ZURICH — The World Health Organization on Thursday listed Pfizer and BioNTech's COVID-19 vaccine for emergency use, in a move seeking to speed 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 established its emergency use listing (EUL) process to help poorer countries without their own regulatory resources quickly approve medicines new diseases like COVID-19, which otherwise could lead to delays.
The WHO'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 Mariangela Simao, the WHO's access to medicines program leader.
"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."
PHILIPPINES AND PFIZER
In late December, Health Secretary Francisco Duque III drew flak over claims he cost the Philippines quick access to Pfizer's COVID-19 vaccine.
Speaking to ANC's "Headstart," he said a confidential disclosure agreement (CDA) he signed with Pfizer had to go through reiterations to ensure the provisions were not "onerous and disadvantageous."
"There's no such thing that I did not act quick enough," he said. "As a physician, my overriding principle in practice of medicine is to err on the side of caution."
He also clarified that Pfizer never promised it would provide the Philippines 10 million doses of its vaccine upon signing the CDA, contrary to reports.
Several officials had said Duque "dropped the ball" in the country's immediate procurement of the Pfizer vaccine, now already in use in the United Kingdom and the United States.
The UN health agency, with the GAVI Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI), are spearheading a global effort called COVAX to secure and distribute vaccines to poorer countries, to ensure shots do not go only to wealthy nations.
The WHO-backed COVAX alliance has agreements for nearly 2 billion doses, with first deliveries due in early 2021. The alliance has been in talks with Pfizer and BioNTech to secure vaccine.
Even so, the Pfizer/BioNTech vaccine's challenging storage and delivery requirements, including keeping it at minus 70 degrees Celsius, have made deliveries challenging in western countries, and may pose bigger hurdles for developing nations without adequate infrastructure.
The vaccine has gotten regulatory backing from the United Kingdom, the European Medicines Agency, U.S. Food and Drug Administration, Health Canada, Bahrain, Israel, Kuwait, Mexico, Oman, Qatar, Saudi Arabia and Singapore.
Pfizer and BioNTech's messenger RNA vaccine was found to be 95% effective after two doses 21 days apart.