It is still a waiting game for health workers in South Africa who enrolled in the Sisonke Johnson & Johnson (J&J) trial programme for the single dose vaccine as the South African Health Professions Regulatory Authority (Sahpra) waited for more information around contamination of the drug from the Food & Drug Administration (FDA) in the US.
Sahpra registered the Covid-19 Vaccine Janssen on 31 March, 2021, with conditions, chief executive Dr Boitumelo Semete-Makokotlela said in a statement on Monday.
The authorisation was subject to a number of conditions, which included that the vaccine should be manufactured under conditions of good manufacturing practices (GMP) “as determined by Sahpra and aligned with global best practice”.
“The manufacturing process of a vaccine and its active pharmaceutical ingredient requires stringent quality checks to ensure that the end product meets the requisite standards,” Semete-Makokotlela said.
For vaccine approvals, this allows Sahpra to access reports produced by other regulatory agencies on inspections, testing and other aspects of manufacturing and testing compliance.
“A concern was identified by the FDA, relating to noncompliance to GMP at the emergent plant in Baltimore, US, during the manufacturing of some active pharmaceutical ingredient used in the Janssen Covid-19 vaccine.
“The noncompliant batch has been rejected.
“However, the incident has led to the investigation of four more batches by the US FDA and Sahpra is awaiting reports from the US FDA on whether or not these other batches were manufactured according to GMP standards and if the batches are contaminated.
“Until the FDA has shared these reports, Sahpra has insufficient information to approve specific batches of the Janssen Covid-19 vaccine.
“Sahpra is in continuous discussion with the US FDA to ensure that this matter is resolved speedily. Sahpra will take all the necessary steps to ensure that the vaccines that are administered to South Africans meet all the requisite stringent standards so that the health and well-being of all are not compromised in any way,” said Boitumelo Semete-Makokotlela.
Meanwhile, teachers and non-teaching staff above the age of 40 are next in line to be vaccinated.
While vaccination is voluntary, the National Professional Teachers’ Organisation of South Africa (Naptosa), together with other teacher unions, has urged all eligible education sector staff to embrace this opportunity.
The long-awaited J&J vaccine suffered some setbacks in the US after contamination problems at a Covid-19 vaccine plant in Baltimore, which has had a knock-on effect locally.
Naptosa has welcomed the additional J&J vaccine doses that have been secured for the education sector.
According to Naptosa executive director Basil Manuel, the director-general of the department of basic education (DBE) confirmed this at a meeting with the unions on Friday.
Manuel said the doses were initially expected to arrive on Friday last week, with vaccination to commence tomorrow.
However, according to independent media organisation Bhekisisa, if the consignment of half a million J&J doses is cleared by the FDA, it will only arrive in South Africa by mid to late next week, with an expiry date of 28 June because this is “the only stock available”.
Additional reporting SAnews. gov.za