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April 21, 2021

J&J Vaccine Paused; Meeting Materials about Serious Adverse Events Unavailable

by Alix Mayer

On April 13, 2021, the Food and Drug Administration (FDA) paused administration of the Johnson & Johnson (J&J) single-shot recombinant vaccine due to reports of a rare blood clotting disorder. The shot was being administered under an Emergency Use Authorization (EUA,) since safety and efficacy trials are not completed. Under EUA, the public has access to the vaccine while the vaccine manufacturer conducts ongoing studies to investigate safety issues and determine if the vaccine prevents moderate to severe cases of the symptoms known as COVID-19.

The next day, the Advisory Committee on Immunization Practices (ACIP) upheld the pause after the group held a four-hour emergency meeting. There are no publicly available meeting materials, slides, or videos, and the live feed was paused or stuck, according to those trying to watch it. The group determined a need for more study regarding six post-vaccination reports of brain blood clots, accompanied by low platelets, termed: cerebral venous sinus thrombosis with thrombocytopenia. The problem isn’t just about blood clots, but that the treatment for blood clots (i.e. “blood thinning” medication) cannot be given due to the accompanying low platelet counts. Blood clots can be deadly with or without use of blood thinners.

J&J knew of this problem last Fall. On October 30, 2020 ACIP held a meeting regarding the COVID vaccines in development. Dr. J. Sadoff of Janssen, the vaccine division of J&J, presented an interim analysis of their Phase III study. 

As of that October 2020 ACIP meeting, Janssen had just re-started their trial after a pause due to an undisclosed serious adverse event. ACIP members were keen to find out more about the patient, and what the reaction was. No fewer than six ACIP members pressed Dr. Sadoff to reveal details, yet he demurred, again and again. From the various questions, anyone watching could piece together that it was a “thrombotic event” in a “young person.” We now know the serious event during the trial occurred in a male in his mid-twenties

Dr. Sadoff replied to his colleagues’ queries in bits and pieces, with the following statements, some of which are paraphrased from my notes, as ACIP has removed the October 2020 minutes, video and J&J slide presentation from its website, as of this writing. Children’s Health Defense has requested these meeting materials from ACIP.

Here is how Dr. Sadoff responded to questions from the ACIP members, whose job it is to determine safety of new vaccines for various populations, so they can recommend them to the public: 

  • Pauses “are not uncommon.”
  • The “safety event” automatically triggered a stopping rule.
  • Janssen had outside experts evaluate the event, from laboratory results and other points of view.
  • It was a “complicated case” and other causes have not been completely determined, but the safety groups concluded it was not related to the vaccine. Clearly, with what is now known, these “safety groups” were a bit hasty in their conclusion.
  • A stunning remark for a meeting where Dr. Sadoff’s colleagues would need to vote in a future meeting on the J&J vaccine, Dr. Sadoff said J&J had been transparent with agencies, but was reluctant to discuss the case in public because the “study is still blinded” and due to “patient confidentiality.” Clearly, these appear to be euphemistic platitudes to cover up that Dr. Sadoff was likely more worried about shaking public confidence in their yet-to-be-released vaccine.
  • J&J would reveal the case in a “timely manner” but refused to define “timely” when pressed.
  • Responding to a question about how many had been vaccinated, he said “we just started the trial in September so we don’t have many thousands of subjects.” In other words, the serious event occurred after only a few thousand doses.
  • One ACIP member seemed to know the event was in a young person and stated, “We need to prove a reduction in person-to-person transmission in pediatric groups, since they are not as vulnerable themselves.” This is a concern shared by many who know the CDC reports the risk of COVID-19 causing death in children to be statistically zero, so it is difficult to justify the risks of a vaccine that would be unlikely to improve their outcomes.

Given that blood clots, which can be life-threatening, are normally treated with blood thinners like heparin, yet these cases also suffered from low platelets which is a contraindication for administration of blood thinners, “we wanted to educate providers to know what to do,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in an American Medical Association webinar.

The media and FDA lead us to believe that blood clotting events in brain veins are only being reported after administration of the J&J vaccine, however, a search of the Vaccine Adverse Events Reporting System (VAERS) which captures a tiny fraction of injuries and deaths reported after vaccine administration shows two reports of cerebral venous thrombosis for J&J and two for Moderna, yet the Moderna shot is not also paused. Note that it is unclear if these reported cases of blood clots in the brain were accompanied by low platelets or not. 

In FDA’s Q&A on their website, regarding whether or not this condition is occurring with other vaccines, FDA statesNo. As of April 13, 2021, no cases of this blood clot issue have been reported [emphasis added] among the more than 180 million people who received the Pfizer-BioNTech or Moderna vaccines.” 

The injury reporting system does not support FDA’s stance. If you run a more general report in VAERS on “embolic and thrombotic events, venous” — meaning reports of life-threatening blood clots in any veins, not just in the brain — you find that J&J has 19 of these events, and Moderna and Pfizer have far more. There are 176 such reports after the Moderna shot, and 152 such reports after the Pfizer shot.* Given the volume of reports, that these conditions are life-threatening, and that blood thinners don’t always prevent death, it is difficult to understand why J&J has been singled out for a pause.  

The FDA’s response denying other reports of this blood clot issue also fails to mention that the Astra-Zeneca COVID vaccine used abroad and now paused, is linked to blood clots. In many patient cases, a connection was found with antibodies which prevent platelet formation. The J&J and Astra-Zeneca vaccines are made the same way, with the SARS CoV-2 spike protein cleaved onto an adenovirus, one of the viruses thought to cause the common cold.

We await FDA’s decision regarding the J&J vaccine, and their guidance on how to treat patients who develop blood clots, but who cannot take blood thinners. And we wonder why almost 350 reports of life-threatening blood clots – with or without low platelets – are not enough to put all three COVID shots used in the U.S. under similar review by the FDA and ACIP. 

*Because some cases have multiple vaccinations and symptoms, a single case can account for multiple entries in this table; this is the reason why the total count is greater than 303 and the total percentage is greater than 100.