Tuesday, September 14, 2021

Moderna presented to us (Medical Team + other interested parties) their data on the open label study involving the crossover from their phase three trial. Consistent with the data from Pfizer they see a waning of immunity particularly in association with the delta variant. This is another bit of data to argue for the booster program that we will soon roll out during the week of September the 20th. Had a very heated and intense Zoom discussion this evening with the medical team as well as people from CDC, FDA, and HHS - Key players among many were: Peter Marks, Janet Woodcock, Rochelle Walensky, Amanda Fine (CDC), Stephen Cha, David Kessler, Vivek Murthy, Leslie Dach, et al. The subject matter of the intense discussion was trying to align the FDA with the CDC in the interpretation of data from Israel regarding the safety and efficacy of a third shot booster dose. It is clear from the Israel data that there is waning immunity across all of the age groups not only for infection protection but also for protection against severe disease. The sticking point is that if the FDA pushes for approval of the third booster shot for all ages there is the question of a lack of a lot of data for safety among young individuals particularly in the context of myocarditis. The CDC , particularly in the person of Amanda Fine, was very concerned that the ACIP would balk at recommending for younger individuals the third dose because there was not enough safety data. As we all know Jeff is very much intense on getting this approval through. I would imagine that he would be OK with the approval now of doses down to around 30 or 40 years old with the stipulation that as soon as safety data comes in for younger people, we could approve that for all ages. We will continue the discussions over the next 24 to 36 hours. What was supposed to be 1/2 an hour meeting tonight turned out to be a 2 1/2 hour meeting. This subject is being intensely discussed throughout the community and into the media. The people who were involved in the Lancet article discussed above we're actually shooting from the hip without knowing anything about the Israeli data. It will become clear that they were completely off base as soon as the Israeli data becomes known to everyone. After the phone call I spoke to Jeff and explain what happened at the meeting. He seemed OK so long as we don't stall on the approval. PRESS: MSNBC – “Morning Joe”; ABC GMA Instagram with Tony Morrison; CNN “The Lead” with Jake Tapper; MSNBC – “All In” with Chris Hayes