WHO lists the 10th Covid-19 vaccine for emergency use

The World Health Organization issued an emergency use listing (EUL) for Nuvaxovid, following its assessment and approval by the European Medicines Agency (EMA) earlier today.

 

The new vaccine was developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI), and is the originator product for the Covovax vaccine that received WHO emergency use listing on 17 December.

 

On December 17, WHO approved the emergency use of the drug Covovax, which is produced in India under the license of the American company Novavax. 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.

 

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.