Johnson & Johnson seeks US authorisation for Covid-19 vaccine
Johnson & Johnson has filed an application seeking emergency use authorisation for its Covid-19 vaccine, bringing the company one step closer to getting the first single shot vaccine distributed in the US.
The world’s largest healthcare company said it expects to supply 100m doses to the US government in the first half of the year, boosting supplies and speeding up the vaccination rollout.
Last week, J&J published interim data that showed its vaccine had a 66 per cent efficacy rate for preventing moderate and severe disease, lower than the first shots approved from BioNTech/Pfizer and Moderna, but above the minimum bar of 50 per cent set by the US regulator.
Paul Stoffels, chief scientific officer, said it is working with “great urgency” to make the vaccine available “as quickly as possible”.
“Upon authorisation of our investigational Covid-19 vaccine for emergency use, we are ready to begin shipping,” he said.
The vaccine is also being reviewed at other health authorities around the world.
If approved, J&J would be the third Covid-19 vaccine to receive emergency use authorisation in the US, which has not yet received an application from Oxford/AstraZeneca. As well as being just one shot — in contrast to two for Moderna and BioNTech/Pfizer — it only requires regular refrigeration, not ultra cold temperatures, so it will be easier to distribute.
But J&J’s interim data was also a “wake-up call” about the potential need to adjust to new variants that have emerged, Anthony Fauci said, as the vaccine appeared to be less effective in South Africa, where the 501.v2 variant dominates.
Shares in J&J added 1.1 per cent in after market trading in New York.