J&J applies to WHO for emergency use approval of its COVID-19 vaccine

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Johnson & Johnson said on Friday it had submitted data to the World Health Organization (WHO) for emergency use listing of its COVID-19 vaccine, which would allow for wider access of the one-dose shot.

J&J said an emergency use listing is a prerequisite for supplying vaccines to the COVAX vaccine program, co-led by WHO, which aims to deliver doses to poor and middle-income countries.

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The J&J vaccine is administered in a single dose and can be stored at normal fridge temperatures, a big selling point in countries with relatively weaker healthcare infrastructure.

The vaccine is under review by the US health regulator, and a panel of the Food and Drug Administration’s experts are expected to discuss the vaccine’s emergency use authorization next week.

The vaccine is being rolled out in South Africa, for the first time outside a major clinical trial.

J&J said last month the vaccine was 66 percent effective in preventing COVID-19 in a large late-stage global trial against multiple variants of the coronavirus. The level of protection of the vaccine varied from 72 percent in the United States, to 66 percent in Latin America and 57 percent in South Africa.

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The company said the data delivered to WHO includes results from the late-stage trial.

J&J entered into an agreement in December in support of the COVAX program.

The company and Gavi, which also co-leads COVAX, expect to enter into an advance purchase agreement that would provide up to 500 million doses of the single-dose vaccine to COVAX through 2022, J&J said.

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