FDA orders J&J to discard 60 million doses of vaccines due to possible contamination

The New York Times reports that the Food and Drug Administration has decided that about 60 million doses of Johnson & Johnson vaccines manufactured at a contaminated plant in the United States be discarded.

The FDA has yet to release a formal statement explaining its decision that could offer greater insight into the viability of two million J&J doses awaiting clearance over contamination concerns in South Africa.

FDA orders the discarding of 60 million doses of the J&J vaccines:

At issue is the Emergent BioSolutions plant in Baltimore which was shut down by the FDA in April after it reported that J&J doses were likely contaminated by a drug material intended for the AstraZeneca vaccine, which was also being manufactured at the plant.

South African Health authorities have been awaiting guidance on about two million J&J doses that were compounded and finished at an Aspen Pharmcare facility in Gqeberha – a decision that could have major implications for South Africa’s scaling up of vaccine administration in the country.

NEW: Just got this update from the FDA on the J&J vaccines after NYT reporting that it ordered 60 million doses from the Emergent BioSolutions plant discarded. See area in red which could have implications for doses in Gqeberha#sabcnews pic.twitter.com/A9qeckrtiD

— Sherwin Bryce-Pease (@sherwiebp) June 11, 2021

Explainer on the FDA’s decision to order J&J to discard its vaccines with Sherwin Bryce-Pease:

Falling behind with vaccination

Earlier, the Department of Health conceded that it is falling behind with its vaccination programme because of the hold on the release of the Johnson & Johnson vaccines.

The department said the vaccines can only be distributed once the FDA gives the green light pending the outcome of its investigation into contamination issues at a plant in the US.

1.2 million doses of the vaccine are awaiting release from the Aspen plant in Gqeberha, of which 500 000 have been secured for the vaccination of teachers. Another 30 million doses were expected to arrive in the country in the next few weeks.

By Thursday night, more than 1.6 million people have been vaccinated, of which more than one million received their first dose of the Pfizer vaccine.

Department of Health Director General, Dr Sandile Buthelezi, said because of the constraints of the delivery of vaccines, they are failing to meet their targets.

“There has been a problem as we are aware through contamination that happened in the factory in the US; hence the Food and Drug Administration is still going to release those vaccines hence we have not received those vaccines. Except for those single doses that were done through Sisonke trial that we used, which was not really commercial vaccines but rather the research stock that we were using. But because of the supplying constraints that we have as a country, we are unable to move as fast as we can as South Africa.”