JOHANNESBURG, June 12 (Reuters) – South African health inspectors will carry out further checks on a batch of Johnson & Johnson 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.
Manufacturing at the Baltimore plant owned by Emergent Biosolutions Inc was halted in April after the discovery that ingredients from AstraZeneca’s COVID-19 vaccine, also being produced at the plant at the time, had contaminated a batch of J&J’s vaccine.
An inspection by the FDA also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant. (Reporting by Tanisha Heiberg Editing by Helen Popper)
(c) Copyright Thomson Reuters 2021. Click For Restrictions – https://agency.reuters.com/en/copyright.html