Benzinga | Dec 22, 2021 08:13AM EST

Novavax Initiates Phase 3 COVID-19 Vaccine Booster Study

Novavax Inc's (NASDAQ:NVAX) first booster doses of NVX-CoV2373 have been administered in an extension of PREVENT-19 Phase 3 trial.

* All PREVENT-19 trial participants are now eligible to receive a third booster dose of NVX-CoV2373.

* The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen (5 micrograms of recombinant Spike protein plus 50 micrograms of Matrix-M adjuvant).

* Related: Novavax's COVID-19 Vaccine Scores Conditional Approval In Europe.

* It may be administered at least six months after receiving the active vaccine.

* Two additional groups will be evaluated in this portion of the trial.

* Also, the WHO's Strategic Advisory Group of Experts on Immunization says that Novavax's COVID-19 vaccine should be administered in a two-dose series.

* A third dose can be given to those who are immunocompromised.

* The vaccine will be marketed as Nuvaxovid by Novavax and Covovax by the Serum Institute of India.

* Related: WHO Issues Emergency Use Listing to Novavax-Serum Institute's COVID-19 Vaccine.

* The Company plans on submitting an Emergency Use Authorization in the U.S. by the end of the year.

* Price Action: NVAX shares are up 0.83% at $192.65 during the premarket session on the last check Wednesday.