4 ms·

No, they're implying that Moderna should have used a high dose flu vaccine in the >65 age group as the control condition in the efficacy trial. EDIT: To be cle

No, they're implying that Moderna should have used a high dose flu vaccine in the >65 age group as the control condition in the efficacy trial. EDIT: To be clear, I'm pretty sure that's just some pretext.

cosmicgadget 8mo ago
Is sandbagging like this normal in getting FDA approvals or did someone at Moderna f this up?
- icegreentea2 8mo ago
  Trial designs are rarely perfect, and drug companies will try to stack the deck. That being said, trial designs aren't made in isolation without consultation. Moderna's press release about this (https://feeds.issuerdirect.com/news-release.html?newsid=7346090610333866&symbol=MRNA https://feeds.issuerdirect.com/news-release.html?newsid=7346...) indicates that 2024 CDC said that performing an efficacy trial without using the higher dose would likely cause complications for recommending the mRNA vaccine for the >65 age group, but would not impact overall approval.
  - stouset 8mo ago
    That was 2024. I wonder what could possibly be different about today, in 2026?
- smt88 8mo ago
  This is specifically a political attempt by RFK Jr. to stop people from getting mRNA flu vaccines.
carbonatedmilk 8mo ago
Context from the CDC guidance from August 2025 (https://www.cdc.gov/mmwr/volumes/74/wr/mm7432a2.htm https://www.cdc.gov/mmwr/volumes/74/wr/mm7432a2.htm) "Except for vaccination for adults aged ≥65 years, ACIP makes no preferential recommendation for a specific vaccine when more than one licensed and recommended vaccine is available. Among adults aged ≥65 years any one of the following higher dose or adjuvanted influenza vaccines is preferentially recommended: HD-IIV3, RIV3, or aIIV3. If none of these three vaccines is available at an opportunity for vaccine administration, any other available age-appropriate influenza vaccine should be used (4,5)"

4 ms·

No, they're implying that Moderna should have used a high dose flu vaccine in the >65 age group as the control condition in the efficacy trial. EDIT: To be cle

by icegreentea2 8mo ago

cosmicgadget 8mo ago
Is sandbagging like this normal in getting FDA approvals or did someone at Moderna f this up?
- icegreentea2 8mo ago
  Trial designs are rarely perfect, and drug companies will try to stack the deck. That being said, trial designs aren't made in isolation without consultation. Moderna's press release about this (https://feeds.issuerdirect.com/news-release.html?newsid=7346090610333866&symbol=MRNA https://feeds.issuerdirect.com/news-release.html?newsid=7346...) indicates that 2024 CDC said that performing an efficacy trial without using the higher dose would likely cause complications for recommending the mRNA vaccine for the >65 age group, but would not impact overall approval.
  - stouset 8mo ago
    That was 2024. I wonder what could possibly be different about today, in 2026?
- smt88 8mo ago
  This is specifically a political attempt by RFK Jr. to stop people from getting mRNA flu vaccines.
carbonatedmilk 8mo ago
Context from the CDC guidance from August 2025 (https://www.cdc.gov/mmwr/volumes/74/wr/mm7432a2.htm https://www.cdc.gov/mmwr/volumes/74/wr/mm7432a2.htm) "Except for vaccination for adults aged ≥65 years, ACIP makes no preferential recommendation for a specific vaccine when more than one licensed and recommended vaccine is available. Among adults aged ≥65 years any one of the following higher dose or adjuvanted influenza vaccines is preferentially recommended: HD-IIV3, RIV3, or aIIV3. If none of these three vaccines is available at an opportunity for vaccine administration, any other available age-appropriate influenza vaccine should be used (4,5)"