J&J Files for COVID-19 Vaccine Authorization in Europe

The European Medicines Agency (EMA) is now reviewing Johnson & Johnson’s (J&J) conditional marketing authorization application for its COVID-19 vaccine, a single-dose inoculation that would help to simplify the EU’s vaccination efforts.

According to the agency, its Committee for Medicinal Products for Human Use (CHMP) will conduct an accelerated assessment of the vaccine and could deliver its opinion by the middle of March if the supporting trial data are robust. Should the panel find the vaccine’s benefits outweigh its risks, the EMA will likely recommend it for authorization by the European Commission.

J&J announced in late January that its vaccine proved 66 percent effective overall at preventing moderate-to-severe COVID 28 days after vaccination in a global phase 3 study. The trial also found that the inoculation provided an 85 percent effectiveness overall in preventing severe disease, though its South African arm showed only 57 percent efficacy against moderate- to-severe COVID-19 infection (DID, Feb. 5). However, the vaccine completely protected against COVID-related hospitalization and death within 28 days, including for multiple viral variants, such as the South African strain.

The EU has secured 200 million doses of the J&J vaccine through a supply agreement that leaves the door open for 200 million additional doses.

So far, the EU has granted conditional marketing authorizations for three COVID-19 vaccines that are now being used by member states in their vaccination programs: Pfizer/BioNTech and Moderna’s messenger-RNA (mRNA)-based vaccines and AstraZeneca/Oxford University’s adenoviral-vector vaccine.

All three of the vaccines authorized in Europe so far are double-dose vaccines. J&J’s vaccine offers significant advantages as its one-shot nature would help stretch supplies and simplify distribution. Additionally, in contrast to the mRNA-based vaccines, which have ultracold temperature requirements, the J&J shot can be shipped using standard distribution methods and stored at refrigerator temperatures for up to three months.

J&J also filed with the FDA for Emergency Use Authorization earlier this month. The agency’s vaccine advisory committee will meet on Feb. 26 to discuss authorization for the single-shot inoculation and an FDA decision is expected shortly afterward (DID, Feb. 5). — James Miessler