The emergency use listing comes a day after the European Medicines Agency recommended the one-dose shot approved across the 27-country European Union.
The World Health Organization granted an emergency use listing Friday for the coronavirus vaccine made by Johnson & Johnson, meaning the one-dose shot can now theoretically be used as part of the international COVAX effort to distribute vaccines globally, including to poor countries without any supplies.
In a statement, the U.N. health agency said “the ample data from large clinical trials” shows the J&J vaccine is effective in adult populations. The emergency use listing comes a day after the European Medicines Agency recommended the shot be given the green light across the 27-country European Union.
“As new vaccines become available, we must ensure they become part of the global solution and not another reason some countries and people are left further behind,” WHO director-general Tedros Adhanom Ghebreyesus said at a Friday press briefing. WHO has previously signed off on COVID-19 vaccines developed by Pfizer-BioNTech and AstraZeneca.
A massive study that spanned three continents found the J&J vaccine was 85% effective in protecting against severe illness, hospitalizations and death.
That protection remained strong even in countries like South Africa where variants have been identified that appear to be less susceptible to other licensed vaccines, including the one made by AstraZeneca.
The U.N. backed COVAX effort previously announced it had an initial agreement with J&J to provide 500 million doses, but that is not legally binding.
Dr. Bruce Aylward, a WHO senior adviser to Tedros, said he hoped J&J might be able to provide at least some of those doses in the coming months.
“We're hoping by at least July that we have access to doses that we can be rolling out, if not even earlier,” Aylward said. He added that officials were particularly keen to get J&J doses to countries because it requires only one dose and can be stored at regular refrigerator temperatures.
J&J has faced production delays in the U.S. and Europe but has recently signed agreements with rival pharmaceuticals who will help make their vaccine.
In February, Sanofi Pasteur said it would be able to make about 12 million doses of the J&J vaccine at one of its French production sites once the shot is cleared by the EMA. It is aiming to make 1 billion doses this year.