The World Health Organization (WHO) approved Pfizer and BioNTech’s coronavirus vaccine for emergency use on Thursday.
The vaccine, which goes by the name Comirnaty, is the first coronavirus vaccine to be approved by the agency and added to its Emergency Use Listing (EUL), according to the announcement.
WHO’s emergency use authorization follows the vaccine’s approval by the U.S. FDA on Dec. 11 and the European Commission on Dec. 21.
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By adding the vaccine to the WHO’s Emergency Use Listing, the agency made it easier for countries to “expedite their own regulatory approval processes to import and administer the vaccine,” the announcement said.
The EUL also allows UNICEF and the Pan-American Health Organization to obtain and distribute the vaccine to countries in need.
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In Thursday’s announcement, Dr. Mariângela Simão, WHO’s Assistant-Director General for Access to Medicines and Health Products, underlined the need for worldwide access to the vaccine.
“This is a very positive step towards ensuring global access to COVID-19 vaccines,” Simão said. “But I want to emphasize the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere.”
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“WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards,” Simão added. “We encourage even more developers to come forward for review and assessment. It’s vitally important that we secure the critical supply needed to serve all countries around the world and stem the pandemic.”
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WHO did not specify what role, if any, the vaccine’s approval might play in its COVAX strategy, which is aimed at providing access to COVID-19 vaccines in developing countries. However, the agency did say that the vaccine is under policy review.
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WHO’s Strategic Advisory Group of Experts on Immunization will be formulating “vaccine specific policies and recommendations” for the Pfizer and BioNTech vaccine in the new year, according to the announcement.
The agency will also be helping countries that don’t have ready access to ultra-cold chain equipment, since the vaccine must be stored at -60°C to -90°C degrees.