Johnson & Johnson announced on Friday that it had submitted its coronavirus vaccine to the World Health Organization for emergency use listing. The vaccine, which is administered in a one-dose jab, is also pending emergency use authorization from the FDA.
"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," Paul Stoffels, Johnson & Johnson vice chairman of the executive committee, and chief scientific officer, said in a news release. "If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries."
The company submitted data including interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial, which reflected 66% effectiveness overall in preventing moderate-to-severe COVID-19 28 days after vaccination. While the efficacy is lower than Pfizer and BioNTech’s 95%, officials said it still provides a degree of protection much higher than the threshold needed to have an impact.
For instance, the annual flu vaccine is typically between 40% and 60% effective.
The company is hoping that the emergency use listing would streamline the process of providing supply to COVAX, which would help distribute vaccines to lower-income countries. The company previously reached an agreement to supply COVAX with up to 500 million doses of the vaccine through 2022.
It was not clear when WHO would issue a decision on J&J’s request, and the FDA is not scheduled to meet to discuss the vaccine until Feb. 26.