Recently, the World Health Organization (WHO) said that it has given Moderna COVID-19 vaccine (mRNA 1273) for use in emergency. Thus, together with the vaccine Pfizer / BioNtech, Astrazeneca-SK Bio, Serum Institute of India and Janssen, this is the 5th vaccine to receive an emergency certification from WHO, for use in emergencies. This also allows countries to expedite their own regulatory approval for the import and administration of COVID-19 vaccines.
The vaccine has been reviewed by the WHO Immunization Strategy Advisory Group (SAGE). This group gives recommendations for the use of the vaccine in the population (i.e. recommended age groups, interval between shots, advice for specific groups such as pregnant and lactating women). . SAGE has recommended this vaccine for all age groups 18 and older.
5 Covid-19 vaccines recognized by WHO in emergency situations
The U.S. Food and Drug Administration issued an emergency use license for Moderna vaccines on December 18, 2020, and a valid marketing license across the European Union has been issued by the Drug Administration. Europe issued on January 6, 2021.
The WHO emergency use process can be implemented quickly as vaccine developers submit all the data required by WHO in a timely manner. Once those data are submitted, WHO can quickly bring together its assessment team and regulatory agencies from around the world to assess information and, when necessary, conduct site inspections. manufacturing.
The process of listing emergency use, assessing the suitability of new medical products in public health emergencies. The goal is to deliver drugs, vaccines, and diagnostics as quickly as possible to address the emergency, while at the same time complying with stringent safety, efficacy and quality criteria; assessment takes into account the threat posed by the emergency as well as the cumulative benefit from using the product against any potential risks.
The emergency use roadmap involves rigorous evaluation of final stage II and phase III clinical trial data, as well as significant additional data on safety, efficacy, quality, and management plan. risk management. These data are reviewed by independent experts and WHO teams who review current evidence on the vaccine, a vaccine use monitoring plan, and a plan for follow-up studies.
As part of the EUL process, the vaccine company must commit to continuing to generate data for full licensing and WHO prequalifies the vaccine. WHO prequalification process will evaluate additional clinical data generated from vaccine trials and deploy on a rotational basis to ensure the vaccine meets the necessary standards of quality and safety. and efficient for wider availability.
Bao Linh (t / h)