WHO authorises AstraZeneca’s COVID-19 vaccine for emergency useFebruary 16, 2021 0 By FM
AstraZeneca’s COVID-19 vaccine has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunisation to prevent COVID-19 in individuals 18 years of age and older, including those over 65.
The authorisation of the vaccine manufactured by AstraZeneca, and Covishiel44844d manufactured by Serum Institute of India (SII), enables global access to the vaccine during the pandemic.
The EUL allows for two doses of the vaccine to be administered at a four to 12-week interval. This regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.
The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) recommended a dosing interval of eight to 12 weeks. In addition, they also recommended use of the vaccine in countries where new variants, including the South African B1.351 variant, are prevalent.
AstraZeneca and SII will now work with the COVAX Facility to begin supplying the vaccine around the world, with the majority going to low and middle-income countries as quickly as possible.
COVID-19 Vaccines Global Access (COVAX), is a global initiative aimed at equitable access to COVID-19 vaccines led by the Global Alliance for Vaccines and Immunization, the World Health Organization, the Coalition for Epidemic Preparedness Innovations, and others.
In the first half of 2021, it is hoped that more than 300 million doses of the vaccine will be made available to 145 countries through COVAX, pending supply and operational challenges. These doses will be allocated equitably according to the COVAX allocation framework.
In June 2020, AstraZeneca had announced a sub-licencing agreement with the SII to manufacture and supply up to one billion doses of the vaccine to low and middle-income countries. The company was the first global pharmaceutical company to join COVAX in June 2020.
AstraZeneca’s COVID-19 vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.