Pfizer Covid-19 vaccines still favourable and safe to be administered – Sahpra

The South African Health Products Regulatory Authority (Sahpra) says Pfizer Covid-19 vaccines are still favourable and safe to be administered as per rollout schedule, according to the latest reported safety data reviewed by the institution.

This comes after the US Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) earlier this week published Pfizer data from its clinical trials in support of a Covid-19 vaccine licence.

The report details several side effects from the vaccine, causing an uproar on social media as some reiterated claims that the vaccines are not safe.

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Pfizer is authorised for use in South Africa in adults and children aged 12 years and older, and according to the institution, all Covid-19 vaccines authorised for use in South Africa have been evaluated for quality, safety and efficacy, and have proven to prevent serious disease and death from Covid-19.

Vaccine manufacturers must provide Sahpra with risk management plans (RMPs), indicating how
identified risks will be mitigated. Safety reports are also submitted to Sahpra during the full
cycle of the vaccine rollout process where vaccine safety issues are identified, monitored and
assessed.

“The safety report issued by Pfizer indicates all AESIs reported during the reporting period. However,
not all AESIs included in the report are linked to the vaccine. As these vaccines are still new, their
safety profiles are evolving and investigations are ongoing; hence the need for the continuous
monitoring,” said Sahpra in a statement of Friday.

“Based on the latest periodically reported safety data reviewed by Sahpra for Pfizer Covid-19 vaccines, the benefit-risk profile of this vaccine remains favourable and safe to be administered as per the rollout schedule.”

No product, including vaccines, will be made available to the public if there are any indications that public safety will be compromised, said Sahpra.

Compiled by Vhahangwele Nemakonde