Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Monkeypox Vaccine: US FDA Eyes Dose-Sparing Strategy For Jynneos

Executive Summary

Switching method of administration from subcutaneous to intradermal would increase by five-fold the number of doses of Bavarian Nordic’s vaccine available to combat the outbreak; an EUA declaration would be needed to make this change, FDA commissioner Robert Califf said.

You may also be interested in...



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

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.

Monkeypox: Siga Says FDA Hasn’t Indicated Emergency Use Authorization An Option for Tpoxx

Siga CSO Dennis Hruby talked with the Pink Sheet about the company’s plans for development of Tpoxx for monkeypox in the US. If the necessary emergency declaration is made that would let FDA issue EUAs, the company would likely try to apply with its current clinical trial-less data set.

Monkeypox: US Gov’t Leaders Say Tpoxx Needs Randomized Control Trial Before Treatment For All

Media reports have emphasized the public’s frustration with gaining access to Tpoxx, an antiviral that may help treat monkeypox. But top officials at FDA, CDC and NIH defend the need to study the drug more first, even as they note they are making expanded access easier.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS146817

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel