WHO lists 9th COVID-19 vaccine for emergency use with aim to increase access to vaccination in lower-income countries
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.
WHO emergency use listing
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 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.
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.
Source: World Health Organization Website