The Pfizer Covid-19 vaccine remains safe and effective, says SA's medicines regulator.

The SA Health Products Regulatory Authority (Sahpra) issued the reassurance in response to alarm on social media about a safety report on the vaccine to the US Food and Drug Administration.

The report considered more than 7-million self-reported instances of negative side effects, with the most common being pain at the injection site, fatigue and headaches.

But it said these faded substantially after a day. “The data does not reveal any novel safety concerns or risks requiring label changes and supports a favourable benefit-risk profile of to the BNT162b2 vaccine,” it said.

Sahpra CEO Dr Boitumelo Semete-Makokotlela said on Friday: “The benefit-risk profile of this vaccine remains favourable and safe to be administered as per the rollout schedule.

“Sahpra ensures that all health products, including vaccines, have undergone the requisite evaluation and assessments that meet regulatory requirement prior to being made available to the public.

“Safety is an important concern and no product, including vaccines, will be made available to the public if there are any indications that public safety will be compromised.”

The regulator said it monitors two types of adverse events: those after immunisation and those of special interest. 

“Vaccine manufacturers must provide risk management plans indicating how identified risks will be mitigated,” it said.

“Furthermore, safety reports are submitted to Sahpra during the full cycle of the vaccine rollout process where vaccine safety issues are identified, monitored and assessed.

“As these vaccines are still new, their safety profiles are evolving and investigations are ongoing; hence the need for the continuous monitoring.”

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