The World Health Organization (WHO) issued an emergency use listing (EUL) for NVX-CoV2373 on Friday, bringing the total number of WHO-validated vaccines against the SARS-CoV-2 virus to seven.
The vaccine, known as CovovaxTM, is manufactured by the Serum Institute of India under license from Novavax as part of the COVAX facility portfolio, providing a much-needed boost to ongoing efforts to vaccinate more people in low-income countries.
The EUL procedure, developed by the World Health Organization, evaluates the quality, safety, and efficacy of COVID-19 vaccines and is a requirement for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval for COVID-19 vaccine import and administration.
“Vaccines remain one of the most effective tools for protecting people against serious illness and death from SARS-COV-2, even as new variants emerge,” said WHO Assistant-Director General for Access to Medicines and Health Products, Dr. Mariângela Simo. ‘This listing aims to increase access, particularly in low-income countries, where 41 countries have yet to vaccinate 10% of their populations, and 98 countries have yet to reach 40%.”
CovovaxTM was evaluated under the WHO EUL procedure, which included a review of the quality, safety, and efficacy data, a risk management plan, programmatic suitability, and inspections of manufacturing sites by the Drugs Controller General of India.
The WHO-convened Technical Advisory Group for Emergency Use Listing (TAG-EUL), made up of experts from around the world, has determined that the vaccine meets WHO standards for COVID-19 protection, that the vaccine’s benefits far outweigh any risks, and that the vaccine can be used globally.
Novavax and the Coalition for Epidemic Preparedness Innovations developed CovovaxTM, a component of the vaccine (CEPI). It is stable at 2 to 8 °C refrigerated temperatures and requires two doses. The vaccine is made using a novel platform in which an engineered baculovirus with a gene for a modified SARS-CoV-2 spike protein is created.
The European Medicines Agency is currently reviewing Novavax’s NuvaxovidTM, the company’s original product (EMA). Once the EMA has issued its recommendation, the WHO will complete its own evaluation of the vaccine.
The vaccine was also discussed at a meeting of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) this week. SAGE develops specific policies and recommendations for the use of vaccines in populations (e.g., recommended age groups, dose intervals, and specific groups such as pregnant and lactating women), and will issue recommendations for NuvaxovidTM/CovovaxTM in the coming days.
The World Health Organization has a list of emergency uses.
The emergency use listing (EUL) procedure determines whether new health products are suitable for use in public health emergencies. The goal is to make medicines, vaccines, and diagnostics available as quickly as possible to respond to emergencies while adhering to strict safety, efficacy, and quality criteria.
According to the WHO, the assessment considers the emergency’s threat as well as the benefit that would result from using the product, as well as any potential risks.
The EUL pathway entails a thorough review of late-stage phase II and phases III clinical trial data, as well as significant additional data on safety, efficacy, quality, and a risk management strategy.
These data are examined by independent experts and WHO teams, who take into account the current body of evidence on the vaccine in question, as well as plans for monitoring its use and future research.
As part of the EUL process, the vaccine manufacturer must commit to continuing to generate data in order for the vaccine to receive full licensure and WHO prequalification.
Additional clinical data generated from vaccine trials and deployment will be assessed on a rolling basis by the WHO prequalification process to ensure the vaccine meets the necessary quality, safety, and efficacy standards for broader availability.