South Africa to Analyze J&J Vaccines Made at U.S. Plant Halted Over Error

Reuters

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic//File Photo

South African health inspectors will carry out further checks on a batch of Johnson & Johnson (JNJ.N) COVID-19 vaccines following a contamination error earlier this year at the U.S. plant where the doses were produced, the health ministry said.

As fears of a third COVID-19 wave grow in the hard-hit country, the ministry said late on Friday that officials from the health products regulator would assess the vaccines to ensure they are suitable for use.

"There is now a real possibility that they may not be, however this is for the regulator to rule on," a ministry statement said.

The ministry said 300,000 J&J doses had been cleared for export to South Africa and that the U.S. Food and Drug Administration (FDA) had approved an extension of the expiry date, saying the vaccine can be stored at 2-8 degrees Celsius for 4.5 months instead of three.

"The FDA is still evaluating some batches and we will await those outcomes, in the hopes that this will make more doses of Johnson & Johnson available to the international community, including South Africa," the ministry added.

South Africa launched phase two of its vaccine rollout in May, aiming to inoculate five million people aged over 60 by the end of June. read more

Manufacturing at the Baltimore plant owned by Emergent Biosolutions Inc (EBS.N) was halted in April after the discovery that ingredients from AstraZeneca's (AZN.L) COVID-19 vaccine, also being produced at the plant at the time, had contaminated a batch of J&J's vaccine. read more

An inspection by the FDA also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant.