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

EMA Considers How To Verify Potency Of Next-Generation COVID-19 Vaccines

Executive Summary

Companies approaching the European Medicines Agency with their development plans for new COVID-19 vaccines are being asked to consider immunobridging studies if placebo-controlled trials are not feasible.

You may also be interested in...



EMA Head Calls For New Global Workshop On Variant Vaccines

Five vaccines and six therapeutics are now available for use against COVID-19 in the EU, but as Omicron shows, there is likely to be a need for new kinds of vaccines against future virus variants.

COVID-19 Vaccines: Regulatory Consortium Addresses Way Forward With Immunobridging Studies

Drug regulators from five countries have outlined their joint expectations on the data companies must submit for the approval of next-generation COVID-19 vaccines if they opt for immunobridging studies instead of large-scale efficacy trials. 

COVID-19 Vaccine Studies Should Look Beyond Neutralizing Antibodies To Assess Variants’ Impact

Cellular responses and other potential immune correlates of protection could be better measurements of efficacy, Janssen’s vaccine discovery head argues at BIO.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS144652

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