WHO lists 9th COVID-19 vaccine for emergency use with aim to increase access to vaccination in lower-income countries
17 December 2021
Today, the World Health Organization issued an emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus. The vaccine, named CovovaxTM, is produced by the Serum Institute of India under licence from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries.
WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
“Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. ‘This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%.”
CovovaxTM was assessed under the WHO EUL procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India. The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally.
CovovaxTM is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). It requires two doses and is stable at 2 to 8 °C refrigerated temperatures. The vaccine uses a novel platform and is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.
The originator product produced by Novavax, named NuvaxovidTM, is currently under assessment by the European Medicines Agency (EMA). WHO will complete its own assessment of this vaccine once the EMA has issued its recommendation.
A meeting of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) this week also reviewed the vaccine. SAGE formulates specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women) and will issue recommendations for NuvaxovidTM/CovovaxTM in the coming days…
Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 16 December 2021
This extraordinary virtual meeting for the Strategic Advisory Group of Experts on Immunization (SAGE) will take place on Thursday 16 December 2021 to propose recommendations to WHO on the use of COVID-19 vaccine [Novavax].
:: Declaration of interest
:: Vaccine safety and efficacy data emerging on the Novavax COVID-19 vaccine clinical trials (phase 1-3 trial results)
::Evidence assessment: NVX-CoV2373 COVID-19 vaccine
Interim recommendations for heterologous COVID-19 vaccine schedules
16 December 2021 Departmental news
This interim guidance has been developed on the basis of the advice issued by the Strategic Advisory Group of Experts (SAGE) on Immunization at its meeting on 7 December 2021 (1)…
The guidance is based on the evidence outlined in this document, which was presented to SAGE on 7 December 2021.
All referenced documents are available on the SAGE COVID-19 webpage: https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/covid-19-materials
Dr Ayoade Alakija appointed WHO Special Envoy for the ACT-Accelerator
16 December 2021 News release
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, has appointed Dr. Ayoade Alakija as WHO Special Envoy for the Access to COVID-19 Tools Accelerator (ACT-Accelerator). Dr Alakija joins former Prime Minister of Sweden Carl Bildt, WHO’s current Special Envoy for ACT-A, in this role.
In her capacity as Special Envoy, Dr Alakija will help lead the collective advocacy for the ACT-Accelerator, mobilizing support and resources so it can deliver against its new Strategic Plan and Budget that was launched on 28 October 2021, and ensuring that the response is characterised by accountability, inclusion, and solidarity…
In the context of the COVID-19 pandemic, she has been a leading voice calling for the urgent reimagining of how the globe should respond more consciously to the COVID-19 pandemic. Dr Alakija is also the co-Chair of the African Union’s African Vaccine Delivery Alliance and founder of the Emergency Coordination Centre in Nigeria, building on her work with over 100 nations around the globe.
“Dr Alakija brings a tremendous track record in advocating for equitable access to vaccines, tests and treatments, especially for Africa,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “She joins us at a critical juncture in the fight against COVID-19, with the Omicron variant threatening to further constrain equitable access to vaccines, just as the pace of supply was improving. We are very much looking forward to working with her to advocate for the full financing of the ACT Accelerator, and to meeting the global targets for COVID-19 vaccination, testing and treatment.”…