Thread by @MichaelGIsonMD

As we are on the cusp of authorization of a 3rd dose of #SARSCoV2 #Vaccine for immunocompromised, I think its time for the entire Transplant Community begin focusing on some important questions that this entire situation has brought up

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1. Transplant patients have reduced protection from all vaccines compared to healthy controls, so the poor response was predicted. Why wasn’t there an a priori plan to study this? Many advocated for studies, but there were no @NIH or #Pharma funding mechanisms

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Lack of investment in focused research funded by @NIH or #Pharma for COVID-19 in immunocompromised patients was consistent across the spectrum of disease. We need to better advocate for #TID-focused funding mechanisms.

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2. The Moderna vaccine was derived from an NIH construct & development heavily funded by USG. Why did it take an obligation of regulatory authority outside the US to require specific studies? This led to the amazing study being done at @UHNTransplant instead of US sites.

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There clearly should have been obligations by @US_FDA for these studies as a condition of approval. Our patients would have benefited from being part of the study and from potentially getting data sooner. W/o an obligation, #Pharma was not supportive of such studies in US.

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3. The biggest question is what is our plan for 45+% of patients who remain without humoral protection? There has been a lot of focus on third dose but there remains a potential gap in protecting our patients.

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Do we need an alternative vaccine strategy? Is there a role of monoclonal antibodies? Other approaches?

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There appears to be no significant progress on this - and much like lack of investment in research by @NIH and #Pharma for vaccine in IC hosts, the same appears to be a challenge with these alternative approaches. Without this, we won’t progress our approach to optimize Px.

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4. Most importantly, we lack clinical correlates of protection with vaccine in these patients? There is a desperate need for data. While there are many hurdles to get this, one wonders if @UNOSNews or @SRTRNews or others should be collecting vaccine and infection data?

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We are getting some signals from the UK @NHSBT group and others that there is a benefit from 2 doses despite the reduced humoral responses with these vaccines in SOT. How will we tell if there is clinical benefit with 2 vs. 3 vaccines?

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Why is all of this so important? We need to optimize the Rx and Px of #COVID19 in #SOT patients today. We also know #COVID19 won’t be the last pandemic to impact our pts. Building the capacity to address these and other important questions will prepare us for the future.

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@EmilyBlumbergMD @camwolfe @PergamIC @nikkitheomd @dktransplant @DocSaimaAslam @AST_IDCOP @mannonmom @IDSAInfo @DrDimpyShah @DonaldVinh