GETTING medicines granted emergency use authorisation (EUA) has moved at a quicker pace since the Covid-19 pandemic.

Vaccines that are circulating all over the world have been accessed through this mechanism to allow them (vaccines) to be used while trials are still underway.

According to the Lancet, an EUA is a regulatory mechanism that enables the public to gain access to promising investigational medical products when those products have not yet received regulatory approval and licensure.

This pathway has previously been used for accessing unlicenced vaccines in public health emergencies and can be ethically justified provided that certain conditions are met, i.e. the unregistered health product is safe, efficacious and of acceptable quality.

In a press release published in February last year, the World Health Organisation said the Emergency Use Listing (EUL) was a procedure to streamline the process by which new or unlicenced products can be used during public health emergencies.

This risk-based procedure is used for assessing and listing unregistered vaccines, therapeutics and in vitro diagnostics with the aim of expediting the availability of these products to people affected by a public health emergency.

One of the requirements on the EUL is that “the disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic and is reasonable to consider the product for an EUL assessment.”

It is through this mechanism that many of the Covid-19 vaccines were made available to the public in less than a year since the virus started wreaking havoc globally.

The other regulatory mechanisms to access unregistered health products during a public health emergency are as follows:

1. Priority registration review.

2. Clinical Trial authorisation.

What is the Section 21 Unit?

In Mzansi, this procedure is called the Section 21 regulatory pathway and according to the South African Health Products Regulatory Authority (SAHPRA) website, the Section 21 (for Category A medicines) processes and evaluates applications from applicants for access to unregistered medication within South Africa.

The applicant establishes whether there is a need for a certain medicine. If the Category A medicine is unregistered within South Africa, the applicant will submit a Section 21 application (Category A medicines).

It has allowed medical practitioners to access life-saving medicines in at least 24 to 48 hours after the practitioner has made an application.

But according to SAHPRA, this process could take longer in cases where the substances or unfamiliar medication requires extensive review to be done by the evaluators.

Which vaccines have EUA in Mzansi?

In Mzansi, there is currently one vaccine that has been granted EUA or Section 21 status, two others have applied and are yet to be approved, according to the regulator.

Up until last week, the AstraZeneca vaccine (COVISHIELD™) had been the only vaccine that was granted Section 21 status by the health products regulator.

Despite being now the vaccine that is used to initiate the Covid-19 vaccine rollout under the phase 3b implementation study, the Janssen vaccine from Johnson and Johnson is yet to receive authorisation by SAHPRA.

Furthermore, the Pfizer vaccine has not yet received approval by SAHPRA.

But their regulatory review for registration is well underway, with information submitted as and when it becomes available.

The government has been racing to ensure these vaccines get authorisation as soon as possible, with the Minister of Health Dr Zweli Mkhize saying that they want to ensure that the inoculation goes ahead as planned.

COVID-19 Conversations is brought to you by the African Alliance in partnership with the South African Medical Research Council, the Department of Science and

Innovation and the Vaccine Advocacy Resource Group.


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