Pharmaceutical group Johnson & Johnson is the first company to apply to register a Covid-19 vaccine in South Africa, the South African Health Products Regulatory Authority (Sahpra) said on Monday (14 December).
Sahpra chief executive Boitumelo Semete told a press briefing on Monday that the application was received on Thursday evening (10 December), and that the regulator has now begun an official review process.
Semete said that the regulator would focus on the safety, quality and efficacy of the vaccine. She added that the regulator has held a number of pre-submission discussions with pharmaceutical companies in which it advised about the data required for a successful application.
In an interview last week, the regulator said the government hopes to receive its first vaccines from the Covax global vaccine distribution scheme in the second quarter of next year.
“Sahpra will prioritise all Covid-19 applications and will apply an expedited approach to health products, including vaccines,” said spokesperson, Yuven Gounden.
The expedited method will include a “rolling review approach” where vaccine candidate evaluation is done as data becomes available, he said.
The regulator will rely on guidance from the World Health Organization and work done by international counterparts, such as European and US pharmaceutical regulators, to avoid repeating work already done that could delay approvals.
“We expect the first vaccine applications in the next week or two,” Gounden said.
President Cyril Ramaphosa said that South Africa is in the process of finalising its process in the Covax facility, which is a resource sharing initiative which will give countries suitable access to several possible vaccines.
“It is anticipated that we could have access to a suitable vaccine by the second quarter of 2021 and will initially receive quantities for at least 10% of the population,” he said in a statement this week.
“While this gives us hope, the reality is that it will take some time before we can vaccinate enough South Africans to be assured of little to no transmission of the virus, and it will be a costly undertaking.
“We need to prepare for this, and be ready to make the difficult decisions about where to find the money and when to deploy it,” he said.
Are Covid-19 vaccines safe?
As with any other medicine that can have side-effects or adverse effects in some individuals while still being effective to cure or control disease, vaccines can prevent disease and also have adverse effects in some individuals, Sahpra said.
Sahpra said it has a mandate to monitor such adverse effects and ensure that they are recorded and managed properly so that, should a vaccine become more dangerous than useful for the purpose it was intended for, regulatory action can be taken to either warn the public about newly discovered adverse effects or remove the vaccine from the market in order to protect the public.
The regulator said that it achieves this through the use of a pharmacovigilance unit.
“The pharmacovigilance unit of Sahpra is responsible for the monitoring, detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems.”
This is to ensure that only safe and effective medicines of high quality are used in South Africa, it said.
“To monitor and detect medicine adverse effects, the unit receives reports of medicine adverse effects from the public and healthcare providers and assesses them in order to make the necessary regulatory decisions to prevent any further potential harms to the public.”