Batches of the Johnson & Johnson Covid-19 vaccine that were mixed and finished at the Aspen Pharmacare plant in Gqeberha (formerly known as Port Elizabeth) will not be released for use in South Africa, the South African Health Products Regulatory Authority (SAHPRA) said early on Sunday morning.

However, in a statement, SAHPRA has indicated that they will release 300,000 Johnson & Johnson vaccines that have been cleared by the United States Food and Drug Administration. The doses will be shipped to South Africa.

In the statement, SAHPRA CEO Dr Boitumelo Semete-Makokotlela said that after reviewing the data provided by the FDA, it has “made a decision not to release vaccines produced using the drug substance batches that were not suitable”.

“SAHPRA focuses on the quality, safety and efficacy of all health products, including COVID-19 vaccines and will ensure that the safety and wellbeing of South Africans will not be compromised in any way.”

SAHPRA had registered the Covid-19 vaccine on 31 March 2021, with conditions that included that the vaccine should be manufactured under conditions of Good Manufacturing Practices (GMP) as determined by SAHPRA and aligned with global best practice.

Last month SAHPRA stressed that they have found the practices at Aspen Pharmacare to comply with these practices but the problem is that the sterile facility, based in the Eastern Cape, had received contaminated batches of ingredients.

A concern was identified by the Food and Drug Administration in the United States relating to non-compliance with rules at the Emergent BioSolutions plant in Baltimore, USA, during the manufacturing of drug substance which is used in the manufacture of the Johnson & Johnson vaccine.

Subsequently, on 11 June 2021, the USFDA authorised two batches of drug substance produced from the Emergent site but further determined that several other batches are not suitable for use. 

The concerns by the FDA as set out in a notice included:

• Concerns over the training of operators and a decision to “abandon the recipe” and initiate a new one;
• The building where ingredients were manufactured did not comply with sanitation and cleanliness requirements;
• The paint in the manufacturing facility was peeling from the walls and inspectors found paint flecks on the floor;
• Inspectors also found a “black substance” and “brown substance” on the walls;
• Medical waste was not decontaminated properly;
• Employees handling medical waste at the facility did not comply with rules and were for instance observed throwing open bags of medical waste into a service elevator;
• Workers were seen compacting medical waste in the same area where the ingredients for the vaccine were manufactured;
• Workers failed to observe protocols to prevent cross-contamination of ingredients.

On Friday Janet Woodcock, the FDA’s Acting Commissioner of Food and Drugs and Peter Marks, the director of the Center for Biologics Evaluation and Research (CBER) explained in a statement that as part of their regulatory processes for reviewing all manufacturing facilities, the FDA recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson Covid-19 Vaccine.

“The FDA has not authorized this facility to manufacture or distribute any of Johnson & Johnson’s COVID-19 Vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the U.S. 

“The FDA’s inspections are thorough, and these assessments review the quality of manufacturing procedures, including records, staff training, facility operations, drug production and testing and the systems in place to ensure product quality. During an inspection of Emergent BioSolutions that ended Tuesday, the FDA cited a number of observations concerning whether the facility’s processes met our requirements and standards.

“The FDA’s observations are intended to identify certain conditions observed during an inspection that have the potential to lead to quality issues during the manufacturing of a product. Once we observe such conditions, we can then work with a company to help identify a path forward to remedy the issues. 

“In the case of Emergent BioSolutions, we are working with the company to address the conditions identified. At the agency’s request, Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues. For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution. We will not allow the release of any product until we feel confident that it meets our expectations for quality. 

“These actions are unrelated to an ongoing evaluation by the FDA and U.S. Centers for Disease Control and Prevention of extremely rare cases of a specific type of blood clot reported in a very small number of individuals after receiving the Johnson & Johnson COVID-19 Vaccine. 

“Johnson & Johnson confirmed on Friday that the United States Food & Drug Administration (FDA) has authorized two batches of drug substance, manufactured at the Emergent BioSolutions, Inc. Bayview facility, under the Emergency Use Authorization (EUA) for its single-shot COVID-19 vaccine.

