Brazilian institute says China’s synovac vaccine is safe


By Roxanne Liu and Anthony Budley

BEIJING / SAO PAULO (Reuters) – An experimental coronavirus vaccine developed by China’s Synovac Biotech appeared safe in a late-stage clinical trial in Brazil, preliminary results showed on Monday.

The Butanton Institute of São Paulo, one of Brazil’s premier biomedical research centers that is carrying out Phase 3 trials, said the two-dose vaccine, called Coronavac, was safe in a trial involving 9 million volunteers Proved to be.

But Butanan director Dimas Kovas said the vaccine would not be effective until testing was completed on all 13,000 volunteers.

Sao Paulo Governor João Doria told reporters, “The first results of a clinical study conducted in Brazil prove that Coronavac is the safest of all vaccines tested in the country and the best with the best rates.”

The result is only preliminary and researchers will monitor participants in the on-going trial. This is Synovac’s first set of results from Phase 3 global trials, which are also being conducted in Turkey and Indonesia.

Kovus stated that there were no serious adverse reactions to the vaccine, with 20% of volunteers reporting mild pain from the injection, while 15% reported a headache after the first dose, dropping to 10% for the second. He said that less than 5% felt nausea or fatigue and muscle pain also decreased.

Sao Paulo State Health Secretary Jean Gorinchetine said that the vaccine produces protective body defenses. The state hopes to get regulatory approval by the end of the year for Coronavac to begin its first vaccination program in the US in 2021.

Sao Paulo signed an agreement with Synovac to purchase 60 million doses by the end of February.

Synovac has wanted Brazil as a testing ground because it has been one of the global hotbeds of the virus, although 43% of its 70,000 new cases a day are at their peak in late July.

Brazil has reported more than 5.2 million COVID-19 cases since the epidemic began, making it the third most affected country in the world after the United States and India.

AstraZeneca plc and the University of Oxford are under analysis for their UK coronavirus vaccine trial. Pfizer Inc. has said it can provide a preliminary analysis of its test this month, and Modern Inc. may announce its results in November. Russia’s Gamalaya Institute could provide an analysis of its vaccines in the next month.

Competitive candidates developed by AstraZeneca and Johnson & Johnson have halted their trial in the United States due to safety issues.

Vaccines are considered an essential tool to prevent the ramping virus, which has killed more than 1 million people globally. Brazil is also hosting a Phase 3 trial for AstraZeneca’s vaccine candidate, while Johnson & Johnson said last month that it intended to extend the final phase of human trials there.

Coronavac uses the inactivated vaccine technique, a traditional method that uses killed viruses that cannot replicate in human cells to trigger an immune response.

Experts warn that the safety of inactivated coronavirus vaccine candidates should be observed over a longer period of time, as some other inactivated vaccines caused disease-enhancing effects where vaccine-triggered antibodies, rather than providing protection, were exposed to people Can make the infection worse. Viruses after vaccination.

(Reporting by Roxanne Liu and Anthony Boodle; Additional reporting by Eduardo Simos in Sao Paulo; Editing by Miyong Kim, Christian Plumb and Leslie Adler)

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