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Immunogenicity Data Drove Monkeypox Dose-Sparring Decision…It Also Drove Initial Approval

 
• By Sarah Karlin-Smith

Comfort with the initial approval based on inferred effectiveness may have made the current EUA process more palatable to US FDA officials but means there is a bigger gap in what’s known about the vaccine’s effectiveness overall.

white house monkeypox press briefing Aug. 9, 2022
Biden administration officials discuss Jynneos EUA or dose-sparing vaccine strategy 9 August. • Source: White House Press Briefing

 The US Food and Drug Administration relied on a 2015 immunogenicity study to grant Bavarian Nordic A/S’ monkeypox vaccine Jynneos an emergency use authorization for administration by intradermal injection, a strategy that will increase the total number of doses available by up to five fold. (Also see "Monkeypox Vaccine: US FDA Eyes Dose-Sparing Strategy For Jynneos" - Pink Sheet, 4 August, 2022.)

One reason the agency may have been comfortable using immunogenicity data to grant the EUA for adults at high-risk of monkeypox is that unlike for most vaccines, the initial Jynneos...

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More from Vaccines

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

More from Pink Sheet

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.