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- Registration for Johnson & Johnson’s ENSEMBLE Phase 3 Covid-19 vaccine trial is now complete, the company announced this week.
- Approximately 45,000 volunteers are participating in the trial, and results are expected in February 2021.
- J&J also became the first of the vaccine developers to apply for Covid vaccine registration in South Africa, SAHPRA confirmed on Monday.
Pharmaceutical company Johnson & Johnson’s (ENSEMBLE) large-scale Phase 3 Covid-19 vaccine clinical trial of its single-dose vaccine candidate Janssen is now fully enrolled with approximately 45,000 participants, the company announced Thursday.
“Given the high incidence of Covid-19 among the general population in the countries where the trial is being conducted, this number of participants will be sufficient to generate the necessary data to determine the efficacy and safety of the Covid-19 candidate vaccine under investigation by the company. ”They stated.
According to their press release, interim data from the ENSEMBLE trial is expected to be available by the end of January 2021. Trials are currently being conducted in the US, UK, South Africa, Belgium, Colombia, France, Germany. and the Philippines.
If the data indicates that the vaccine is safe and effective, J&J expects to submit an emergency use authorization request to the U.S. Food and Drug Administration (FDA) in February 2021, and said more will follow. health regulatory applications around the world in parallel. .
This announcement comes shortly after the executive director of the South African Healthcare Products Regulatory Authority (SAHPRA), Boitumelo Semete, gave an update Monday during a virtual press conference on the measures in place that guide the safe and effective deployment of Covid-19 vaccines in the country, and said that they had received their first candidate application of the Covid-19 vaccine from J&J and that they had begun the review process.
Phase 2 J&J data is being reviewed
A J&J spokesperson told Health24: “Janssen has submitted the Phase 2 data to the Health Products Regulatory Authority of South Africa, according to the European Medicines Agency (EMA) submission.
“This is a rolling [review] and additional data will be submitted as it becomes available. “
What is a continuous review?
The company describes the ongoing review referred to as “a regulatory tool used by regulatory authorities to accelerate the evaluation of potentially promising investigational drugs or vaccines during a public health emergency,” the company explains, adding:
“Under normal circumstances, all data on the efficacy, safety and quality of an investigational vaccine, as well as all required documents, must be submitted together at the beginning of a license application procedure. However, in the case of an ongoing review, a regulatory authority will review the data as it becomes available from ongoing studies. “
By reviewing the data as it becomes available, a regulatory authority can make an earlier decision about whether a vaccine should be licensed, they say.
Products will comply with safety principles, SAHPRA assures
During the briefing, Semete explained that SAHPRA has engaged with other companies conducting clinical trials of Covid vaccines and hopes to see more vaccine submissions as soon as they expect their vaccines to be available in South Africa.
Semete added that, as regulators, it is important to be “facilitators” of access, but at the same time, as a South African regulator, to ensure that quality products reach the country’s market.
He also highlighted the importance of giving the public confidence that SAHPRA will ensure that any product launched in the country will comply with the principles of safety, quality and efficacy.
“It is important that all of us as regulators really give our citizens the comfort and confidence that any product that enters the market will be a quality product,” he said, saying that no corners would be cut and that they would apply continuous review. in all submissions – a similar process that other regulators have applied.
According to Professor Helen Rees, president of the organization’s council and co-director of the Wits vaccine center, licenses have not yet been approved in South Africa.
Rees also warned that the vaccines would be available in limited quantities when they finally arrive in the country, with a carefully selected group – that is, healthcare workers, people over 65, as well as those living with comorbidities – being the first to receive. the vaccine. .
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