Vaccines

Pink Sheet editors discuss the impact of a federal judge’s decision that the recent ACIP membership turnover and vaccine schedule changes likely violated statutes, as well as the FDA’s look at new opioid disposal requirements.

With the US CDC Advisory Committee on Immunization Practices sidelined by the courts, the Pink Sheet imagined how a past version of the panel may have spent the spring, including tracking a fast‑moving pipeline of flu, RSV, Lyme, dengue, and next‑generation combination vaccines.

Vaccine manufacturers warned the FDA vaccines advisory committee that international genetic resource rules are delaying influenza virus sharing and creating regulatory hurdles that could undermine seasonal vaccine preparedness.

Plaintiffs are likely to succeed on the merits of claims that reconstitution of the Advisory Committee on Immunization Practices violated the Federal Advisory Committee Act and the CDC improperly bypassed ACIP in adopting a new childhood vaccine schedule, a Boston judge said.

Trivalent formulations for the 2026-2027 northern hemisphere flu season address the swift rise of subclade K, but the persistent need for broader antigen coverage keeps quadrivalent possibilities in mind.

Significant viral drift and a temporarily rebuilt committee set the stage for a high‑stakes VRBPAC vote on updates to the three influenza vaccine strains for the 2026–2027 season.

US FDA’s vaccine advisors will meet in March to make flu strain selection recommendations, but the context for the meeting makes a “routine” event feel extraordinary.

Vinay Prasad will leave the FDA less than a year after his initial arrival, having served two tenures as head of the biologics center.

FDA Principal Deputy Commissioner Sara Brenner and Tracy Beth Høeg, then special assistant to the commissioner, wrote the scientific analyses underlying HHS' May 2025 decision to eliminate the recommendation that healthy children and pregnant women get vaccinated for COVID-19.

Albert Bourla once again publicly criticized CBER Director Vinay Prasad’s attempts to overrule career FDA staff decisions on vaccines, but was more positive about other US policy reforms.

Results from two studies did not establish efficacy or a causal link to serious adverse events in both subgroups, but the Comirnaty labeling update is notable given the sea change in US vaccine regulation and policy since Pfizer submitted the sBLA in April 2025.

The overhaul of the EU pharmaceutical package is expected to introduce two new regulatory “concepts” relating to platform technologies. A European Commission expert explains how the changes could impact industry and what the expected benefits are.

Pink Sheet editors consider the impact of Trump Administration-aligned proposals on the FDA user fee program, as well as discuss the latest updates on the Moderna flu vaccine application.

Centers for Medicare and Medicaid Services Administrator Mehmet Oz and Pfizer CEO Albert Bourla proposed ways pharma and the Administration could build on the relationships forged through Most Favored Nation pricing deals.

The US FDA agreed to revive Moderna’s influenza vaccine BLA by splitting between the accelerated and traditional approval pathways, but the unusual maneuver leaves uncertainty in its wake.

The US FDA commissioner also defended CBER Director Vinay Prasad’s role in the agency’s decision to refuse to file the company’s application for its novel flu vaccine.

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

The company expressed disappointment at the FDA’s decision to reject the mRNA flu vaccine’s submission during its fourth-quarter earnings call.

Pink Sheet editors discuss the battle between Moderna and the FDA over the company’s application for a seasonal flu vaccine that the agency refused to file, including the new concerns that could spur an RTF action.

A Pink Sheet analysis found that of more than 87,000 written comments to a Vaccines and Related Biological Products Advisory Committee meeting docket, only a fraction were anti-vaccine, and many were the same or similar statements sent repeatedly.