J&J submits single-dose COVID-19 vaccine for EMA review

The European Medicines Agency announced Tuesday that it has received a conditional marketing application for Johnson & Johnson's COVID-19 vaccine candidate Ad26.COV2.S, and that it intends to review the submission under an accelerated timetable. The regulator indicated that the filing, which follows Johnson & Johnson's recent request for emergency authorisation in the US, could receive an opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) by the middle of March.

The EU has so far authorised three coronavirus vaccines, including Pfizer and partner BioNTech's Comirnaty (BNT162b2), Moderna's mRNA-1273 and AstraZeneca's AZD1222, which is being co-developed with the University of Oxford. All three decisions were made the same day that the CHMP had issued positive opinions for their respective candidates.

The EMA noted that it has already had a chance to review some data as part of a rolling review of Johnson & Johnson's single-dose, adenovirus serotype 26 vector-based candidate, including quality data and preclinical results that looked at how well Ad26.COV2.S triggers the production of antibodies and immune cells targeting SARS-CoV-2. It also looked at clinical safety data on the viral vector used in the vaccine. The EMA said it is now assessing "additional data on the efficacy and safety of the vaccine as well as its quality."

Efficacy varied by region

According to recent interim results from the Phase III ENSEMBLE trial, the single-dose inoculation demonstrated overall efficacy of 66% at preventing moderate-to-severe COVID-19 at 28 days post-vaccination. That rose to 85% when it came to preventing severe disease, while the vaccine completely protected against coronavirus-related hospitalisations and death. The global study also shed light on the potential of Ad26.COV2.S to confer immunity against emerging viral mutations, with efficacy varying by region. In the US, protection against moderate-to-severe COVID-19 infection was found to be 72%, but that dropped to 66% in Latin America and 57% in South Africa, where the B.1.351 variant is predominant.

Last week, the EMA indicated plans to fast-track variant-modified COVID-19 vaccines, in part by allowing much smaller trials of only a few hundred participants, rather than the usual 30,000 to 40,000, and by streamlining regulatory procedures as well.

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