Johnson & Johnson the first to apply for Covid-19 vaccine registration as South Africa starts review process

Pharmaceutical company Johnson & Johnson was the first to apply for Covid-19 vaccine registration in South Africa and its jab is one of at least four being trialled in the country, along with those developed by Novavax, AstraZeneca and Pfizer.

In a recording of a media briefing by the South African Health Products Regulatory Authority (SAHPRA) on Monday, 14 December, Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA, said: “We received one application. This was received on Thursday evening [10 December] from Johnson & Johnson and we’ve started the review process.” 

The regulator would “review the safety and efficacy of each vaccine on a case-by-case basis and will only grant approval for public use once it has met acceptable standards of quality, safety and efficacy”.

The readiness programme includes the Covid-19 Vaccine Registration Working Group, comprising external and SAHPRA experts in vaccinology, manufacturing, clinical trials, epidemiology, vigilance and other specialisations informing quality, safety and efficacy.

Chairperson of the regulator’s board, Professor Helen Rees, said many of these experts are part of a global collaborative review of vaccines, in which “South Africa is really playing quite an important part”.

SAHPRA would prioritise all Covid-19 vaccine registration applications and apply an expedited approach. This will include performing rolling reviews of submissions by reviewing available data and accepting ongoing data in batches for review, relying on regulatory work by other regulators with which SAHPRA aligns, and a collaborative approach with the World Health Organisation (WHO).

The expedited process would not come at the expense of safety, quality and efficacy. “The first is to give the public confidence that [the] regulator will ensure that whatever product is eventually available in the country will be a product that complies with the principles of safety, quality and efficacy,” Rees said.

SAHPRA has a mandate to monitor any adverse effects and ensure they are recorded and managed correctly so regulatory action can be taken. The regulator says the “development and authorisation of Covid-19 vaccines must be supported by toxicology and safety studies in relevant animal models in compliance with the international standards of Good Laboratory Practices. If the candidate Covid-19 vaccine is to be used in pregnant women, then developmental and reproductive toxicity studies must be conducted to better understand the risks.”

Upon approval, the National Department of Health will determine access, the rollout strategy and distribution.

Rees said that, with a small exception, the public and the scientific community endorse a vaccine and that this is “the most important public health intervention that we have”.

Rees and Semete-Makokotlela echoed the critical role vaccines play in the elimination of major diseases such as polio and have helped with the deadly Ebola virus.

Rees said that “if we look at the numbers of people dying, the first thing about a vaccine is it stops people getting desperately ill and it stops people dying. The second thing is that we will stop transmission of this virus and we will cut this terrible pandemic.” DM/MC

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