US Regulator Set to Approve J&J COVID-19 Jab Despite Severe Reactions in Patients

South Africa, the place two extreme allergic reactions to the Johnson & Johnson vaccine got here to mild on Friday, acquired a second batch of 80,000 doses from Belgium on Saturday morning to be used in a mass scientific trial of up to half-a-million healthcare staff.

The US Food and Drug Administration (FDA) is about to accredited Johnson & Johnson’s COVID-19 vaccine — regardless of take a look at topics struggling extreme negative effects.

The FDA’s Vaccines and Related Biological Products Advisory Committee advisable approval for the single-dose jab on Friday, which might see it cleared for common use as early as Saturday.

But that was after a scientist for the US drug large advised the FDA she had acquired two experiences of extreme allergic reactions — one a doubtlessly life-threatening anaphylactic response — to the vaccine from an ongoing trial amongst healthcare staff in South Africa.

Earlier this week the FDA stated it knew of three different instances of “severe side effects” from the vaccine, together with one “hypersensitivity” response.

South Africa acquired a second batch of 80,000 doses of the J & J vaccine on Saturday morning, to be used in the mass scientific trial on up to 500,000 healthcare staff. A specially-chartered flight by state-owned South African Airways introduced the cargo from Belgium to Johannesburg’s O R Tambo airport.

The trial of the jab, but to be accredited for common use by the South African Health Products Regulatory Authority (SAHPRA), is the nation’s solely coronavirus vaccine programme to date.

Health Minister Zweli Mkhize hailed the supply, together with information of the FDA’s advice the evening earlier than.

​The authorities determined to give away 1,000,000 doses of the AstraZeneca ‘Oxford’ vaccine from the Serum Institute of India to regional cooperation bloc the African Union, after an un-reviewed research claimed it was much less efficient towards the dominant native pressure of the virus. Similar research outcomes for the J & J vaccine have been dismissed by South African well being officers.


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