Decision from FDA on J&J vaccine ‘could come before end of week’, says Professor Helen Rees

Decision from FDA on J&J vaccine ‘could come before end of week’, says Professor Helen Rees

A decision on the safety of the Johnson & Johnson vaccine, from the United State’s Food and Drug Administration (FDA), can be expected by the end of the week.

J and J vaccine

This is according to Professor Helen Rees, an Executive Director at the Wits RHI and member of the World Health Organisation.


“Many other regulating authorities are also anxious to get this feedback from the FDA. It could be that they are not leaving a leaf unturned. We are awaiting the response, we are understanding now that it would be delayed until the end of the week. We were hoping it would be earlier this week. But we are in constant contact with the FDA.” 


Last month the distribution of the Johnson & Johnson vaccine was halted due to contamination of the doses at a plant in Baltimore in the US. 



Rees says part of the reasons why there has been a delay is due to the fact that it’s the regulator’s responsibility in that particular country to clear the vaccines. 

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“That is the responsibility of the exporting countries' regulatory authority. When they come here we will confirm the quality of those vaccines just to say for example that nothing has happened. 


“In this case, the kinds of tests that the FDA is able to do and has to do are quite specific for these new vaccines and this is not technology that Sahpra could anyway be able to assess.”


If the doses have been cleared, South Africa will be in line to secure half a million of those doses immediately to help it fight the third wave of the Covid-19 infections. 


All those doses are expected will go to inoculating the country's school teachers. 

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