Novavax, Serum Institute Of India Receive Emergency Nod For COVID-19 Vaccine In Philippines

Novavax Inc. (NVAX) and Serum Institute of India Pvt. Ltd. said that the Philippine Food and Drug Administration has granted emergency use authorization for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.

The vaccine will be manufactured and marketed in the Philippines by Serum Institute of India under the brand name COVOVAX.

The vaccine is stored with standard refrigeration at 2° to 8° Celsius.

The Philippines Food and Drug Administration has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg for active immunization of individual 18 years of age and older for the prevention of COVID-19.

The Novavax/Serum Institute of India vaccine has recently received EUA in Indonesia and the companies have also filed for emergency authorization in India and for Emergency Use Listing with the World Health Organization (WHO).

Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada and with the WHO, as well as the complete submission of all data and modules in the European Union to support the final regulatory review of its dossier by the European Medicines Agency.

Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) in South Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Starbucks has dropped its vaccine or weekly test requirement against Covid-19 for U.S. employees in the wake of last week's U.S. Supreme Court ruling. The court, in a 6-3 vote, has blocked President Joe Biden's vaccine-or-test mandate for private companies with 100 or more employees. However, it allowed the vaccine mandate to stand for certain health care workers. Mylan Pharmaceuticals Inc., affiliated to healthcare company Viatris Inc., is recalling one batch of its non-interchangeable Semglee (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens due to the potential for a missing label, the U.S. Food and Drug Administration said. Mushie & Co, LLC is recalling FRIGG Silicone Pacifiers citing choking risk, the U.S. Consumer Product Safety Commission said. The recall involves about 333,725 units of FRIGG silicone pacifiers that came in two designs: Classic and Daisy. According to the agency, the base of the silicone nipple has a fine slit that can cause the nipple to detach from the plastic shield, posing a choking hazard.
Follow RTT