The World Health Organization (WHO) has issued an emergency use listing (EUL) for Nuvaxovid, following its assessment and approval by the European Medicines Agency (EMA) earlier today, Tuesday, December 21, 2021.
This is the 10th COVID-19 vaccine to be listed by the WHO for emergency use. 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 December 17, 2021.
According to the WHO, both vaccines are made using the same technologies, require two doses and are stable at 2 to 8 °C refrigerated temperatures.
WHO’s Strategic Advisory Group of Experts on Immunization has also issued policy recommendations for Nuvaxovid / Covovax, the WHO said in a statement.
The recommendations were based on the advice of independent experts, who have considered the best available evidence, a risk–benefit analysis and other factors, as appropriate.
The recommendations issued by the Strategic Advisory Group of Experts on Immunization included the use of medicinal products, its dosage, dose regimen, population or other use parameters that are not included in the approved labelling.
WHO does not take responsibility for procurement
The Advisory Group urged the relevant stakeholders to familiarize themselves with applicable national legal and ethical requirements. WHO does not accept any liability for the procurement, distribution or administration of any product for any use, the group said in the statement.
The guidance is based on the evidence summarized in the background document on the NVX-CoV2373 Nuvaxovid vaccine against COVID-19 developed by Novavax, and the annexes, which include GRADE and Evidence to Recommendations tables.
Per the guidelines issued, NVX-CoV2373 will be marketed as Nuvaxovid (Novavax) and COVOVAX (Serum Institute of India). These vaccines are considered fully equivalent, although they are produced at different manufacturing sites and assigned different product names, the WHO said.
WHO emergency use listing
The WHO explained that 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 WHO disclosed.
“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”.
WHO
As part of the EUL process, WHO further detailed that 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, the WHO stressed.
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