WHO Approves Pfizer/BioNTech COVID-19 Vaccine For Emergency Use

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.”

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.