The release of SA’s first commercial shipment of Johnson & Johnson’s (J&J’s) Covid-19 vaccine from Aspen Pharmacare’s Gqeberha facility is being delayed as a “precautionary” safety measure after problems at a US company contracted by J&J to make a key vaccine ingredient, health minister Zweli Mkhize announced on Sunday.
While Pfizer’s planned deliveries are still on track, with the first shipment of 325,260 doses expected on Sunday night, the delay in the J&J shots could slow the start of the vaccine rollout, which begins on May 17.
The government has ordered 31-million doses of J&J’s single-shot vaccine, which it is banking on to be the workhorse of its national inoculation drive since it is easier to administer and handle than Pfizer’s double-dose vaccine, which requires ultracold storage.
Aspen has 1.1-million doses of J&J’s Covid-19 vaccine ready for dispatch, but cannot release the stock until medicine regulators in the US and Europe give the nod to J&J stock worldwide after mistakes by its US contract manufacturer, Emergent BioSolutions, Mkhize said. The government expects Aspen’s stock will be released by mid-May, he said.
However J&J said it is premature to speculate on the timing of vaccine deliveries.
Emergent BioSolutions was contracted by J&J to produce a key component of its vaccines, which is provided to other contract manufacturers, including Aspen Pharmacare. In early April J&J announced that Emergent BioSolutions, which was also making vaccines for AstraZeneca, had mixed up ingredients for the two jabs.
Mkhize said international regulatory agencies, including the US Food & Drug Administration (FDA) and the European Medicines Authority, are assessing J&J stock worldwide, and that these assessments are still under way.
J&J said it is working with the FDA to secure emergency-use authorisation for the drug substance manufactured at Emergent as quickly as possible.
“We continue to update the SA government as we adjust delivery timelines for our single-shot Covid-19 vaccine and work towards producing safe, high-quality vaccines for people in SA and around the world. We look forward to meeting our commitment to supply 31-million doses of our single-shot Covid-19 vaccine to help bring an end to this global pandemic,” it said.
Business for SA (B4SA) chair Martin Kingston said if J&J vaccines are released from Aspen’s plant by May 15 it is unlikely to affect stock availability for the commencement of phase 2 of the rollout.
Documents presented to parliament in mid-April show the health department estimates it will take five days to dispatch and distribute J&J vaccines from Aspen to health facilities, and nine days for Pfizer’s vaccines to reach health facilities after they land in SA.
Mkhize said the government is continuing to vaccinate health-care workers with research stock provided by J&J for the Sisonke study, which aims to reach 500,000 people. As of Saturday, 318,670 health-care workers had been vaccinated. Once the Sisonke stocks have been administered, the government will have supplies from Pfizer available for health-care workers, he said.
Mkhize urged people over the age of 60 to register for vaccination, a call echoed by B4SA, as so far registration has been slow. By April 27 only 533,283 people aged over 60 had registered on the government site, far short of the 5.4-million people who fall into this age band, according to Stats SA’s midyear population estimate for 2020.
The government plans to start vaccinating people over the age of 60 in phase 2, in parallel with the continued vaccination of health-care workers.
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