Johnson & Johnson will be submitting the manuscript of its Phase III ENSEMBLE Covid-19 vaccine trial within the coming weeks for peer review, said a company spokesperson. The aim was to send the paper for review on 8 March to the New England Journal of Medicine, a trial investigator noted.
The review is likely to take about a week, and the paper will discuss more detailed data of the single-dose JNJ-78436735 vaccine, the investigator added. The date of publication is not known at this time, the spokesperson said, and the investigator noted it will likely be published sometime this month.
JNJ-78436735, a recombinant adenovirus type 26 vector carrying the SARS-CoV-2 spike protein, is the third Covid-19 vaccine to be authorised in the US. It secured Emergency Use Authorisation (EUA) from the FDA on 27 January, with the CDC recommending the vaccine for use in people ages 18 years and over.
ENSEMBLE topline data was announced on 29 January, with the single-dose vaccine being 66% effective overall in preventing moderate-to-severe Covid-19 28 days after vaccination, the trial’s primary endpoint. The level of protection in the US cohort was 72%, compared with 66% in Brazil and 57% in South Africa.
JNJ-78436735 efficacy in South Africa seem to be dampened by the variant of concern first detected in the country, B.1.351, which caused 95% of local infection events in the trial. A two-dose schedule of JNJ-78436735 is also under investigation in the Phase III ENSEMBLE 2 trial, which is still enrolling, as per ClinicalTrials.gov.
On 23 February, this news service reported a South Africa-based Phase IIIb observational trial of single-dose JNJ-78436735 enrolled 18,000 healthcare workers of its 500,000-volunteer target within a week of trial initiation. On 5 March, the vaccine was granted an interim order authorisation in Canada. JNJ-78436735 has been submitted for emergency use listing with the Who (19 February) and marketing authorisation with the EMA (16 February).
Due to the possibility of revaccinations to combat variants of concern, JNJ-78436735’s vaccine technology could be at a disadvantage. Companies with an adenovirus vector would have to monitor anti-vector response and adjust the vector accordingly, on top of needing to be nimble against variants of concern, this news service reported 12 February. Adenovirus vectors are large enough to carry other SARS-CoV-2 proteins beyond the spike to bolster efficacy against variants of concern, though this would complicate production lines and increase manufacturing costs without guaranteed efficacy benefit, this news service reported 26 February.
Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.