Quick note to highlight that Makary is out at the FDA. Don't know if this will be a bad thing or potentially good thing for getting expanded access to Pemgarda or VYD2311 their new mAbs. Hopefully the later.

Marty Makary resigns as FDA commissioner after internal tensions - CBS News

Invyvid & Dr. Putrino (Mt Sinai CORE Center) have just published (5/11) a new advocacy piece on medRxiv. They conclude that mAbs show strong safety profiles and argue this should prompt a reevaluation of how we assess vaccine safety expectations — suggesting that the bar for accepting side effects from vaccines might be too lenient compared to the cleaner profile of these engineered antibodies.

Invivyd and Collaborators Author New Manuscript Evaluating Early Tolerability of COVID Monoclonal Antibody and Comparing Results to COVID Vaccination - Invivyd

"Safety first: should the high tolerability of intramuscular anti-spike COVID-19 monoclonal antibody change our expectations of vaccine safety" https://www.medrxiv.org/content/10.64898/2026.05.08.26352596v1

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