New Delhi (NVI): The World Health Organization (WHO) has approved the Johnson & Johnson’s single-dose COVID-19 vaccine for emergency use in all countries and for COVAX roll-out.
The decision comes after the authorisation from the European Medicines Agency (EMA), which was declared on Thursday.
According to an official statement, the World Health Organisation listed the COVID-19 vaccine Ad26.COV2.S, developed by Janssen (Johnson & Johnson), for emergency use in all countries.
“Every new, safe and effective tool against COVID-19 is another step closer to controlling the pandemic. But the hope offered by these tools will not materialize unless they are made available to all people in all countries,” WHO director-general Dr Tedros Adhanom Ghebreyesus said in a statement.
He added that, “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.”
The vaccine from J&J is the first to be listed by WHO as a single dose regimen, which should facilitate vaccination logistics in all countries.
WHO noted that the ample data from large clinical trials shared by the company also shows that the vaccine is effective in older populations.
The UN organization further said that its assessment also considered suitability requirements such as cold chain storage and risk management plans to be implemented in countries.
“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,” it added.
According to the WHO, 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 degrees Celsius and it has a long shelf life of two years.
WHO will convene its strategic advisory group on immunization experts next week to formulate recommendations on use of the vaccine.
It also continues to work with countries and COVAX partners to prepare for roll-out and safety monitoring, while COVAX facility has booked 5,00 million doses of the vaccine, the statement said.
Earlier, the UN organization also listed two-shot regimens of Pfizer/BioNTech and AstraZeneca for emergency use.