China’s Sinovac was among the first group of companies to initiate development of a vaccine against COVID-19. Work on the inactivated vaccine prospect began in late January and clinical development got underway in mid-April.
Sinovac has now shared details of the effect the rapid R&D program is having on its finances. In the second quarter, Sinovac spent $14.5 million on R&D, up from $6.3 million in the comparable period of last year.
The heavy second quarter spending, coupled to a more conventional first quarter, brings Sinovac’s R&D outlay so far in 2019 up to $20.2 million. That is almost as much as the $24.3 million Sinovac spent on R&D across all of last year.
In explaining the 130% second quarter increase, Sinovac pointed to the development of its COVID-19 vaccine and its continued investment in other pipeline assets such as its near-market Sabin inactivated polio vaccine and 23-valent pneumococcal polysaccharide vaccine.
The spending has put Sinovac in a position to be among the first companies to win full approval for a COVID-19 vaccine. Sinovac began a phase 3 clinical trial in Brazil in July. A second phase 3 trial started in Indonesia the following month.
As with all COVID-19 vaccine trials, the timing of data from the two phase 3 studies will depend on the level of viral transmission among participants. The more subjects are exposed to the virus, the faster Sinovac will be able to show if it prevents infection.
Sinovac’s choice of Brazil could help it deliver data quickly. Since the phase 3 trial began on July 11, Brazil’s rolling 7-day average of new cases per million people has been above 150. For most of the phase 3 trial, the number has been above 175 and it spent several weeks above 200.
Confounding variables, such as testing capacity, can make cross-country comparisons unreliable but Indonesia appears to have lower levels of viral transmission. The case count per million people is rising but the rolling 7-day average is yet to hit 10.
The trials will provide evidence to support or dispel the signs of efficacy seen in Sinovac’s phase 2 program. Sinovac linked a two-dose regimen of its vaccine to increased antibody levels. There were no serious adverse events in the 743 subjects dosed across the phase 1/2 program.