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On Call: The Risks vs. the Benefits

Thu, 04/22/2021 - 12:59

Last week, the news broke that the Centers for Disease Control and Prevention and the Federal Drug Administration here in the United States had called for a pause in administration of the single-dose Johnson and Johnson Covid-19 vaccine following reports of blood clots after administration of this vaccine.

In their joint statement regarding this, the C.D.C. and F.D.A. noted that out of more than 6.8 million doses of the Johnson and Johnson vaccine in the United States, there were six reported cases of a rare type of clot known as a cerebral venous sinus thrombosis, and that the C.D.C. would convene the Advisory Committee on Immunization Practices to discuss these reports.

Understandably, this next development in the war against Covid-19 has concerned many people, particularly as it comes after the health care community has, by an overwhelming margin, strongly advocated for the safety and use of the available vaccines against Covid-19. Does this report of rare blood clots in the brain mean that doctors and public health officials had lied or downplayed the risks?

Not at all. It means that, in this as in all things we do as health care providers, we felt that the risks of not being vaccinated against Covid-19 vastly outweighed the risks of vaccination. All medical choices in terms of medications or interventions generally come down to this sort of risk-versus-benefits assessment, and the risks of vaccination based upon the studies and available data to date indicated that the risk of serious side effects related to the vaccination, such as anaphylaxis, is extremely low in terms of several cases per million. These reports of cerebral venous sinus thrombosis mirror that very low risk.

In contrast, pre-publication data released this week from Taquet et al. at the University of Oxford indicate that the incidence of cerebral venous thrombosis after a diagnosis of Covid-19 was around 39 per million in the over 500,000 patients with Covid-19 that they analyzed, repre-senting an almost six times greater incidence than the six reports seen after the Johnson and Johnson vaccine.

Which, again, suggests that the benefit of vaccination outweighs the risks.

This does not mean that the reports should be minimized, or that they should not be studied more in depth. On the contrary, that is exactly what should happen -- that’s the very scientific process made manifest. We should constantly re-examine what we do in medicine based on new evidence so that we always do the best for our patients.

But that should not lead to a doubt about the entire scientific process itself. It should not lead to panic or cries of conspiracy. Already at least in part because of mass vaccinations, we are seeing lower cases in certain areas, lower hospitalization burdens, decreased deaths, and a slow inching back toward normalization of life and society.

And, most important, we know that vaccination protects against serious Covid-19 illness and death to a very high degree. In the trials, it was almost (not quite) 100 percent effective against these serious outcomes, and while the real-world data slowly come in and may, as sometimes happens, show a slight lowering of this effectiveness in practice and against rising variants, that level of protection still represents an extraordinary step.

Ultimately, what should happen is exactly what is happening in this instance. With two other vaccines against Covid-19 available, we hope that the F.D.A. and C.D.C. will have time to finish their analysis of the Johnson and Johnson vaccine and make updated recommendations. In fact, by the time this article goes to print, perhaps that will have already happened. In the meantime, we will continue doing the best we can with the information and tools we have in our fight against Covid-19.

Joshua Potter, D.O., a physician with Stony Brook Southampton Hospital's Meeting House Lane Medical Practice, oversees the practice's Shelter Island office. He specializes in family and neuromusculoskeletal medicine. Opinions expressed in this column are his personal and professional views and not necessarily those of his employer.

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