Johnson & Johnson’s (J&J) investigational COVID-19 vaccine candidate has begun a rolling submission by the European Medicines Agency (EMA).
The EMA has launched a rolling review the vaccine candidate, based primarily on positive non-clinical data demonstrating that the vaccine produces a ‘robust’ immune response.
This rolling review will enable the EMA to accelerate the assessment of J&J’s vaccine by allowing the agency to review data as and when it becomes available.
When the EMA’s human medicines committee (CHMP) determines that it has sufficient data, J&J can then submit a formal application for approval of the vaccine within the European Union.
J&J is also in talks with other global health regulatory authorities as it preps regulatory review processes for the COVID-19 vaccine to be used during the pandemic response period.
The investigational candidate uses J&J’s AdVac vaccine platform, which was also used to develop the company’s approved Ebola vaccine regimen, as well as additional investigational vaccines for the Zika virus, RSV and HIV.
In September, J&J advanced the vaccine into phase 3 testing, following positive interim results from a phase 1/2a trial of the shot.
In an interim analysis of results from the ENSEMBLE phase 1/2a trial, J&J’s vaccine demonstrated a promising safety profile and immunogenicity after a single dose.
The pharma giant is initiating the phase 3 ENSEMBLE trial in collaboration with the US Department of Health and Human Services’ (HHS), Biomedical Advanced Research and Development Authority (BARDA) and the US National Institute of Allergy and Infectious Diseases (NIAID).
In a separate principle agreement, J&J will also collaborate with the UK government on a phase 3 clinical trial in multiple countries to explore a two-dose regimen of its COVID-19 vaccine candidate.
A number of COVID-19 vaccine candidates are now seeking regulatory approval through similar rolling review processes, including those from Pfizer/BioNTech, Moderna and AstraZeneca.
Pfizer/BioNTech’s mRNA-based COVID-19 vaccine is the first among these to have received emergency use authorisation, after scoring approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) today.