South Africa doesn’t need FDA approval for J&J shot – WHO

South Africa can begin administering the Johnson & Johnson vaccine to citizens as it is on the emergency use list, says the World Health Organization.

DURBAN, June 8 (ANA) – The World Health Organization (WHO) said this week that South Africa does not need approval from the Food and Drug Administration (FDA) in the US before it can begin administering the Johnson & Johnson vaccine to citizens as it is on the emergency use list.

Assistant director-general for Access to Medicines, Vaccines and Pharmaceuticals Mariangela Simao said on Monday that the vaccine itself has received an emergency use listing from the WHO.

“South Africa does not rely on the FDA approval to use it, and South Africa, I believe, has the emergency use authorisation to use (it),” Simao said during a press conference.

The Johnson & Johnson vaccine came under scrutiny following a report by independent media organisation Bhekisisa, which said that the vaccination of teachers in South Africa may have to be halted pending the outcome of an FDA investigation into a manufacturing plant in the US.

The report quoted the director-general in South Africa’s health department, Dr Nicholas Crisp, as saying the FDA had yet to rule on whether the drugs had not been contaminated during production and could therefore be used.

South African online newspaper Daily Maverick quoted Crisp as saying during a webinar that the country had procured a total of 31 million Johnson & Johnson doses, but the first two batches of 1.1 million and 900,000 could not be released until the FDA gave approval.

An FDA report found that the manufacturing rooms and corridors at the Emergent BioSolutions production plant, where key vaccine ingredients are made, had not been cleaned and were unsanitary.

Teachers in KwaZulu-Natal province were prioritised to receive the Johnson & Johnson Covid-19 vaccine from Wednesday, Premier Sihle Zikalala said at the weekend.

Zikalala said 21 new vaccination sites would be opened during the course of the week to drive the roll-out and that KZN would receive 110,400 doses of the Johnson & Johnson vaccine expected in the country.

“Some districts will open new sites where sites don’t already exist, while others will have to designate their existing sites accordingly, to accommodate the teachers,” he told journalists.

“We’re also exploring the possibility of opening these vaccination sites on weekends, because educators work Monday to Friday.”

KwaZulu-Natal already has 142 vaccination sites, 18 of which are linked to private institutions, while the rest are public.

The province has so far inoculated 360,451 health workers as well as senior citizens aged 60 and above, using the Covid-19 vaccine manufactured by Pfizer.

– African News Agency (ANA); Editing by Yaron Blecher