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Novavax, Inc. (NVAX) CEO Stanley Erck Presents at 40th Annual J.P. Morgan Healthcare Conference (Transcript), Jan. 10, 2022
Stanley Erck - President and CEO (and others)
"We've achieved regulatory authorizations for our first vaccine, Novavax 2373 on a global scale. As of today, we have authorizations through the WHO in Europe, in India, in Indonesia and in the Philippines. And over the next 30 to 90 days, we have the potential to expand those authorizations to include the U.S., the U.K., Australia, Canada, Japan, New Zealand, the UAE, Korea, South Africa and others. We began shipping our first product last quarter. And in December, we started vaccinating people in low and middle income countries. In Indonesia, we shipped over 10 million doses, and we'll deliver another 40 million doses to Indonesia in the coming quarters."
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"Please turn to Slide 6. We've made tremendous progress advancing 2373 toward regulatory approvals. As of today, we've received authorization from the World Health Organization, European Commission, Indonesia, India and the Philippines for our product, NUVAXOVID and 2373 manufactured market by Serum Institute, which is being marketed as COVOVAX. These authorized geographies include over 6 billion individuals where vaccine has the potential to reach. In other major markets, we've completed 10 additional regulatory submissions, which include an additional 0.5 billion lives. This includes a filing for authorization in South Africa, not reflected on this slide, because we just announced it this morning. We are in active discussions with regulatory authorities and remain focused on gaining additional authorization for 2373. I note that in the U.S. we completed the submission of our final CMC data package to the FDA at the end of 2021. And at the end of this month, we expect to submit our formal request for emergency use authorization which will mark a critical milestone toward making our vaccine available in the U.S."
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"Please turn to Slide 7. As we pursue additional regulatory authorizations for 2373, we believe there is a significant global market opportunity for our vaccine. We believe 2373's highly efficacious and well-understood technology provides a critical alternative for primary vaccination to individuals who may be vaccine hesitant or seeking alternative options. For Booster vaccinations, we believe waning immunity and the emergence of variance will fuel an ongoing need for booster doses, and we're building a body of evidence that our vaccine, which induces broad immune responses to variants, including Omicron will be an important option for boosters. Existing data demonstrates that 2373 is capable of boosting a homologous and heterologous primary vaccination series with a favorable tolerability profile. In pediatric populations, we believe 2373's overall product profile positions our vaccine as a desirable future alternative in a rollout of pediatric vaccines globally. Through our cumulative commitment in partnership with Serum Institute of 1.1 billion doses to the COVAX facility, our expansion supply network and our favorable distribution storage profile we believe 2373 is an ideal option to address gaps and vaccine access to lower middle and low income countries. And we are committed to ensuring equitable access to 2373 around the world." |
