Well, this was actually a bit more interesting than I anticipated (but the amount of “your on mute” and frozen screens and delayed timing was a bit painful to watch). There were four topics that dominated discussions…
Adverse events
There were three adverse events during the clinical trial that may have been due to the vaccine (although still very rare): clotting disorder, buzzing or ringing in the ears (tinnitus), and hives (urticaria).
It is very plausible that hives was caused by the vaccine
The vaccine causing clotting disorders or tinnitus could not be ruled out. All these participants also had underlying conditions making the causal link more challenging to parse out
What happens when ENSEMBLE2 results come?
Today’s FDA meeting is for the one-dose trial (the study is called ENSEMBLE). However, there’s a two-dose trial (ENSEMBLE2) currently underway that enrolled 33,000 people. The purpose of ENSEMBLE2 is to see whether efficacy increases with 2 doses (opposed to 1). Results are expected in May. If results for ENSEMBLE2 are positive, there is a very difficult situation on our hands. If ENSEMBLE2 is more efficacious, what happens? Does everyone who got the one-dose regimen then get a second dose?
For one, this will cause quite the public confusion. Clear communication is already difficult and this will only get harder as time moves on. For example, what if a booster for variants (outside of the 2 doses) is also needed in the meantime?
There’s also a regulatory perspective. The FDA said that there have been extensive internal conversations about this. If this becomes the case, the FDA can amend their emergency approval to the two-dose regimen. They can also change their FDA approval when J&J goes up for licensure. So the FDA should allow this to happen, which is useful to know.
The final problem (which I think is the most challenging) is that the amount of antigen used in the one-dose trial is higher than the amount used in the individual doses in the two-dose trial. So, to add to the confusion, J&J is studying the impact of “a late boost” with “a small amount of antigen” to people who got the one-dose regimen would heighten the protection they get from the vaccine.
So yes, this will get complicated fast.
Placebo
What to do with the placebo participants? J&J plans to do a cross-over study in the next week or month (depending on the country). In other words, those with the vaccine will get a placebo and those with the placebo will get the vaccine (but they still won’t know which one they have). By doing this, they hope participants will stay in the study and not get another vaccine on their own.
Random points (I don’t know where else to put them)
J&J is making a new vaccine to address the circulating variants as a precaution. This vaccine would be ready for Phase I before summer. But, J&J is happy with the efficacy against current variants thus far
The J&J pediatric trial is starting to recruit adolescents next week. But other sponsors are having issues enrolling children in these studies. J&J’s backup plan is to run this trial in multiple countries (which will hopefully increase interest in enrollment).
CDC reported an anaphylaxis rate of 4.7 cases per 1M of Pfizer and 2.5 cases per 1M of Moderna
Vote
Then the external committee voted: “Based on the totality of scientific evidence available, do the benefits of the J&J Covid-19 vaccine outweigh its risks for use in individuals 18 years of age and older?”
Yes- 22; No- 0; Abstention- 0
No one is surprised. The next step is that FDA either grants or denies emergency authorization (we expect this will happen tomorrow). Then a CDC external advisory committee meets (a far more lively and interesting meeting, in my opinion). Then CDC publishes recommendations.
If all goes well, 100M J&J doses are ready to go. But won’t likely reach arms until April.
Love, YLE
Jumping in on an older post here, I know, and I apologize. I wonder, can you speak to the thought as to whether this vaccine would have a better chance of being accepted by those who are Covid vaccine hesitant than the mRNA vaccine? The adenovirus technology is not as "new," correct? I'm wondering if this would be a good option to present to those who are leery of the mRNA option.