The World Health Organization approved Johnson & Johnson’s Janssen COVID-19 vaccine for emergency use on Friday, adding a fourth shot to the international arsenal of medicines, vaccines and diagnostics against the year-long pandemic.
The emergency use listing, which is not meant to replace the approval process of national regulators, helps expedite regulatory approval processes and enables international organizations to distribute vaccine in places where it is most needed.
The U.N. health agency’s first such listing since the pandemic began was on December 31 for Pfizer-BioNTech’s two-shot coronavirus vaccine Comirnaty®. Then on February 15 it listed two more two-shot vaccines for emergency use, both from AstraZeneca, as a further step towards broadening access to vaccines globally.
The J&J listing, the first for a one-shot coronavirus vaccine, enables it to be used as part of the COVAX Facility’s vaccines distributed to low-income and developing countries. COVAX, which is co-led by WHO, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations, is part of the Access to Covid-19 Tools (ACT) Accelerator, a global collaboration among 10 international organizations to provide coronavirus tests, medicines and vaccines worldwide.
The emergency use listing procedure assesses the suitability of novel health products during public health emergencies – to make 💊,💉 & 🧪 available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy & quality. pic.twitter.com/bYaCU5l4rx
— World Health Organization (WHO) (@WHO) March 12, 2021
Need for ‘global public goods’
WHO said it found the J&J vaccine is effective among adults based on “ample data from large clinical trials shared by the company.” Its decision came a day after the European Medicines Agency authorized the use of the vaccine for the 27-nation European Union and a month after the U.S. Food and Drug Administration approved it for the United States.
The vaccine has been found to be 85 percent effective against severe illness, hospitalization and death from COVID-19 infections. “Every new, safe and effective tool against COVID-19 is another step closer to controlling the pandemic,” WHO Director-General Tedros Adhanom Ghebreyesus said in a statement.
“But the hope offered by these tools will not materialize unless they are made available to all people in all countries,” he said. “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.”
WHO said that the use of the first approved one-shot coronavirus vaccine will likely facilitate the logistics of vaccinating people around the world. It has to be stored at extremely low temperatures, but can be kept for three months at temperatures slightly above freezing and has a two-year shelf life.