22 March 2021
The Janssen COVID-19 Vaccine is the first single-dose vaccine regimen to ever be granted WHO emergency use listing and is now eligible for distribution via COVAX.
The World Health Organization (WHO) has listed the Janssen COVID-19 Vaccine (known as Ad26.COV2-S during development) for emergency use in all countries and for COVAX roll-out.
The decision follows the European Medicines Agency (EMA)’s committee for human medicinal products recommending the vaccine for conditional marketing authorisation in the EU to prevent COVID-19 in individuals 18 years of age and older.
Janssen’s vaccine is the first single dose regimen to be emergency use listed (EUL) by WHO, which should expedite vaccination in all countries.
The EUL process was expedited by the WHO and a team of assessors adopting a ‘abbreviated assessment’ based on outcomes of the EMA review and an 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°C, which may prove challenging in some environments, it can be kept for three months at 2-8°C and it has a 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. Meanwhile, the organisation will work with countries and COVAX partners to prepare for roll-out and safety monitoring. The COVAX Facility has so far procured 500 million doses of the Janssen COVID-19 Vaccine.
The EUL process assesses the suitability of novel health products during public health emergencies, weighing 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 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 Comirnaty® and COVID-19 Vaccine AstraZeneca vaccines (one produced by Astrazeneca and SK Bio, the other by the Serum Institute of India) for emergency use.Print
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