FDA revokes J&J's EUA for their adenoviral vector-based vaccines

Jun 05, 2023

In following the expiration of the last batch of J&J COVID vaccines, as covered by Stephanie Brail in her post, the FDA has now gone further to fully revoke the EUA that was given to this pharmaceutical giant.

This revocation came within a press briefing from Friday, noting the following:

On Thursday, the FDA revoked the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine. On May 22, Janssen Biotech Inc. requested the voluntary withdrawal of the EUA for this vaccine. Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and they do not intend to update the strain composition of this vaccine to address emerging variants.

As noted, the last of the vaccines purchased by the government expired in early May. Due to the lack of demand, likely made so by the concerns over blood clots which had limited their use in Spring of 2022, and due to a letter sent to the FDA on May 22nd asking for the EUA removal, the FDA seems to have went ahead and finalized the removal of the EUA.

The letter sent to J&J is included within the press briefing, which doesn’t provide additional context:

On one hand, the removal of these vaccines is a plus for those concerned about all of the harms caused by these vaccines.

On the other hand, the finalization of removing these EUAs means that researchers will no longer be incentivized to look into these adverse reactions. That means many people who are still dealing with these adverse reactions, and likely may continue to suffer in the coming years, will now be left to their own devices in navigating how to manage their adverse reactions.

But what’s also made strange about this situation is whether these concerns over blood clot risks were enough to warrant such a limitation on the use of these vaccines.

Adverse reactions have generally been viewed from the perspective of relative risk. That is to say, is the risk of adverse reactions seen from the vaccines comparable to actually getting COVID? More importantly, were the adverse reactions seen in one vaccine platform, such as J&J’s adenoviral vaccine platform, comparable to the mRNA vaccines?

It doesn’t seem that the second question has been properly addressed, and yet the J&J vaccines were removed while the mRNA vaccines continue to see use, even though there’s been clear evidence of risks associated with these vaccines.

So why is it that one vaccine platform was greatly scrutinized while another has been left to stay on the market, even as more evidence of mRNA-vaccine harms continue to come out?

I don’t have the answer to this, but I wouldn’t be surprised if artificially-inflated demand by way of praising the mRNA vaccines and deeming them “safe”, while also poisoning the well on the adenoviral-vector vaccines by way of “blood clot risks”, may have drastically changed public perception on these vaccines and have kept the “want” of mRNA vaccines afloat even up to this day (at least for some people).

It should be clear that I don’t find the use of these vaccines to be necessary given the risks and lack of efficacy data, especially now that most people seem to want to move on from COVID.

But this still doesn’t remove the fact that there are many questions left unanswered, including how to help those who have suffered adverse reactions. If the FDA and CDC consider the removal of the EUA as a remark that they no longer will look into adverse reactions related to the adenoviral vaccines, then what avenues are there left for those wanting answers?

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