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The pharmaceutical company Johnson & Johnson is the first to apply for the Covid-19 vaccine registration in South Africa. (Photo: foxbusiness.com / Wikipedia)
South Africa’s health products regulator says it will take an “accelerated approach” when reviewing candidates for the Covid-19 vaccine.
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 tested in the country, along with those developed by Novavax, AstraZeneca and Pfizer.
in a recording Speaking at a South African Healthcare Regulatory Authority (SAHPRA) press conference on Monday, December 14, Dr. Boitumelo Semete-Makokotlela, SAHPRA CEO, said: “We received an application. This was received on Thursday evening. [10 December] Johnson & Johnson and we have begun 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 program includes the Covid-19 Vaccine Registry Working Group, comprised of external and SAHPRA experts in vaccinology, manufacturing, clinical trials, epidemiology, surveillance, and other specializations reporting quality, safety, and efficacy.
Chairman of the regulatory council, professor Helen rees, said many of these experts are part of a global collaborative vaccine review, in which “South Africa is really playing a very important role.”
SAHPRA would prioritize all Covid-19 vaccine registration requests and apply an expedited approach. This will include conducting ongoing reviews of submissions by reviewing available data and accepting ongoing data in batches for review, relying on the regulatory work of other regulators that SAHPRA aligns with, and a focus on collaboration with the World Health Organization (WHO).
The expedited process would not come at the expense of safety, quality, and efficiency. “The first is to give the public confidence that [the] The regulator will ensure that any product that is finally available in the country will be a product that complies with the principles of safety, quality and efficacy, ”said Rees.
SAHPRA is mandated to monitor any adverse effects and ensure they are properly recorded and handled so that regulatory action can be taken. The regulator says that “the development and authorization of Covid-19 vaccines must be supported by toxicology and safety studies in relevant animal models in accordance with international standards of Good Laboratory Practice. If the Covid-19 candidate vaccine is to be used in pregnant women, developmental and reproductive toxicity studies should be conducted to better understand the risks. “
Upon approval, the National Department of Health will determine access, implementation strategy, and distribution.
Rees said that with one minor exception, the public and scientific community support a vaccine and that this is “the most important public health intervention we have.”
Rees and Semete-Makokotlela echoed the critical role vaccines play in eliminating important diseases like polio and helping with the deadly Ebola virus.
Rees said that “if we look at the number of people who die, the first thing a vaccine has is that it prevents people from getting seriously ill and people from dying. The second is that we will stop the transmission of this virus and we will cut this terrible pandemic. DM / MC
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