South Africa rejects 2 million J&J vaccines due to USFDA decision

South Africa’s COVID-19 vaccine rollout has been hit by further delays after authorities decided to discard at least 2 million Johnson & Johnson vaccines.

In a statement, the South African Health Products Regulatory Authority said they decided not to issue the vaccines, that came from a batch of possibly contaminated doses.

This is the latest setback to South Africa’s vaccine rollout which has so far given shots to just over 1% of its 60 million people.

The vaccines were found by the U.S Food and Drug Administration to be unsuitable for use due to possible contamination of their ingredients at a Baltimore plant. 

The production of the J&J vaccine at South Africa's Aspen Pharmacare manufacturing plant in the eastern city of Gqeberha, formerly known as Port Elizabeth, was eagerly awaited to give a much-needed boost to the country's vaccination drive. 

The factory has contracted with J&J to produce the vaccine using large batches of the basic ingredients supplied by Johnson & Johnson. The South African plant then blends those components and puts them in vials - a process knowns as “fill and finish.”

The South African plant has the capacity to produce about 200 million doses annually of the J&J vaccine and had already manufactured 2 million. 

But they were produced using ingredients from the Baltimore plant and therefore must not be used, according to the ruling by the FDA and South Africa's health officials.

Health authorities were expecting to use them to inoculate its health care workers and people aged 60 and older.

South Africa will now only receive 300,000 doses of the J&J vaccine which have been cleared by the FDA. But South Africans reacted very strongly to the lack of vaccines.

Early this year the country rejected about 1 million doses of the AstraZeneca vaccine after a preliminary study found the vaccine offered a reduced protection against the variant that is dominant in South Africa. 

To date, the country has given jabs to more than 1.7 million people, including nearly 480,000 health workers who were inoculated as part of a study trial of the Johnson & Johnson vaccine.