“Since establishing our COVID-19 vaccine program, Johnson & Johnson has committed to producing safe, high-quality vaccines in order to bring health and hope to people everywhere,” said Kathy Wengel, Executive Vice President and Chief Global Supply Chain Officer, Johnson & Johnson. “Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale, and we appreciate the close collaboration with the FDA and global health authorities.

“The Company continues to substantially expand its global vaccine manufacturing network as we work with regulatory and health authorities to supply our COVID-19 vaccine worldwide.”

Speaking earlier, National Health Department spokesperson Lwazi Manzi said the Department noted the statement by the FDA.

“The implications for South Africa are as follows: The vaccines awaiting distribution from the Gqeberha plant need further assessment by SAHPRA and SAHPRA will soon advise if they are suitable for use in South Africa (SAHPRA subsequently said no). There is now a real possibility that they may not be, however this is for the regulator to rule on.

“In total, 300,000 doses are cleared to be shipped to South Africa as a matter of extreme urgency. Furthermore, the FDA announced that, after careful evaluation of these doses, they approved an extension of the expiry date after determining that the vaccine can be stored in 2-8 degrees celsius (normal bar fridge) for four and a half months instead of three months. Work is being undertaken to identify more safe doses for the rest of the mass vaccination programme. We further note that the FDA is still evaluating some batches and we will await those outcomes, in the hopes that this will make more doses of Johnson & Johnson available to the international community, including South Africa,” she said. 

Last week a deputy director in the Department of Health, Dr Nicholas Crisp, who is currently in charge of the country’s Electronic Vaccination Distribution System (EVDS), said they were ready to scale up their registration, allocation and distribution of vaccines as soon as the Johnson & Johnson vaccines are received. 

South Africa’s rush to vaccinate comes as the  Covid-19 statistics from 12 June show South Africa recorded 9,320 new cases, an alarming figure as the country battles the third wave of coronavirus infections.  

According to the National Institute of Communicable Diseases, this indicates a 16.6% positivity testing rate. 

Gauteng had the majority of new cases with 63%, followed by the Western Cape (11%) and North West province (6%).

By Saturday there was an increase of 435 hospital admissions and 62 in-hospital deaths.  

Gauteng, Western Cape, North West, the Free State and the Northern Cape are already in their third waves.  

With Gauteng as the epicentre of the coronavirus, the province is looking at introducing tighter restrictions to curb the spread.  

During a visit to the vaccination centre at the Chris Hani Baragwanath Hospital on Saturday Premier David Makhura said level 2 restrictions were not sufficient.  

“People are going on as if we are really not in the middle of a raging pandemic,” he said.  

The country moved to adjusted Level 2 lockdown restrictions on 31 May.  

Over the course of seven days, Gauteng recorded more than 24,000 new cases while hospitalisations in public and private facilities currently sit at close to 3,800 people.  

Alarm bells over bed space have been ringing since cases started rising in the province last month. With 4,415 beds available for Covid-19 patients the Gauteng Command Council said it was well-placed to deal with hospitalisations.  

Acting national Health Minister Mmamoloko Kubayi-Ngubane said an intervention team would be sent into the province to bolster human capital and manage the surge in cases. 

The country technically entered its third wave on Thursday 10 June. According to the Ministerial Advisory Committee on Covid-19, a new wave starts when the seven-day moving average of new infections surpasses 30% of the previous wave. 

On Thursday, the Western Cape announced its entry into the third wave with a 34% week-on-week Covid-19 case increase. The province is sitting at 987 new cases.

There were 1,028 patients with Covid-19 complications in hospitals across the province by Thursday (457 in public hospitals and 571 in private facilities).

Provincial health department head Dr Keith Cloete said the third wave is expected to last between eight and 10 weeks, with the peak of infections and its decline based on the province’s first and second waves. DM