As J&J eyes approval for its one-shot COVID-19 vax, it sends off phase 3 data for a swift WHO listing

Johnson & Johnson has sent off its phase 3 data package to the World Health Organization (WHO) for its one-and-done COVID-19 vaccine shot just a few weeks after showing off its efficacy.  

Specifically, J&J’s research arm Janssen has asked for an Emergency Use Listing (EUL) from the WHO, a procedure designed to speed up the use of new or unlicensed products during public health emergencies, such as COVID-19. It has already been used for several others, including the COVID-19 vaccine from AstraZeneca and the University of Oxford.

Though its vaccine efficacy was below that off mRNA developers such as Moderna and Pfizer-BioNTech, it still cut out hospitalizations and deaths, and poses fewer logistical challenges than its rivals, meaning it can be distributed more easily around the world, and easier to administer as it only requires one shot.

This will likely be a bonus for the WHO, which uses the EUL to boost access to these sorts of vaccines to countries around the world. It’s also a prerequisite to supply vaccines to the new COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.

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But production may still prove a barrier: But J&J's early supplies of its vaccine are extremely limited, a White House adviser said this week. It is expecting a FDA emergency use green light next month, but only has a few million doses upfront. The company remains however optimistic, saying in response that it “expects to supply 100 million doses to the U.S. in the first half of 2021.”

“Our filing with the World Health Organization marks another important step in our effort to combat COVID-19 and also in our unwavering commitment to equitable access,” said Paul Stoffels, M.D., chief scientific officer at Johnson & Johnson. “If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries.”