Phase 3 of Covid-19 vaccine trial kicks off in South Africa

  • Johnson & Johnson's Phase 3 trial of its Covid-19 vaccine has officially launched in South Africa
  • The SA trial will take place across approximately 31 sites across the country with high rates of Covid-19 cases
  • These sites include Gauteng, the North West, and the Western Cape

Johnson & Johnson has commenced its Phase 3 ENSEMBLE trial of its investigational Janssen Covid-19 vaccine, also known as Ad26.COV2.S, in South Africa, a news release by the pharmaceutical company stated.

READ | Leading Covid-19 vaccine candidate 90% effective in Phase 3 trial

The first South African ENSEMBLE participants were dosed last week Friday. The study is currently ongoing in the US, Brazil, Chile, Colombia, and Argentina. 

According to the company, the global study is a randomised, double-blind, placebo-controlled clinical trial that will evaluate the safety and efficacy of a single vaccine dose versus placebo in up to 60 000 adults 18 years old and older.

The trial will also include significant representation from those over the age of 60, as well as those with and without comorbidities associated with an increased risk of severe Covid-19.

The vaccine candidate is included in the World Health Organization’s (WHO) latest list, dated 3 November, of the most viable candidate vaccines to go into human clinical trials, and uses a technology that has a long safety record in vaccines for other diseases.

Results from the initiation of the ENSEMBLE trial showed positive interim results, and was published in medRxiv in September 2020.

Around 31 trial sites across SA

“Built on a legacy of purpose-driven actions and a commitment to diversity and inclusion, Johnson & Johnson aims to achieve broad representation of participants, including older adults and ethnically diverse populations in the implementation of its Covid-19 Phase 3 trial programme,” the release states.

In South Africa, the trial will take place across approximately 31 trial sites in locations with high rates of Covid-19 infections, including Gauteng, North West, Eastern Cape, Western Cape, Limpopo, Mpumalanga, and the Free State.

The company explained that these sites were determined in close collaboration with local health authorities, and took into account current disease prevalence, population demographics and regulatory authorities’ requirements.

Manufacturing and access

Earlier this month, SA pharmaceutical company Aspen announced that one of its subsidiaries, which trades as Aspen Pharmacare, entered into a preliminary agreement with Johnson & Johnson to manufacture Ad26.COV2-S in Port Elizabeth, Health24 reported.

The agreement is “subject to the successful completion of the relevant technology transfer activities and finalisation of certain commercial manufacturing terms,” the company mentioned.

Aspen's Group Chief Executive, Stephen Saad, told Health24 that one of the attractive factors of this vaccine is that it does not have to be kept frozen, which simplifies the logistics around transport and distribution.

Saad also commented that should the vaccine prove efficacious, manufacturing should begin in March or April 2021, and that the PE production facility has the capacity to produce more than 300 million doses per annum.

Johnson & Johnson has also committed to allocate up to 500 million vaccine doses toward international efforts to ensure access for lower-income countries.

“Johnson & Johnson is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use, provided the vaccine is demonstrated to be safe and effective and following regulatory approval,” the company said.

READ | Leading Covid-19 vaccine candidate to be manufactured in SA

READ | SA to take part in two more Covid-19 vaccine trials

READ | Why vaccines need to be tried and tested in different populations across the world

Image credit: Getty/Catherine Falls Commercial

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