- Enrollment for the Johnson & Johnson's ENSEMBLE Phase 3 Covid-19 vaccine trial is now complete, the company announced this week
- Approximately 45 000 volunteers are partaking 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 SA, SAHPRA confirmed on Monday
Pharmaceutical company Johnson & Johnson’s large-scale Phase 3 Covid-19 vaccine clinical trial (ENSEMBLE) of their Janssen single-dose vaccine candidate is now fully enrolled with approximately 45 000 participants, the company announced on 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 data needed to determine the efficacy and safety of the Company’s investigational Covid-19 vaccine candidate,” they stated.
According to their news release, interim data from the ENSEMBLE trial are currently anticipated to be available by the end of January 2021. The trials are currently being run in the US, UK, South Africa, Belgium, Colombia, France, Germany, and the Philippines.
If the data indicate that the vaccine is safe and effective, J&J expects to submit an Emergency Use Authorisation application to the US Food and Drug Administration (FDA) in February 2021, and said that other health regulatory applications around the world will be made in parallel.
This announcement comes shortly after the South African Health Products Regulatory Authority’s (SAHPRA) Chief Executive Officer Boitumelo Semete gave an update on Monday during a virtual media briefing regarding measures in place guiding the safe and effective rollout of Covid-19 vaccines in the country, and said that they had received their first Covid-19 vaccine candidate application from J&J, and have started the review process.
Phase 2 J&J data being reviewed
A J&J spokesperson told Health24: “Janssen has submitted Phase 2 data to the South African Health Products Regulatory Authority, as per the European Medicines Agency (EMA) submission.
“This is a rolling [review] and additional data will be submitted as it becomes available.”
What is a rolling review?
The rolling review being referred to is described by the company as “a regulatory tool used by regulatory authorities to speed-up the assessment of potentially promising investigational medicines or vaccines during a public health emergency”, the company explains, adding:
“In normal circumstances, all data on an investigational vaccine’s efficacy, safety, and quality, as well as all required documents, must be submitted together at the start of a license application procedure. However, in the case of a rolling review, a regulatory authority will review data as they become available from ongoing studies.”
By reviewing data as they become available, a regulatory authority can then reach its decision sooner on whether a vaccine should be authorised, they state.
Products will comply with safety principles, reassures SAHPRA
During the briefing, Semete explained that SAHPRA has engaged with other companies conducting Covid vaccine clinical trials and expects to see more vaccine submissions as soon as they hope to make their vaccines available in South Africa.
Semete added that as regulators, it is important to be “enablers” of access, but at the same time, as a South African regulator, to ensure that quality products reach the country’s market.
She also stressed the importance of giving the public the confidence that SAHPRA would ensure that whatever product is rolled out in the country would comply with the principles of safety, quality and efficacy.
“It’s important that all of us as regulators really give our citizens the comfort and the confidence that whatever product enters the market will be a quality product,” she said, saying that no corners would be cut and that they would apply a rolling review on all submissions – a similar process that other regulators have applied.
According to Professor Helen Rees, chairperson of the entity’s board and co-director of the Wits centre for vaccinology, no licences have been approved in SA yet.
Rees also cautioned that vaccines would be available in limited quantities when they eventually reach the country, with a carefully selected group, i.e. healthcare workers, people over the age of 65 years, as well as those living with comorbidities being the first to receive the jab.