J&J applies to WHO for COVID vaccine approvalFriday, February 19, 2021
NEW BRUNSWICK, New Jersey (AP) — Johnson & Johnson has applied to the World Health Organization for emergency approval of its COVID-19 vaccines, which should help speed up its use in countries around the world.
J&J said Friday that its Janssen-Cilag International subsidiary has submitted to the WHO the last testing data needed on its vaccine's efficacy and safety, completing the New Brunswick, New Jersey company's application for an emergency use listing.
Obtaining that listing will expedite access to J&J's single-dose vaccine for United Nations procurement agencies and scores of countries. The listing also is required for Johnson & Johnson to supply doses of its vaccine to what's called the COVAX Facility, a WHO-backed project to ensure equitable access to vaccines for about 190 low- and middle-income countries. Johnson & Johnson in December agreed to provide up to 500 million doses of its vaccine to COVAX through 2022.
“If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries,” Johnson & Johnson Chief Scientific Officer Dr Paul Stoffels said in a statement.
The company is supplying the vaccine at not-for-profit prices during the pandemic's acute phase.
Besides requiring only one dose, J&J's vaccine can be stored for at least three months at standard refrigerator temperatures, making it a good fit for poor and rural areas and developing countries that lack infrastructure for the ultracold storage some other COVID-19 vaccines require.
Interim results from a 44,000-volunteer late-stage testing found the Johnson & Johnson vaccine was 66 per cent effective at preventing moderate to severe cases of COVID-19 in Latin America and 57 per cent effective in South Africa, where a more-contagious variant is spreading. It was 72 per cent effective in the US.
Testing also indicated the vaccine was 85 per cent protective against the most serious symptoms — and starting 28 days after their shot, researchers found no one who got the vaccine needed hospitalization or died.
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