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The World Health Organization (WHO) said it approved on Thursday the COVID-19 vaccine candidate from US pharmaceutical company Pfizer-BioNTech for emergency use, and said the move opens the door for countries to accelerate their own approvals for import and inject.
Once a vaccine has been listed for emergency use by the WHO, the United Nations health agency said, “it engages its regional regulatory networks and partners to inform national health authorities about the vaccine and its anticipated benefits based on In clinical study data to date. “
The WHO review found that the vaccine met essential criteria for safety and efficacy established by the WHO, and that the benefits of using the vaccine to address COVID-19 outweigh the potential risks, the WHO said in a statement.
“This is a very positive step to ensure global access to COVID-19 vaccines. But I want to emphasize the need for an even greater global effort to achieve sufficient vaccine supply to meet the needs of priority populations everywhere, ”said Dr Mariangela Simao, WHO Deputy Director General for Access to Medicines and Health Products.
The WHO, together with the GAVI Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI), are spearheading a global effort called COVAX to distribute vaccines to low- and middle-income countries, to help ensure that vaccines do not go only to wealthy nations.
The COVAX alliance has said it has deals for nearly 2 billion doses, with the first deliveries expected in early 2021. The alliance has said it has been in talks with Pfizer and BioNTech to secure the vaccine.
The Pfizer and BioNTech messenger RNA vaccine was 95% effective in preventing disease symptoms after two doses 21 days apart. Delivery is challenging as it needs to be stored at minus 70 degrees Celsius.
The vaccine has been previously approved for emergency use in the United States and Great Britain, and has conditional marketing approval in Europe and Switzerland, among other countries, where distribution of concentrated injections to older people and healthcare workers began in December. .
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