AstraZeneca’s coronavirus vaccine was granted Emergency Use Listing by the World Health Organization in individuals 18 years of age and older, including those over 65.
The AstraZeneca vaccine is still going through trials in the U.S., with results possibly going to the Food and Drug Administration this spring. It has been approved in the UK, Mexico, and Australia.
The US has agreed to buy 300 million doses of the AstraZeneca vaccine.
AstraZeneca’s vaccine can be stored, transported, and handled at normal refrigerated conditions (36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
Current vaccines from Moderna and Pfizer require a freezer and, in Pfizer’s case, an ultra-cold freezer. Doses, once thawed, have to be used within hours.
The storage capability is key to vaccinating populations in less wealthy countries.
The authorization of Covid-19 Vaccine AstraZeneca manufactured by AstraZeneca and Covishield manufactured by Serum Institute of India clears global access to the vaccine.
The OK allows for two doses of the vaccine to be administered at four to 12-week intervals.
The regimen was shown in clinical trials to be safe and effective in preventing symptomatic Covid-19, with no severe cases and no hospitalizations more than 14 days after the second dose.
The WHO’s Strategic Advisory Group of Experts on Immunization recommended a dosing interval of eight to 12 weeks. They also recommended using the vaccine in countries where new variants, including the South African B1.351 variant, are prevalent.
South Africa had earlier pulled back on the AstraZeneca vaccine, citing indications that it might not be effective against the variant.
AstraZeneca and SII will now work with the Covax Facility to begin supplying the vaccine worldwide, with the majority going to low and middle-income countries as quickly as possible.
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. These doses will be allocated equitably according to the COVAX Allocation Framework.
Pascal Soriot, the AZ CEO, said: “Today’s approval endorses that the vaccine can be used to help protect populations across the world, including adults over 65 years and in countries where different variants of the SARS-CoV-2 virus are in circulation. This is a huge step towards ensuring global access to our vaccine and helping us fulfill our public health commitment to broad and equitable access at no profit during the pandemic.”
AstraZeneca has committed to making its Covid-19 vaccine available to as many countries as possible and at no profit during the pandemic period. In June 2020, the company announced a sub-licensing 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. This international mechanism is working to accelerate the development, production, and equitable access to new Covid-19 tools worldwide for all participating countries, regardless of income level.
Covid-19 Vaccine AstraZeneca was co-invented by the University of Oxford and its spin-out company, Vaccitech.
The WHO approval was based on pooled analysis for efficacy from 11,636 participants aged 18 years and older in the UK and Brazil.
Overall safety was based on an interim analysis of pooled data from four clinical trials conducted in the UK, Brazil, and South Africa, including 23,745 participants aged 18 years or older. Covid-19 Vaccine AstraZeneca was well tolerated, and there were no serious safety events confirmed related to the vaccine. The participants were from diverse ethnic and geographic groups who were healthy or had stable underlying medical conditions.
In addition to the program led by Oxford University, AstraZeneca is conducting a large trial in the US and globally. In total, Oxford University and AstraZeneca expect to enroll up to 60,000 participants globally.
AstraZeneca’s COVID-19 vaccine has already been granted a conditional marketing authorization or emergency use in more than 50 countries. The WHO EUL now accelerates the pathway to access in up to 145 countries through Covax.
AstraZeneca employs about 1,500 in Delaware.