While the efficacy figure for the single-dose vaccine compares favorably with AstraZeneca shot’s roughly calculated 60%, it is at the same time far lower than the 95% shown by the two m-RNA vaccines of Pfizer-BioNTech, Moderna and, more recently, Novavax.

Efficacy figures can vary, depending on where a vaccine is tested. In US trials, the J&J candidate developed by pharma subsidiary Janssen was shown to be 72% effective in in preventing severe to moderate Covid-19, while efficacy was only 66% in Latin America and 57% in South Africa, where a new mutant is now taking over.

Trial results also indicated that protection against Covid-19 was “generally consistent” across race and age groups, including adults over 60 years of age, who made up about a third of the volunteers.

Beyond efficacy, the adenovirus-based shot modified from an Ebola vaccine has the advantage of requiring only a single dose. Also, it can be stored at normal refrigerator temperatures for up to three months and shipped in a five-dose vial that doesn’t require dilution.

Application to FDA expected “soon”

J&J indicated that it was satisfied with the results and said Janssen plans to apply to the US Food and Drug Administration (FDA) for an emergency use authorization (EUA) soon. An application for approval by the European Medicines Agency would come at an as yet undetermined date.

“This is a single shot that can be given easily, it protects completely from that which we fear, having to go to the emergency room or a hospital,” Mathai Mammen, head of global research and development at Janssen, said in a US interview, “It’s going to change the nature of the disease.”

Janssen is currently in Phase 2 trials with a two-dose vaccine program and expects to report results later this year.

In a conference call with analysts, J&’s chief financial officer, Joe Wolk, said all  order commitments would be met, but timelines may be fluid. Target date for the US rollout is the end of June 2021. European deliveries would start toward the end of the year, thus doing nothing to alleviate the current shortage.

The EU has ordered 200 million doses, the US 100 million. The UK reportedly has signed on for 30 million, with an option for 22 million more. The healthcare group has agreed to supply a further 100 million doses to developing countries through the vaccine alliance Gavi. In all, J&J said it is on track to produce around 1 billion doses this year.

All of the orders in hand will be filled at cost, not exceeding $10 per shot, Wolk said, adding that in future supply negotiations the volume of doses ordered will impact the selling price. Johnson & Johnson received $1.5 billion in financial support for the vaccine’s development from the US Operation Warp Speed initiative.

Without providing details, the New Jersey-based group said Janssen’s Phase 3 study results showed that the vaccine it developed could deal with new strains of Covid, including some highly infectious variants seen in the US, Latin America and South Africa. J&J said it is already testing and creating vaccines with the ability to respond quickly to the South African variant.

Not only for J&J, however, tweaking an already made vaccine may be tougher than expected. Reports from the UK published on Feb. 2 suggested that the British and South African mutants may have merged.

Author: Dede Williams, Freelance Journalist