Vaccine latest: SAHPRA gives Sinovac the thumbs up

More good news on the vaccine front for the country: The South African Health Products Regulatory Authority (SAHPRA) has given the Sinovac COVID-19 vaccine the green light – which means it can now be acquired by the country, to further ramp up its vaccination roll-out.

The Sinovac vaccine is only administered to people aged between 18 and 59 years. Just like the Pfizer vaccine, it is given in two doses – with the second jab administered between 14 and 28 days after the first dose.

SAHPRA: Sinovac vaccine accepted ‘on conditions’

SAHPRA said the authorisation of the CoronaVac COVID-19 vaccine was based on certain conditions.

“This authorisation is based on the safety, quality and efficacy data submitted by Curanto Pharma (Pty) Ltd to SAHPRA between 22 March 2021 and 22 June 2021. Although the data submitted are considered acceptable at this point, the authorisation is subject to a number of conditions,” SAHPRA said.

“Specifically, the applicant is required to submit the final results of ongoing clinical studies. SAHPRA also took account of the World Health Organization (WHO) Emergency Use Listing (EUL) report on this vaccine”

The South African Health Products Regulatory Authority (SAHPRA)

The health regulator added that the conditions require the submission of periodic safety updates, in line with its guidelines, as well as conformance with pharmacovigilance activities.

“As outlined in the clinical trial evidence submitted by the applicant, most of the side effects following administration of the CoronaVac vaccine were mild or moderate in nature, and cleared within a couple of days. The frequently-reported adverse reactions were: pain at the injection site, headache, fatigue, muscle pain, diarrhoea and nausea”

The South African Health Products Regulatory Authority (SAHPRA)

The news will likely please the Economic Freedom Fighters (EFF) who had held a protest, demanding that SAHPRA approve the Sinovac and Sputnik vaccines, which were manufactured in China and Russia respectively.

Another condition by SAHPRA: Curanto Pharma (Pty) Ltd, which imports the vaccine, must provide information which is relevant to the risk or benefit profile of the product and also to the conditions of use.