The US Food and Drug Administration (FDA) is set to approved Johnson & Johnson's COVID-19 vaccine — despite test subjects suffering severe side effects.
The FDA's Vaccines and Related Biological Products Advisory Committee recommended approval for the single-dose jab on Friday, which could see it cleared for general use as early as Saturday.
But that was after a scientist for the US drug giant told the FDA she had received two reports of severe allergic reactions — one a potentially life-threatening anaphylactic reaction — to the vaccine from an ongoing trial among healthcare workers in South Africa.
Dr Macaya Douoguih told the committee there had not been any previously reported cases of anaphylaxis in trials.
Earlier this week the FDA said it knew of three other cases of "severe side effects" from the vaccine, including one "hypersensitivity" reaction.
South Africa received a second batch of 80,000 doses of the J & J vaccine on Saturday morning, to be used in the mass clinical trial on up to 500,000 healthcare workers. A specially-chartered flight by state-owned South African Airways brought the shipment from Belgium to Johannesburg's O R Tambo airport.
The trial of the jab, yet to be approved for general use by the South African Health Products Regulatory Authority (SAHPRA), is the country's only coronavirus vaccine programme to date.
Health Minister Zweli Mkhize hailed the delivery, along with news of the FDA's recommendation the night before.
"FDA approval of the single-dose J & J vaccine for general use is expected this weekend, paving the way for similar approval by SAHPRA in a few weeks," Mkhize said.
— Dr Zweli Mkhize (@DrZweliMkhize) February 27, 2021