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NOVAVAX Creating Tomorrow's Vaccines Today Novavax Reports First Quarter 2021 Financial Results and Operational Highlights May 10 , 2021 - Significant progress in PREVENT - 19 study ; final data expected in the second quarter of 2021 - Initiated pediatric extension of PREVENT - 19 in the U.S. - Evaluating COVID - 19 booster performance in U.S. and Australia Phase 2 and South Africa Phase 2b studies , as well as study with the University of Oxford - Finalized APA with Gavi to supply 1.1 billion doses for the COVAX Facility - Company to host conference call today at 4:30 p.m. ET GAITHERSBURG , Md . , May 10 , 2021 / PRNewswire / -- Novavax , Inc. ( NASDAQ : NVAX ) , a biotechnology company developing next - generation vaccines for serious infectious diseases , today announced its financial results and operational highlights for the first quarter ended March 31 , 2021 . " Novavax made great strides over the first quarter to pave the path for our COVID - 19 vaccine candidate , NVX - CoV2373 , notably achieving statistically significant efficacy across our Phase 3 UK and Phase 2b South Africa trials , " said Stanley C. Erck , President and Chief Executive Officer , Novavax . " In parallel , we have secured additional manufacturing and supply agreements , expanding our global supply chain to over 10 countries . In the coming months , we look forward to delivering on critical milestones , including announcing final data from our PREVENT - 19 Phase 3 trial , completing our regulatory submissions , evaluating NVX - CoV2373 in younger populations and continuing to develop our booster strategy to address the evolving COVID - 19 pandemic . As we continue our dialogue with regulatory authorities for authorization , we remain committed to promptly delivering our vaccine globally , ensuring equitable access and expansive distribution . " First Quarter 2021 and Recent Highlights COVID - 19 Clinical Development • Reported final efficacy analysis from UK Phase 3 trial and complete analysis from South Africa Phase 2b trial , expanding upon previously reported interim results o Demonstrated 100 % protection against severe disease o Confirmed 96.4 % efficacy against original strain of COVID - 19 and 86.3 % efficacy against B.1.1.7 variant strain in UK Phase 3 trial o Demonstrated efficacy of 88.9 % in adults over the age of 65 and efficacy of 90.9 % in adults with high - risk medical comorbidities in UK Phase 3 trial o Demonstrated efficacy of 55.4 % among HIV - negative participants in South Africa Phase 2b trial , with the vast majority of cases due to the B.1.351 escape variant o South Africa Phase 2b results published in the New England Journal of Medicine o UK Phase 3 results submitted for publication to peer - reviewed journal and posted to medRxiv.org • Completed successful enrollment of 30,000 participants for PREVENT - 19 ; final analysis to be reported in the second quarter of 2021 • Initiated pediatric expansion of PREVENT - 19 to evaluate efficacy , safety and immunogenicity of NVX - CoV2373 in adolescents o Enrolling up to 3,000 adolescent participants aged 12-17 across up to 75 sites in the U.S. o Blinded crossover expected to begin six months after initial set of vaccinations • Initiated crossovers and progressed booster studies of NVX - CoV2373 o Initiated crossovers in PREVENT - 19 , UK Phase 3 and South Africa Phase 2b trials to ensure all trial participants have access to active vaccine o Completed 6 - month booster doses in the U.S. and Australia Phase 2 study with immunology results expected in the third quarter of 2021 o Com - COV2 Phase 2 clinical trial conducted by University of Oxford and UK Vaccines Taskforce ■ NVX - CoV2373 is one of four COVID - 19 vaccines administered during trial to evaluate combined vaccine regimens in 1,050 participants ■ Top - line data expected in the third quarter of 2021 • Advanced development of variant strain vaccines into preclinical studies o Preclinical data from study of B.1.351 variant strain vaccine candidate showed strong antibody response and