J&J Files for WHO Emergency Use Listing of Its COVID-19 Vaccine
Johnson & Johnson (J&J) has filed with the World Health Organization (WHO) for an Emergency Use Listing (EUL) for its COVID-19 vaccine — a listing that would clear the way for the vaccine to be distributed through the WHO’s COVAX vaccine-sharing program.
J&J reached an agreement in December with Gavi, the Vaccine Alliance, a co-leader of COVAX, to provide up to 500 million vaccine doses through 2022.
To support the EUL filing, J&J submitted data from an ongoing global phase 3 trial, in which the vaccine showed 66 percent efficacy in preventing moderate-to-severe infection 28 days after inoculation (DID, Feb. 1). The one-dose vaccine also demonstrated 85 percent efficacy in preventing severe disease and provided full protection against COVID-19-related hospitalization and death, including against the variant strain first identified in South Africa.
The WHO has already granted EULs for the AstraZeneca/Oxford University and Pfizer/BioNTech vaccines, but the J&J vaccine has significant advantages as it requires just a single dose and can be stored at normal refrigeration temperatures.
J&J has also applied for conditional marketing authorization from the European Medicines Agency (EMA) and for FDA Emergency Use Authorization (EUA). The EMA is expected to make a decision by mid-March (DID, Feb. 17), while the FDA’s vaccines advisory committee will consider the EUA in a Feb. 26 meeting (DID, Feb. 5). ― Jason Scott