EMA Starts Review Of Sanofi-GlaxoSmithKline's COVID-19 Vaccine

The European Medicines Agency has started reviewing Sanofi SA SNY and its partner GlaxoSmithKline Plc's GSK application seeking conditional authorization for their COVID-19 vaccine.
The vaccine candidate, Vidprevtyn, was already being evaluated under a rolling review by EMA.
The drugmakers had earlier said that they would seek regulatory approval for their COVID-19 vaccine to be used as a booster and a standalone two-dose shot.
In support of the companies' application, the final data package comprising a late-stage vaccine trial and another trial testing it as a booster was submitted to the EMA on March 29, the drugmakers said in an email to Reuters.
Last month, the final analysis of the booster trial showed it could increase neutralizing antibodies by 18 to 30 times.
Separately, the European drug regulator has started a review for Novavax Inc's NVAX COVID-19 vaccine to extend use to adolescents aged 12 to 17 years.
The World Health Organization, European Union, India, Indonesia, Philippines, and Australia have conditionally authorized the vaccine.
However, the two-dose COVID vaccine is yet to receive FDA authorization.
Related: Novavax's COVID-19 Shot Inches Up To FDA Authorization: WSJ.
Price Action: SNY shares are up 0.34% at $51.60, GSK stock is up 0.62% at $43.56, NVAX shares are down 4.99% at $74.90 during the market session the last check Wednesday.

Overview Rating:

Speculative

0100