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News & Media Novavax Reports Third Quarter 2021 Financial Results and Operational Highlights November 4 , 2021 GAITHERSBURG , Md . , Nov. 4 , 2021 / PRNewswire / -- Novavax , Inc. ( NASDAQ : NVAX ) , a biotechnology company dedicated to developing and commercializing next - generation vaccines for serious infectious diseases , today announced its financial results and operational highlights for the third quarter ended September 30 , 2021 . " We are excited by the significant progress made over the quarter , including our landmark milestone of gaining the first regulatory approval for our COVID - 19 vaccine , " said Stanley C. Erck , President and Chief Executive Officer , Novavax . " With additional regulatory submissions around the world , we are prepared to deliver our vaccine globally . We believe the highly encouraging results from our six - month booster study complement the strong efficacy demonstrated by NVX- CoV2373 to date , and we remain confident that our vaccine will serve as an important tool to fight COVID - 19 in the come . Third Quarter 2021 and Recent Highlights COVID - 19 Vaccine Regulatory Pathway years to • Received emergency use authorization ( EUA ) from National Agency of Drug and Food Control of the Republic of Indonesia , in partnership with Serum Institute of India Pvt . Ltd. ( SII ) 。 NVX - CoV2373 to be marketed by SII under the brand name COVOVAXT • Novavax completed multiple regulatory submissions 。 U.K. Medicines and Healthcare products Regulatory Agency ( MHRA ) for conditional marketing authorization 。 Australia Therapeutic Goods Administration ( TGA ) for provisional approval 。 Health Canada for authorization 。 New Zealand Medsafe for provisional approval o World Health Organization ( WHO ) for emergency use listing ( EUL ) 。 European Medicines Agency ( EMA ) ( submitted all final data and modules ) • SII , our licensee , completed multiple regulatory submissions for our COVID - 19 vaccine • 。 Drugs Controller General of India ( DCGI ) and the Philippines for EUA o WHO for EUL Expect to submit the complete regulatory package to the U.S. FDA by the end of 2021 COVID - 19 Vaccine Advanced Purchase Agreements • Executed advance purchase agreement with European Commission to supply a minimum of 20 million doses and up to 100 million initial doses 。 Option to purchase an additional 100 million doses through 2023 COVID - 19 Vaccine Manufacturing and Supply • Achieved capacity of 100 million doses per month as of the end of the third quarter of 2021 , on track to achieve capacity of 150 million doses per month by the end of the fourth quarter of 2021 , and expect to have capacity in excess of 2 billion annual doses in 2022 • Collaborated with licensed manufacturers to enable distribution of NVX - CoV2373 globally 。 Expanded partnership with SII through a supply agreement ○ Takeda Pharmaceutical Company Limited finalized agreement with government of Japan's Ministry of Health , Labour and Welfare for purchase of 150 million doses , with anticipated distribution in 2022 COVID - 19 Vaccine Clinical Development • Completed crossover arms in U.K. Phase 3 , South Africa Phase 2b , PREVENT - 19 Phase 3 , and pediatric expansion of PREVENT - 19 trials Ongoing pediatric expansion of PREVENT - 19 Phase 3 trial ○ Completed enrollment of 2,248 adolescents aged 12-17 years across up to 75 sites in the U.S.