CoronaVac COVID-19 vaccine is safe and protects against disease, interim analysis of phase 3 trial suggests
20.07.2021 / Publications

The preliminary findings, published in The Lancet, indicate that CoronaVac induces a robust antibody response. No severe adverse events or deaths were reported among the more than 10,000 trial participants in Turkey, with most adverse events mild and occurring within 7 days of an injection.

 

Between September 14, 2020, and January 5, 2021, 10,218 adults between 18 and 59 years were randomly assigned to receive two doses of the vaccine (6,650) or a placebo (3,568). The trial was conducted across 24 centres in Turkey. The average age of the participants was 45 years and 5,907 (58%) were male.

In a sub-group of 1,400 participants, the vaccine induced a robust immune response in 90% of participants.

No severe adverse events were observed, and most adverse events (90%) were mild and included fatigue, injection site pain, and aching muscles.

Lead author Professor Murat Akova, from Hacettepe University Medical School, Turkey, said: “In order to bring the COVID-19 pandemic under control, the world needs every single dose of safe and effective vaccines, and our results add important evidence of the safety and effectiveness of inactivated-virus vaccines. One of the advantages of CoronaVac is that it does not need to be frozen, making it easier to transport and distribute. This could be particularly important for global distribution, as some countries may struggle to store large amounts of vaccine at very low temperatures.”

CoronaVac uses an inactivated whole virus. When people receive the vaccine, their immune system attacks the harmless form of the virus by producing antibodies to fight it off, leading to immunity. Developed by Sinovac Life Sciences, the vaccine – which can be stored and transported at 2-8°C – has been approved for emergency use in 22 countries, and has been in phase 3 trials since mid-2020 in Brazil, Indonesia, Chile, and Turkey. In this trial, participants were given two 3μg doses of CoronaVac 14 days apart.

You may find the full article via the link below:

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01429-X/fulltext