroup, as the group met Wednesday. “For me, it’s about risk comparisons.”
Committee members agreed to come back when they had more time to gather and evaluate how they could be at risk of complications, as well as how this relates to the risk of catching and distributing covid.
The six cases reported when the vaccine became available were found in women; another additional event — male — was reported in a clinical trial. All patients were between 18 and 48, and several were treated with very low heparin, which was used to cover but improved the condition of these patients. These symptoms appear to be similar to those related to the AstraZeneca covid vaccine, which many European countries have failed or stopped. The active ingredient is delivered to cells and adenoviruses that have been modified to reproduce.
But since there are other drugs that use different methods, experts say it makes sense to work to see if more information is available. The Johnson & Johnson vaccine counts for themselves 7.5 million Americans 195 million million were shot; Pfizer-BioNTech and Moderna, which use mRNA instead of adenoviruses, are the main culprits.
“The risks and benefits of continuing to offer J&J vaccines cannot be underestimated,” says Seema Shah, a medical specialist at Lurie Children’s Hospital in Chicago. “If people have alternatives, especially when the FDA is considering matters, it makes sense to guide people to guide these methods.”
The resumption of the Johnson & Johnson shoot doesn’t mean it is available to everyone, however. Vaccine safety is important because it is provided to healthy people, rather than treating people who are already ill, and recognizing which groups would see the greatest benefit – or serious harm – could mean that U.S. authorities have provided appropriate guidance. A number of EU countries, for example, say that AstraZeneca vaccine should be given to older people who are at high risk for covid-related complications, rather than young people who may be at high risk of vaccination.
“At the end of the day, the hard part is that if I’m 30 and get vaccinated, how can it increase my risk of doing this bad thing?” said Arthur Reingold, chairman of the California Covid-19 Scientific Safety Review Workgroup and a former member of the CDC’s vaccination team.
The most difficult question is for the committee to reconsider its decision.
Not enough information
Much may be less because of the urgency of the situation, and because the Johnson & Johnson vaccine is currently being used in the US (the company said it was too late to bring it to the European Union.)
Without medical care, there is no way to address the problems and benefits in the various groups that have received the vaccine. There is no official way to link patients with vaccination records. Instead, authorities expect paramedics to hear the case and immediately report cases that have not been linked to the vaccine.
“It would be encouraging for one patient to say, ‘Oh my God, Mrs. Jones had that three weeks ago,’ ‘says Reingold. In addition, he says, “there are still a few people who have received the dose in the last two weeks, and some of them may have a deficiency problem.”
The voluntary approach may seem old-fashioned, but that is how the six cases under consideration identified the authorities. He was notified by the CDC through an online store called Vaccination System Disruption of Events, or VAERS. It is an open page for medical professionals, patients, and caregivers to inform the government of potential complications.
Because the system is open, and requires participation, it is impossible to calculate the actual risks using VAERS data. Diagnostics think that it is a place to look at ideas that tie the vaccine to its effects, not to a source that can be used to prove their skepticism.