(Reuters) – The European Union’s drug regulator has started reviewing Sanofi and its British partner GlaxoSmithKline’s application seeking conditional authorization for their COVID-19 vaccine, the agency said on Wednesday.
The drugmakers had earlier said that they would seek regulatory approval for their COVID-19 vaccine to be used as a booster as well as a standalone two-dose shot.
In support of the companies’ application, the final data package comprising a late-stage trial of the vaccine and another trial testing it as a booster was submitted to the European Medicines Agency (EMA) on March 29, the drugmakers said in an email to Reuters.
Last month, the companies said final analysis of the booster trial, which included participants previously given shots based on mRNA technology or adenovirus viral vectors, showed it could increase neutralising antibodies by 18 to 30 times.
Early data from the late-stage trial of the vaccine as a standalone two-dose shot showed it was 100% effective against severe COVID-19 and hospitalisation.
The vaccine candidate, Vidprevtyn, was already being evaluated under a rolling review by the EMA.
Sanofi, which plans to produce the vaccine in France, Italy and the United Sates, is hoping for a comeback after falling behind in the race for COVID-19 shots.
The companies will submit final applications to the U.S. FDA and other regulatory agencies in the coming weeks in countries with which they have advanced purchase agreements, a GSK spokesperson said.
Both the companies said they were unable to speculate on regulatory approval timelines but were in dialogue with health authorities to ensure they have all information needed to authorize the vaccine as soon as possible.
In 2020, the EU agreed to purchase 300 million doses of the vaccine in exchange for a down payment of 324 million euros.
(Reporting by Mrinalika Roy in Bengaluru and Ludwig Burger in Frankfurt; Editing by Saumyadeb Chakrabarty and Maju Samuel)