Can a vaccine be recalled?

You’ve had your jab and believe you are better protected from the coronavirus, but can the vaccine later be recalled?

According to the World Health Organisation (WHO), vaccine recalls or withdrawals due to safety issues are rare.

The vaccine goes through several strict safety tests by the SA Health Products Regulatory Authority (Sahpra) before it is given the green light to be used in SA.

“The normal process for the evaluation of a vaccine necessitates that all the required information regarding product safety, efficacy and quality be provided at the time of submission. In other words, all the clinical trial data for safety and efficacy from phase one to three should be provided together with manufacturing information of the product quality,” Sahpra explained.  

“The assessment is then conducted considering all information provided. In the context of the pandemic, Sahpra has fast tracked all Covid-19 product reviews and like other countries, has approved products on an emergency use basis with product specific requirements for ongoing monitoring.”

The authority also looks at local variants of the virus and asks manufacturers to provide laboratory and clinical studies showing how effective it is against the dominant strain in SA. 

The WHO said if a recall had to occur it would be picked up by the manufacturer before any adverse effects were reported.

“Recalls are usually initiated voluntarily by a vaccine manufacturer before any adverse events are reported. For example, ongoing monitoring of vaccine production may show that an irregularity has caused a batch of vaccines to lose their strength.”

If this had to be the case and you were given a vaccine from the batch, you would likely need to go for the jab again.

“People who have received a vaccine from that batch may need to be vaccinated again to ensure they are protected.”