Delay in J&J shots after mistakes by US firm could slow start of vaccine rollout

Business Live Premium: Tamar Kahn

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.