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Pharmaceutical group Johnson & Johnson is the first company to apply for registration of a Covid-19 vaccine in South Africa, the South African Health Products Regulatory Authority (Sahpra) said on Monday (December 14).
Sahpra CEO Boitumelo Semete told a press conference on Monday that the request was received on Thursday night (December 10) and that the regulator has started an official review process.
Semete said the regulator would focus on the safety, quality and efficacy of the vaccine. He added that the regulator has held a series of pre-filing discussions with pharmaceutical companies in which it advised on the data necessary for a successful application.
In a interview Last week, the regulator said the government expects to receive its first vaccines from the Covax global vaccine distribution scheme in the second quarter of next year.
“Sahpra will prioritize all Covid-19 applications and apply an accelerated approach to health products, including vaccines,” said spokesperson Yuven Gounden.
The accelerated method will include a “continuous review approach” in which evaluation of the vaccine candidate is done as data becomes available, he said.
The regulator will build 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 applications of the vaccine in the next week or two,” Gounden said.
President Cyril Ramaphosa said South Africa is in the process of finalizing its process at the Covax facility, which is a resource sharing initiative that will provide countries with adequate access to various potential vaccines.
“It is anticipated that we could have access to a suitable vaccine by the second quarter of 2021 and we 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 sure that there will be little or no transmission of the virus, and it will be an expensive undertaking.
“We need to prepare for this and be ready to make tough decisions about where to find the money and when to deploy it,” he said.
Are Covid-19 Vaccines Safe?
As with any other drug that can have side effects or adverse effects in some people and at the same time be effective in curing or controlling disease, vaccines can prevent disease and also have adverse effects in some people, Sahpra said.
Sahpra said he is mandated to monitor such adverse effects and ensure they are properly recorded and managed so that if a vaccine becomes more dangerous than useful for the purpose for which it was designed, regulatory action can be taken to warn the public. about newly discovered adverse effects or recall the vaccine from the market to protect the public.
The regulator said it achieves this through the use of a pharmacovigilance unit.
“The Sahpra pharmacovigilance unit is responsible for monitoring, detecting, evaluating, understanding and preventing adverse effects or any other drug-related problem.”
This is to ensure that only high-quality safe and effective drugs are used in South Africa, he said.
“To monitor and detect adverse effects of medications, the unit receives reports of adverse effects of medications from the public and healthcare providers and evaluates them to make the necessary regulatory decisions to prevent any additional potential harm to the public.” .
Read: Some nationwide lockdown restrictions in South Africa could return sooner than expected – Analysts
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