Johnson & Johnson introduced on Friday that it had submitted its coronavirus vaccine to the World Health Organization for emergency use itemizing. The vaccine, which is run in a one-dose jab, can also be pending emergency use authorization from the FDA.
“Our submitting with the World Health Organization marks one other vital step in our effort to fight COVID-19 and in addition in our unwavering dedication to equitable entry,” Paul Stoffels, Johnson & Johnson vice chairman of the chief committee, and chief scientific officer, mentioned in a information launch. “If we’re to finish the worldwide pandemic, life-saving improvements like vaccines have to be inside attain for all nations.”
The firm submitted knowledge together with interim efficacy and security outcomes from the Phase 3 ENSEMBLE scientific trial, which mirrored 66% effectiveness general in stopping moderate-to-severe COVID-19 28 days after vaccination. While the efficacy is decrease than Pfizer and BioNTech’s 95%, officers mentioned it nonetheless supplies a level of safety a lot larger than the brink wanted to have an effect.
For occasion, the annual flu vaccine is often between 40% and 60% efficient.
The firm is hoping that the emergency use itemizing would streamline the method of offering provide to COVAX, which might assist distribute vaccines to lower-income nations. The firm beforehand reached an settlement to provide COVAX with as much as 500 million doses of the vaccine via 2022.
It was not clear when WHO would subject a choice on J&J’s request, and the FDA will not be scheduled to satisfy to debate the vaccine till Feb. 26.