The decision by the US Food and Drug Administration (FDA) on whether millions of Covid-19 vaccines manufactured by Johnson & Johnson (J&J) can be released has been delayed and is likely to come later in the week, the head of SA’s medicines regulator said on Monday.
The FDA is in the process of determining whether substandard manufacturing conditions at troubled J&J contractor Emergent BioSolutions have been fixed. It is also looking into the extent to which the contamination issues it identified earlier this year affect batches of vaccines manufactured by J&J contractors that relied on ingredients supplied by Emergent, including Aspen Pharmacare.
SA Health Products Regulatory Authority (Sahpra) CEO Boitumelo Semete-Makokotlela said the FDA had completed its inspection of the Emergent facility in Baltimore and its decision on whether the facility can continue manufacturing and on the release of specific batches of vaccine linked to the site is expected later this week.
No specific date had been provided at this stage, she said. “We are engaging with the head of the FDA.”
The government urgently needs answers from the FDA, as its vaccination plans rely heavily on J&J’s shot. It has ordered 31-million doses of the single-shot vaccine, which was intended to be the backbone of the national rollout. Without these shots, it has only limited quantities of Pfizer’s vaccine on hand, which requires two jabs 42 days apart and is difficult to provide to rural areas because of its more complex storage requirements.
Teachers are anxiously watching developments, as the feasibility of a plan to inoculate educators with a separate consignment of vaccines offered to SA by J&J hinges on the FDA’s decision and how soon it comes. The consignment has already been thawed and needs to be used by June 28, leaving a rapidly shrinking window in which to safely administer the shots if they are given the go-ahead by regulators.
Sahpra registered J&J’s Covid-19 vaccine on March 31, subject to conditions including a requirement that it be manufactured at sites that comply with good manufacturing practice (GMP) standards.
In a statement issued on Monday afternoon, it said the contamination incident that triggered the FDA’s probe of Emergent and forced J&J to destroy 15-million vaccines had triggered the investigation of four more batches.
“Sahpra is awaiting reports from the FDA on whether or not these 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 J&J vaccine,” it said.
Sahpra has formal relationships with several medicine regulators, including the FDA, that enable the exchange of confidential information including reports on inspections, tests and other aspects of compliance with GMP standards.
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