Valneva has started a pivotal phase 3 test for its experimental COVID-19 vaccine in a head-to-head against AstraZeneca's conditionally approved pandemic shot Vaxzevria.
The inactivated vaccine, known as VLA2001 uses Dynavax's CpG 1018 adjuvant as part of its tech, and will go against AZ’s vax in a comparative immunogenicity trial. This comes after AstraZeneca has been blighted by a series of rare blood clots in some, typically younger and female subjects who have been given its shot.
The so-called Cov-Compare (VLA2001-301) trial works as a randomized, observer-blind, controlled, comparative immunogenicity trial in around 4,000 adults, and will be undertaken across 25 sites in the U.K., with help from the country’s National Institute for Health Research.
Its primary objective is to show superiority of VLA2001 compared to Vaxzevria via a two-dose immunization schedule four weeks apart, in terms of Geometric Mean Titer (GMT) ratio of SARS-CoV-2-specific neutralizing antibodies at two weeks after the second vaccination (i.e., day 43) in adults aged 30 years and older.
It will also evaluate the safety and tolerability of VLA2001 at two weeks after the second vaccination in adults aged 18 years and older, something that will likely be keenly watched, despite the technology differences, given the blood clot issues seen with AstraZeneca and Janssen’s single-shot vaccine.
Should the data show strong efficacy and safety, Valneva “intends to make a regulatory submission in the autumn of 2021 for initial approval,” it said in a statement. If it can match or best AstraZeneca’s efficacy, and with a clean safety profile, this could garner interest from those who have been dropping AZ’s vaccine, or reducing its use in younger adults.
Valneva has already penned a collab with the U.K. government to provide up to 190 million doses of VLA2001 through 2025, of which 100 million doses have already been ordered. But talks with the EU have broken down, with the company saying it will now go via a country-by-country basis for contract talks.
“We are excited to see the rapid initiation of the comparative phase 3 clinical trial, providing an opportunity for Valneva's inactivated whole virus vaccine candidate adjuvanted with CpG 1018 to demonstrate superior immunogenicity with respect to the comparator,” said Ryan Spencer, CEO of Dynavax.
“We are proud to be collaborating with Valneva on the development of this vaccine for COVID-19 and are committed to supporting Valneva in making the vaccine available.”
The company also this month said it was seeking a Nasdaq IPO worth $100 million.