03.15.21

J&J’s Coronavirus Vaccine Garners WHO Emergency-Use Listing

Source: Johnson & Johnson

Johnson & Johnson said that the World Health Organization (WHO) has issued an emergency-use listing for its single-dose coronavirus vaccine Ad26.COV2.S to prevent COVID-19 in people 18 years and older. Chief scientific officer Paul Stoffels stated that “achieving this important prerequisite for distributing our vaccine through the [WHO co-led] COVAX facility…is a major step forward in making our vaccine accessible for all.”

The WHO listing comes on the heels of a conditional marketing authorisation for Ad26.COV2.S in the EU, as well as an emergency-use authorization granted by the FDA late last month. Johnson & Johnson said it shared clinical data with the WHO demonstrating a 67% reduction in symptomatic COVID-19 disease among vaccine recipients, and that the inoculation was 85% effective at preventing severe disease across countries with different variants, including the highly transmissible B.1.3.5 strain.

In addition, Mathai Mammen, global head of Janssen R&D at Johnson & Johnson, noted that “a single-shot COVID-19 vaccine that can be distributed and stored using established supply chains has the potential to be very meaningful in the face of this global pandemic.” The company’s vaccine is estimated to remain stable for two years at -25°C to -15°C, and a maximum of three months of which can be at routine refrigeration at temperatures of 2°C to 8°C, allowing it to be shipped via “the same cold-chain technologies used to transport other medicines and vaccines in routine use,” the company said.

In December, Johnson & Johnson entered into an agreement in principle with Gavi, the Vaccine Alliance, to support the COVAX facility by providing up to 500 million doses of Ad26.COV2.S to the global distribution scheme through 2022. The WHO said it will convene its Strategic Advisory Group on Immunization Experts next week to formulate recommendations on use of the vaccine.

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