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The world of public health was ready for something like this. They didn’t know what something was going to be. “When these vaccines were given to the world’s population, billions of people, we knew they were going to have unintended side effects,” says Eric Topol, director of the Scripps Research Translational Institute. These are very rare: Johnson & Johnson is a millionaire, AstraZeneca is one in a hundred thousand. That’s pretty good. It doesn’t give a lot of peace of mind to anyone, but it should give a lot of peace of mind. “
However, it’s not easy to get that message across, especially when the numbers still don’t tell the whole story. Regulators and vaccine researchers are still waiting for the most basic information about the mechanism behind clots, the most vulnerable subpopulations, and the true frequency of these dangerous clots.
The J&J and AstraZeneca vaccines encode a “protein nail” on the surface of the virus that causes Covid-19. Vaccines transmit a portion of this biochemical code to a person’s immune system through a different virus, specifically adenoviruses that are altered in the “vectors” that will carry the virological burden. That association—Between blood clots that use the Adenobirus vector and Covid vaccines — it seems pretty clear.
Although J&J vaccine has so far accounted for only 5% of all vaccines given in the US, these numbers are on the rise. These notebooks are so weird that more have gone unnoticed or will come even more – which means epidemiologists don’t know the actual number of people with the problem (numerator, so to speak) or the number of real people I’ve received the J&J vaccine in the last two weeks (denominator) . And these types of clots, generally without a small number of platelets, are already a a rare but well-known complication Covid-19, too, so getting a background isn’t easy either.
Since there are only six incidents at work, no one can say whether all of the affected people are significant to have women under the age of 50 or not. Maybe it’s just a coincidence, a statistical noise. Or maybe young women are weaker. If this is true, their risk is not one in a million; because they were generally smaller subgroups of people with the vaccine, they are larger. Or maybe there’s another risk factor, yet to be identified.
Now, perhaps that risk is worth it compared to getting Covid-19. That’s what European regulators say he concluded About the risks and benefits of the AstraZeneca vaccine, at least for some groups of people. “I think the peculiarity of the constellation of symptoms is that it has been preferred to appear in a group at lower risk of serious illness, which encourages some reflection,” says biostatistician Natalie Dean of the University of Florida. . “Everything goes back to the risk-benefit calculation, and these happen at the subpopulation level, not just the entire population.”
So why didn’t these regulators have their epidemiologists doing math in the background, quietly, instead of running for this national break? The real question that the FDA and its advisors will have to answer is the same as for any medical intervention: How do the risks pile up next to the benefits? In the case of the J&J vaccine, the benefits are clear, but the risks are not, at least not entirely. The risks and benefits are different for people of different age groups in places with different levels of Covid-19 prevalence. Earlier this month, researchers at the Winton Center for Risk and Evidence Communication tried run these numbers AstraZeneca for vaccine. For young people at low risk of contracting the virus, the vaccine can cause approximately 1.1 blood clots per 100,000 people, and has prevented only 0.8 visits for Covid-related emergencies. Among high-risk people between the ages of 60 and 69, the vaccine could be behind 0.2 clots per 100,000 and prevent nearly 128 emergency admissions. It looks like a good deal.
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