Sao Paulo State Seeking ANVISA Greenlight for CoronaVac Registration: Buys 46m at $1.95 per Dose

Sao Paulo State Seeking ANVISA Greenlight for CoronaVac Registration Buys 46m at $1.95 per Dose

Sao Paulo state government in Brazil has requested from Brazil’s national health regulator, Anvisa, to register CoronaVac, the vaccine candidate developed by China’s Sinovac Biotech Ltd, for the use against COVID-19. This move represents a material data point as governor Joao Doria suggests this could become the very first COVID-19 vaccination program in the Americas (both North and South). In fact, the governor seeks to start inoculations in Sao Paulo with CoronaVac by mid-December representing one of the world’s most aggressive timelines outside of Russia and China.

COVID-19 in Brazil

The third major hotspot for the pandemic with over 4.9 million cases, as of this writing, 146,011 have passed due to the pandemic. The State of Sao Paulo has 1 million reported cases, by far the largest concentration of any state. And with 136, 136 reported deaths, no other Brazilian state comes close except for Rio de Janeiro State at 18,749.

Sao Paulo is the nation’s most populous state with approximately 46 million residents. Home to one of the sites of the Phase 3 Sinovac clinical trials, the Butantan Institute leads the study’s conduct there.

Sao Paulo does Buys in Bulk: $1.95 per Dose

Last week, the State of Sao Paulo inked a $90 million contract to receive 46 million doses of the experimental CoronaVac coming to a price of $1.95 per dose. Note that the price points for bulk purchases in the United States—far bigger bulk purchases—equals over ten times this price at $20 per dose.

Anvisa Approval Required

For Brazil’s national regulator, the approval of such a COVID-19 product registration must involve extensive amounts of data to support a sound and rational decision for the Brazilian people and the citizens of that state. According to a recent update by Reuters, the national regulator in fact has received the first batch of data covering CoronaVac. So, it would appear that this process is in fact starting to unfold.

On Pace for the First Vaccination In the Americas

Currently the AstraZeneca vaccine in the United States, testing AZD1222 (Oxford vaccine) is on hold indefinitely due to a safety incident. Moderna’s CEO recently reported their vaccine probably wouldn’t be ready for broad distribution until the Spring of 2021. Moreover, Pfizer/BioNTech could possibly have data to regulators within a couple months but more than likely no mass vaccinations before the end of the year.

However, in Sao Paulo State, the mood is upbeat that something can happen soon. Again, with Anvisa now reviewing data, part of the commercialization process, Sinovac is gaining momentum. Moreover, the vaccine was already accelerated for a number of demographics in China.

The point is that should the events proceed at a certain pace and if the data reveals efficacy and no adverse safety signals, SinoVac may be the first company to achieve regulatory approval (Registration) in the Americas (both North and South).

About the Butantan Institute

This is the major trial site for the Phase 3 clinical trial in the state. Butantan Institute is a Brazilian biologic research center located in Butanta, in the western part of the City of Sao Paulo, Brazil. A public institution affiliated with the Sao Paulo State Secretary of Health, it’s considered one of the major scientific centers in the world.

About CoronaVac

A potential vaccine candidate developed by Chinese company SinoVac, the investigational product is now in Phase 3 clinical trials. 

Phase 2 studies completed in July 2020 revealed immunogenicity at a low 3ug dose, offering 92.4 percent seroconversion in adults between ages 18-59. Based on an inactivated pathogen made by developing the whole virus in a lab and then terminating it, this is comparable to how polio shots are made. Over all, as reported in Precision Vaccinations, their strategy is similar to a number of other vaccine development efforts centering on COVID-19 in that they are using the DNA or RNA of the vaccine candidates. However, the newer technologies, such as mRNA, for example, take longer to produce as the live virus needs to be cultivated, cultures inactivated, etc.

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