- A key part of the regulatory approval process for the Johnson & Johnson Covid-19 vaccine got under way on Friday.
- The company has been sharing data with SA regulators for months.
- There is no evidence that similar, necessary application for the Oxford/AstraZeneca vaccine has been filed, despite doses expected to arrive within days.
A key part of the regulatory approval process – an application for a genetically modified organisms (GMO) permit - for Johnson and Johnson's Covid-19 vaccine got under way on Friday, becoming the first confirmed vaccine to undergo this process.
Meanwhile, the health department has refused to clarify the status of a similar application for the Oxford/AstraZeneca vaccine, which is expected to arrive within days from the Serum Institute of India (SII).
News24 previously reported that the GMO permit application for the vaccine from the SII had not yet been filed as of 15 January, which cast doubt on Health Minister Zweli Mkhize's timeline for the arrival and distribution of the country's first Covid-19 vaccine jabs.
He reiterated this week that the first million doses of the Oxford/AstraZeneca vaccine would arrive before the end of the month. The lack of clarity around the GMO permit application, however, has resulted in uncertainty over whether, on arrival, the doses may have to be kept in a warehouse for at least 30 days prior to distribution.
It is unclear if this 30-day period will be waived for the SII-made vaccine doses. The health department was first asked to clarify this issue on 14 January, but beyond denying any oversights on its part, did not respond to further queries sent on Tuesday.
A search of national publications has not revealed any advertisement for a notice such as that published regarding the J&J vaccine.
One industry expert told News24 that customs may not clear the consignment without the necessary GMO permit. It is understood that the Pfizer/BioNTech and Moderna Covid-19 vaccines would not require a GMO permit, due to difference in the types of vaccines they produce.
On Friday, Mkhize announced that the South African Health Products Regulatory (SAHPRA) had given the health department approval to procure vaccines from the SII.
He was mum on the issue of the GMO permit or its application, which News24 understands the Biovac Institute was mandated to secure.
30-day public input period
National newspapers on Friday and Monday carried a notice published by the GMO Registrar, inviting the public to provide comments and input on the approval of a permit for the importation of the J&J vaccine – a requirement of the GMO Act.
The GMO registrar is housed within the Department of Agriculture, Land Reform and Rural Development (DALRRD).
By law, the public input period is 30 days, after which a committee examines the inputs and comments as well as technical information before a decision is made.
The GMO permit is required before importing or "general use" of any GMO, whether medicinal or agricultural.
In October, a similar notice was published for the J&J vaccine, for a permit to allow doses to be imported for phase three trials of the vaccine locally. South Africa participated in a global phase three trial of 45 000 participants.
It is unclear whether a permit was obtained for trials of the Oxford/AstraZeneca vaccine held in the country, which started in June 2020. Online searches of national newspapers did not reveal any published notices.
According to one industry expert, the GMO approval can take up to three months under normal circumstances, but expedited approval processes in response to the Covid-19 pandemic may shorten this considerably.
SAHPRA can approve vaccines for emergency use under Section 21 of the Medicines and Related Substances Act – but the Section 21 approval and the GMO permit approval are co-dependent, News24 understands from explanations offered by SAHPRA and DALRRD.
J&J is yet to seek similar approvals for its vaccine in the US and elsewhere, but News24 understands the company has been sharing data with South African regulators throughout clinical trial phases, with an eye on shortening time delays around approvals.
Results from the company's phase three trials, which included participants from South Africa, are expected to be released this week or in the first week of February.
It is one of the most closely watched vaccines as a result of early data that indicated it was effective with just a single dose, compared to two-dose regimens required with other vaccines.
In November, President Cyril Ramaphosa announced that Aspen Pharmacare would be producing 300 million doses of the J&J vaccine at its Port Elizabeth factory.
Health officials earlier this month confirmed a nine million dose deal with J&J, but the regulatory process started this week could see regulators giving the vaccine the green light only in late February.
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