- The European Medicines Agency has started reviewing Sanofi SA (NASDAQ:SNY) and its partner GlaxoSmithKline Plc's (NYSE: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 (NASDAQ: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.
