Johnson & Johnson announced on Friday that it had presented its coronavirus vaccine to the World Health Organization for an emergency use list. The vaccine, which is administered in a single dose, is also pending FDA emergency use authorization.
“Our registration 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, vice president, executive committee and scientific director, Johnson & Johnson in a press release. “If we want to end the global pandemic, life-saving innovations like vaccines must be available to all countries.”
The company presented data including interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial, which reflected 66% overall effectiveness in preventing moderate to severe COVID-19 28 days after vaccination. Although the effectiveness is less than 95% for Pfizer and BioNTech, employees said it still provides a much higher degree of protection than the threshold required to have an impact.
PFIZER COVID-19 85% EFFECTIVE VACCINE AFTER SINGLE DOSE, ISRAELI RESEARCHERS FIND
For example, the annual flu vaccine is usually between 40% and 60% effective.
The company hopes that the emergency use list will streamline the process of supplying supplies to COVAX, which would help distribute vaccines to low-income countries. The company had already closed an agreement to supply COVAX with up to 500 million doses of the vaccine by 2022.
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It was unclear when WHO would issue a decision on J&J’s request, and the FDA is not scheduled to meet to discuss the vaccine until February 26.