06 Aug 2020: India's Serum Institute signs COVID-19 vaccine deal with America's Novavax
The Adar Poonawalla-led company, which is already in the process of bringing Oxford and AstraZeneca's ChAdOx1 vaccine to the country, has signed a deal to locally manufacture and commercialize Novavax's shot once it is ready and proven effective.
Here's all you need to know about it.
Agreement: Supply and License agreement between the two organizations
In a recent filing with the US Securities and Exchange Commission, Novavax said that it has entered a "supply and license agreement" with the SII.
Under this deal, the company said it will give the Indian organization exclusive and non-exclusive licenses for the "development, co-formulation, filling and finishing, registration and commercialization" of its NVX-CoV2373 vaccine candidate for the SARS-CoV-2 virus.
Fact: SII will source key components from Novavax, share revenue
The filing notes that SII will source two key components from Novavax to start manufacturing NVX-CoV2373 - the antigen drug substance and Matrix-M adjuvant. Also, once it starts selling the shot in India (post approvals), both the parties will equally share the generated revenue.
Terms: Agreement excludes rich countries
Notably, under the terms, Novavax has given exclusive rights to SII for its COVID-19 vaccine in India during the term of the deal - 15 years - as well as non-exclusive rights during the "Pandemic Period" in all countries, except those designated by the World Bank as upper-middle/high-income countries.
For these rich countries, the company said it retains the right for the vaccine.
Effectiveness: Vaccine proven effective in early-stage trials
The deal between the SII and Novavax was struck just a few days before the latter announced promising results from the Phase-1 clinical trial of its COVID-19 vaccine.
According to the data, the shot in question was able to induce a high level of neutralizing antibodies in all 131 of the study participants, without any major side effects.
Working: How it works in the human body?
The Novavax vaccine is a stable, prefusion protein that sends harmless copies of the coronavirus spike protein in the patient's body to train their immune system to fight off the actual infection when needed.
According to the Associated Press, the company's scientists extracted the actual spike protein, purified it, and then packaged it into virus-sized nanoparticles to create the delivery shot.
Fact: Late-stage trials might begin next month
Currently, the NVX-CoV2373 vaccine, which has been backed by the US government, is in the Phase-2 of human trials. It is expected to move into a larger Phase-3 by the end of September and become available by the end of 2020.