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The World Health Organization (WHO) today listed two versions of the AstraZeneca / Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be deployed globally via COVAX. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
The WHO Emergency Use List (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for the vaccine supply to the COVAX center. It also allows countries to speed up their own regulatory approval to import and administer COVID-19 vaccines.
“Countries without access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, thus contributing to the COVAX Centre’s objective of equitable distribution of vaccines,” said Dr Mariângela Simão , WHO Assistant Director-General for Access to Medicines and Health Products.
“But we must keep up the pressure to meet the needs of priority populations everywhere and facilitate global access. To do this, we need two things: increased manufacturing capacity and prompt submission by developers of their vaccines for WHO review. ”
The WHO EUL process can be implemented quickly when vaccine developers submit complete data required by WHO in a timely manner. Once this data is submitted, WHO can quickly bring together its assessment team and regulatory bodies from around the world to assess the information and, if necessary, carry out inspections of manufacturing sites.
In the case of the two AstraZeneca / Oxford vaccines, WHO assessed the data for quality, safety and efficacy, risk management plans and the adequacy of programs, such as cold chain requirements. The process took less than four weeks.
The vaccine was reviewed on February 8 by the WHO Strategic Advisory Group of Experts on Immunization (SAGE), which makes recommendations for the use of vaccines in populations (i.e. groups recommended age, intervals between injections, advice for specific groups such as pregnant and lactating women). SAGE has recommended the vaccine for all age groups 18 years and older.
The AstraZeneca / Oxford product is a viral vector vaccine called ChAdOx1-S [recombinant]. It is produced at several manufacturing sites, as well as in the Republic of Korea and India. ChAdOx1-S has been shown to have 63.09% efficiency and is suitable for low and middle income countries due to easy storage requirements.
WHO Emergency Use List
The Emergency Use List (EUL) procedure assesses the suitability of new health products during public health emergencies. The aim is to make drugs, vaccines and diagnostics available as quickly as possible to deal with the emergency, while respecting strict criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefits that would result from the use of the product against the potential risks.
The EUL journey involves a rigorous evaluation of data from late phase II and phase III clinical trials, 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 review the current body of evidence on the vaccine under consideration, plans for monitoring its use, and plans for further studies.
As part of the EUL process, the company that produces the vaccine must commit to continuing to generate data to enable full approval and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated by vaccine trials and deployment on an ongoing basis to ensure that the vaccine meets the necessary standards of quality, safety and efficacy for greater availability. .
WHO also listed the Pfizer / BioNTech vaccine for emergency use on December 31, 2020.
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