Why is Johnson & Johnson Vaccine So Difficult to Review? Data.
“We will never have perfect dates and there will always be uncertainty,” said Grace Lee, a professor at Stanford University and chair of the advisory board’s Covid-19 Vaccine Safety technical subgroup, when the group met on Wednesday. “For me, it’s really about getting better risk estimates.”
Committee members agreed to meet again as soon as they had more time to collect and assess data on who could be most at risk of complications and how that compares to the risk of catching and spreading Covid.
All six cases reported after the vaccine became widely available occurred in women; Another case – a man – was reported during clinical trials. All patients were between 18 and 48 years old, and some were treated with the blood-thinning heparin typically used for blood clots, but these patients’ condition worsened. The symptoms appear to be very similar to those associated with the AstraZeneca Covid vaccine, which many European countries have limited or no longer using. The active components of both are delivered by adenoviruses to cells that have been modified so that they cannot replicate.
However, since there are other treatments out there that use completely different methods, experts feel it makes sense to hold back to see if more information is available. The Johnson & Johnson vaccine accounts for only 7.5 million of America’s 195 million shots fired. The Pfizer BioNTech and Moderna vaccines, which use mRNA instead of adenoviruses, are responsible for the rest.
“We will never have perfect data and there will always be uncertainty. For me, it’s really about getting better risk estimates. ”
“The risks and benefits of further administration of the J&J vaccine cannot be considered in isolation,” said Seema Shah, bioethicist at Lurie Children’s Hospital in Chicago. “When people have alternatives, at least while the FDA is figuring things out, it makes sense to steer people towards those alternatives.”
However, the resumption of Johnson & Johnson recordings may not mean they will be available to everyone. Ensuring the safety of vaccines is especially important as they are given to healthy people rather than treating people who are already sick. Successfully figuring out which groups see the greatest benefit or harm, can lead to tiered recommendations. For example, several EU countries have stated that the AstraZeneca vaccine should be given to older people at higher risk of complications from Covid, rather than younger people who are at higher risk of vaccination complications.
“At the end of the day, if I’m a 30-year-old woman and I get this vaccine, how much will it increase my risk for this bad cause?” says Arthur Reingold, chairman of the California Covid-19 Scientific Safety Review Workgroup and former member of the CDC’s Vaccine Advisory Board.
A more complicated question is what dates the committee will look at in order to make a final decision.
No comprehensive data
Information may be limited as the problem was quickly identified and the Johnson & Johnson vaccine is currently only used in the United States (the company said it had delayed delivery to countries in the European Union). However, making a decision can also prove difficult as America’s medical data is highly fragmented.
Without a national health system, there is no comprehensive way to assess risks and benefits for different groups who have received the vaccine. There is no routine federal ability to link patient records to vaccine records. Instead, regulators hope doctors will learn about the break and proactively report cases they had not previously associated with vaccinations.
“It might inspire a clinician to say, ‘Oh my god, Mrs. Jones had this three weeks ago,” says Reingold. Additionally, he says, “There are still some people who have had a dose in the past two weeks and some of them could develop this rare side effect. “
The voluntary system may seem archaic, but this is how the authorities became aware of the six cases under investigation. They were reported to the CDC through an online database called the Vaccine Adverse Events Reporting System (VAERS). It is an open website through which healthcare workers, patients and caregivers can inform the government about possible side effects of the vaccine.
Because the system is so open and requires participation in the opt-in, it is impossible to calculate the exact risks using VAERS data. Epidemiologists generally view it as a place to search for hypotheses linking vaccines to side effects, rather than a source to use to confirm their suspicions.