American vaccine developer Novavax Inc. has entered into a supply and license agreement with Pune-headquartered Serum Institute of India (SII). According to the Maryland-headquartered Novavax’s filing in the US Securities and Exchange Commission (SEC), the deal between the two companies was signed on July 30 for the “development, co-formulation, filling and finishing, registration and commercialization” of its COVID-19 vaccine candidate, NVX-CoV2373.
Novavax reported on Tuesday that its vaccine candidate had successfully produced antibodies against the coronavirus during early stage human trials.
According to the agreement, the Serum Institute will get exclusive rights for the supply of vaccine in India and non-exclusive rights in all countries except those in the upper-middle or high-income groups during the ‘pandemic period’. After the pandemic period, SII will be able to supply the vaccine in low and middle-income groups.
Under the agreement, SII would purchase two components of the vaccine, namely- the antigen drug substance and Novavax’s trademarked adjuvant (which is a component added to the vaccine to produce more antibodies in those who have been injected with it).
Both the parties will split the revenue equally generated from sale of the product in its licensed territory as mentioned in the filing. SII will exercise “commercially responsible efforts to develop and obtain regulatory approval” for the vaccine in countries pertaining to its licensed territory. The deal will expire on a country-by-country basis 15 years from its first commercial sale in those countries. After expiration, SII will retain a “fully paid, non-exclusive license” that will permit it to proceed with its manufacturing and commercialization rights on a country-by-country basis within its licensed territory.
Novavax has also expressed that it could start a large pivotal phase III trial of the vaccine as soon as late September and produce 1 billion to 2 billion doses of the vaccine by 2021.
Last week, SII had also received an approval from the Drug Controller General of India to conduct phase II and III human trials of the COVID-19 vaccine candidate developed by Oxford University and British-Swedish pharmaceutical firm AstraZeneca. The Serum Institute is also engaged in developing a vaccine with another American firm, Codagenix although this vaccine is still in the pre-clinical stage.
Researchers across the globe are racing to decode a coronavirus vaccine for public use amid rising cases worldwide. The coronavirus has infected more than 1.87 crore people globally and has claimed 7,06,041 lives. India has reported 19, 64, 536 cases and more than 40,000 deaths so far, making it to the world’s third worst-affected country.