Medicines regulator confirms J&J vaccine registration conditions restrict sale to state
Most Read
Most Read
Most Read
Most Read
Most Read
Most Read
Most Read
Most Read Only the national government can purchase and oversee the rollout of vaccines, bypassing the private sector BL PREMIUM 13 April 2021 - 11:52 Tamar Kahn
SA’s medicines regulator has confirmed that one of the conditions attached to its approval of Johnson & Johnson’s (J&J) Covid-19 vaccine restricts its sale to the national government, Business Day has learnt.
This means that neither provincial governments nor private-sector entities, such as large employers or pharmacies, can buy directly from the vaccine manufacturer, even if it were willing to sell directly to them. J&J and several other vaccine manufacturers have previously indicated they will only sell to the national, but private-sector players have been hopeful that this position will shift at some point.
MONEYWEB
app instead?
Will meet Wednesday. 16:44
Image: Stephen Zenner/Bloomberg
South African health authorities and scientists will meet Wednesday to discuss the US decision to suspend use of Johnson & Johnsonâs Covid-19 vaccine after it was linked to rare blood clots.
The Ministerial Advisory Committee on Covid-19 will be part of the meeting and will advise the government, Barry Schoub, the head of the group, said in an interview. The South African Health Regulatory Products Authority and the scientists running a trial of J&Jâs vaccine will be part of the meeting, according to Yuven Gounden, a spokesman for the regulator.
Sahpra mum on possible ‘halt’ of J&J vaccine after US rollout pause South Africa has ordered 30 million doses of the J&J vaccine, already approved by the SA Health Products Regulatory Authority last week. South Africa received the first delivery of the Johnson & Johnson Covid-19 vaccine on 16 February 2021 at the OR Tambo International Airport. Picture: GCIS
This follows recommendations of a rollout pause by the US Food and Drug Agency (FDA) and the Centers for Diseases Control (CDC) after “six reported cases of a rare blood clot in patients who have received the shot”.
Editor’s note: Following the publication of this article it was announced that Health Minister, Dr Zwelini Mkhize, would make an “announcement on South Africa’s response in consideration of the FDA’s decis
Daily Maverick 168 weekly newspaper.
As the South African Health Products Regulatory Authority (Sahpra) settled several court applications on Tuesday 6 April to provide wider access to ivermectin for the treatment of Covid-19, the country’s infectious disease specialists insisted that this was not the right way to do it.
Despite battling through two brutal waves of the Covid-19 pandemic, South Africa’s frontline doctors, all infectious disease specialists, were among a group of esteemed medical experts who told the court that it was not in the public interest to allow broad access to ivermectin through legal action, insisting that evidence of the drug’s efficacy and safety were still lacking.
Johnson & Johnson Covid vaccine approved for general use in South Africa
Bloomberg1 April 2021
Subscribe
Johnson & Johnson’s coronavirus vaccine has been approved by South African regulators for general use days after President Cyril Ramaphosa said the country will get more than 30 million doses.
The South African Health Products Regulatory Authority has backed the single-shot candidate with conditions, spokesman Yuven Gounden said by phone on Thursday, without giving further detail.
The US drug maker’s vaccine has so far only been used in the country to inoculate health workers, and its approval is a boost to a national roll out that’s been hit by a series of delays.