WHO approves China’s Sinovac jab – but SA’s regulator is still silent after 2 months
- The World Health Organisation has approved the CoronaVac Covid-19 vaccine, produced by China’s Sinovac Biotech, for emergency use.
- This Emergency Use Listing allows the jabs to be acquired by and dispersed through the global COVAX initiative.
- It also “allows countries to expedite their own regulatory approval”.
- South African President Cyril Ramaphosa welcomed the news on Wednesday, saying that it was a “crucial step” for the country’s own health regulator.
- But the South African Health Products Regulatory Authority, which has been studying Sinovac’s application since March, has not yet commented on the WHO’s approval.
- For more stories go to www.BusinessInsider.co.za.
The CoronaVac Covid-19 vaccine, produced by Chinese pharmaceutical company Sinovac Biotech, has been approved for emergency use by the World Health Organisation (WHO). South Africa’s medicines regulator, which has been testing the vaccine for more than two months, has yet to authorise the jab or comment on the WHO’s recommendations.
The Sinovac jab, which has already been administered in 20 countries around the world, received approval from the WHO on Tuesday. Under the organisation’s Emergency Use Listing (EUL), CoronVac doses can now be supplied to the COVAX Facility tasked with ensuring global equitable access to vaccines.
This approval comes at a critical time for COVAX, which is far behind its delivery targets and was recently dealt a blow when the Serum Institute of India announced that it would only begin resupplying the facility with AstraZeneca doses at the end of 2021.
Assessing the quality, safety, efficacy, and storage capabilities of Covid-19 vaccines, the WHO’s EUL approval “allows countries to expedite their own regulatory approval to import and administer” the jabs.
“The Sinovac-CoronaVac product is an inactivated vaccine. Its easy storage requirements make it very manageable and particularly suitable for low-resource settings,” noted the WHO advisory published on Tuesday.
South African President Cyril Ramaphosa welcomed the recent WHO approval during his budget speech to parliament’s National Assembly on Wednesday.
“This is a crucial step that should allow our own health products regulatory authority, Sahpra, to expeditiously consider the application from Sinovac,” explained Ramaphosa.
At the end of March, Ramaphosa confirmed that government was in talks with Sinovac and that the "approval process for use of the vaccines in South Africa" was in the final stages.
The South African Health Products Regulatory Authority (Sahpra), tasked with conducting data studies, received an application from Sinovac on 10 March 2021. Only vaccines approved by Sahpra may be used in South Africa. Only the Johnson & Johnson (J&J) jabs and Pfizer-BioNTech vaccine have Sahpra’s stamp of approval.
The AstraZeneca vaccine was one of the first to receive Sahpra’s approval in January but was later abandoned by the national health department due to decreased efficacy in combatting the 501Y.V2 variant.
Pfizer was the first Covid-19 vaccine manufacturer to receive EUL approval from the WHO on 31 December 2020. Pfizer’s Section 21 application – which permits emergency use for a period of six months – was received by Sahpra in early February and was approved on 16 March.
During his budget speech, Ramaphosa stressed the importance of engaging with multiple vaccine manufacturers to procure jabs which could strengthen South Africa’s vaccine rollout. Since the rollout began in February, South Africa has managed to administer just over 1 million doses, with only half of those signifying fully vaccinated healthcare workers who received the single-shot J&J jab.
“Vaccine efficacy results showed that the [Sinovac] vaccine prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalization in 100% of the studied population,” the WHO noted, adding that an advantage of the CoronaVac jab was its ability to be stored in a normal refrigerator at between 2°C and 8°C.
Sahpra has not yet provided any updates on Sinovac’s application. Business Insider South Africa reached out to Sahpra for comment on the recent WHO approval and if that would influence the regulator’s decision to authorise the vaccine’s use in South Africa.
Sahpra, although confirming receipt of these questions, had not replied at the time of publication.
(Compiled by Luke Daniel)
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