Rubin Lab

Tweetorial to Clarify the NYT Article From 15 April and Further Explain/Clarify the UK CLARITY IBD Study

David T. Rubin

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I’ve previously commented about the CLARITY IBD Study (Kennedy, et al). paper in this forum, but it bears repeating and further explanation now.

The recent NYT article highlights the important issues/concerns of those who are immune compromised due to innate disorders, chemotherapy, or some treatments. It is important to emphasize the ongoing work and need for good research about COVID-19 and vaccines.

However, there are a number of errors in interpretation and misstatements in the NYT article that have led to confusion and consternation by patients and providers alike. It’s understandable. There are a lot of moving pieces in this story now and things change quickly.

But, the first problem is not all immune disorders are the same. Those with inherited or innate immune deficiencies and those who receive chemotherapy or immune suppression for organ transplants are not the same as our IBD population. Lumping all together is confusing and not accurate.

The second error of NYT: The statement/assumption that lack of antibodies to SARS-CoV-2 after INFECTION implies lack of response to VACCINES. This is not true for many different reasons, including the timing of assessment and the type of antibodies being measured.

The fact that immunity from infection with COVID-19 isn’t the same thing as vaccine-induced immunity is also why we recommend vaccination even if a person has had COVID19. And know that those with prior COVID-19 actually have a prompt response to the first dose of vaccine!

The third area of confusion from the NYT article is that it doesn’t explain more details of the CLARITY IBD Study. I get it, that may be getting into the weeds in an article that is meant to be broader, but the details matter.

The CLARITY IBD study found that patients who received the first dose of the SARS-CoV-2 vaccine and who were receiving infliximab didn’t have the same antibody titers as those who were receiving vedolizumab. When they got their second dose, they responded appropriately.

Related to this study, though, there are 2 important points:

  1. This is not a relevant analysis if you get 2 doses of vaccine as recommended.
  2. The antibodies measured (nucleocapsid) are not the specific antibodies related to the spike proteins produced by the mRNA vaccines.

Why was this study done, you may ask? In the U.K. there was an attempt to improve vaccine availability by only giving one dose of the vaccine initially and delaying the second dose. This is why the study (performed in the U.K.) is so important for them

Remember that this same study (and other studies including the pivotal Pfizer and Modern studies) in fact DO show that when patients receive their second dose of vaccine (the aptly named “booster” dose), they then mount an appropriate immune response. Just as would be expected.

This additional finding – that ultimately the immune response was appropriate- essentially negates and neutralizes concerns about these findings for our patients with IBD and was not clarified properly in the NYT. As I’ve said before, these are two dose vaccines for a reason.

By the way, we don’t even know that measuring antibodies (nucleocapsid or spike) is actually predictive of immunity. There is a thought that while this is of interest, it is not sufficient. Click here for an excellent article that gets at some of this.

Separately, now IN PRESS in Gastroenterology is the initial report from the ICARUS study. ICARUS is a multi-center study of the COVID-19 vaccines in patients with IBD led by Dr. Serre-Yu Wong and Dr. Jean-Frederic Colombel at Mount Sinai IBD Center.

This paper of patients with IBD who received the Pfizer and Moderna mRNA vaccines found appropriate and expected antibody responses in ALL patients. Most of these patients were receiving biological therapies (and most were anti-TNF therapies). There were NO safety issues.

In summary,

  1. The mRNA vaccines are SAFE and EFFECTIVE regardless of the IBD therapy (except maybe high dose steroids).
  2. They should be given as they are designed – as two doses.
  3. We don’t know yet that antibody titers are needed (or how to interpret).

Meanwhile, the international IBD community is amazing and is continuing to focus on all of this. Check out any one of these great studies to be part of them if you have IBD and are getting vaccinated:


CORALE-V (Vaccine IBD)