WHO grants emergency use listing to Janssen vaccine

MANILA, Philippines — The World Health Organization (WHO) has issued an emergency use list (EUL) to the Janssen Pharmaceutical Company of Johnson & Johnson for its single-shot vaccine against COVID-19.

The EUL allows the emergency use of Janssen’s COVID-19 vaccine, Ad26.COV2.S, in all countries and for vaccination roll-out through the COVAX Facility.

“Every new, safe and effective tool against COVID-19 is another step closer to controlling the pandemic,” said WHO director general Tedros Adhanom Ghebreyesus in a statement.

But he noted that “the hope offered by these tools will not materialize unless they are made available to all people in all countries.”

“I urge governments and companies to live up to their commitments and to use all solutions at their disposal to ramp up production so that these tools become truly global public goods, available and affordable to all, and a shared solution to the global crisis,” he added.

The granting of EUL to Janssen comes on the back of the European Medicines Agency (EMA) authorization.

The vaccine from Janssen is the first to be listed by WHO as a single dose regimen, which should facilitate vaccination logistics in all countries.

According to WHO, the ample data from large clinical trials shared by the company also show that the vaccine is effective in older populations.

To expedite listing of the vaccine, WHO and a team of assessors from all regions adopted what is called an “abbreviated assessment” based on outcomes of the EMA review, and evaluation of quality, safety and efficacy data focused on low- and middle-income country needs.

The WHO assessment also considered suitability requirements such as cold chain storage and risk management plans to be implemented in countries.

“While the vaccine needs to be stored at -20 degrees, which may prove challenging in some environments, it can be kept for three months at 2-8°C and it has a long shelf life of two years,” a WHO statement showed.

Earlier, WHO had also listed the Pfizer/BioNTech, AstraZeneca-SK Bio and Serum Institute of India vaccines for emergency use.