Today WHO listed The modern COVID-19 vaccine (mRNA 1273) for emergency use, making it the fifth vaccine to be urgently validated by the WHO.
The WHO Emergency List (EUL) assesses the quality, safety and efficacy of COVID-19 and is a prerequisite for the supply of COVAX Facility vaccines. It also allows countries to speed up their own regulatory approvals for the import and administration of COVID-19 vaccines.
The vaccine has already been reviewed by the World Strategic Advisory Group of Immunization Experts (SAGE), which makes recommendations for vaccine use in populations (i.e., recommended age groups, injection intervals, advice for specific groups such as pregnant and lactating women). SAGE recommended the vaccine for all age groups of 18 years in its interim recommendations of January 25, 2021
The US Food and Drug Administration issued an emergency marketing authorization for Moderna on December 18, 2020, and the European Medicines Agency The European Medicines Agency issued a marketing authorization valid throughout the European Union.
The WHO SAD procedure can be carried out quickly when vaccine manufacturers provide all the information required by the WHO in a timely manner. Once this data is submitted, the WHO can quickly assemble its assessment team and regulators from around the world to assess the information and, if necessary, inspect production sites.
Vaccine Modern is a vaccine based on mNRA. SAGE found that the efficacy was 94.1%, based on a median follow-up of two months. Although the vaccine is given as a frozen suspension at -25 ºC to -15 ºC in a multi-dose vial, the vials can be refrigerated at 2–8 ° C for up to 30 days before the first dose is withdrawn, which means that ultra-cold chain equipment may not always be needed to set up the vaccine.
WHO list for emergency use
The emergency use inventory process assesses the suitability of new health products during public health emergencies. The goal is to make drugs, vaccines, and diagnostics available as quickly as possible to address an emergency, adhering to strict criteria of safety, efficacy, and quality. The assessment weighs the threat posed by the necessity as well as the benefit that would result from using the product in relation to the potential risks.
The SAD pathway includes a rigorous assessment of data from late phase II and III clinical trials, as well as significant additional data on safety, efficacy, quality and risk management plan. These data are reviewed by independent WHO experts and teams that take into account the current amount of evidence of the vaccine under consideration, monitoring plans for its use, and plans for further studies.
As part of the SAD process, the vaccine company must commit to continue collecting data to allow full licensing and pre-qualification of the WHO for the vaccine. The WHO prequalification process will assess additional clinical data obtained through testing and application of the vaccine on an ongoing basis to ensure that the vaccine meets the required quality, safety and efficacy standards for wider availability.
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