Johnson & Johnson has asked WHO for emergency approval of its COVID-19 vaccine

Johnson & Johnson on Friday asked the World Health Organization (WHO) to approve its COVID-19 vaccine for emergency use, which should help accelerate its use in countries around the world.

The company indicated that its pharmaceutical arm -Janssen-Cilag International- has sent the UN-dependent international agency the latest necessary data from clinical trials on the efficacy and safety of its inoculant, thus fulfilling all the necessary requirements. To get a positive response, it would become the third inoculant to be approved by the organization, which has also given the green light to those developed by Pfizer, AstraZeneca and Oxford.

Approval would speed up access to the vaccine, which requires a single dose, for UN procurement agencies and dozens of countries. Johnson & Johnson must also provide doses of its vaccine to the COVAX mechanism, a WHO-supported 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 are to end the pandemic, vital innovations such as vaccines must be available in all countries,” said Dr Paul Stoffels, Scientific Director of Johnson & Johnson, in a statement.

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

In addition to requiring a single dose, the 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 without infrastructure for extremely cold storage required by other COVID-19 vaccines.

Interim results of an advanced phase trial with 44,000 volunteers found 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 a more contagious variant is spreading. In the United States, the efficiency was 72%.

The tests also indicated that the vaccine provided 85% protection against the most severe symptoms, and from 28 days after injection, the researchers found that no one who had been vaccinated needed hospitalization or died. In addition, they indicated that the percentage against hospitalization or death was 100%.

“We are delighted to see that this vaccine has good efficacy against mild illnesses and exceptional efficacy against severe illnesses in all geographic regions studied.Added Dr. Dan Barouch of Beth Israel Deaconess Medical Center, who collaborated with Johnson & Johnson in the development of the trial.

At the end of January, the pharmaceutical company applied for emergency clearance in the United States. In this case, it would also be the third inoculant to start being supplied in the country, given that the Food and Drug Administration (FDA) has already approved those from Pfizer and Moderna. The company reported that could deliver 100 million doses to the United States by June if the FDA gives the green light to the trial.

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USA: Johnson & Johnson requested authorization for emergency use of its COVID-19 vaccine

Johnson & Johnson’s single-dose vaccine was effective in its Phase III studies, although slightly less than two-dose formulations