Allergic reactions came up again. Moderna provided some important context. The company has 12 other mRNA vaccine trials (for other viruses), totaling 17,000 participants. Among these trials, there was only 1 person with a severe allergic reaction (she had a soy allergy). BUT this allergic reaction was 2 months after vaccination, so not related to the vaccine. This is important to know because all of Moderna’s trials use the same fat bubble (the thing that causes side effects). Moderna’s fat bubble (I’ve posted about this before) is different than Pfizer’s fat bubble; Moderna’s is more stable (hence why it doesn’t have to be refrigerated at such drastic temperatures compared to Pfizer). Because of that, we should not (and cannot) pool severe reactions, like allergies, from the two trials. We have to treat them separately, even though they are using the same biotechnology concept.
Moderna then dropped some exciting news that they have a LOT more data coming soon. For this emergency authorization, they needed 196 cases of COVID19 to test efficacy. But, they already have 450 more cases. Unfortunately, 1 person in the placebo group has died of COVID19.
Then there was discussion about one unexpected side effect…facial swelling. Three participants had facial swelling after vaccination. Interestingly, all 3 had facial dermal fillers (2 in the cheeks; 1 in the lips). All 3 cases of swelling were resolved with steroids, but the FDA is planning on noting this in the prescribing information.
Then the external committee voted: “Based on the totality of scientific evidence available, do the benefits of the Moderna Covid-19 vaccine outweigh its risks for use in individuals 18 years of age and older?”
Yes- 20; No- 0; Absention- 1
No one is surprised, as Moderna has put on a very impressive trial with beautiful data to accompany it. As Dr. Hayley Gans stated, “This is a really opportune time to move science forward, and I would say that the evidence — which has been studied in great detail — on this vaccine highly outweighs any issues that we’ve seen”.
Next steps: FDA now either grants or denies emergency authorization. Then a CDC external advisory committee meets (a far more lively and interesting meeting, in my opinion). Then CDC publishes recommendations.
To read about the fat bubble, check out my previous post here: https://yourlocalepidemiologist.com/covid19-vaccine-side…/