Sinovac has made some big data claims on its way to a tentative approval in China for its Covid-19 vaccine. New Phase III data show promising results in preventing severe disease, but will it be enough to convince international regulators?
Phase III trials of the vaccine, also called CoronaVac, began back in July and were ongoing in Brazil, Turkey, Indonesia and Chile using a 0/14 day schedule with a total enrollment of 25,000 participants.
The trials in Brazil and Turkey comprised 12,396 health care workers over the age of 18, and only 253 positive cases were found during the observational period in the randomized, double-blind and placebo-controlled studies.
Fourteen days after receiving two doses of the vaccine, CoronaVac prevented 50.65% for all Covid-19 cases, 83.70% of cases requiring medical treatment, and 100% of hospitalizations, and severe or fatal cases.
Also of note for the trial in Turkey, a second stage of testing included members of the general population between the ages of 18 and 59. There were 6,453 participants involved in the latter trial (in addition to 918 participants in the health care worker-exclusive trial), and 1,322 people completed the two-dose vaccination.
Sinovac said that an analysis of 29 of those cases revealed a vaccine efficacy rate for preventing Covid-19 of 91.25% after 14 days.
The results were promising enough that the company said it had officially filed for conditional market authorization for CoronaVac with China’s National Medical Products Administration and continues to actively seek regulatory approval for CoronaVac in other countries.