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March 13, 2021

WHO adds Johnson & Johnson's Janssen vaccine to the list of safe and effective emergency tools against COVID−19.

Johnson & Johnson

Who, Vaccine

Geneva, March 12, 2021 - The World Health Organization (WHO) today listed the COVID-19 vaccine Ad26.COV2.S, developed by Janssen (Johnson & Johnson), for emergency use in all countries and COVAX roll-out. The decision comes on the back of the European Medicines Agency (EMA) authorization, 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, facilitating vaccination logistics in all countries. The company’s comprehensive data from large clinical trials shows that the vaccine is effective in those 18 years of age and older.

To expedite the vaccine’s listing, WHO and a team of assessors from all regions adopted an ‘abbreviated assessment’ based on outcomes of the EMA review and evaluation of quality, safety, and efficacy data focused on low- and the middle-income country needs. The WHO assessment also considered suitability requirements such as cold chain storage and risk management plans.

While the vaccine needs storage at -20 degrees, which may prove challenging in some environments, we can keep it for three months at 2-8°C, and it has a long shelf life of two years.

Next week, WHO will convene its Strategic Advisory Group on Immunization Experts to formulate recommendations on using 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 novel health products’ suitability during public health emergencies. The objective is to make medicines, vaccines, and diagnostics available as rapidly as possible to address the crisis while adhering to stringent criteria of safety, efficacy, and quality. The assessment weighs the threat posed by the emergency and the benefit that would accrue from using the product against any potential risks.

The EUL pathway involves a rigorous assessment of late phase-II and phase-III clinical trial data and substantial additional data on safety, efficacy, quality, and a risk management plan. Independent experts and WHO teams review this data, consider the current body of evidence on the vaccine under consideration, monitor its use, and plan further studies.

As part of the EUL process, the company producing the vaccine must generate data to enable full licensure and WHO prequalification. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the immunization 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.

Source: WHO

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Edited & Posted by the Editor | 6:34 AM | Link to this Post

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