The FDA just released a statement this afternoon announcing the extension of the EUA for COVID-19 boosting with Moderna and Janssen vaccine. The FDA also authorized heterologous boosting (mix and match).
I still can’t make heads or tails out of what’s happening with the CDC Advisory Committee on Immunization Practices (ACIP) meeting today and tomorrow. The agenda is still in draft form and it’s dated “Draft—October 14, 2021.” I’m writing this as the ACIP web page is testing it’s incoming and outgoing audio at 8:40 AM, CDT. I’m updating today as the meeting proceeds.
I thought the meeting was going to be mainly about the Moderna and Janssen COVID-19 vaccine boosters, but there are no slides published yet and the agenda looks like it’s mainly about other vaccines. There is one presentation scheduled for this afternoon about influenza vaccines entitled “Phase II safety and immunogenicity study of the coadministration of Fluzone® High-Dose Quadrivalent Influenza Vaccine and a third dose of mRNA-1273 COVID-19 vaccine (Moderna).” I have a stake in the meeting as I wait for the Moderna booster to get the green light.
Tomorrow’s agenda still says “Coronavirus Disease 2019 (COVID-19) Vaccines, TBD.” The only votes so far pertain to the pneumococcal and zoster vaccines, which is for later this afternoon.
There’s also no FDA website update on the final decision regarding recommendations for the Moderna and Janssen booster vaccines. There have been media rumors that the FDA might recommend heterologous boosting (mix and match).
The meeting started on time at approximately 9:00 AM, CDT and the agenda was abruptly updated to final form (which looked like it contained a typo for the presentation about the combination injection of the Fluzone and Moderna booster (omitted after the words “…third dose of…” compare above). The final agenda revealed discussion of the boosters tomorrow starting at 9:15 AM, CDT. Also updated were some of the slide presentations (just for today). There will be a vote tomorrow afternoon on the Moderna and Janssen boosters. This will follow presentations on Moderna and Janssen booster data, NIH mix-and-match booster study, COVID-19 vaccine safety data including data about myocarditis, effectiveness of COVID-19 vaccines, evidence for recommendations, and policy questions.
There was an announcement that the FDA favored using heterologous boosting and that later today that would be posted on the FDA website.
I’ll probably only be spot-checking the proceedings during the day, since it looks like the main event for COVID-19 boosters will take place tomorrow.
Afternoon Update: The presentation “Phase II safety and immunogenicity study of the coadministration of Fluzone® High-Dose Quadrivalent Influenza Vaccine and a third dose of mRNA-1273 COVID-19 vaccine (Moderna)” started around 1:30 PM, CDT this afternoon. Fatigue was the most frequently reported systemic reaction. There were no serious adverse events. The combination can be given safely together without evidence of immunogenicity interference. The shots were given in different arms. All subjects had previously received the primary series (both shots) of the Moderna vaccine. The CDC website already has indicated on their website that the COVID-19 vaccine and the flu vaccine can be given at the same visit.