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.
PFIZER COVID-19 VACCINE 85% EFFECTIVE AFTER SINGLE DOSE, ISRAELI RESEARCHERS FIND
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.
CLICK HERE FOR COMPLETE CORONAVIRUS COVERAGE
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.
