What’s happening?
The world’s largest manufacturer by volume, Serum Institute of India (SII), announced earlier this month that it has entered into a new partnership with the Bill & Melinda Gates foundation. Under this agreement, the foundation will provide an at-risk funding of $150 million which will be used by the SII to manufacture the potential vaccine candidates. The “at-risk” funding means that the investment will not be recouped irrespective of the success or failure of the vaccine and that this fund is just to help boost mass manufacturing.
Details of the agreement
The funding will actually be provided via Gavi (established by the Gates foundation), which is a public–private global health partnership with the goal of increasing access to immunisation in poor countries. This funding will help SII increase their manufacturing capacity. As soon as a vaccine gains approval from the WHO, the SII will be ready to mass produce as many as 100 million doses for India as well as other low- and middle-income countries (LMICs). The vaccine is capped at Rs. 225/dose, or just under $3. The vaccine will be made available to the 92 countries included in Gavi's COVAX index.
Why is it important?
India is a leader in affordable drugs and vaccines, which is not the case around the world. Medicines have entered a very gray area where they are patented and renewed with minor changes so the parent company can continue making a profit. If a private organisation were to do the same with a Covid vaccine, a long and tiresome legal and humanitarian battle would ensue.
Gavi is an international organisation working tirelessly to bring affordable vaccines to the masses. Multiple Covid-19 vaccines have been registered under Gavi. This means that whichever vaccine passes the WHO regulatory trials will be ready to manufacture by SII and will be sold at the price cap. This will prevent a price war and the jacking up of vaccine cost, as feared by many.
Which vaccines are being considered?
The frontrunner for manufacturing is the vaccine being developed by Oxford University licensed by AstraZenca. It has shown highly encouraging results in phase 1 and 2 clinical trials. Of 1,077 people that took part in the trials, 90 percent developed antibodies that neutralized Covid-19 after just one vaccine dose. The phase 3 trials are set to begin in India this week.
The risk
“The declaration of a vaccine being safe and effective will be the beginning, not the end.” As noted by Carolyn Johnson in the Washington Post. The SII is taking a pretty big risk by forging ahead with these plans, even outside of the fact that the Oxford vaccine hasn’t yet passed Phase 3 clinical trials. If the vaccine falls through for any reason, Serum stands to lose up to $200 million. Even once a vaccine is determined safe, cranked out at lightning speed, and distributed, there’s no guarantee it will eradicate Covid-19. However, with times as dire as now, it is clearly a risk that they are willing to take.