Sanofi, GSK COVID-19 vaccine to advance to phase III trials

By The Science Advisory Board staff writers

May 17, 2021 -- Sanofi and GlaxoSmithKline's (GSK's) adjuvanted, recombinant COVID-19 vaccine candidate produced strong rates of neutralizing antibody responses in all adult age groups in a phase II study with 722 volunteers. Now the firms are advancing to a phase III study that is expected to start in the coming weeks.

Interim results of the phase II trial showed 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses (5, 10, and 15 µg). The vaccine candidate was acceptably tolerated and didn't trigger any safety concerns. The neutralizing antibody levels were comparable with those generated by natural infection. However, higher neutralizing antibody levels were seen in younger adults (18 to 59 years old). Also, after a single injection, high neutralizing antibody levels were seen in study participants with evidence of prior SARS-CoV-2 infection.

The phase III study will be randomized and double-blind using a 10-µg dose in combination with GSK's pandemic adjuvant involving more than 35,000 adults from a variety of countries. The study will assess the efficacy of two vaccine formulations including the D614 (Wuhan) and B.1.351 (South African) variants.

Sanofi and GSK also intend to conduct booster studies with various variant formulations to assess the ability of a lower vaccine dose to generate a strong booster response regardless of the initial vaccine platform the study participant received.

If the phase III study goes well, the firms expect vaccine approval in the fourth quarter of this year.

Copyright © 2021
To access all The ScienceBoard content create a free account now:

Email Address:  

First Name:

Last Name:

Learn about ScienceBoard

Get the latest life sciences research and industry news, delivered straight to your inbox, for free.

Why subscribe?

ScienceBoard is uniquely focused on the business of research, addressing the biggest problems that the biomedical industry face. You’ll get breaking news, events coverage, and deep dives into the science that drives innovation, delivered to your inbox daily.

Letter from the Editor Please send me twice-weekly roundups of all the latest life research and industry news.
SAB Announcements Please send me the latest announcements from The Science Advisory Board and their partners.
Spotlight Receive notifications about new content, services, or educational resources designed to help you sharpen your skills and grow professionally.
I have read and agree to the privacy policy and terms of service and wish to opt-in for

Already have an account? Sign in here