Geneva, 12 March, 2021 – The decision comes on the back of the European Medicines Agency (EMA) authorization, which was announced yesterday.
“Every new, safe and effective tool against COVID-19 is another step closer to controlling the pandemic,” said WHO Director-General, Dr Tedros Adhanom Ghebreyesus. “But 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.”
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. The ample data from large clinical trials shared by the company also shows 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.
WHO will convene its Strategic Advisory Group on Immunization Experts next week to formulate recommendations on use of the vaccine. In the meantime, WHO continues to work with countries and COVAX partners to prepare for roll-out and safety monitoring. The COVAX Facility has booked 500 million doses of the vaccine.
WHO emergency use listing
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.
As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.
WHO has also listed the Pfizer/BioNTech, Astrazeneca-SK Bio and Serum Institute of India vaccines for emergency use.
