SA still waiting for answers on J&J shots from US regulator
A decision by the Food and Drug Administration is likely to come later in the week, says Boitumelo Semete-Makokotlela
The decision by the US Food and Drug Administration (FDA) on whether millions of Covid-19 vaccines manufactured by Johnson & Johnson (J&J) can be released has been delayed and is likely to come later in the week, the head of SA’s medicines regulator said on Monday.
The FDA is in the process of determining whether substandard manufacturing conditions at troubled J&J contractor Emergent BioSolutions have been fixed. It is also looking into the extent to which the contamination issues it identified earlier this year affect batches of vaccines manufactured by J&J contractors that relied on ingredients supplied by Emergent, including Aspen Pharmacare...