Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Trial Dropouts Illustrate Worries For J&J, Other Later Entrants To COVID Vaccine Space

Executive Summary

More than 5% of participants in J&J’s vaccine trial chose to be unblinded because they were eligible to receive a vaccine that had already gained a US FDA emergency use authorization.

You may also be interested in...



AstraZeneca COVID-19 Vaccine Data ‘Not Sufficient’ For Approval In Switzerland

Switzerland's medicines agency says it wants to see more data on AZD1222 before it can approve the vaccine. Also, a rolling review of Novavax's NVX-CoV2373, yet another COVID‑19 vaccine, is under way at the European Medicines Agency. 

AstraZeneca Sees COVID Vaccine Trial Dropouts Due To Pfizer, Moderna Authorizations In US

Approximately 9% of subjects have withdrawn from the 32,000-person trial because they were eligible to receive one of the mRNA vaccines in the US; AstraZeneca expects limited impact on efficacy assessment but is working on a potential plan for crossover of all participants to try to keep as many in the study as possible for safety follow-up.

Unblinding Plans For COVID-19 Vaccine Trials Take Roads Less Travelled

Pfizer relies on investigators to determine when prioritization recommendations apply, Moderna offers unblinding to everyone.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143846

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