The South African Health Products Regulatory Authority (SAHPRA) has authorised the administering of the Chinese-manufactured Sinovac vaccine to South Africans under “certain conditions”.
One of these conditions from SAHPRA includes the periodic submission of safety data.
Previously, the South African health products authority said that it would need to be guided by science and available data before approval of any vaccine product and that it had some concerns about the efficacy of Sinovac, as well as the Russian-made Sputnik vaccines, against the Delta variant that currently fueling the third wave of infections in South Africa.
SAHPRA had said that it needs more data from the respective manufacturers before the vaccines could be approved in the country.
It seems now the manufacturers of Sinovac have sent the corresponding information, with SAHPRA saying that the current authorisation of Sinovac “…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. Specifically, the applicant is required to submit the final results of ongoing clinical studies. SAHPRA also took account of the World Health Organisation (WHO) Emergency Use Listing (EUL) report on this vaccine,” said SAHPRA.
According to SAHPRA, via News24, side-effects experienced with Sinovac include pain at the injection site, headache, fatigue, muscle pain, diarrhoea and nausea. Most recorded side-effects were mild or moderate in nature and usually cleared away in a few days.
WHO Approves Sinovac for Emergency Use
“WHO today validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use, giving countries, funders, procuring agencies and communities the assurance that it meets international standards for safety, efficacy and manufacturing. The vaccine is produced by the Beijing-based pharmaceutical company Sinovac,” the World Health Organisation (WHO) said last week Thursday.
“The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products.
“We urge manufacturers to participate in the COVAX Facility, share their know-how and data and contribute to bringing the pandemic under control.”
The WHO surveyed the Sinovac manufacturing facility and made several other assessments before it came to the decision. Noting that there were benefits to the Sinovac vaccine, including the fact that the Sinovac-CoronaVac product is an inactivated vaccine. Its easy storage requirements make it very manageable and particularly suitable for low-resource settings.
WHO recommends the vaccine for use in adults 18 years and older, in a two-dose schedule with a spacing of two to four weeks.
Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalization in 100% of the studied population.
Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group.
Nevertheless, WHO is not recommending an upper age limit for the vaccine because data collected during subsequent use in multiple countries and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons.
There is no reason to believe that the vaccine has a different safety profile in older and younger populations. WHO says.
WHO recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to verify the expected impact and contribute to making the recommendation more robust for all countries.