ZURICH • The World Health Organisation (WHO) has listed Pfizer-BioNTech's coronavirus vaccine for emergency use, in a move seeking to speed up access in the developing world.
The United Nations health agency said it will work with regional partners to tell national health authorities about the two-dose shot and its anticipated benefits.
The WHO's emergency use listing process aims to help poorer countries without their own regulatory resources to quickly approve medicines for new diseases such as Covid-19.
The agency's review found Pfizer-BioNTech's vaccine met the must-have criteria for safety and efficacy benefits outweigh its risks.
"This is a very positive step towards ensuring global access to Covid-19 vaccines," said Dr Mariangela Simao, the leader of WHO's access to medicines programme. "But I want to emphasise the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere."
The UN health agency - with the Gavi Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations - is leading a global effort called Covax to secure and distribute vaccines to poorer countries, to ensure that shots do not go only to wealthy nations. Covax has agreements for nearly two billion doses, with first deliveries due early this year. The alliance has been in talks with Pfizer-BioNTech to secure its vaccine.
Even so, the Pfizer-BioNTech vaccine's storage and delivery requirements, including keeping it at a temperature of minus 70 deg C, have made deliveries challenging in Western countries, and may pose bigger hurdles for developing nations without adequate infrastructure.
The vaccine has received regulatory backing from Britain, the European Medicines Agency, the US Food and Drug Administration, as well as health authorities in Canada, Bahrain, Israel, Kuwait, Mexico, Oman, Qatar, Saudi Arabia and Singapore.
Pfizer-BioNTech's messenger RNA vaccine has been found to be 95 per cent effective after two doses 21 days apart.