Is it safe & how many doses do I need? - 5 questions about the Sinovac Covid-19 vaccine answered

The SA Health Products Regulatory Authority (Sahpra) has approved the use of the CoronaVac Covid-19 vaccine.

The regulator made the announcement in a statement on Saturday, authorising it for emergency use in the country.

“The SA Health Products Regulatory Authority (Sahpra) has authorised the CoronaVac Covid-19 vaccine, manufactured by Sinovac Life Sciences Co,” it said.

“The authorisation was done in terms of section 21 of the Medicines and Related Substances Act — a mechanism in the Medicines Act that enables emergency-use access and also enables Sahpra to authorise a medicine subject to certain conditions.”

The decision came a week after the EFF marched to the regulator demanding CoronaVac and others be approved for use in SA’s vaccine rollout programme.

Here is what you need to know about the vaccine that will soon be used across SA:

WHERE DOES IT COME FROM?

The CoronaVac vaccine is manufactured by the Chinese biopharmaceutical company Sinovac. It is imported into SA by Curanto Pharma (Pty) Ltd.

The vaccine is recommended by the World Health Organization (WHO) and passed the WHO Strategic Advisory Group of Experts (Sage) assessment on quality, safety and efficacy.

HOW MANY DOSES DO I NEED?

CoronaVac is administered as two doses, with the second dose administered between 14 and 28 days after the first jab. 

“CoronaVac is indicated for active immunisation in individuals aged between 18 and 59 years against Covid-19, the disease caused by SARS-CoV-2 virus,” Saphra said.

According to the WHO, if the second dose is administered less than two weeks after the first, the dose does not need to be repeated. However, if administration of the second dose is delayed beyond four weeks “it should be given at the earliest possible opportunity”.

WHAT COUNTRIES USE THE SINOVAC VACCINE?

According to a Covid-19 vaccine tracker, CoronaVac has been approved for use in 33 other countries including Egypt, Brazil, China, Albania, Turkey, Mexico and Zimbabwe.

IS IT EFFECTIVE AGAINST THE DELTA VARIANT?

The WHO said vaccine efficacy results showed CoronaVac prevented symptomatic disease in 51% of those vaccinated and prevented severe Covid-19 and hospitalisation in 100% of the studied population.

Former deputy director at the Chinese Center for Disease Control and Prevention, Feng Zijian, said antibodies triggered by two Chinese vaccines were found to be less effective against the Delta variant when compared with other variants. He did not say whether CoronaVac was one of these.

However, Sinovac spokesperson Liu Peicheng told Reuters preliminary results based on blood samples from those vaccinated with its shot showed a three-fold reduction in neutralising effect against the Delta variant.

He said a booster shot after the two dose-based regimen could quickly produce a stronger and more durable antibody reaction against the variant, but did not provide detailed data on this.

WHAT IF I AM OVER 60? 

The WHO’s Sage said data is limited on how the vaccine affects people above 60 years of age because of the small number of participants in clinical trials.

“While no differences in safety profile of the vaccine in older adults compared to younger age groups can be anticipated, countries considering using this vaccine in people older than 60 years should maintain active safety monitoring,” it said.