J&J asks WHO for approval of its vaccine against COVID-19

Johnson & Johnson has applied to the World Health Organization for approval of its COVID-19 vaccine for emergency use, which should help accelerate its use in countries around the world.

J&J said Friday that its Janssen-Cilag International subsidiary has submitted the latest necessary data from clinical trials on the efficacy and safety of its vaccine to the WHO, completing the New Brunswick, NJ-based company’s request for endorsement. for emergency use.

The approval would speed up access to the J&J vaccine, which is a single dose, for United Nations procurement agencies and for dozens of countries. It is also required for Johnson & Johnson to supply doses of its vaccine to the COVAX Mechanism, a WHO-backed project to ensure equitable access to vaccines for some 190 low- and middle-income countries. In December, Johnson & Johnson agreed to provide up to 500 million doses of its vaccine to COVAX through 2022.

“If we want to end the pandemic, life-saving innovations such as vaccines must be available to all countries,” said Dr. Paul Stoffels, Johnson & Johnson’s chief scientific officer, in a statement.

The company will supply the vaccine at non-profit prices during the acute phase of the pandemic.

In addition to requiring a single dose, J&J vaccine can be stored for at least three months at normal refrigerator temperature, making it a good choice for poor and rural areas and for developing countries lacking infrastructure. for extremely cold storage required by other COVID-19 vaccines.

Interim results from an advanced phase trial with 44,000 volunteers revealed that the Johnson & Johnson vaccine was 66% effective in preventing moderate and severe COVID-19 cases in Latin America and 57% in South Africa, where it is spreading a more contagious variant. In the United States, the efficacy was 72%.

The tests also indicated that the vaccine was 85% protective against the most severe symptoms, and starting 28 days after the injection, the researchers found that no one who was vaccinated required hospitalization or died.