Sinovac’s CoronaVac trial reauthorized by Anvisa: Phase 3 Clinical Trial Continues on

Sinovac’s CoronaVac trial reauthorized by Anvisa Phase 3 Clinical Trial Continues on

TrialSite recently reported that the Brazilian drug regulatory authority has halted the Sinovac (CoronaVac) COVID-19 vaccine trial, however days later Brazil’s National Health Surveillance Agency (Anvisa) authorized the resumption of the Phase 3 clinical trial testing the inactivated COVID-19 vaccine known as CoronaVac®. The Brazilian study is sponsored by Butantan Institute.

According to a Sinovac press release, Anvisa failed to receive key data sent by Butantan Institute in time and consequently, suspended the clinical trial on Nov. 9. However, the following day, Butantan Institute was in touch communicating with Anvisa and the report from Data and Safety Monitoring Board (DSMB) was submitted to Anvisa on the same day. Once Anvisa was able to review the data, the regulatory body made a timely decision to resume the trial.

Suspensions Common

Regulatory agencies around the world are known to pause or suspend trials from time to time for a plethora of reasons and this happened to be one of those cases. In this case, a death not associated with the study triggered the halt. The point of the Sinovac communication is that a suspension doesn’t necessarily equate to a faulty product or quality issue. 

Political Rumblings

TrialSite covered the initial halting of the study and the overall concern expressed by the sponsor (Butantan Institute) as well as the Chinese press (Sinovac is Chinese vaccine maker). Sinovac, of course, was relieved with the news of the continuing of the study, noting in their recent press release that the event showcases overall a “sensitive, timely and effective” regulatory process in Brazil.

Vaccine Safety: It’s Already in Use under EUA

It should be noted that the CoronaVac investigational product is already under emergency use authorization (EUA) in China. For example, back in Oct., Reuters reported that the Sinovac investigational vaccine product was now part of a Chinese national program for distribution to essential workers and other high risk demographic cohorts in at least one city (Jiaxing) for a cost of about $60.

Sinovac declares in its recent press that they fully stand by their confidence in the vaccine candidate’s safety.   

Other Clinical Trials

Phase 3 clinical trials assessing CoronaVac continue in Indonesia and Turkey. TrialSite has reported on the deal making in the former with Indonesia state-owned Bio Farma. Sinovac announced the launch of the Phase 3 clinical trial in Turkey back on Sept 22.

Costs

In Indonesia, Sinovac’s deal with Bio Farma totaled an initial 40 million doses of CoronaVac for $13.60 per dose. 

Of course, China is a community country and the government has the authority to impose various rules, including price controls on pharmaceuticals and vaccines. According to a report by Reuters, Chinese vaccine companies must price their products at close to cost.