Johnson & Johnson submits the COVID-19 vaccine to the WHO for emergency listings

Johnson & Johnson announced Friday that they have submitted their coronavirus vaccine to the World Health Organization for emergency listings. The vaccine, which is administered in a single-dose jab, is also awaiting FDA approval for emergency use.

“Our submission to the World Health Organization is another important step in our efforts to combat COVID-19 and also in our unwavering commitment to equitable access,” said Paul Stoffels, vice president of Johnson & Johnson of the executive committee and chief scientist . in a news release. “If we want to end the global pandemic, life-saving innovations such as vaccines must be achieved within all countries.”

The company submitted data, including interim efficacy and safety results of the Phase 3 ENSEMBLE clinical trial, which reflect 66% efficacy in preventing moderate to severe COVID-19 28 days after vaccination. Although the efficiency is lower than the 95% of Pfizer and BioNTech, officials said it still offers a degree of protection that is higher than the threshold needed to have an impact.

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The annual flu vaccine, for example, is between 40% and 60% effective.

The company hopes the emergency listings will streamline the process of supplying COVAX, which will help distribute vaccines to lower-income countries. The company had earlier reached an agreement to deliver up to 500 million doses of the vaccine to COVAX by 2022.

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It was not clear when WHO would make a decision at J & J’s request, and the FDA would only meet on February 26 to discuss the vaccine.

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