(Adds details, context)
PARIS, Dec 15 (Reuters) - French drugmaker Sanofi
and its British partner GlaxoSmithKline said on
Wednesday a single booster dose of their recombinant adjuvanted
COVID-19 vaccine candidate delivered consistently strong immune
responses.
"The booster was well tolerated, with a safety profile
similar to currently approved COVID-19 vaccines. This is the
most comprehensive booster trial to date to explore boosting
across different vaccine technologies used for primary
vaccination", the companies said in a statement.
"To provide the necessary data to regulatory authorities for
the booster vaccine submission, the trial will continue to
accrue the number of events needed for analysis, with results
expected in Q1, 2022."
At the end of September, Sanofi dropped its plans for its
own mRNA-based COVID-19 vaccine because of the dominance
achieved by BioNTech-Pfizer and Moderna
in using the technology to fight the pandemic.
Sanofi is hoping for a comeback after falling behind rivals
in the race for COVID-19 shots, with a vaccine candidate based
on the more conventional protein-based approach.
"Preliminary results from the VAT0002 clinical trial
investigating the safety and immunogenicity of the booster
showed neutralizing antibodies increased nine to 43-fold
regardless of the primary vaccine received (AstraZeneca,
Johnson & Johnson, Moderna, Pfizer/BioNTech) and for all
age groups tested", Sanofi said.
The company said this was the most "comprehensive" booster
trial to date as European countries are both grappling with a
new wave of COVID-19 infections fuelled by the Delta variant of
the virus and are gearing up for the new more contagious Omicron
variant.
"The ongoing global Phase III trial ... includes regular
reviews by an independent Data Safety Monitoring Board (DSMB).
During its last review, the DSMB identified no safety concerns
and recommended the trial to continue into early 2022 to accrue
more data," the companies said.
Sanofi also it was continuing "its contribution to global
public health needs" with the manufacturing of up to half a
billion doses from BioNTech/Pfizer, Moderna, and Johnson &
Johnson vaccines.
(Reporting by Benoit Van Overstraeten; Editing by Tom Hogue and
Louise Heavens)