US curb on J&J vaccine threatens African manufacturing plans

The recent decision by US authorities to limit the use of Johnson & Johnson’s (J&J) coronavirus vaccine over concerns about a rare blood-clotting disorder will fuel hesitancy about its use in other parts of the world and may jeopardise SA’s vaccine manufacturing ambitions, Medical Research Council president Glenda Gray warned on Monday.  

The US Food and Drug Administration (FDA) announced on Friday that people should get immunised with mRNA vaccines made by Pfizer or Moderna instead of J&J’s shot, unless they had medical reasons not to, did not want an mRNA jab, or mRNA shots were not available. Citing data previously flagged by other US authorities, the FDA said the risks of the J&J shot outweighed the benefits for adults who could get an alternative.

The FDA’s decision does not directly affect SA’s provision of J&J’s vaccine, which has been approved by the SA Health Products Regulatory Authority (Sahpra) but it may have a chilling effect on public perception, slow demand for the shot in Africa, and threatens Aspen Pharmacare’s vaccine manufacturing plans, said Gray.

“It has the potential to be tragic for our vaccine manufacturing capability”, she said, referring to Aspen Pharmacare’s recent warning that it is considering closing its vaccine manufacturing plant due to lack of orders. It bottles J&J’s Covid-19 vaccine for Africa, and had intended to make its own copy of the shot, branded Aspenovax, but the dearth of orders has left those plans hanging in the balance.

“There has been no procurement from multilateral agencies for any African-produced vaccine, which goes against all the policy commitments that African and European leaders made. Unless the procurement dynamics change, all African vaccine manufacturing capacity will be placed in jeopardy,” said Aspen head of strategic trade Stavros Nicolaou.

Gray, who drove the initiative to provide SA’s front-line healthcare workers with J&J shots in the Sisonke trial, said the vaccine was effective and had an acceptable safety profile. Unlike the US, many African countries did not have ready alternatives to the J&J shot, she said. Most African countries are unable to provide mRNA vaccines because of their ultra-cold storage requirements.

Barry Jacobson, president of the Southern African Society of Thrombosis and Haemostasis, said evidence from SA did not confirm US data published by the FDA on Friday, showing 3.23 cases of thrombosis with thrombocytopenia syndrome (TTS) per million doses administered. More than 8.5-million J&J shots have been administered in SA to date and only two cases of TTS have been reported in SA, neither of them fatal, he said. “It is as rare as getting struck by lightning.”

The health department’s Nicholas Crisp said any negative news about coronavirus shots risked further damage to SA’s flagging vaccination programme, which provides both J&J and Pfizer shots. The government has seen demand for vaccines plummet to a fraction of the peak recorded last August, falling from a  seven day moving average of 214,000 shots a day to little more than a  seven day moving average of 35,000 shots per day.

 Vaccine uptake has been so far below target that the government has had to destroy more than 90,000 expired Pfizer shots, and does not expect to use most of the 5.6-million Pfizer jabs that expire at the end of June, according to Crisp. The government has 22.8-million Covid-19 vaccine doses on hand, with roughly equal volumes of J&J and Pfizer, he said. The J&J shots do not expire until 2023 and 2024, he said.

kahnt@businesslive.co.za